An Open Trial of an AcceptanceGeneralized Anx

Lizabeth Roemer, University oSusan M. Orsillo, S

Borkovec, Newman, Lytle, & Pincus, 2002; Ladou-

Behavior Therapy 38 (2ceur et al., 2000, for recent randomized controlledtrials), it remains the least successfully treated of theanxiety disorders (Brown, Barlow, & Liebowitz,1994; Roemer, Orsillo, & Barlow, 2002). Despitethe apparent efficacy of cognitive-behavioralapproaches, none have yielded high end-statefunctioning (i.e., clients returning to normativelevels on key outcome measures) for a largeproportion of the treated sample. Ladouceur et al.

This study was supported by NIMH Grant MH63208. Theauthors thank Dave Barlow and the staff at the Center for Anxietyand Related Disorders for their support of this research. We alsothank Tom Borkovec and Steve Hayes for their helpful consulta-tions. We thank our therapists, Laura Allen, Kristi Salters-Pedneault, Jenn Block Lerner, LaTanya Rucker, Laura Campbell-Sills, Sue Raffa, and David Moscovitch, as well as our clients, forsharing their experience and their wisdom with us. Finally, we alsoResearch suggests that experiential avoidance may play animportant role in generalized anxiety disorder (GAD; see ,

Roemer, L., & Orsillo, S.M. (2002). Expanding ourconceptualization of and treatment for generalized anxietydisorder: Integrating mindfulness/acceptance-basedapproaches with existing cognitive-behavioral models.Clinical Psychology: Science and Practice, 9, 5468, for areview). Therefore, a treatment that emphasizes experientialacceptance, as well as intentional action, may lead to bothreduced symptomatology and improved quality of life andfunctioning for individuals with this chronic disorder. In anopen trial of a newly developed acceptance-based behaviortherapy for GAD, 16 treated clients demonstrated signifi-cant reductions in clinician-rated severity of GAD andreports of anxiety and depressive symptoms and fear andavoidance of their internal experience, as well as significantimprovements in reports of quality of life, at bothposttreatment and 3-month follow-up. Directions for futuretreatment development and research are discussed.thank Laura Allen for her exceptional management of the projectand Matt Tull and Shannon Erisman for their invaluable assistancewith data management.

Address correspondence to Lizabeth Roemer, University ofMassachusettsBoston, Department of Psychology, 100 MorrisseyBlvd.,Dorchester,MA02125,USA; e-mail: lizabeth.roemer@umb.edu.0005-7894/06/072085/$1.00/0 2006 Association for Behavioral and Cognitive Therapies. Published byElsevier Ltd. All rights reserved.-Based Behavior Therapy foriety Disorder

f Massachussetts - Boston

uffolk University

GENERALIZED ANXIETY DISORDER (GAD) is adisorder characterized by chronic, pervasive,uncontrollable worry (as well as associated somaticcomplaints; American Psychiatric Association,1994) for which we have yet to develop sufficientlysuccessful interventions. GAD has a lifetime pre-valence estimate of 5.7% (Kessler et al., 2005). Inaddition, GAD is associated with high rates ofcomorbidity (Brown, Campbell, Lehman, Grisham,& Mancill, 2001) and has been linked to impairedwell-being and life satisfaction beyond its associa-tion with major depression (Stein & Heimberg,2004), as well as with impaired quality of life,beyond that accounted for by comorbid diagnoses,among older adults (Wetherell et al., 2004). Recentstudies in primary care settings have consistentlyfound that GAD is associated with impairment inmultiple domains (see Kessler, Walters, &Wittchen,2004, for a review).Although efficacious cognitive-behavioral inter-

ventions have been developed for GAD (seeBorkovec & Ruscio, 2001, for a review; see

www.elsevier.com/locate/bt007) 7285(2000) and Borkovec and Costello (1993) eachfound that 58% of those clients receiving CBTdemonstrated high end-state functioning at 12-month follow-up, whereas Borkovec and colleagues(2002) reported somewhat lower proportions ofclients who met criteria for high end-state function-ing (e.g., 43% in their CBT condition at 12-month

follow-up), despite a longer duration of treatment.In addition, these studies have not examinedthe impact of treatment on quality of life andfunctioning. Thus, more efficacious treatmentsare needed, and investigations are needed to assessthe impact of these treatments on psychosocialimpairment.These concerns have led to the development of

73acceptance - ba s ed behav ior therapy for gadnew treatments that expand cognitive behavioralapproaches to better target the function of worryand the nature of GAD. Borkovec and colleagues(e.g., Newman, Castonguay, Borkovec, & Molnar,2004) have focused on interpersonal and experi-ential aspects of GAD; Ladouceur and Dugas (e.g.,Ladouceur et al., 2000) have targeted intolerance ofuncertainty; Mennin and colleagues (e.g., Mennin,2004) are developing a treatment that targetsemotion regulation difficulties; and Wells (1995)has targeted meta-worry (or worry and othernegative responses to ones worry). Of these ap-proaches, only Ladouceur et al. (2000) and Dugaset al. (2003) have thus far published data support-ing the efficacy of their treatment (in comparison toa waitlist control condition). Our own work hasfocused on developing a treatment for GAD thatspecifically targets the experiential and behavioralavoidance that characterizes this disorder, in orderto both improve quality of life and reducesymptoms of GAD.1 This approach arose fromthe convergence of accumulated knowledge frombasic research and theories of GAD with newdevelopments in the treatment literature that high-light the potential efficacy of integrating mind-fulness/acceptance elements (e.g., promotingpresent-moment focus and nonjudgmentalresponses to ones internal experience) and tradi-tional cognitive-behavioral techniques. Below weprovide a brief review of how an empirically basedconceptualization of GAD informed the develop-ment of an acceptance-based behavior therapy totreat this chronic anxiety disorder. Our treatmentdraws heavily from Borkovecs cognitive beha-vioral therapy for GAD and Hayes and colleaguesAcceptance and Commitment Therapy (ACT;Hayes, Strosahl, & Wilson, 1999), as well as fromSegal and colleaguesMindfulness-Based CognitiveTherapy (MBCT; Segal, Williams, & Teasdale,

1 A discussion of similarities and differences between theseapproaches to treating GAD is beyond the scope of this manuscript.Acceptance-based behavior therapy explicitly focuses on the role ofexperiential avoidance in symptoms of GAD and directly targetsexperiential avoidance, in part by incorporating mindfulnesspractice into treatment. Other approaches may similarly targetexperiential avoidance, but it is not done in the same explicitmanner.2002) and Linehans Dialectical Behavior Therapy(DBT; Linehan, 1993a, 1993b).GAD is centrally defined by chronic worry, which

is repeated verbal-linguistic activity focused onpotentially negative events in the future (e.g.,Borkovec, 2002). Information-processing studiesindicate that GAD is associated with habitual,narrowed attention to potential, typically future-oriented threat (see MacLeod & Rutherford, 2004,for a review). Thus, training in the skill of mind-fulness (i.e., paying attention, on purpose, in thepresent moment in a nonevaluative and expandedway to both internal and external sensations;Kabat-Zinn, 1990; Segal et al., 2002) may help tobreak this habitual anxious cycle of worry.Empirical support for Borkovecs avoidance

theory of worry (Borkovec, Alcaine, & Behar,2004) also provides evidence for the promise ofan acceptance-based approach to treatment.Extensive research over the past 15 years hasdemonstrated that worry is associated, paradoxi-cally, with decreased subsequent physiologicalreactivity to distressing stimuli, suggesting thatworry may serve an avoidant function. Forinstance, participants who worried prior toimagining giving a speech showed less heart-rateresponse to the speech imagery than those whoengaged in neutral or relaxed thinking (Borkovec& Hu, 1990). However, this initial worry-relatedreduction in heart rate response was associatedwith maintenance of the response, as opposed tothe habituation evidenced by participants in theother conditions. Further, worriers themselvesreport that their worry serves to distract themfrom more emotionally distressing topics (Borko-vec & Roemer, 1995; Freeston, Rheaume, Letarte,Dugas, & Ladouceur, 1994). Taken together, thesefindings suggest that worry may lead to initialdecreases in somatic distress, but then interferewith emotional processing, so that this distress ismaintained over time (Borkovec et al., 2004). Thistheory is similar to Hayes, Wilson, Gifford,Follette, and Strosahls (1996) model of psycho-pathology, which suggests that experiential avoid-ance (i.e., attempts to avoid or change the formor frequency of internal events such as thoughts,feelings, bodily sensations, or memories) is para-doxically associated with increased distress.Recent research has demonstrated that indivi-

duals with GAD exhibit a number of difficultieswith emotions and other internal experiences.Mennin, Heimberg, Turk, and Fresco (2005)found that, in both analogue and clinical samples,reports of GAD diagnostic criteria were associatedwith more intense emotions, poorer understandingof emotions, reactivity to emotions (i.e., negative,

74 roemer & ors i l lojudgmental, and/or anxious responses to ones ownemotions) and difficulty managing emotions, evenbeyond the shared association with worry. Wesimilarly found that reports of both reactivity toemotions and experiential avoidance showed aunique association to self-reported severity of GAD,beyond a shared association with worry (Roemer,Salters, Raffa, & Orsillo, 2005). Further, negativereactions to worry itself have been associated withreports of worry and GAD symptoms in analoguesamples (Davis&Valentiner, 2000;Wells&Carter,1999). Finally, intolerance of uncertainty, ornegative reactions to feeling uncertain, has beenassociated with reports of GAD symptoms anddiagnoses (see Dugas, Buhr, & Ladouceur, 2004,for a review). Taken together, these findings suggestthat individuals with GAD have trouble under-standing and utilizing their emotions effectively,react negatively to both their thoughts and theiremotional responses, and make efforts to avoidthese unwanted internal experiences. This suggeststhat treatment that reduces negative reactivity,increases clarity of emotions, and reduces effortsto avoid internal experiences (e.g., Hayes et al.,1999) may be beneficial.Although GAD is perhaps most associated with

experiential avoidance, difficulties in the behavioraldomain also seem to play an important role inthe disorder. The majority of clients with GADdo report areas of behavioral avoidance (Butler,Gelder, Hibbert, Cullington, & Klimes, 1987).Also, although individuals with GAD repeatedlygenerate possible negative future outcomes, thisactivity does not seem to result in successful, con-crete problem-solving, and instead may be asso-ciated with procrastination (Borkovec, Hazlett-Stevens, & Diaz, 1999; Stber, 1998). Further,worry slows decision-making speed (Metzger,Miller, Cohen, Sofka, & Borkovec, 1990). AsBorkovec and colleagues (1999) note, individualswith GAD, with their chronic apprehension ofpotential future threat, seem to be faced withrepeated fight or flight responses without anyfighting or fleeing behaviors available. Thus, theyrestrict their behavior, worrying about possiblefuture catastrophes but not necessarily movingtoward either their desired or their feared out-comes. These individuals are not inactivetheyoften engage in excessive, nervous activity. How-ever, their activity does not seem to be directedtoward solving problems, facing fears, or pursuingdesired activities. Also, clinical experience suggeststhat when individuals with GAD do engage indesired activities, they are still engaged in the worryprocess and thus are often emotionally andcognitively disengaged from their current activity.Therefore, interventions that specifically encourageintended action despite distress (such as the valuedaction component of ACT; Hayes et al., 1999),along with mindfulness practice that facilitatespresent-moment engagement, may be particularlyhelpful with these individuals. Such approachesmay have been overlooked in the past in partbecause behavioral avoidance in GAD is not limitedto a circumscribed domain as it is with otheranxiety disorders (e.g., Butler et al., 1987). Also, theemphasis in typical outcome studies on symptomreduction more than improved functioning mayhave detracted attention from the proposed re-stricted range of instrumental behaviors amongindividuals with GAD.Taken together, these findings suggest that an

emphasis on (a) expanding present-moment aware-ness, (b) encouraging acceptance (a willingness tohave ones internal responses in order to participatein meaningful experiences) rather than judgmentand avoidance of internal experiences, and (c)promoting action in areas of importance to theindividual might be a particularly efficaciousapproach to the treatment of GAD. We developedan acceptance-based behavior therapy based onthese principles. We use the term acceptance-basedbehavior therapy to highlight the role that promo-tion of acceptance rather than judgment oravoidance plays in the treatment, as well as theemphasis on behavioral principles of learning newskills, practicing these skills, and engaging in actionso as to increase contact with natural contingenciesthat will maintain adaptive behavior. We considerthis treatment to fall into a class of therapies thatincludes ACT, MBCT, and DBT, as well as othertreatments that emphasize these principles (seeHayes, Follette, & Linehan, 2004, for a book-length review of these approaches and theirinterrelationships). These treatments share anemphasis on strategies that alter a clients relation-ship to his or her internal experiences, rather thanstrategies that aim to directly alter the content ofthese experiences (Hayes, 2004).Several experimental, analogue studies have

tested the conceptual basis of this treatment (thatexperiential acceptance [versus control/avoidanceefforts] reduces reactivity and facilitates functioningamong anxious or anxiety-prone individuals).Levitt, Brown, Orsillo, and Barlow (2004) foundthat panic patients who were given acceptanceinstructions prior to CO2 exposure reported lesssubjective anxiety and more willingness to partici-pate in a similar task than those who were giveninstructions to try to control their experience or aneutral narrative. Eifert and Heffner (2003) simi-larly found that individuals high in anxiety

(indicating that they met criteria for GAD but it did

75acceptance - ba s ed behav ior therapy for gadsensitivity who were given acceptance instructionsprior to CO2 exposure reported lower levels ofavoidance, subjective fear, and catastrophic cogni-tions than those given control instructions or noinstructions. Campbell-Sills, Barlow, Brown, andHofmann (2006) found that individuals withanxiety or mood disorders showed better cardiacrecovery following a distressing film clip in anacceptance than in a suppression condition.Data have begun to accumulate indicating that

acceptance- and mindfulness-based treatments areefficacious for a range of psychological disorders,although no published studies to date have appliedthese treatments to anxiety disorders. Hayes,Masuda, Bissett, Luoma, and Guerrero (2004)recently reviewed 23 empirical publications (includ-ing 8 randomized controlled trials [RCTs]) on ACTand 15 empirical publications (including 7 RCTs)on DBT and concluded that while the researchin this area is still preliminary, there is growingsupport for their efficacy across a broad domain ofpresenting problems that may result from experi-ential avoidance. Further, MBCT has been found tosignificantly reduce relapse rates among recovereddepressed individuals with histories of three ormore depressive episodes (Ma & Teasdale, 2004;Teasdale et al., 2000). Although data are too pre-liminary to identify specific mechanisms of change,these findings suggest that applying acceptance-and mindfulness-based approaches to GAD, whichis theoretically and empirically linked to experien-tial avoidance and also commonly comorbid withdepression (Brown, Campbell, et al., 2001), may bebeneficial.Similar to other acceptance-based behavior ther-

apies, our acceptance-based behavior therapy forGAD includes many standard cognitive-behavioraltechniques (specifically, we include self-monitoring,skills development, behavioral assignments, psy-choeducation, and relaxation exercises [with ins-tructions altered so that they are mindfulnessexercises rather than efforts to control anxious ex-perience]). However, we also incorporate andemphasize many strategies drawn from otheracceptance-based behavior therapies, particularlyACT. Traditional cognitive-behavioral techniquesthat emphasize changing the content of internalexperience (such as cognitive restructuring) are notincluded so that treatment presents a consistentmodel encouraging acceptance and nonjudgment ofinternal experience rather than efforts to alter onesexperience. (See Methods section for a more in-depth description of the treatment.) The initialversion of this treatment was tested in a groupformat with 10 sessions of treatment focusedprimarily on psychoeducation regarding the func-not historically precede the initial onset of MDD,although they had periods in which they experi-enced GAD symptoms without MDD symptoms)were asked which set of symptoms was currentlymore problematic and for which they most wantedhelp. Those who reported GAD symptoms werecurrently most severe and most in need ofintervention were eligible for the study. Participantswere eligible regardless of previous treatmenthistory, although only one participant had receivedcognitive behavior therapy prior to enrollment inthe study. No participants had received acceptance-based treatment prior to enrollment.Nineteen clients consented to treatment; 3 of

these individuals withdrew from the study prema-turely. One individual withdrew due to an increasein depressive symptomatology following the deathtion of emotions, the problems associated withefforts at experiential control, obstacles to valuedaction, and promotion of adaptive behavior in thepresence of distress. Initial findings were promising,with three of four clients demonstrating reductionin symptoms and all clients making significant lifechanges (Orsillo, Roemer, & Barlow, 2003). Wesubsequently revised the treatment extensively,changing to an individual format and further de-veloping the mindfulness skills training component(drawing heavily on MBCT and therefore alsoMindfulness-Based Stress Reduction [Kabat-Zinn,1990, 1994] on which MBCT is based) and thevalued action component. Here we present findingsfrom the first open trial of clients treated with thisacceptance-based behavior therapy for GAD.

Methodparticipants

Participants were recruited from a pool individualswho sought treatment at the Center for Anxietyand Related Disorders at Boston University andwere assessed using the Anxiety Disorders Inter-view Schedule for DSM-IVLifetime Version(ADIS-IV-L; DiNardo, Brown, & Barlow, 1994).Individuals who (a) received a principal diagnosisof GAD or major depressive disorder (MDD) plusGAD, with GAD symptoms causing the mostsignificant distress and interference; (b) did notreport current suicidal intent (those with suicidalideation were eligible); (c) did not meet criteria forcurrent bipolar disorder, substance dependencedisorder, or psychotic disorders; and (d) were 18or older were contacted, told about the study, andbrought in for an initial consent meeting if theywere interested in participating. Individuals whoreceived a diagnosis of MDD with GAD subsumed

76 roemer & ors i l loof a family member, prompting a referral to treat-ment more directly focused on depression, anotherwithdrew after missing several sessions due tomedical concerns and then later relocating foremployment, and a third never attended a therapysession due to scheduling conflicts. The 16 clientswho completed treatment ranged in age from 19 to58, with an average of 36.44 (SD=12.34). Seven ofthese clients were male; 1 client self-identified asLatina, 1 self-identified as White and SoutheastAsian, and the rest self-identified as White. Ana-lyses were based on this sample of 16.The 16 clients who completed treatment received

an average pretreatment clinicians severity ratingof 5.94 (SD=0.93) from ADIS assessors (rated on a08 scale, with 4 indicating severity sufficient towarrant a diagnosis), indicating a severity levelequal to or higher than participants treated in otherstudies of the treatment of GAD (e.g., Borkovecet al., 2002; Ladouceur et al., 2000). Participantsreceived an average of 1.31 (SD=1.08) additionaldiagnoses. Two clients were diagnosed with MDD(with GAD subsumed, as described above). Themost common additional diagnoses were socialanxiety disorder (n=5), specific phobia (n=4),MDD (n=3, including the two clients with MDD-GAD described above), dysthymia (n=3), andpanic disorder with agoraphobia (n=2). This issimilar to comorbidities found in other studies oftreatment-seeking individuals with GAD (e.g.,Brown Campbell et al., 2001). Six clients weretaking psychotropic medications (anxiolytics orantidepressants or both) and agreed not to increasetheir medication use throughout the course oftreatment. One additional client was taking alpra-zolam PRN and agreed to discontinue use duringthe treatment. Eleven clients had received priorpsychotherapy for anxiety, and 11 had a history oftaking psychotropic medications for anxiety ormood problems. One client maintained intermittentcontact with a long-term psychotherapist through-out treatment but did not address anxiety concernswith this therapist; all other clients refrained fromadditional psychotherapy of any sort. The oneclient who maintained contact with a therapist wasa responder at posttreatment but not at follow-up(see below for description), suggesting that thisadditional contact did not contribute to prolongedtreatment response.

measures

Pre-, post-, and 3-month follow-up assessmentsincluded measures of anxiety and worry, depres-sion, quality of life and functioning, and proposedmechanisms of change (fear and avoidance ofinternal sensations).Assessment of anxiety and GAD symptoms.Anxiety disorders interview schedule for DSM-IVLifetime version (ADIS-IV-L DiNardo et al.,1994). This diagnostic interview comprehensivelyevaluates DSM-IVanxiety and mood disorders andelicits information necessary for differential diag-noses (e.g., mania, substance and alcohol use). TheADIS-IV-L has a reliability for principal GADdiagnoses of k=.67, in a study conducted at thesame site as the current study, following the sametraining procedures (Brown,DiNardo, Lehmann,&Campbell, 2001). In addition to providing diagnos-tic information on both GAD and any othercomorbid diagnoses, the ADIS-IV-L includes aclinicians severity rating (CSR) for each diagnosisreceived ranging from 0 to 8 (extreme interferenceor distress); the CSR for GAD was a primaryoutcome measure. Ratings of 4 and higher indicatesufficient distress and impairment for the diagnosisto be given. The full ADIS was administered duringthe first assessment; an abbreviated version asses-sing only diagnosesmet during the initial assessmentwas administered at posttreatment and follow-upassessments. All assessments were administered bydoctoral students at the Center for Anxiety andRelated Disorders who had undergone extensivetraining and demonstrated reliability. Diagnoseswere confirmed in consensus meetings with adoctoral-level psychologist (Dr. T. A. Brown).Therapists also confirmed diagnoses in their initialmeeting with clients using an abbreviated version ofthe ADIS-IV.

The Penn State Worry Questionnaire (PSWQ; Meyer,Miller, Metzger, & Borkovec, 1990). This 16-itemmeasure of trait worry has demonstrated good tovery good internal consistency (s ranging from .86to .93 across clinical and college samples) as well asadequate to good test-retest reliability (rs rangingfrom .74 to .93 across periods ranging from 2 to 10weeks; Molina & Borkovec, 1994). In addition, ithas been found to discriminate GAD from all otheranxiety disorders (Brown, Antony, & Barlow,1992), demonstrating its validity. Clients indicatethe extent to which each statement describes themusing a 5-point Likert-type scale. Sample itemsinclude Ive been a worrier all my life and OnceI start worrying, I cant stop. Alphas in the currentstudy were .81 at pretreatment assessment, .92 atposttreatment assessment, and .94 at follow-upassessment.

Depression Anxiety Stress Scales21-item version(DASS-21; Lovibond & Lovibond, 1995). Thismeasure yields separate scores for depression,anxiety (i.e., anxious arousal) and stress (e.g.,

77acceptance - ba s ed behav ior therapy for gadtension). Sample items include I couldnt seem toexperience any positive feelings (depression), Ifelt scared without any good reason (anxiety),and I found it hard to wind down (stress).Participants indicate how much each item appliedto them over the past week on a 4-point Likert-type scale. Subscales demonstrate excellent inter-nal consistency (s ranging from .88 to .94 in aclinical sample; Antony, Bieling, Cox, Enns, &Swinson, 1998) and adequate test-retest reliability(coefficients ranging from .71 to .81 in a clinicalsample using the 42-item version of the scale;Brown, Chorpita, Korotitsch, & Barlow, 1997).The factor structure of the DASS-21 was sup-ported in community and clinical samples (Ant-ony et al., 1998). Construct and discriminantvalidity have been supported through findings ofstronger correlations between the Anxiety scaleand measures of anxiety (than the other twoscales) and the Depression scale and measures ofdepression and positive affect (than the other twoscales) in a clinical sample (Brown et al., 1997).Most notably, scores on the Stress subscalesignificantly discriminate between clients withGAD and those with panic disorder, social phobiaand specific phobia (Brown et al., 1997), suggest-ing that it is a particularly useful measure withthis clinical population. The Anxiety scale assessesanxious arousal symptoms. The Depression sub-scale was used as one indicator of depressivesymptoms. In the current study, internal consis-tency for the Depression subscale was .91 atpretreatment assessment, .86 at posttreatmentassessment, and .89 at follow-up. Internal con-sistency for the Anxiety subscale was .82 atpretreatment assessment, .83 at posttreatmentassessment, and .29 at follow-up assessment.Internal consistency for the Stress subscale was.88 at pretreatment assessment, .82 at posttreat-ment assessment, and .77 at follow-up. Inspectionof the data suggested that the low reliability forthe Anxiety subscale at follow-up was due torestricted range (very few arousal symptoms wereendorsed at all, so that the few high ratingsskewed results) and lower power due to thereduced sample size.Assessment of depressive symptoms. Beck

Depression Inventory (BDI-I-A; Beck, Rush, Shaw,& Emery, 1979). This 21-item measure is one ofthe most widely used measures of depressivesymptoms in clinical outcome studies. This scale,along with the DASS-Depression subscale, wasused to assess the effect of treatment on comorbiddepressive symptoms, which are common inGAD. A meta-analysis of the BDIs internalconsistency in studies of psychiatric samplesduring a 25-year period yielded a mean coefficientalpha of .86 and test-retest correlations rangingfrom .48 to .86 (Beck, Steer, & Garbin, 1988).Concurrent validity of the BDI with clinicalassessments of depression and the HamiltonPsychiatric Rating Scale for Depression was alsoestablished to be high, 0.72 and 0.73 respectively.Finally, a number of studies have found the BDIto have good discriminant validity in differentiat-ing psychiatric patients from nonpsychiatric com-parison groups (Beck et al., 1988). A revisedversion (BDI-II; Beck, Steer, & Brown, 1996) hasbeen developed to more closely reflect thediagnostic criteria of depression; these two scaleshave comparable internal consistency, while theBDI-I-A seems to yield scores that are about 2points lower than the BDI-II (Beck, Steer, Ball, &Ranieri, 1996). Our use of the scale is solely toestimate changes in level of depressive symptoms,rather than diagnosis. Internal consistency withinour sample was .80 at pretreatment assessment,.85 at posttreatment assessment, and .89 atfollow-up.Assessment of quality of life. Quality of Life

Inventory (QOLI; Frisch, Cornwell, Villanueva, &Retzlaff, 1992). This measure is based on anempirically validated model of life satisfactionthat conceptualizes satisfaction as the sum ofsatisfactions in areas of life that are important toan individual. Sixteen areas of life (e.g., goals andvalues, health, work, romantic relationships,friends, recreation) are assessed in terms of degreeof importance (0=not important, 1 = slightlyimportant, and 2= extremely important) andlevel of satisfaction (ranging from 3=very dis-satisfied to 3=very satisfied). These values arethen multiplied for each domain (and unimpor-tant domains are dropped from analysis), result-ing in an average satisfaction level across domainsthat ranges from 6 to 6. The QOLI demonstratesgood internal consistency (s ranging from .83 to.89 in clinical samples) and excellent test-retestreliability (r= .91 in a sample of veterans whohad successfully completed an inpatient alcoholtreatment program; Frisch et al., 1992). Its valid-ity is supported by significant correlations withother measures of well-being and satisfaction,significant negative correlations with measures ofpsychopathology, and the absence of a signifi-cant relationship with social desirability in aninpatient VA sample (Frisch et al., 1992). Itscorrelations with psychopathology are modest(ranging from .39 to .50), suggesting itassesses a related, but distinct, construct. In thecurrent study, we administered a shortened ver-sion of the QOLI consisting of 11 domains of

functioning.2 Internal consistency with this ver-sion of the measure in the current sample was.80 at pretreatment assessment, .86 at posttreat-ment assessment, and .86 at follow-up.Assessment of fear and avoidance of internal

experiences: proposed mechanisms of change.Action and Acceptance Questionnaire (AAQ;Hayes, Strosahl, et al., 2004). This 9-item self-report measure assesses emotional avoidance and

78 roemer & ors i l loemotion-focused inaction. High scores correspondto high experiential avoidance, or the unwillingnessto remain in contact with particular feelings andthoughts, whereas low scores reflect acceptance andaction. Sample items include When I am feelingdepressed or anxious, I am unable to take care of myresponsibilities and I rarely worry about gettingmy anxieties, worries, and feelings under control(reverse scored). The scale has demonstrated ade-quate internal consistency (=.70), and test-retestreliability (r=.64 in an undergraduate sample over aperiod of 4 months; Hayes, Strosahl, et al., 2004).Its validity is demonstrated by significant, moder-ate correlation with related constructs such ascognitive avoidance (r=.50 in a clinical sample)and avoidant coping (r=.38). Further, it demon-strates significant associations with measures ofpsychopathology, even after controlling for arelated measure of cognitive avoidance (e.g.,r= .53 with the BDI in a clinical sample; Hayes,Strosahl, et al., 2004). The internal consistency inthis sample was .67 at pretreatment assessment,.84 at posttreatment assessment, and .79 at follow-up assessment.

Affective Control Scale (Williams, Chambless, &Ahrens, 1997). This 42-item measure wasdesigned to extend the well-established fear offear construct (Goldstein & Chambless, 1978) byassessing fearful reactions to a range of emotionalresponses (fear, sadness, anger, and positive emo-tions). The scale yields an overall mean scorereflecting degree of fear of emotions, as well assubscales for each of the four target emotions.Sample items include Depression is scary to meIam afraid that I could get depressed and neverrecover and I love feeling excitedit is a great

2 Unfortunately, due to a clerical error, 5 domains were omittedfrom the measure in this sample (children, relatives [other thanchildren or partners], home, neighborhood, and community) so thevalues reported reflect responses to the 11 remaining domains(health, self-esteem, goals-and-values, finances, work, recreation,learning, creativity, social/community action, romantic relation-ship, friends). Given that internal consistency for the scale inclinical populations has been found to be good (s ranging from.83 to .89 in clinical samples; Frisch et al., 1992), these values canbe considered reasonable estimates of overall quality of life.feeling (reverse-scored). The ACS has demon-strated good internal consistency (=.92, for thefull scale; subscales range from .72 to .91) andgood test-retest reliability (r=.77) in an under-graduate sample (Williams et al., 1997). The scalesvalidity is demonstrated by the finding that thethree nonanxiety subscales of the ACS predict fearof laboratory-induced panic sensations above andbeyond variance predicted by the anxiety subscale(Williams et al., 1997). This finding has beenreplicated, further controlling for state and traitanxiety (Berg, Shapiro, Chambless, & Ahrens,1998). Internal consistency for the full scale inthe current study was .89 at pretreatment assess-ment, .95 at posttreatment assessment, and .91 atfollow-up.

treatment

Following informed consent, clients were seen for16 sessions of individual treatment, with the first4 sessions lasting 90 minutes, the rest lasting60 minutes, and the last 2 sessions tapered (fromweekly to every other week). The treatment manualwas developed for this study, drawing from existingcognitive behavioral treatments for GAD (particu-larly Borkovec et al., 2002), ACT (Hayes et al.,1999), MBCT (Segal et al., 2002), and DBT(Linehan, 1993a, 1993b). More detailed descrip-tion of the treatment is available elsewhere (Roemer& Orsillo, 2005; Roemer, Salters-Pedneault, &Orsillo, 2006); here we will highlight the mainelements.Introducing and demonstrating a model of GAD

and treatment. A central component of thisacceptance-based behavior therapy for GADinvolves sharing and demonstrating an empiricallybased model of GAD. This model highlights thehabitual nature of anxious responding (Borkovec etal., 2004), the function of our emotional responses(Linehan, 1993b), and the role that judgmentalresponses to and efforts to avoid internal experi-ences play in paradoxically worsening distress andinterfering with functioning by motivating subtleand overt behavioral avoidance (Hayes et al.,1999). Sessions 1 through 4 include presentationof these elements of the model through handoutsand explanation, experiential demonstrations, andbetween-session self-monitoring. The therapist andclient work together to form an idiosyncraticconceptualization of how experiential avoidanceplays a role in the clients difficulties. The connec-tion is made between this model and the model fortreatment in which clients learn to (a) change theirrelationship to their internal experience (so thatthey are more aware, more compassionate, lessfused with their thoughts and feelings, and more

their responses to situations and behave inten-

79acceptance - ba s ed behav ior therapy for gadable to use their emotional responses as informationthat they can choose or not choose to follow); (b)reduce efforts at avoidance (both internal andexternal); and (c) increase adaptive action in theareas of life that matter to them.Mindfulness and acceptance-based strategies. In

order to promote a compassionate, willing (asopposed to critical and avoidant) response tointernal experiences, an alternative response ofaccepting these experiences is introduced. Begin-ning with Session 2, clients are taught a variety ofmindfulness practices, many of which are drawnfrom Kabat-Zinn (1990, 1994), Segal et al. (2002),and other sources. We also adapt diaphragmaticbreathing and progressive muscle relaxation (Bern-stein, Borkovec, & Hazlett-Stevens, 2000) so thatthey promote awareness and acceptance rather thanchange efforts. Clients are encouraged to practicemindfulness both formally (in a planned exercise)and informally (while engaging in typical activities)every day. Metaphors and exercises are taken fromACT to illustrate how individuals can allow theirinternal experience and take it with them whilethey engage in important actions, rather thanengaging in a constant struggle with those ex-periences. Clients are taught that mindfulness isa skill and a process, rather than a desired end-state. Mindfulness exercises are practiced at thebeginning of every session, moving from mind-fulness of breath and sensations to mindfulnessof emotions and thoughts as therapy progresses.Additionally, in each session, particular skills ofmindfulness (such as awareness, beginners mind,compassion, and developing a sense that thoughtsand feelings are separate from ones self) areemphasized.Behavior change and valued action. Throughout

treatment, an emphasis is placed on helpingclients live the life they choose, taking the focusaway from changing internal experience andfocusing instead on actions they could take tochange their external experience (drawing heavilyfrom the valued action component of ACT; Hayeset al. 1999; Wilson & Murrell, 2004). Early intreatment, clients complete several written emo-tion processing exercises that assist them inidentifying how experiential avoidance is compro-mising their quality of life and reconnecting withwhat is important to them in three domains oflife: interpersonal, educational/occupational, andpersonal interests/self-care. They then closelymonitor their daily activity to get an accuratesense of how often they are engaging in valuedactivities and to note obstacles that result inmissed opportunities to pursue valued activities.After Session 6, clients complete a written emo-tionally rather than reactively.

therapists and treatment integrity

The first 5 clients were treated by the authors, whodeveloped the treatment. The remaining 11 clientswere treated by doctoral students and one post-doctoral therapist, under the supervision of theauthors. These therapists had 1 to 4 years of clinicalexperience. Two sessions (one from the first half oftherapy and one from the second) from each clientwere randomly selected and rated by graduatestudent raters for adherence to the protocol. Anadherence checklist was developed, adapted fromBorkovec (2001, personal communication), thatlisted 12 elements allowed (and encouraged) insession (such as promoting awareness of thoughts,emotions, or bodily sensations, promoting senseof self as separate from experiences, and discuss-ing or identifying values), and five elementsforbidden (such as emphasizing the need to changecognitions. or identifying errors in thinking).

Resultstreatment adherence

Twenty-five percent of the therapy tapes rated foradherence were rated by two independent raters.These raters demonstrated good reliability on theadherence forms (kappa=.81). Therapists wereextremely adherent to the protocol. Of the 12elements listed on the checklist (which are notrequired in each session), tapes averaged 11.11items per session. Only one nonprotocol event wasrecorded in one session (a comment regardingpotential errors in thinking).

effects at posttreatment assessment

In order to assess the impact of treatment on GADand anxious symptoms, depressive symptoms,tional processing homework exercise aimed athelping them increase their willingness to make acommitment to pursuing valued activities know-ing that painful thoughts, feelings, and emotionsmay arise. Beginning with Session 7, the clientand therapist choose actions for the client to takeduring each week and review progress in thesebehavior change efforts. Sometimes these plannedactions involve bringing mindful awareness toactions in which clients are already engaging(such as playing with ones child), whereas atother times they involve making changes (such asmaking requests of ones partner). Clients con-tinue to practice mindfulness throughout this pe-riod and are encouraged to use their mindfulnessand acceptance-based skills to help them notice

80 roemer & ors i l loTable 1Means (and Standard Deviations) of all variables at Pre-, Post- andFollow-up (n=16 at pretreatment and posttreatment assessments,n=12 at the 3-month Follow-up assessment)

Pre-assessment

Post-assessment

Follow-up

GAD and Anxiety SymptomsGAD CSR 5.94 (0.93) 2.75 (1.61) 3.33 (1.67)PSWQ 69.34 (7.81) 51.08 (11.15) 55.83 (12.65)DASS-Anx 16.00 (9.44) 4.88 (6.06) 5.17 (4.13)DASS-Stress 23.88 (10.54) 11.63 (7.09) 12.83 (7.21)

Depressive SymptomsBDI 19.99 (8.96) 5.25 (5.34) 6.50 (6.47)DASS-Dep 14.75 (11.52) 3.88 (5.68) 9.00 (9.05)

Quality of LifeQOLI 0.15 (2.16) 1.81 (1.81) 1.56 (2.13)

Mechanism of ChangeAAQ 44.56 (5.99) 29.81 (7.41) 34.17 (7.76)ACS mean 3.97 (0.62) 2.94 (0.77) 3.31 (0.54)

Note. GAD=generalized anxiety disorder, CSR=CliniciansSeverity Rating from the Anxiety Disorders Interview Schedulefor DSM-IV, Lifetime Version; PSWQ=Penn State Worry Ques-tionnaire; DASS-Anx=Depression Anxiety and Stress ScalesAnxiety subscale; DASS-Stress=Depression Anxiety and Stressquality of life, and fear and avoidance of internalexperiences, a series of repeated measures multi-variate analyses of variance (MANOVAs) andunivariate analyses of variance (ANOVAs) wereconducted on pre- and posttreatment scores withineach group of measures. See Table 1 for means andstandard deviations of all variables. In order tominimize both Type I and Type II error (with thelatter being a particular concern with such a smallsample), a modified Bonferroni procedure (Jaccard& Wan, 1996) was used. With this procedure,significance levels are rank ordered by size and thelowest one must exceed the traditional Bonferronilevel (.05/number of analyses) while for eachsubsequent value, .05 is divided by a number thatis one fewer (i.e., .05/number of analyses 1, .05/number of analyses 2, etc.). This method preserveson overall Type 1 error rate of .05, withoutoverinflating Type II error. Statistical significanceis noted below when p values met these criteria.Effect sizes (p

2) are also reported (an effect size ofp2 =0.06 is considered a medium effect and p

2=0.14, a large effect; Cohen, 1988).As a test of treatment effects on GAD and anxiety

symptoms, the MANOVA conducted on the ADIS-

ScalesStress subscale; BDI=Beck Depression Inventory;DASS-Dep=Depression Anxiety and Stress ScalesDepressionsubscale; QOLI=Quality of Life Inventory; AAQ=Acceptance andAction Questionnaire; ACS=Affective Control Scale.IV-L, GAD-CSR, PSWQ, DASS-Anxiety, andDASS-Stress scores revealed a significant maineffect of time, F(4, 12)=18.29, p

forward for a conservative estimate of prolonged

81acceptance - ba s ed behav ior therapy for gadeffects. The client who had reduced his medicationat posttreatment had discontinued his medicationat this assessment (and remained a responder).One client had begun taking methylphenidate, amedication for attention deficit disorder that iscountraindicated for individuals with significantanxiety. This individual was also classified as aresponder at this assessment.In order to assess prolonged effects of treatment

on GAD and anxious symptoms, depressive symp-toms, quality of life, and fear and avoidance ofinternal experiences, a series of repeated measuresMANOVAs and ANOVAs were conducted on pre-and 3-month follow-up scores within each group ofmeasures. As noted above, modified Bonferronicorrections were applied within each family offollow-up analyses. Statistical significance isreported below when it remained after alphaadjustment. See Table 1.TheMANOVA conducted on GAD-CSR, PSWQ,

DASS-Anxiety, and DASS-Stress scores revealed asignificant main effect of time, F(4, 8)=5.31,p< .05, p

2 = 0.73. Each follow-up univariateANOVA was also significant; CSR: F(1, 11)=19.61, p

reduction was medium to large, suggesting thismight be due to reduced power in the follow-upsample. More importantly, a significant effect wasfound using the BDI, which is a much morecommonly used outcome measure in treatment

(Dugas et al., 2003; Ladouceur et al., 2000), so

82 roemer & ors i l lostudies. Clients scores decreased from an averageindicating moderate depression according to theBDI (a mean of almost 20) to a level that falls withinthe normative range (a mean of 6.50), suggesting atherapeutic effect of the current treatment oncomorbid depressive symptoms that is maintainedfor at least 3 months. This is a particularlyimportant finding given that comorbid depressionwas allowed in this trial when it is often excludedfrom studies of the treatment of GAD, despite theprevalence of comorbid depression among indivi-duals presenting with GAD.3

Although these findings are promising, it isimportant to note that effect sizes declined fromposttreatment assessment to follow-up assessment.We have revised the treatment so that it nowincludes a stronger emphasis on relapse preventionin later sessions, including review and consolidationof important treatment concepts, development ofstrategies to assist in bringing mindfulness andacceptance into clients daily lives more effectively,and rehearsal of and preparation for future stressesand lapses andmethods to address them.We believethis will address the slight decline in improvementobserved in this initial trial.At posttreatment assessment, the proportion of

individuals that met responder criteria was some-what higher than in previous trials, although theproportion that met criteria for high endstatefunctioning was essentially comparable. However,these proportions dropped by 3-month follow-upso that proportions were either comparable to, orslightly lower than, previous trials. It is importantto recognize that cross-study comparisons areproblematic, given the nonequivalence of samples.For instance, Borkovecs studies (1993, 2002)excluded clients who were taking antidepressantsor met criteria for panic disorder, while both wereincluded in this trial. As noted above, future studieswill determine whether recent refinements to theprotocol improve clinical significance over time.Theoretically, the emphasis on life changes shouldlead to more durable changes for clients; studieswith longer follow-up periods are needed to testthat hypothesis.

3 Effect sizes for changes in BDI over time for only those clientswho had comorbid MDD were p

2=0.88 (n=3) at post and 0.99(n=2) at follow-up, suggesting treatment was targeting depressionin those with comorbid depression, although this subsample is sosmall that findings should be interpreted very cautiously.this is unlikely. A randomized controlled trialcomparing this treatment to a waitlist controlgroup is currently under way to more definitivelyrule out this possibility. Future studies will comparethis acceptance-based behavior therapy to empiri-cally supported treatments for GAD in order todirectly test whether this treatment offers enhancedefficacy. Further, studies with assessments at multi-ple time points will allow us to test whether thetreatment is efficacious through the proposedmechanisms of change (in other words, whetherchanges in these mechanisms precede and predictchanges in outcome measures). Finally, it will beimportant to examine the portability of the treat-ment to other settings and its applicability with amore diverse range of clients, particularly in termsof race and ethnicity.Despite these limitations, the current findings

suggest that interventions that incorporate mind-fulness- and acceptance-based strategies may beefficacious in treating generalized anxiety disorderand its associated features. Eifert and Forsyth(2005) have recently published a manual presentingan ACT approach to treating all anxiety disorders(including GAD) and a randomized controlled trialis currently under way comparing its efficacy toCBT (Forsyth, personal communication, 2006).Germer (2005) has also recently presented anintegrative approach to incorporating mindfulnessin the treatment of anxiety disorders that similarlyreflects many of these principles. Randomizedcontrolled trials, coupled with basic research testingspecific mechanisms of change, will help us todetermine the added efficacy of these approachesand the optimal forms of delivery.

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RECEIVED: September 19, 2005ACCEPTED: April 24, 2006Available online 24 October 2006

85acceptance - ba s ed behav ior therapy for gad

An Open Trial of an Acceptance-Based Behavior Therapy for Generalized Anxiety DisorderMethodParticipantsMeasuresAssessment of anxiety and GAD symptomsAnxiety disorders interview schedule for DSM-IVLifetime version (ADIS-IV-L DiNardo et al., 199.....The Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990)Depression Anxiety Stress Scales21-item version (DASS-21; Lovibond & Lovibond, 1995)

Assessment of depressive symptomsBeck Depression Inventory (BDI-I-A; Beck, Rush, Shaw, & Emery, 1979)

Assessment of quality of lifeQuality of Life Inventory (QOLI; Frisch, Cornwell, Villanueva, & Retzlaff, 1992)

Assessment of fear and avoidance of internal experiences: proposed mechanisms of changeAction and Acceptance Questionnaire (AAQ; Hayes, Strosahl, et al., 2004)Affective Control Scale (Williams, Chambless, & Ahrens, 1997)

TreatmentIntroducing and demonstrating a model of GAD and treatmentMindfulness and acceptance-based strategiesBehavior change and valued action

Therapists and treatment integrity

ResultsTreatment adherenceEffects at posttreatment assessmentProlonged treatment effects at 3-month follow-upClinical significance

DiscussionReferences