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Meyer TD, Hautzinger M. Cognitive Behaviour Therapy and Supportive Therapy for Bipolar Disorders

– Relapse rates for treatment period and 2 year follow-up. Psychological Medicine 2012, 42(7), 1429-

1439.

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Robinson Library, University of Newcastle upon Tyne, Newcastle upon Tyne.

NE1 7RU. Tel. 0191 222 6000

Cognitive Behaviour Therapy and Supportive Therapy

for Bipolar Disorders

– Relapse rates for treatment period and 2 year follow-up

Thomas D. Meyer 1) 2) & Martin Hautzinger 1)

1) Eberhard Karls Universität Tübingen

2) Newcastle University

Accepted for publication: Psychological Medicine

Notes. Thomas D. Meyer, Ph.D, and Martin Hautzinger, Ph.D., conducted this research at the Eberhard Karls University of Tübingen, Psychological Institute, Department of Clinical and Developmental Psychology. Correspondence should be sent to Thomas D. Meyer, who is currently at Newcastle University, Institute of Neuroscience, Doctorate in Clinical Psychology, Ridley Building, Newcastle upon Tyne, NE1 7RU, United Kingdom, Email: [email protected] Acknowledgements: This research was supported by a grant provided from the Deutsche Forschungsgemeinschaft (DFG ME 1681/6-1 to 6.3). We are indebted to all the therapists and independent raters, especially Dr. Peter Peukert and Dr. Katja Salkow as well as research assistants for their enormous work, support and help. We also especially thank Prof. Jan Scott who provided very helpful and highly valued comments on an earlier draft of this paper with regards to the analyses, and Dr. Jacqui Rogers for final editing and proofreading.

Declaration of Interest:

None

CBT vs ST for BD – 2 years 2

Abstract

Background: The efficacy of adjunctive psychosocial interventions such as Cognitive

Behaviour Therapy (CBT) for Bipolar Disorder (BD) has been shown in several uncontrolled

and controlled studies. However all of these studies compared CBT to either a waiting list

control group, brief psychoeducation or treatment-as-usual. The primary goal was to examine if

CBT is superior to Supportive Therapy (ST) of equal intensity and frequency in preventing

relapse and improving outcome at post-treatment. A secondary goal was to look at predictors of

survival time.

Methods: We conducted a randomized controlled trial in Germany at the outpatient clinic of a

Psychological Institute (n = 76 patients with BD). Both CBT and ST consisted of 20 sessions

within 9 months. Patients were followed up for a further 24 months.

Results: Although changes over time were observed in some variables, they were not

differentially associated with CBT or ST. CBT showed a non-significant trend for preventing

any affective, specifically depressive episode during the time of therapy. Kaplan Meier survival

analyses revealed that 64.5% of patients experienced a relapse during the 33 months. Number of

prior episodes, number of therapy sessions and type of BD predicted survival time.

Conclusions: No differences in relapse rates between treatment conditions were observed,

suggesting that certain shared characteristics (e.g. information, systematic mood monitoring)

might explain the effects of psychosocial treatment for bipolar disorder. Our results additionally

suggest that a higher number of prior episodes, a lower number of therapy sessions and a

diagnosis of bipolar-II-disorder are associated with shorter time before relapse.


Bipolar disorders (BD) are more frequent and disabling than originally thought with many

patients showing significant impairment or subsyndromal symptoms between episodes (e.g.

Judd & Akiskal, 2003; Judd et al., 2002; Solomon et al., 2010). Although medication is needed,

the role of psychosocial factors for onset and course of BD has become obvious (e.g. Alloy et

al., 2005; Johnson, 2005) and led to the development of several psychosocial interventions.

Cognitive Behaviour Therapy (CBT) relies on the assumption that the interaction of

thoughts, behaviours and emotions is underlying psychopathology, including depression and

mania. Indeed empirical evidence has demonstrated the role of cognitive vulnerability factors

such as dysfunctional attitudes or attributional style for BD and mania (e.g. Alloy et al., 2009;

Johnson, 2005; Jones et al., 2005), Several reviews have been published looking at the efficacy

of psychotherapy for BD (e.g. Beynon et al., 2009; Miklowitz & Scott, 2009; Szentagotai &

David, 2010), and briefly summarized indicate that CBT for BD works better than waiting for

treatment (Scott et al., 2001), is more beneficial than brief psychoeducation (Zaretsky et al.,

2008) and mostly proved to be superior to treatment-as-usual (TAU) with respect to functioning

and relapse prevention (e.g. Ball et al., 2006; Lam et al., 2003). Focusing on overall relapse

rates from four RCTs in their meta-analysis, Lynch et al. (2010) conclude that CBT is not

effective for BD. Indeed Scott et al. (2006) did not find an overall effect for CBT with regard to

relapse prevention for severe BD but individuals with fewer episodes benefitted from receiving

CBT. Despite these encouraging results, there are limitations, for example the amount of

attention patients in the control groups received has not been controlled. For example, waiting

for treatment has its own negative effects with 30% of patients dropping out (Scott et al., 2001).

TAU, on the other hand, mostly included regular visits to the psychiatrist, and crises

management. This was usually provided to all study participants, so that in effect CBT was

actually an add-on intervention. Therefore, the patients treated with CBT received much more

attention and support of any kind compared to those in the control conditions. This renders


interpretations ambiguous (e.g. Goldfried & Wolfe, 1998). The primary goal of our study

therefore was to examine if the positive results with regard to relapse rates and post-treatment

improvements in former studies are still evident if people are randomized to CBT or another

treatment condition that is matched in frequency and intensity of contact (i.e. ‘supportive

therapy’). We used relapse rates as the main outcome variable but also considered symptom

levels and indicators of cognitive vulnerability (e.g. locus of control). It was expected that CBT

would lead to lower relapse rates, decrease symptoms levels and cognitive vulnerability (e.g.

increased internal locus of control). A secondary goal was to test whether illness related

variables which have been identified in other studies predict survival time, specifically length of

treatment, number of prior episodes, age of onset, medication, psychosocial functioning and

type of BD (e.g. Zaretsky et al., 2008; Miklowitz et al., 2003; Scott et al., 2006, 2007).

Method

Participants. Recruitment took place in the Department of Psychology, University of

Tübingen, Germany, between August 1999 and September 2004. The patients were either

referred by local hospitals, psychiatrists or were self-referrals due to public information in

newspapers or on radio. Participants were invited to a screening session in which they were

informed about the study and gave written informed consent. Baseline assessment consisted of

at least three consecutive sessions, in which clinical interviews (e.g. Structured Clinical

Interview for DSM-IV axis I and II) and self-ratings (e.g. BDI) were completed.

The inclusion criteria for the study were a) a primary disorder of BD according to DSM-IV

(APA, 1994), b) age between 18 and 65 years, and c) willingness to continue current or start

medication. Exclusion criteria were: a) the primary diagnosis is a non-affective disorder

including schizoaffective disorder, b) current major affective episode (depressed, mixed or

mania according to SCID-I) or Bech Rafaelsen Melancholia Scale > 14 or Bech Rafaelsen

Mania Scale > 9, c) affective disorder substance-induced or due to a general medical condition,


d) current substance dependency requiring detoxification [abuse did not qualify for exclusion],

e) serious cognitive deficits (IQ < 80), f) being currently in psychological treatment.

Treatment conditions: Patients were randomly allocated to individual CBT or ST using a

stratified randomization strategy controlling for gender, bipolar I or II disorder, and age of onset

(before/ after age of 20). Treatment started within 2-4 weeks after the assessments. Both

treatments consisted of 20 sessions (50 to 60 minutes) distributed over nine months. The first 12

sessions were provided on a weekly basis, then bi-weekly sessions were offered for the next two

months and the remaining sessions were scheduled monthly. Manuals were provided for both

treatments with the CBT one being published (Meyer & Hautzinger, 2004). Both treatment

conditions included information (e.g. symptoms, aetiology, medication) and mood monitoring in

the form of a mood diary. The difference between therapies was such that in the ST condition

therapists adopted a client-centered focus meaning that whatever problems the patient presented

were dealt with by providing emotional support and general advise. If no specific topic was

mentioned by the patient, information about BD and medication was delivered by the therapist

without referring to written or any other materials. In contrast to the CBT no efforts were made

to specifically link this information to the individuals’ biography or experience. The mood diary

was checked by the therapist who provided brief feedback (e.g. regularity of medication, of

sleep and overall mood) or probed for missing information but without using any CBT-related

techniques such as guided discovery, problem solving or reality testing,

CBT covered a) an information and motivation module (providing and jointly elaborating

information and an understanding of bipolar disorder, its symptoms, aetiology, course, triggers,

and pharmacotherapy based and linked to the individual’s experience, but also addressing for

example in this context potentially dysfunctional beliefs about bipolar disorder and medication),

b) an individual relapse module (including life chart analysis, identification and monitoring of

individual early warning symptoms for mania and depression, functional behaviour analysis or

risky behaviours, coping with prodromal symptoms), c) Cognitive and behavioural strategies


dealing with depression and mania (e.g. cognitive restructuring, activity schedule/daily routine,

planning pleasurable activities), and d) training of communication skills and/or problem solving

skills depending on the individuals strengths and deficits.

Therapists (n = 8, one being the first author) had a least one-year postgraduate training in

CBT and had attended a specific 2-day workshop about CBT and ST for BD with role plays and

video training. All therapy sessions were video-taped and weekly supervision was provided.

Materials and Procedures:

The Structured Clinical Interview for DSM-IV Axis I and II (SCID, First et al., 1996) was

used by trained clinical psychologists to diagnose mental health problems at baseline and in the

follow-up period. All interviews were videotaped, and a random sample of 53 patients was used

to estimate reliability, which proved to be excellent (k = .93 for bipolar I, k = .89 for bipolar II).

Relapse was defined as any mood episode which fulfilled DSM-IV criteria. Throughout the

therapy period recordings were made of hospitalizations and episodes obtained by the

clinicians’s notes and from the patients’ mood diaries (including also weekly CES-D

assessments (Radloff, 1977: Hautzinger & Meyer, 2003). Severity of symptoms and functioning

was also repeatedly assessed throughout the study period using the BRMS, BRMAS and Global

Assessment Scale (GAS)(with good reliability (ICC = .87, .77 and .81 respectively). In addition

several self-rating measures were used such as the Beck Depression Inventory (BDI, Beck &

Steer, 1987; α=.89), the Self Rating Mania Inventory (SRMI, Shugar et al., 1992; α=.94).

Furthermore the Locus of control for health and illness (LC; Lohaus & Schmitt, 1989) and

Disease concept scale (‘Krankheitskonzeptskala’ [KK]; Linden et al., 1988) was used. The 21

items of the LC are rated on a scale from ‘1’ totally true to ‘6’ not at all true and 3 composite

scores can be calculated, i.e. internal locus of control (α=.89), external locus of control –

powerful others (α=.76), and external locus of control – chance (α=.88). The KK is so far the

only existing German scale that has been evaluated to assess subjective illness concepts of


patients. All 29 items are rated on a 5-point scale (‘0’ do not agree at all’ to ‘4’totally agree’). 7

subscales were derived through factor analysis: trust in medication, trust in psychiatrist, negative

expectations, guilt, chance, vulnerability, and idiosyncratic assumptions ( .67 [chance] < α < .85

[trust in medication]). The LC and KK scales were assumed to be psychological concepts related

to adherence and to reflemct effects of psychotherapy. To estimate adherence to medication the

Somatotherapy Index (Bauer, 2001) was used. The best available data is used (mostly blood

serum levels) to ensure the most accurate reporting of the maximum level of somatotherapy

across medication types (i.e. ‘0’ no or very low levels of medication; ‘4’ indicating optimal

pharmacotherapy). Cognitive testing was undertaken to ensure that intellectual functioning was

sufficient (Leistungsprüfsystem, Horn, 1983).

After baseline assessment (t0) participants were randomly assigned to CBT or ST.

Immediately following treatment the post-treatment assessment (t1) took place with raters who

were blind to the treatment conditions. Further follow-up assessments took place every three

months for the first year and one more after 2 years. The analysis reported here will focus on

immediate effects of CBT on symptoms and psychological variables comparing pre- (t0) and

post-treatment assessment (t1) as well as relapse rates for the total 33 month period.

Statistical analysis: In the original planning stage a power analysis assuming a large effect

size (with power = .80, p < .05) suggested a required sample size of 2 x 20 patients to detect

mean differences and 2 x 26 for detecting differences in χ2-tests (Cohen, 1988). According to

Chambless and Hollon (1998) such a sample size should reveal differences to be clinically

meaning.

Baseline comparisons were done if appropriate parametrically using t-tests for dimensional

measures and used χ2 for categorical variables. All main analyses are presented as intend-to-treat

analyses. Using SPSS 17.0 treatment effects were analysed with analysis of variance with

repeated measurements including the factors time, treatment condition and their interaction. For

the analyses, exact p-values will be reported up to p = .15. The primary hypothesis referring to


survival time (in weeks) was analyzed using Kaplan Meier curves with significance tests based

on the log rank test. The secondary hypothesis was tested by running Cox proportional

regressions to estimate the effects of the specified covariates for the whole sample including

therapy condition: number of prior episodes, diagnosis (coded as ‘1’ bipolar I, ‘2’ bipolar II) age

of onset, medication adherence (Somatotherapy index, 0 to 4), number of therapy sessions, and

baseline overall functioning (GAS). Skew, kurtosis and univariate outliers were checked, and

‘number of episodes’ was transformed using the natural logarithm (ln). No transformation

improved skew of ‘number of therapy sessions’ so the original raw scores were used. Two

multivariate outliers were identified (both men in their sixties with a comorbid personality

disorder, one CBT/one ST) but since their inclusion did not change the results, they were

included in the analyses. Analyses were conducted separately for any new affective episode, as

well as for depressive and manic episodes (including hypomanic and mixed episodes).

Results

Patient characteristics

Overall 141 patients contacted us (Figure 1). In some cases the only contact was via phone,

Twenty individuals did not have a primary BD. Two patients were excluded because they had a

current substance dependency. Nine patients withdrew their informed consent prior to start of

treatment (mainly because of the required video taping of the therapy sessions). Comparing the

randomized patients to the non-participating ones revealed no differences with respect to gender,

type of BD, lifetime diagnosis of alcohol- or substance related disorders, personality or anxiety

disorders, all χ2 or Fishers’s exact tests p>.10, The same was true for age, age of onset, current

medication adherence or current level of depression, all t<│1.15│. Patients who participated

had low but significantly higher manic ratings (BRMAS), than those who discontinued,

t(77.76)=2.73, p<.008, d=.41, M=1.68 [SD=3.22] vs. 0.50 [SD=0.86] respectively. Despite their

higher subsyndromal manic symptoms, their current psychosocial functioning was considered


significantly higher than those who did not continue with the study, t(90) =2.10, p<.05, d=.58,

M=69.59 [SD=12.64] vs. 62.31 [SD=12.45] respectively.

Fifty-three (69.7%) out of the 76 patients had at least one mood stabilizer (and in 17 cases

this was accompanied by an antidepressant medication). Seven (9.2%) were only on

antidepressant medication, and16 (21.1%) did not take any medication at the beginning of the

study. Of the 53 receiving mood stabilizers, the majority (51.3%, n = 39) had one, 13 (17.1%)

had a combination of two and one individual (1.3%) three mood stabilizers (Lithium: n = 30;

valproate: n = 16; carbamazepine: n = 9; antipsychotics: n = 13). The groups did not differ in the

whether they had a mood stabilizer or antidepressant medication, all χ2≤ 1.27, n.s. (data not

shown).

In Table 1 the baseline characteristics of the final sample are displayed. No significant

baseline differences between CBT and ST were found for any of the variables suggesting

successful randomisation. Completers were those patients who attended at least 16 out of 20

sessions. A total of 11 patients attended less than 16 sessions and were considered dropouts

(14.5%). Most patients dropped out (82%) before session 10. Dropping out was unrelated to

treatment condition, sex, marital status, type of BD or comorbid substance-use or anxiety

disorders, all χ2≤ 1.81 or Fisher’s exact test p>.15. The same was true for age, current symptoms

of depression, number of episodes, or psychosocial functioning according to the GAS, all

t<1.58. Dropouts were more likely to have a personality disorder diagnosis (54.5%) than

completers (13.8%) (Fisher´s p=.006). When excluding dropouts, the average number of

sessions attended was 18.53 (SD=1.09) for CBT and 19.28 (SD=1.17) for ST.

Primary outcomes: post-treatment effects and relapse rates:

Post-treatment effects: Descriptive data are displayed for baseline and post-treatment

symptoms and indicators for psychosocial functioning in Table 2. As can be seen symptoms of

depression significantly decreased over time, but there was no significant time x treatment


interactions for self-ratings or observer-ratings. Self-rated but not clinician-rated manic

symptoms significantly decreased over time. Psychosocial functioning (GAS) improved, but this

was not specific to either treatment condition. Using the Somatotherapy Index to quantify

current medication adherence based on blood levels of different medications, there was no

evidence for any change.

Internal locus of control significantly increased over time, and external locus of control

(chance) decreased but no significant time x treatment interaction was observed. Internal locus

of control (powerful others) did not change over time. Some of the illness-related cognitions

(e.g. negative expectations, idiosyncratic assumptions) changed over time in the expected

direction, but no significant effect was found favouring CBT. There was only a non-significant

trend for CBT-treated patients to trust their clinicians more after therapy.

Relapse rates: Overall 64.5% (n=49) of the patients had at least one recurrence within the 33

study months (see Table 1). On average the first recurrence occurred 67.53 (SE=9.21) after

treatment for the CBT group and 66.25 weeks (SE=10.58) for the ST group. Kaplan Meier

analyses revealed that survival times until first recurrence of any affective episode did not

significantly differ between therapy conditions, Log Rank (Mantel-Cox) χ2=0.004, n.s. (Figure

2). Looking at first depressive recurrence, the mean survival times were 86.05 (SE=9.75) and

88.86 (SE=11.15) for CBT and ST respectively, Log Rank χ2 =0.02, n.s. The equivalent survival

times for any hypomanic, manic or mixed episode were 95.85 (SE=10.05) and 113.60

(SE=0.97), again revealing no significant difference in survival time, Log Rank χ2=1.33, n.s.

Secondary outcomes: predictors of survival time:

Proportionality of hazards was tested and was given for all but ‘number of prior episodes

(ln)’ so that its interaction with time was included in the analysis. The results of the Cox

regression model are displayed in Table 3. Confirming the prior analysis, there was no

statistically significant effect of therapy condition after adjusting for the seven covariates, -2

Log Likelihood χ2(df=1)=0.11, p=.75, R2=.001, Survival time till any mood episode was,


however, predicted by the set of covariates, Log Likelihood χ2(df=7)=20.12, p<.005, R2=.23,

with three predictors being significant and not including 1.00 in the C.I.. Patients with bipolar-I-

disorder had a 60% decrease in risk for a recurrence compared to bipolar-II-patients.

Examination of the logarithm of the number of episodes each increase of one point increased

risk for relapse by 7 %. However, risk for a relapse decreased by 10% with each therapy session.

Analysis of survival time until first depressive episode, indicates that again the covariates

contributed significantly to the prediction, Log Likelihood χ2(df=7)=20.68, p<.005, R2=.24, with

bipolar-I versus -II and number of therapy sessions being significant predictors. More therapy

sessions were again associated with longer time until depressive episode, and bipolar-II was

associated with increased risk for depressive relapse. A different picture emerged for manic-like

episodes. Although number of prior episodes emerged as significant predictor of shortened

survival time, overall the set of covariates did not significantly predict survival time, Log

Likelihood χ2(df=7)=8.11, n.s., R2=.10 (Table 3),

Discussion

Several reviews conclude that overall studies have shown that adjunctive psychotherapy has

beneficial effects for patients with BD (e.g. Beynon et al., 2009; Miklowitz & Scott, 2009;

Szentagotai & David, 2010), However, at least when focusing on the studies evaluating CBT it

is only justified to conclude that adjunctive CBT is mostly more effective than treatment-as-

usual or waiting for treatment. We addressed therefore the question of whether CBT shows any

evidence for post-treatment benefits and relapse prevention that go beyond those of a supportive

therapy (ST) equal in number and duration of sessions and including information and a mood

diary.

Disregarding any trends, the general picture is that the changes observed over time in both

CBT and ST in subsyndromal symptoms and cognitive factors such as locus of control were the

same but that the treatments did not differ on post-treatment outcome. The same was true for


rates of recurrence and time until recurrence. Partially in line with prior studies (e.g. Scott et al.,

2006; Zaretsky et al., 2008) higher risk for any recurrence was predicted by a higher number of

prior episodes, lower number of therapy sessions and bipolar-II-disorder. The pattern for

depressive and manic recurrence was different but it is not clear whether this is due to low

power for distinct episodes or evidence for polarity-specific predictors (e.g. Johnson & Meyer,

2004).

Our results contrast with other studies which showed that psychosocial treatments

significantly reduced relapse rates (e.g. Lam et al., 2003; Miklowitz et al., 2003). However,

most studies either used a waiting list control group, TAU or fewer sessions (e.g. Zaretsky et al,

2008). While Colom et al (2003) used an unstructured group setting as a control condition, their

and our study are not directly comparable; they focused on group treatment while we had an

individual therapy setting. Most closely resembling our ST condition, is the ‘intensive clinical

management’ used by Frank et al. (2005) as a control group in their RCT evaluating IPSRT.

Initial analyses revealed that it is not the specific kind of treatment per se but the continuity of

the treatment condition from the acute to the maintenance phase that was beneficial (Frank et

al., 1999).

What do our results imply? Time effects do not necessarily reflect treatment effects because

other factors could contribute to or account for those changes as well. Non-significant

differences in relapse rates can indicate either a lack of efficacy for both CBT and ST or equal

effectiveness. The pattern of results – decreases in depression, increases in psychosocial

functioning, no changes in medication adherence, specific changes in locus of control –

resemble other studies (e.g. Lam et al., 2003, Scott et al., 2001). Very few other studies included

such a long follow-up of 2 years in addition to the treatment period, but the overall relapse rate

of 64.5% for 33 months is still within the range of relapse rated reported by some others (e.g.

Colom et al., 2003: 66.7% versus 91.7%; Lam et al., 2005: 63.8% versus 84%). We therefore


conclude that the observed effects are unlikely in the absence of any treatment added to

medication.

The question remains why CBT and ST actually led to these comparable outcomes? First of

all, information was incorporated in both conditions and is generally considered essential in all

psychosocial treatments for BD (Scott et al., 2007; Miklowitz & Scott, 2009). Secondly, the

mood diary was originally used to increase credibility of our ‘control condition’ and to disguise

outcome of the randomisation process. However, we believe that the self-monitoring proved to

be central for many patients and triggered in many patients self-management and self-regulation

processes regardless of the treatment condition.

Before drawing final conclusions, some limitations should be considered; Firstly, the sample

size might be considered small. Although we acknowledge that this study is smaller than others

(e.g. Lam et al., 2003, 2005; Scott et al., 2006), the sample was larger than needed according to

our original power analysis. Additionally, the effect size of R2=.001 for treatment effects with

regard to recurrences, implies that only an enormous sample would potentially find any

evidence for differential effects or moderators for CBT versus ST. Secondly, we did not

formally assess adherence to the treatment manuals. We cannot totally rule out that this could

have affected results, but the training and especially the weekly video-based supervision was

aimed at reducing risk of deviating from the manuals. Finally, a potential bias in participation

and drop-out was observed which affects generalizability of the results but is not surprising (e.g.

McFarland & Klein, 2005; Shea et al., 1990). However, we were less restrictive in our inclusion

criteria than other studies trying to increase external validity.

In summary, our study adds to the complex picture that CBT might work better when there is

nothing else in place (e.g. waiting, TAU), but we did not find much evidence for specific effects

of CBT for BD. Given that there are several psychological approaches for BD, future research

should focus on the question of matching patients to treatments. Furthermore, considering

depression different treatments have been developed so that treatment options now differ for


acute depression, for chronic depression or for recurrent depression (e.g. Barton et al., 2008;

McCullough, 2000; Segal et al., 2002). A similar approach might be needed for improving

outcomes in patients with bipolar-I or -II disorder or those with different comorbidities.


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Figure 1:

Flowchart of recruitment of patients

Total sample n = 141

- n = 11 just phone contact

- n = 23 baseline assessment incomplete

(e.g. in psychotherapy)

N = 107 Baseline

assessment completed

- n = 9 ‘informed consent’

withdrawn

- n = 20 No bipolar disorder diagnosis

- n = 1 opiate dependency

- n = 1 alcohol dependency

N = 76 randomized

CBT n = 38

ST n – 38

Episodes during treatment:

- any mood: n = 12

- depressed: n = 7

- (hypo)manic: n = 10

Episodes during treatment:

- any mood: n = 20

- depressed: n = 14

- (hypo)manic: n = 8

- n = 33 completers - n = 5 dropouts

- n = 32 completer - n = 6 dropouts


Table 1: Baseline characteristics of patients before treatment (t0) as well as recurrence rates during follow-up

Treatment condition Cognitive Behavior Therapy (n = 38)

Supportive Therapy (n = 38)

Statistics

Gender (% women) 18 (47.4 %) 20 (52.6 %) χ2(1, n = 76) = 0.61, n.s.

Age (M +/- SD) 44.4 (11.0) 43.5 (12.7) t (74) = 0.32, n.s.

Age of onset (M +/- SD) 26.6 (9.2) 29.8 (12.4) t (74) = -1.28, n.s. Martial status – single – married – divorced

16 (42.1 %) 15 (39.5 %) 7 (18.4 %)

16 (41.0 %) 16 (41.0 %) 7 (17.9 %)

χ2(2, n = 76) = 0.11, n.s.

Diagnosis - Bipolar I - Bipolar II

30 (78.9 %) 8 (21.1 %)

30 (78.9 %) 8 (21.1 %)

χ2(1, n = 76) = 0.00, n.s.

Comorbid Axis I –Diagnosis – Alcohol abuse/- dependency – Substance abuse/- dependency – Anxiety disorders

8 (21.1 %) 6 (15.8 %) 8 (21.1 %)

9 (23.7 %) 4 (10.5 %) 10 (26.3 %)

χ2(1, n = 76) = 0.08, n.s.

χ2(1, n = 76) = 0.46, n.s.

χ2(1, n = 76) = 0.29, n.s.

Personality disorder 7 (18.4 %) 8 (21,1 %) χ2(1, n = 76) = 0.08, n.s.

Beck Depression-Inventory 13.50 (9.8) 11.03 (7.60) t (74) = 1.29, n.s.

Hamilton Depression Scale (23) a 9.6 (6.2) 10.2 (6.3) t (74) = -0.41, n.s.

Self Rating Mania Scale 17.7 (11.0) 19.3 (11.2) t (73) = 0.63, n.s.

Young Mania Rating Scale 4.0 (5.5) 2.3 (4.6) t (74) = 1.52, n.s.

Global Assessment Scale 67.4 (12,4) 71.8 (12.6) t (74) = 1.55, n.s..

Somatotherapy-Index a 2.7 (1.5) 2.6 (1.3) t (74) = 0.15, n.s..

Cognitive functioning b 56.9 (7.2) 59.6 (6.2) t (74) = -1.58, n.s..

Recurrence (9 months treatment) 12 (31.6%) 20 (52.6%) χ2(1, n=76)=3.46, p = 0.06

Recurrence (9 months plus 24 months follow-up)

Major depressive episode 19 (50 %) 17 (44.7 %)

Any manic episodes 16 (42.1 %) 11 (28.9 %)

Hypomanic episode 10 (26.3 %) 5 (13,2 %)

Manic episode 10 (26.3 %) 7 (18.4 %)

Mixed episode 0 (0,0 %) 1 (1.3 %)

Any affective episode 26 (68,4 %) 23 (60.5 %)

a Somatotherapy-Index (Mark Bauer et al., Providence, RI, unpublished manuscript) b Cognitive functioning was assessed with an intelligence test (Leistungsprüfsystem, Horn, 1983) which provide standardized T scores (M = 50, SD =10)


Table 2: Symptoms and indicators of psychosocial functioning pre (t0) and post intervention (t1)

Outcome Cognitive Behavior Therapy

Supportive Therapy

Statistics a)

N M SD n M SD

Drop-outs 5 (13,2 %)

6 (15,8 %)

χ

2(1, n = 76) = 0.11

Beck Depression Inventory t0 t1

13.50 10.93

9.38 9.17

11.03 6.00

7.60 4.35

T: F = 17.81, p < .001 TxI: F = 1.86

Self Rating Mania Inventory t0 t1

17.65 15.83

10.98 11.66

19.27 15.18

11.22 10.09

T: F = 7.07, p < .01 TxI: F = 1.05

Bech Rafaelsen Melancholia Scale

t0 t1

6.08 4.29

4.70 5.08

5.55 3.47

5.24 4.53

T: F = 10.26, p < .005 TxI: F = 0.06

Bech Rafaelsen Mania Scale t0 t1

2.34 1.64

3.69 3.37

1.03 0.79

2.56 1.19

T: F = 2.14 TxI: F = 0.53

Global Assessment Scale t0 t1

67.37 73.29

12.43 14.11

71.82 76.32

12.62 16.79

T: F = 8.90, p < .01 TxI: F = 0.17

Medication adherence (Somatotherapy-Index) b)

t0 t1

2.55 2.53

1.59 1.45

2.50 2.53

1.41 1.47

T: F = 0.00 TxI: F = 0.03

LC - Internal locus of control t0 t1

26.42 28.13

7.54 5.15

26.24 28.41

5.60 5.59

T: F = 12.68, p < .011 TxI: F = 0.17

LC - External locus of control – Powerful others

t0 t1

24.24 24.92

5.34 4.88

25.59 25.30

5.72 5.36

T: F = 0.13 TxI: F = 0.84

LC - External locus of control – Chance

t0 t1

20.34 18.03

7.74 7.10

22.66 20.76

7.29 7.02

T: F = 10.29, p < .01 TxI: F = 0.10

Trust in medication (KK) t0 t1

37 13.14 13.78

3.77 4.10

38 13.21 12.61

4.05 4.48

T: F = 0.00 TxI: F = 2.63, p = .11

Trust in psychiatrist (KK) t0 t1

38 9.95 10.58

2.78 3.22

38 10.05 9.84

2.90 2.39

T: F = 0.89 TxI: F = 3.55, p = .06

Negative expectations (KK) t0 t1

38 7.53 6.79

4.17 3.43

38 8.00 7.36

3.42 3.31

T: F = 4.559, p < .05 TxI: F = 0.02

Feeling of guilt (KK) t0 t1

38 4.71 5.03

3.04 2.40

38 5.34 4.95

2.27 2.48

T: F = 0.02 TxI: F = 1.56

Chance (KK) t0 t1

37 7.27 6.92

3.53 3.70

38 8.63 7.63

3.72 3.95

T: F = 3.23, p = .08 TxI: F = 0.74

Personal vulnerability (KK) t0 t1

38 6.13 6.45

3.21 3.06

38 6.11 6.05

2.68 2.85

T: F = 0.35 TxI: F = 0.68

Idiosyncratic assumptions (KK) t0 t1

38 6.92 6.21

3.66 4.02

37 8.30 7.62

3.57 3.01

T: F = 4.82, p < .05 TxI: F = 0.00

Notes: KK: Krankheitskonzept Skala (Illness Concept scale) Linden et al. and its subscales; LC (Locus of Control) scales. a) T: F-value for main effect of time, I: F-value for main effect of treatment condition, IxT: F-value for the interaction term of time and treatment condition b) Somatotherapy-Index: This index is a score varying between 0 and 5 to describe the quality of prescribed and taken medication based primarily on blood serum levels (Mark Bauer et al., Providence, RI, unpublished manuscript)


Table 3: Predictors in the Cox regression models for recurrence of depression, mania and any affective episode

Variables B (SE) Wald Odds Ratio CI 95 %

Any affective episode

Diagnosis -.91 (.37) 6.07* 0.40 0.20 – 0.83

Medication adherence .04 (.11) 0.00 1.00 0.81 – 1.25

Age of onset .20 (.01) 2.13 1.02 0.99 – 1.05

Psychosocial functioning (GAS t0) -.01 (.01) 0.39 0.99 0.97 – 1.02

Number of episodes .57 (.25) 5.27* 1.77 1.09 – 2.87

Number of episodes x time -.16 (.01) 6.77** 0.98 0.97 – 1.00

Number of therapy sessions -.11 (.04) 6.45* 0.90 0.83 – 0.98

Treatment condition .10 (.30) 0.11 1.10 0.61 – 1.96

Recurrence of depression

Diagnosis -1.05 (.41) 6.65** 0.35 0.16 – 0.78

Medication adherence -.07 (.12) 0.30 0.94 0.73 – 1.19

Age of onset .03 (.02) 3.81‡ 1.03 1.00 – 1.06

Psychosocial functioning (GAS t0) -.02 (.02) 1.16 0.98 0.96 – 1.01

Number of episodes .47 (.29) 2.70 1.60 0.91 – 2.81

Number of episodes x time -.02 (.01) 4.70* 0.98 0.07 – 1.00

Number of therapy sessions -.11 (.05) 4.95* 0.90 0.81 – 0.98

Treatment condition -.01 (.01) 0.00 0.99 0.97 – 1.00

Recurrence of mania

Diagnosis -.60 (.48) 1.57 0.55 0.21 – 1.40

Medication adherence -.06 (.15) 0.19 0.94 0.71 – 1.25

Age of onset -.02 (.02) 0.82 0.98 0.95 – 1.02

Psychosocial functioning (GAS t0) .00 (.02) 0.03 1.00 0.97 – 1.04

Number of episodes .71 (.32) 4.95* 2.04 1.09 – 3.81

Number of episodes x time -.01 (.01) 2.36 0.99 0.98 – 1.00

Number of therapy sessions -.07 (.08) 0.96 0.93 0.80 – 1.08

Treatment condition .51 (.40) 1.62 1.66 0.98 – 1.00

Notes: Diagnosis coded ‘1’ as Bipolar I and ‘2’ as Bipolar II; Number of prior episodes – logarithmically transformed (Ln), Medication adherence – scores according to Somatotherapy index, 0 = no medication, and 4 = optimal level of medication; treatment condition coded as ‘0’ Supportive Therapy, ‘1’ Cognitive Behavior Therapy’ ‡ p < .10 * p < .05 ** p < .01


Figure 2: Cumulative survival functions with regard to recurrence of any affective episode for Cognitive Behaviour Therapy and Supportive Therapy

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