School of Psychological Sciences, University of Manchester, UK
Manchester Mental Health & Social Care Trust, Manchester, UK
School of Epidemiology and Health Science, University of Manchester, UK
School of Psychological Sciences, University of Manchester, UK
Correspondence: Professor Christine Barrowclough, School of Psychological Sciences, Rutherford House, Manchester Science Park, Lloyd Street North, Manchester M15 6SZ, UK. Email: christine.barrowclough{at}manchester.ac.uk
Declaration of interest None. Funding detailed in Acknowledgements.
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Aims To evaluate the effectiveness of group cognitive–behavioural therapy for schizophrenia.
Method In all, 113 people with persistent positive symptoms of schizophrenia were assigned to receive group cognitive–behavioural therapy or treatment as usual. The primary outcome was positive symptom improvement on the Positive and Negative Syndrome Scales. Secondary outcome measures included symptoms, functioning, relapses, hopelessness and self-esteem.
Results There were no significant differences between the cognitive–behavioural therapy and treatment as usual on measures of symptoms or functioning or relapse, but group cognitive–behavioural therapy treatment resulted in reductions in feelings of hopelessness and in low self-esteem.
Conclusions Although group cognitive–behavioural therapy may not be the optimum treatment method for reducing hallucinations and delusions, it may have important benefits, including feeling less negative about oneself and less hopeless for the future.
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Participants
Ethical agreement for the study was obtained from local research ethics
committees. Inclusion criteria were:
Recruitment and randomisation
Potential participants were identified from databases in the five
participating National Health Service (NHS) mental health trust sites, and
consenting patients were assessed for symptom criteria. Recruitment,
randomisation and the running of groups were staggered. Within each site,
sufficient participants to form one CBT group and an equal number for the
control condition (approximately 12 people) were identified. They were then
allocated to the two conditions using a programme operated by an individual
independent of the research team, following the minimisation method of
stratification (Pocock, 1983)
for chronicity (3 years or less v. greater than 3 years).
Intervention
The group intervention ran for 6 months, with 18 sessions covering the
following themes:
Sessions lasted 2 hours including breaks, and followed a detailed plan and timetable contained in the therapy manual (a copy of which can be obtained from the first author). The session plan included setting the days agenda, introducing the main topic, reviewing homework, applying the topic to individuals own experiences, problem formulations in small groups, discussion and comparison of group members experiences, setting homework and eliciting feedback on the session.
Treatment quality and adherence
Two therapists conducted each session, and at least one therapist per group
had training in CBT meeting the British Association of Behavioural and
Cognitive Psychotherapy accreditation standards, plus experience in using CBT
with people with psychosis. All therapists were provided with an initial
training programme, and supervision sessions occurred monthly. Independent
assessment of treatment adherence from audiotaped sessions was not possible
because of problems in obtaining consent for taping from all group
participants. An alternative measure of treatment adherence (available from
the first author) was devised; checklists were completed at each session by
both therapists and participants independently, to assess whether key elements
of the CBT protocol were adhered to. These elements included agenda-setting,
session structure, therapist–patient collaboration, focus on patient
cognitions and behaviours, homework-setting and review.
Independently completed checklists from all therapists and participants present were collected on random session dates (20 for participants and 25 for therapists). Interrater reliability was high; there was 92.57% participant agreement and 96.33% therapist agreement. As regards the patient ratings of treatment fidelity, in 164 checklists the percentage of full-adherence scores ranged from 77.4% to 94.5%. For the therapist ratings of treatment adherence 233 checklists were completed. Across all completed checklists, the percentage rated as fully adherent ranged from 86.3% to 94.4%. Hence the checklists indicated that participants and therapists themselves considered they had adhered very closely to the protocol.
Primary outcome measure
This was improvement in positive symptoms as measured by the positive
symptom sub-scale of the PANSS. Interrater reliability was assessed on this
clinician-rated assessment by computing interclass correlation coefficients
for the rating of eight videotaped interviews before starting the trial by the
five assessors in this study, and the ratings from gold-standard assessments
by four research psychiatrists external to the study. Averaged over the five
assessors, the interclass correlation coefficients for the PANSS sub-scales
were: positive, 0.84; negative, 0.88; general, 0.71; and total symptoms, 0.91.
During the study, random reliability checks were made on ten interviews for
each assessor, and average interclass correlation coefficients were: positive,
0.85; negative, 0.84; general, 0.91; and total symptoms, 0.78.
Secondary outcome measures
Secondary interviewer-rated outcome measures included the negative, general
and total PANSS scores, and the Global Assessment of Functioning (GAF;
American Psychiatric Association,
1987) using the two-scale scores (0–100) of symptoms and
disability. Reliability of the interviewers for the latter was assessed using
a subsample of 40 participants and two raters. The intraclass correlations
were: r=0.96 (symptoms) and r=0.87 (disability).
Secondary self-report outcome measures
These were the Social Functioning Scale (SFS;
Birchwood et al,
1990); the Hospital Anxiety and Depression Scale (HADS;
Zigmond & Snaith, 1983);
the Beck Hopelessness Scale (BHS; Beck, 1974); and the Rosenberg Self-Esteem
Scale (RSE; Rosenberg,
1965).
Relapse and readmission
Finally, two methods of assessing the frequency and duration of relapse and
readmission to hospital in the 6 months after the treatment period ended (12
months follow-up) were measured using definitions from a previous trial
(Barrowclough et al,
1999). These were the number and duration of hospital admissions
identified from hospital record systems, and the number and duration of
exacerbations of symptoms lasting longer than 2 weeks and requiring a change
in patient management (increased observation or medication change made by
clinical team as assessed from hospital case notes). Where symptom
exacerbation preceded admission to hospital, only one relapse was recorded.
Interrater reliability for the number and duration of exacerbations was
checked by comparing ratings for ten randomly selected participants. No
differences were found between the two independent assessors for these
variables.
Strategy for statistical analyses
To minimise the number of missing cases, separate cross-sectional analyses
were performed to examine the treatment effects for each outcome measure at 6
months (post-treatment) and 12 months (followup). A linear random effects
model adjusted for the outcome measure at baseline, together with age, gender
and time since onset. Since treatment administered in a group can create
dependencies among observations that violate the independence of observations
assumption of statistical tests (Baldwin
et al, 2005), the model included a random effect to
account for the between-group variation, analogous to that used in cluster
randomised trials (Roberts & Roberts,
2005). As noted above, within each participating NHS trust
patients were randomised in blocks of approximately 12, to permit patients
from one locality to form a CBT group and an equal number to experience the
control condition. Therefore the analyses also included a random effect for
block to prevent between-block variation (due to unknown factors peculiar to
that group of patients) inflating the between-treatment arm variation. From
the estimates of the variance of random effects, intracluster correlation
coefficients were calculated as a measure of the lack of independence
resulting from patients being treated in groups. These coefficients would take
on a value of zero if there was no intragroup correlation, and one if there
was complete concordance in outcome for members of the same group, for all
groups.
A longitudinal model was also fitted to the 6- and 12-month data combined. As well as the baseline covariates, this included time point (6 or 12 months), treatment (group CBT or treatment as usual), and a time–treatment interaction as well as random effects for participants and therapy group. In these analyses, a significant time–treatment interaction effect would be interpreted as change in the treatment effect from 6 to 12 months. If there was no interaction, the main effect of treatment would indicate that the treatment effects of group CBT and treatment as usual were similar at 6 and 12 months.
To facilitate comparison between measures and other trials, standardised treatment effects were computed by dividing the treatment effect by the pooled baseline standard deviations for the group CBT and treatment as usual. Finally, relapse outcomes were analysed using a survival model.
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![]() View larger version (18K): [in a new window] [as a PowerPoint slide] |
Fig. 1 Flow of participants through the study. CBT, cognitive–behavioural
therapy; TAU, treatment as usual.
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The mean number of group CBT sessions attended was 10.4 (s.d.=6.5). Using a cut-off for attendance of at least 6 sessions, 41 (72%) of the CBT group could be classed as attenders; 34 (60%) attended 12 or more sessions. All analyses were reported on an intention-to-treat basis, whereby all participants who agreed to assessment were included.
Sample characteristics
Of the total study sample, 82 (72.6%) were men; the mean age of the
participants was 38.83 years (s.d.=8.6); the mean illness duration was 13.67
years (s.d.=7.99); 73 participants were single (64.6%), 19 (16.8%) married or
cohabiting and 21 (18.6%) separated or divorced; 48 (42.5%) lived alone, 24
(21.2%) lived with a relative or caregiver, 33 (29.2%) lived in a supported
hostel or flat and 7 (6.2%) lived in unsupported hostel or other
accommodation. The majority of participants (101, 89.1%) were diagnosed with
schizophrenia and 12 (10.9%) had a diagnosis of schizoaffective disorder. The
mean IQ score estimated from the National Adult Reading Test (NART;
Russell et al, 2000)
scores for the sample was 105.2 (s.d.=11.5). There were no differences between
groups on any of the demographic variables assessed.
Outcomes
Table 1 gives the summary
statistics for the outcome measures, estimates of the treatment effects from
the cross-sectional analyses, and the intercluster correlation coefficients
for the effects of the groups. For most outcome measures there was little
evidence of similarity in outcome due to group membership. There was no
evidence of a treatment effect of group CBT as compared with treatment as
usual either at completion of treatment or at 1-year follow-up for the PANSS
positive sub-scale, nor other PANSS component or total scores. Similarly,
group CBT did not appear to affect outcome for SFS total, HADS or the GAF
symptom or disability scores. However, there was improvement in the BHS and
RSE scores in favour of the group treatment at the 12-month time point.
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View this table: [in a new window] | Table 1 Summary outcome data with estimates of treatment effects |
In the longitudinal analyses, there was no evidence of a time–treatment interaction except for the variable PANSS negative symptoms scores where results were of borderline significance (P=0.054). From examination of Table 1, it can be seen that the group CBT treatment effect for PANSS negative symptom scores changed from a very slight detrimental effect at 6 months to a larger beneficial, but still non-significant, effect at 12 months. When models were fitted without an interaction term, there was evidence of a significant effect in favour of the group treatment in the pooled estimate for BHS (P=0.028) and RSE (P=0.027), but not for other measures.
As regards relapse outcomes, data on relapse were gathered for 110 of the
original 113 participants in the study–1 patient in the
treatment-as-usual group died and notes were missing for two in the CBT group.
At the end of the 12-month followup period, 18 members of the CBT group had
had at least one relapse (32.7%) compared with 15 (27.3%) in the
treatment-as-usual group (
2=0.82, P=0.365).
There were no differences between the two groups in terms of number of days in hospital (CBT median=0, range=0–181; treatment-as-usual median=0, range=0–88; z=0.14, P=0.887), number of days in exacerbation (CBT median=0, range=0–188; treatment-as-usual median=0, range=0–212; z=0.34, P=0.737) and the total number of days in relapse (CBT median=0, range=0–188; treatment-as-usual median=0, range=0–212; z=0.20, P=0.844). Time until relapse or admission was analysed using a Cox proportional hazard model. Robust standard errors were used to adjust for any clustering associated with therapy group. Table 2 gives the relative risk for admission and relapse for the group CBT participants as compared with those in treatment as usual. There was no difference between groups, although the relatively low relapse rates meant that this comparison had low power to detect statistical difference.
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View this table: [in a new window] | Table 2 Hospital admissions and relapse |
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Why did group CBT fail to improve psychotic symptom outcomes? Is the studys failure to match such outcomes for individually treated patients in previous studies due to methodological differences or weaknesses? Or are factors inherent in the group format not conducive to reducing psychotic symptoms?
Methodological issues
Were the therapists inadequately trained? The recent randomised controlled
trial of group CBT for individuals who hear voices
(Wykes et al, 2005)
concluded that hallucinations were not reduced unless therapy was conducted by
expert therapists. In the current trial, it seems unlikely that failure to
replicate good outcome could be accounted for in terms of inferior quality of
therapy. A number of the therapists had worked on previous CBT trials for
psychosis that had had good symptom outcomes; high standards for training and
supervision were adhered to; and measures of treatment fidelity indicated that
there were no significant deviations from the treatment protocol.
Did the therapy protocol deviate from that of other CBT and psychosis studies? The therapy protocol followed in our trial met all the inclusion criteria for CBT suggested by the Pilling et al (2002) metaanalytic review. With a total of 18 2-hour sessions over a 6-month period, it also fell within the longer-term treatments which the review suggests may be associated with a better outcome. However, although attendance at the group treatment was quite good, with 60% attending at least two-thirds of the sessions, the total amount of therapy for some participants may have been inadequate.
Did the sample population differ from that of previous trials? Like several key previous trials (e.g. Kuipers et al, 1997; Tarrier et al, 1998) we included only out-patients who were persistently treatment resistant, and all our inclusion criteria were in line with those of previous studies. Our sample was slightly older than the mean age for the six trials reported by Pilling et al (2002) (38.8 years v. 33.9 years) and contained more men (72.6% v. 60.4%) although there are no indications that these differences would have been meaningful in terms of outcomes.
Was the study methodologically rigorous in terms of measuring outcomes? All the assessors were trained to a reliable standard at the start, and their reliability was monitored throughout the study, so there are no indications that assessment of outcome was not methodologically rigorous. Breaks in masking were not assessed but there is no evidence of bias in favour of the CBT groups since only self-report assessments showed superior outcomes for such therapy. Differences in the delivery and take-up of standard care, including medication adherence, were not measured, although the method of randomisation within each hospital site would most likely have reduced the possibility of between-group differences.
Was the sample size adequate? With an initial 113 participants and relatively little attrition, the study was adequately powered to test for differences in terms of improvement in positive symptoms suggested by the version of the Cochrane Library review that was available at the time the study was planned. However, it falls short of the 70 people per group recommended in the current revision (Jones et al, 2005). Seeing that in this study most of the intraclass correlation coefficients for patients being treated in groups were very small, the sample size was close to that recommended for maintaining 80% power for treatment in such groups (recommended n=128 for 5 members per group, where intraclass correlation coefficient=0.00, Baldwin et al, 2005).
Interpretation of outcome for group CBT for psychosis
Previous published studies of group CBT for schizophrenia reporting
positive symptom improvements (Gledhill
et al, 1998; Wykes
et al, 1999) have had small sample sizes, did not have
control groups or masked assessment and failed to take account of the
potential lack of independence in outcomes of group-treated patients that can
increase type 1 errors dramatically
(Baldwin et al, 2005).
The results of the study reported here are consistent with the recently
published randomised controlled trial of group CBT for people who hear voices
(Wykes et al, 2005).
In that study, there was no impact on auditory hallucinations. There were
promising results for secondary outcomes, with a borderline significant
advantage to the members of the CBT group for self-esteem and a significant
improvement in social functioning.
Wykes et al (2005) point out that one clear disadvantage of group work for people with complex problems is that it lacks the flexibility to respond to diverse problem presentations, and they suggest that group CBT for psychosis might be more effective if there were homogeneity of symptom experience. However, in their study, even when the group focused on the common experience of hearing voices, hallucinations were not reduced (although there was some indication that participants treated by more expert therapists fared better).
Participants in our study were surveyed as to the advantages and disadvantages of the groups. Overall, feedback from attendees was very positive, and can be summarised in terms of the opportunity to share difficulties in a supportive context. Negative feedback focused on two sets of issues: factors that would lead to a problem in group dynamics, such as participants being dissimilar in terms of age or gender, and factors which might be seen as interfering with new learning, such as disruptions from agitated patients and inconsistent or poor attendance by some members. These factors also presented problems for therapists, and might be addressed in clinical practice where it is possible to select group participants on the basis of homogeneity of symptoms and demographic characteristics. Unfortunately, these issues were not systematically measured in our study, so their impact on outcomes could not be assessed.
A tentative conclusion is that for people with psychosis who have a broad range of persistent positive symptoms, group is less likely than individual CBT to have an impact on hallucinations and delusions, even when delivered by experienced therapists. The study design did not permit us to assess the contribution of group attendance per se to the outcomes. Factors such as getting out of the house for an afternoon each week, and meeting new people in a supportive environment, may have contributed to any patient gains rather than the specific therapeutic input of the CBT. However, the study demonstrated that group cognitive–behavioural work may have important potential benefits, including feeling less negative about oneself and less hopeless for the future. The importance of these changes should not be underestimated, in view of the prominent role that hope and empowerment have been given in recent models of recovery (Resnick et al, 2005). Future group work with people who have psychosis may be more effective if it specifically targets outcomes such as affect and self-esteem.
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The study was funded by the National Health Service Executive North West Research and Development Funding and from Pennine Care NHS Trust Research & Development monies.
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