Long-term outcome of cognitive behaviour therapy clinical trials in central Scotland.

OBJECTIVES: To establish the long-term outcome of participants in clinical trials of cognitive behaviour therapy (CBT) for anxiety disorders and psychosis, examining the effectiveness and cost-effectiveness associated with receiving CBT in comparison with alternative treatments. DESIGN: An attempt was made to contact and interview all of the participants in eight randomised, controlled, clinical trials of CBT for anxiety disorders and two randomised, controlled, clinical trials of CBT for schizophrenia conducted between 1985 and 2001. Case note reviews of healthcare resources used in the 2 years prior to entering the trials and the 2 years prior to follow-up interview were undertaken. SETTING: Mixed rural and urban settings in five localities in central Scotland. Anxiety disorder trials were conducted mainly in primary care and included three with generalised anxiety disorder, four with panic disorder and one with post-traumatic stress disorder (PTSD). The psychosis studies (one on relapse prevention and one with chronic disorder) were conducted in secondary care. PARTICIPANTS: Of the 1071 entrants to the 10 studies, 489 agreed to participate (46% of original entrants, 52% of those available to contact). INTERVENTIONS: Follow-up interviews took place between 1999 and 2003, 2-14 years after the original treatment. Interviews for Trials 1-8 were conducted by a research psychologist blind to original treatment condition. Interviews for Trials 9 and 10 were conducted by community psychiatric nurses also blind to treatment condition. Case note reviews were completed following the interview. MAIN OUTCOME MEASURES: For Trials 1-8 the main interview-based outcome measures were: Anxiety Disorders Interview Schedule-DSM-IV for diagnosis and co-morbidity, Clinical Global Severity (0-8) and the Hamilton Anxiety Rating Scale. The main patient-rated measures were: Brief Symptom Inventory, SF-36 II, Clinical Global Improvement (1-7), and the Positive and Negative Affect Scale. For Trials 9 and 10 the primary outcome measure was the interview-based Positive and Negative Syndrome Scale (PANSS). RESULTS: For the anxiety disorder studies (Trials 1-8), over half of the participants (52%) had at least one diagnosis at long-term follow-up, with significant levels of co-morbidity and health status scores comparable to the lowest 10% of the general population. Only 36% reported receiving no interim treatment for anxiety over the follow-up period with 19% receiving almost constant treatment. Patients with PTSD did particularly poorly. There was a 40% real increase in healthcare costs over the two time periods, mainly due to an increase in prescribing. A close relationship was found between poor mental and physical health for those with a chronic anxiety disorder. Treatment with CBT was associated with a better long-term outcome than non-CBT in terms of overall symptom severity but not with regard to diagnostic status. The positive effects of CBT found in the original trials were eroded over longer time periods. No evidence was found for an association between more intensive therapy and more enduring effects of CBT. Long-term outcome was found to be most strongly predicted by the complexity and severity of presenting problems at the time of referral, by completion of treatment irrespective of modality and by the amount of interim treatment during the follow-up period. The quality of the therapeutic alliance, measured in two of the studies, was not related to long-term outcome but was related to short-term outcome. The cost-effectiveness analysis showed no advantages of CBT over non-CBT. The cost of providing CBT in the original trials was only a very small proportion (6.4%) of the overall costs of healthcare for this population, which are high for both physical and mental health problems. In the psychosis studies (Trials 9 and 10), outcome was generally poor with only 10% achieving a 25% reduction in total PANSS scores from pretreatment to long-term follow-up, also cost-effectiveness analysis showed no advantages of CBT over non-CBT, although healthcare costs fell over the two time periods mainly owing to a reduction in inpatient costs. CONCLUSIONS: Psychological therapy services need to recognise that anxiety disorders tend to follow a chronic course and that good outcomes with CBT over the short term are no guarantee of good outcomes over the longer term. Clinicians who go beyond standard treatment protocols of about 10 sessions over a 6-month period are unlikely to bring about greater improvement. Poor outcomes over the long term are related to greater complexity and severity of presenting problems at the time of referral, failure to complete treatment irrespective of modality and the amount of interim treatment during the follow-up period. The relative gains of CBT are greater in anxiety disorders than in psychosis. Longitudinal research designs over extended periods of time (2-5 years), with large numbers of participants (500+), are required to investigate the relative importance of patient characteristics, therapeutic alliance and therapist expertise in determining the cost-effectiveness of CBT in the longer term.

On predicting improvement and relapse in generalized anxiety disorder following psychotherapy.

This paper concerns an investigation of outcome predictors in a clinical trial of psychological therapies for generalized anxiety disorder. A variety of information of potential predictive value was obtained at three stages of patient contact: the initial referral, a screening interview and early sessions of therapy. Three measures of the clinical significance of change over a 12-month follow-up period were used to construct a composite measure which categorized outcome in terms of sustained improvement, relapse and no consistent change. Logistic regression was used to examine the validity of predictors identified in previous research and the relative importance of data obtained from the three different stages. Seventy-one per cent of patients were correctly classified as improved or not from initial data with a significant increase in accuracy with information from the screening interview (77 per cent) and early sessions (82 per cent). Patients who relapsed or not were predicted with considerable accuracy from initial data (90 per cent) and there was no significant increase in predictive power with additional information. The most powerful and robust predictors were: type of treatment received, marital status, marital tension and complexity of clinical presentation in terms of axis 1 co-morbidity. A conceptual framework for prediction is outlined.

Lewinsohn's behavioral measures of social skill: their stability and relationship to mood level and depression among college students.

Reports on investigations of the stability of eight of Lewinsohn's (1975) measures of social skill and their relationship to indices of depression and mood level in college students who are attending small informal discussion groups. Five of his measures showed no significant degree of stability across group sessions. The remaining measures, mainly indices of activity level, showed a significant though only moderate degree of generalizability. No significant differences in activity level were found between depressed and nondepressed Ss. However, several post-hoc analyses revealed that the variability of the Ss' mood and behavior across group sessions was associated significantly with their D30 scores. Depressed Ss were more variable in their mood and behavior. Implications of these results are discussed briefly.

Psychological treatment of generalised anxiety disorder. A review of the clinical significance of results in outcome studies since 1980.

Comparative outcome studies of generalised anxiety disorder suggest that psychological therapy is a potentially valuable alternative to anxiolytic medication. However, on average psychological therapy results in modest improvements in symptoms, with about 50% of patients achieving normal functioning. Limited follow-up data indicate that these changes are maintained over six months. Cognitive therapy appears to be most effective, although comparisons with other therapies are limited and non-specific factors are clearly important. There is also evidence of considerable variability in outcome between studies, with the best results obtained with patients who are free of anxiolytic medication and recruited directly from primary care or other non-psychiatric settings. The effects on outcome of patient characteristics known to be associated with more severe illness and complexity of clinical presentation have yet to be explored. A balanced appraisal of the value of psychological therapy with this common condition requires a fuller description of sample characteristics and more systematic investigation of the clinical significance of treatment effects over the long term.

Recovery rates in generalized anxiety disorder following psychological therapy: an analysis of clinically significant change in the STAI-T across outcome studies since 1990.

BACKGROUND: There have been six randomized controlled trials of psychological therapy with generalized anxiety disorder (GAD) using DSM-III-R and DSM-IV. All have used the Trait version of the Spielberger State-Trait Anxiety Inventory (STAI-T) as one of several outcome measures. Each study, however, employed different methods of calculating the clinical significance of outcomes making it difficult to reach a balanced appraisal of the efficacy of psychological treatment. METHODS: Raw data on STAI-T scores at pre-, post- and follow-up were obtained for each of the six studies (total N = 404). Jacobson methodology for defining clinically significant change (criterion c, reliable change index = 8, cut-off point = 46) was used to allocate each patient to one of four outcomes: worse, unchanged, improved and recovered. The proportion of patients in each category was calculated for treatment conditions in each study and also for aggregate data across types of treatment. RESULTS: A recovery rate of 40% was found for the sample as a whole with 12 of the 20 treatment conditions obtaining very modest recovery rates of 30% or less. Two treatment approaches--individual cognitive behavioural therapy and applied relaxation--do relatively well with overall recovery rates at 6-month follow-up of 50-60%. CONCLUSIONS: Jacobson methodology, in distinguishing between improvement and recovery on a standardized measure of general vulnerability to anxiety, provides a stringent but clinically more meaningful evaluation of the efficacy of psychological therapies with GAD than has been available hitherto. Systematic focus on either excessive worry or physiological arousal gives worthwhile results.

Does cognitive-behavioural therapy influence the long-term outcome of generalized anxiety disorder? An 8-14 year follow-up of two clinical trials.

BACKGROUND: Generalized anxiety disorder is a common condition of excessive worry and tension which tends to run a chronic course associated with significant psychiatric and medical problems. Cognitive behaviour therapy (CBT) has been shown to be of clinical value in about 50% of cases with treatment gains maintained over follow-up periods ranging from 6 to 12 months. The potential value of CBT over the longer term has not been subject to rigorous investigation. METHOD: Results are reported of 8-14 year follow-up of two randomized controlled trials of cognitive-behaviour therapy for generalized anxiety disorder employing structured interview with an assessor blind to initial treatment condition. Comparison groups included medication and placebo in one study based in primary care, and analytical psychotherapy in the other based in secondary care. Follow-up samples (30% and 55% of trial entrants) were broadly representative of the original cohorts. RESULTS: Overall, 50% of participants were markedly improved of whom 30-40% were recovered (i.e. free of symptoms). Outcome was significantly worse for the study based in secondary care in which the clinical presentation of participants was more complex and severe. For a minority (30-40%), mainly from the secondary care study, outcome was poor. Treatment with CBT was associated with significantly lower overall severity of symptomatology and less interim treatment, in comparison with non-CBT conditions, but there was no evidence that CBT influenced diagnostic status, probability of recovery or patient perceptions of overall improvement. CONCLUSIONS: Both CBT and the complexity and severity of presenting problems appear to influence the long-term outcome of GAD.

Cognitive therapy, analytic psychotherapy and anxiety management training for generalised anxiety disorder.

BACKGROUND: We test the hypotheses that (a) cognitive therapy is of comparable efficacy to psychodynamic psychotherapy, (b) 8-10 sessions of therapy is as effective as 16-20 sessions, and (c) brief therapist training is as effective as intensive training. METHOD: Of 178 out-patients referred to a clinical trial of psychological treatment for generalised anxiety, 110 patients met DSM-III-R criteria for generalised anxiety disorder and were randomly assigned to three different forms of psychotherapy. The main comparison was between cognitive therapy and analytic psychotherapy, delivered by experienced therapists at weekly or fortnightly intervals over six months. A third treatment, anxiety management training, was delivered at fortnightly intervals by registrars in psychiatry after a brief period of training. Eighty patients completed treatment and were assessed before treatment, after treatment, and at six-month follow-up. RESULTS: Cognitive therapy was significantly more effective than analytic psychotherapy, with about 50% of patients considerably better at follow-up. Analytic psychotherapy gave significant improvement but to a lesser degree than cognitive therapy. There was no significant effect for level of contact. Patients receiving anxiety management training showed similar improvements to cognitive therapy after treatment, with rather lower proportions showing clinically significant change. CONCLUSIONS: Cognitive therapy is likely to be more effective than psychodynamic psychotherapy with chronically anxious patients. Significant improvements in symptoms can be achieved by trainee psychiatrists after only brief instruction in behaviourally based anxiety management. However, the superiority of cognitive therapy at follow-up suggests that the greater investment of resources required for this approach is likely to pay off in terms of more sustained improvement. There is no evidence that 16-20 sessions of treatment is more effective, on average, than 8-10 sessions.