Cognitive-behavioural therapy for patients with multiple somatoform symptoms – a randomised controlled trial in tertiary care
Bleichhardt G, Timmer B and Rief W;
Commented by , 18 Jun 2004
Background
Cognitive-behaviour therapy (CBT) is a promising treatment for somatisation syndromes, however, previous research has been limited to small samples.
Purpose
- Examine the effect of an inpatient CBT program on somatisation compared with wait-list controls.
- Evaluate the differential effect of an additional group somatisation versus relaxation module.
Methods
The treatment sample consisted of 191 consecutive patients with somatisation syndrome (≥ 8 DSM-IV somatoform symptoms), admitted to a tertiary care behavioural medicine inpatient unit in Germany. 34 wait-list patients served as controls.
All patients received “standard treatment”, and were randomly assigned to additional “management training of somatisation (soma)” or “progressive muscle relaxation (PMR).” The standard CBT program included: individual and group problem-focused therapy, assertiveness training, modules targeting comorbid mood-anxiety disorders where indicated.
Soma and PMR consisted of 8x100 minute manualized group sessions with trained therapists. The soma group was CBT-oriented, and included: psychoeducation, coping strategies, behavioural experiments, role-play, relaxation-training, biofeedback, cognitive restructuring, reduction of avoidance behaviour.
A battery of psychometric instruments at admission, discharge and 1-year follow-up measured: somatoform symptoms, general psychopathology, anxiety, depression, life satisfaction, quality of life, healthcare utilization and occupational disability. Repeated measures ANOVA tested outcome (time effect) and time by group interaction effect. Effect sizes and additional intention-to-treat (ITT) analysis were performed.
Results
Females represented 73.3% of the sample. Mean age of 43.9, Mean treatment duration of 51.9 days. There were no between group differences on baseline variables. Comorbid affective and anxiety disorders were found in 74% and 47% of the sample, respectively. Patients had a mean 9.2 years history of mental illness, and a mean number of 20.6 somatoform symptoms and 40 doctor visits/year. The 1-year response rate was 82%.
Across all the outcomes, there was significant 1-year improvement for both treatment groups, with effect sizes of d=0.65 and 0.57 for soma and PMR, respectively. While soma achieved a trend for greater improvement, a significant time by group interaction was only found for doctor visits, with a 39% vs. 18% reduction. Response rates (< 8 somatoform symptoms) were 59% for soma and 48% for PMR. There were no changes in wait-list controls. The ITT analysis yielded similar findings.
Discussion
The added effect of the soma module could not be demonstrated beyond a >50% reduction in doctor visits. This finding alone is an important outcome. The failure to find further improvements across other outcomes may be attributable to the therapeutic effects of the program as a whole, with the sum greater than its individual parts. It also raises questions about the specificity or active ingredients of the program.
Were patients able to apply the CBT paradigm to their somatisation syndromes independent of a soma module? With the high rates of mood-anxiety comorbidity, were somatic improvements secondary to the impact of CBT on mood-anxiety syndromes?
Additional therapeutic factors also bear consideration. For example, adjunctive physiotherapy, occupational therapy, or psychopharmacology was not made explicit. Their findings could have been strengthened with more objective outcome measures, mitigating a response bias.
This is the second consecutive commentary in this section of CNSforum bringing attention to emerging CBT programs for somatoform disorders. Considering the morbidity of the treatment sample, these findings are encouraging.
They underscore the treatable nature of these disorders, and the important role that mental health practioners may play in the treatment of this population.