Immediate help through group therapy for patients with somatic diseases and depressive or adjustment disorders in outpatient care: study protocol for a randomized controlled trial

BACKGROUND: One in three people with a chronic somatic disease suffer from a comorbid mental disorder. Most common comorbidities are depressive, anxiety and adjustment disorders. These lead to an increase in morbidity and mortality, and a deterioration of quality of life and healthcare costs. Treatment of mental disorders is of great importance, but the waiting time for outpatient individual psychotherapy can be up to six months in Germany. Group therapy has comparable treatment effects and is considerably more economic than individual therapy; however, it is still almost unused in the outpatient care system. The introduction of a stepped care approach, such as attending a group program before individual therapy, could improve this issue. For this purpose we developed a group program (STEpS), and its efficacy will be evaluated in this study. METHODS/DESIGN: A randomized controlled trial will be conducted to evaluate the efficacy of a cognitive behavioral therapy (CBT) group program for patients with somatic diseases and depressive or adjustment disorders, compared to a wait-list control group. A total of 128 adults with any chronic somatic disease and comorbid depression or adjustment disorder will be recruited in our outpatient clinic, and will be randomly assigned to participate in the group program immediately after contacting the clinic (intervention group) or after a waiting period of four months (wait-list control group). Primary outcomes will be self-reported depressive and anxiety symptoms. Secondary outcomes will be self-reported psychological distress, changes in experience and behavior, health-related quality of life, state of self-esteem and subjective need for therapy. Assessments will take place at baseline, 10 weeks (post-treatment) and 18 weeks (follow-up) after randomization. Additionally, treatment acceptance and psychotherapeutic process will be assessed after each session. DISCUSSION: This study investigates whether the CBT group program is an effective treatment to reduce depressive and anxiety symptoms and psychological distress in these patients. If the group program is effective, it could be implemented as a treatment option prior to individual outpatient therapy. These results will contribute to improving outpatient care for mental disorders in patients with somatic diseases. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005140 (27 August 2013).