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To explore whether and how group cognitive-behavioural therapy (GCBT) plus medication differs from medication alone for the treatment of generalized anxiety disorder (GAD).
170 patients were randomly assigned to the GCBT plus duloxetine (n=89) or duloxetine group (n=81). The primary outcomes were Hamilton Anxiety Scale (HAMA) response and remission rates. The explorative secondary measures included score reductions from baseline in the HAMA total, psychic and somatic anxiety subscales (HAMA-PA, HAMA-SA), the Hamilton Depression Scale (HAMD), the Severity Subscale of Clinical Global Impression Scale (CGI-S), Global Assessment Function (GAF), and the 12-item Short-Form Health Survey (SF-12). Assessments were conducted at baseline, 4-weeks, 8-weeks and 3-monthsfollow-up.
At 4-weeks, HAMA response (GCBT group 57.0% vs. control group 24.4%, p=0.000, Cohen d=0.90) and remission rates (GCBT group 21.5%vs. control group 6.2%, p=0.004; d=0.51), and most secondary outcomes (all p<0.05, d=0.36-0.77) showed that the combined therapy was superior. At 8-weeks, all the primary and secondary significant differences found at 4-weeks were maintained with smaller effect sizes (p<0.05, d=0.32-0.48) . At 3-months follow-up, the combined therapy was only significantly superior in the HAMA total (p<0.045, d=0.43) and HAMA-PA score reductions (p<0.001, d=0.77). Logistic regression showed superiority of the combined therapy for HAMA response rates (OR=2.12, 95% CI 1.02-4.42, p=0.04); and remission rates (OR=2.80, 95% CI 1.27-6.16, p=0.01).
Compared with duloxetine alone, GCBT plus duloxetine showed significant treatment response for GAD over a shorter period of time, particularly for psychic anxiety symptoms, which may suggest GCBT was effective in changing cognitive style.