RESUMO
Objective: Behavioral activation (BA) is an effective treatment for depression. We investigated the effectiveness of add-on group-format BA and peer support (PS) with treatment as usual (TAU) in a registered randomized clinical trial in psychiatric outpatient settings (ISRCTN10647845). Methods: Adult outpatients (N = 140) with major depressive disorder (MDD) and Patient Health Questionnaire (PHQ-9) score ≥10 were randomized into a) group BA, consisting of eight 90-minute weekly group sessions plus TAU; b) group PS, including eight 90-minute weekly group sessions plus TAU; or c) TAU alone. The primary outcome was a within-individual change in PHQ-9 score between baseline and 8 weeks. Secondary outcomes were 1) response, 2) remission, and 3) functional impairment at 8 weeks, plus 4) change in PHQ-9 at 6 months. Results: Of the randomized patients, 100 (71.4%) completed treatments, including 29/45 (64.4%) patients in the BA group, 39/49 (79.6%) in the PS group, and 32/46 (69.6%) in the TAU group. By 8 weeks, PHQ-9 scores declined most in the TAU group [BA -0.28 (95% CI -2.48, 1.92), PS -0.58 (-2.09, 0.94) vs. TAU -3.32 (-5.21, -1.44); group-difference test, p = 0.034]. The secondary outcomes in the BA or PS arms did not significantly differ from those in TAU. Videotaped sessions revealed marked variation in briefly trained therapists' adherence to the treatment manual. Conclusions: In this randomized trial, the effectiveness of treatments with the added BA and PS groups did not exceed that of TAU alone. The preconditions in which brief BA or PS group interventions benefit outpatients with depression in psychiatric settings warrant critical investigation.
RESUMO
BACKGROUND: Behavioral therapy (BT) has been proven effective in the treatment of supragastric belching (SGB) in open studies. The aim was to compare BT to follow-up without intervention in patients with SGB in a randomized study. METHODS: Forty-two patients were randomized to receive 5 sessions of BT, comprising diaphragmatic breathing exercises, or to follow-up without intervention. Patients were evaluated at 6 months, at which point the control group was also offered BT and evaluated after another 6 months. The frequency and intensity of belching and mental well-being were evaluated with a visual analog scale (VAS). Depression, anxiety, and health-related quality of life (HRQoL) were evaluated with four questionnaires: BDI, BAI, 15D, and RAND-36. KEY RESULTS: The frequency and intensity of SGB were significantly lower in the therapy group (n = 19) than in the control group (n = 18) at the 6-month control (p < 0.001). When all patients (n = 36) were evaluated 6 months after BT, in addition to relief in the frequency and intensity of belching (p < 0.001), mental well-being had also improved (p < 0.05). Of all 36 patients, 27(75%) responded to BT. Depression scores were lower after therapy (p < 0.05). Only minor changes occurred in anxiety and HRQoL. CONCLUSIONS AND INFERENCES: Behavioral therapy is superior to follow-up without intervention in patients with SGB in reducing belching and depression; it also improves mental well-being but has only a modest effect on anxiety and HRQoL.
