OBJECTIVE: To evaluate the effectiveness and feasibility of a cognitive-behavioral program for patients in primary care units who were diagnosed as having abridged somatization disorder. METHOD: A multicenter, randomized controlled trial was designed. One hundred sixty-eight patients were recruited from 29 primary care units and randomly assigned to one of three arms: treatment as usual (TAU), individual cognitive-behavioral therapy (CBT), and group CBT. Somatic symptoms were measured using the Screening for Somatoform Disorders and the Severity of Somatic Symptoms scale. The Hamilton Anxiety Rating Scale and the Hamilton Depression Rating Scale were used to assess the severity of anxiety and depression. RESULTS: Individual CBT achieves greater changes in the Screening for Somatoform Disorders posttreatment compared with group CBT (mean [95% confidence interval], 14.17 [11.9-16.3] versus 11.63 [9.4-13.7], p < .001). These improvements were observed at 6 and 12 months (p < .001 and p < .001, respectively). For individual CBT versus TAU, the number-needed-to-treat was 8, whereas for group CBT versus TAU, the number-needed-to-treat was 9. Individual CBT treatment resulted in lower anxiety scores compared with group CBT and TAU (7.33 [5.4-9.2] versus 11.47 [9.4-13.9] versus 13.07 [10.9-15.2], p < .001) posttreatment. Individual CBT and group CBT were associated with sustained benefits at 12-month follow-up compared with TAU (8.6 [6.6-10.6] versus 9.28 [7.2-11.2] versus 16.2 [13.9-18.5], p < .001). Depressive symptoms were lower for individual CBT posttreatment than for TAU (6.96 [5.3-8.6] versus 10.87-12.7], p < .01). CONCLUSIONS:CBT in individual and group settings results in significant improvements in somatic symptoms among patients with somatoform abridged disorder compared with TAU. Individual CBT results in greater posttreatment improvements at 6-month and 12-month follow-ups. TRIAL REGISTRATION: current controlled trials identifier ISRCTN69944771.
RCT Entities:
OBJECTIVE: To evaluate the effectiveness and feasibility of a cognitive-behavioral program for patients in primary care units who were diagnosed as having abridged somatization disorder. METHOD: A multicenter, randomized controlled trial was designed. One hundred sixty-eight patients were recruited from 29 primary care units and randomly assigned to one of three arms: treatment as usual (TAU), individual cognitive-behavioral therapy (CBT), and group CBT. Somatic symptoms were measured using the Screening for Somatoform Disorders and the Severity of Somatic Symptoms scale. The Hamilton Anxiety Rating Scale and the Hamilton Depression Rating Scale were used to assess the severity of anxiety and depression. RESULTS: Individual CBT achieves greater changes in the Screening for Somatoform Disorders posttreatment compared with group CBT (mean [95% confidence interval], 14.17 [11.9-16.3] versus 11.63 [9.4-13.7], p < .001). These improvements were observed at 6 and 12 months (p < .001 and p < .001, respectively). For individual CBT versus TAU, the number-needed-to-treat was 8, whereas for group CBT versus TAU, the number-needed-to-treat was 9. Individual CBT treatment resulted in lower anxiety scores compared with group CBT and TAU (7.33 [5.4-9.2] versus 11.47 [9.4-13.9] versus 13.07 [10.9-15.2], p < .001) posttreatment. Individual CBT and group CBT were associated with sustained benefits at 12-month follow-up compared with TAU (8.6 [6.6-10.6] versus 9.28 [7.2-11.2] versus 16.2 [13.9-18.5], p < .001). Depressive symptoms were lower for individual CBT posttreatment than for TAU (6.96 [5.3-8.6] versus 10.87-12.7], p < .01). CONCLUSIONS: CBT in individual and group settings results in significant improvements in somatic symptoms among patients with somatoform abridged disorder compared with TAU. Individual CBT results in greater posttreatment improvements at 6-month and 12-month follow-ups. TRIAL REGISTRATION: current controlled trials identifier ISRCTN69944771.
Authors: Joanna Leaviss; Sarah Davis; Shijie Ren; Jean Hamilton; Alison Scope; Andrew Booth; Anthea Sutton; Glenys Parry; Marta Buszewicz; Rona Moss-Morris; Peter White Journal: Health Technol Assess Date: 2020-09 Impact factor: 4.014
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