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临床试验/DRKS00016495
DRKS00016495已完成未知

Behavioural activation for depressive syndromes in rehabilitation - VADIR

Deutsche Rentenversicherung Bund0 个研究点目标入组 375 人开始时间: 2019年2月27日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
375

研究概览

简要总结

Background: Behavioral activation (BA) and cognitive-behavioral therapy (CBT) have shown to be effective treatment methods of depression. Previous studies focused mostly on outpatient setting either in group or individual setting. The present study aimed at comparing the efficacy of group treatment BA vs. treatment-as-usual, in this case CBT (CBT-TAU), when embedded in inpatient psychosomatic rehabilitation treatment. Methods: 375 inpatients were randomly assigned to either BA (N = 174) or CBT-TAU (N = 201). We used established scales for depression such as the Beck Depression Inventory II (BDI-II, self-rating), the Quick Inventory of Depressive Symptomatology (QIDS; expert rating) and the Behavioral Activation for Depression Scale (BADS) to assess changes over the course of the treatment and at follow-up (4 to 6 months). In addition, we measured disability-related functioning with the Mini-ICF-APP, a rating scale built in reference to the International Classification of Functioning, Disability and Health (ICF). Multilevel models with repeated measures were conducted to examine the differences between groups in relation to change over time with patients’ random effects. Results: Both group formats showed substantial reduction in depressive symptoms at the end of treatment (d= 0.83 BA vs. d= 1.08 CBT-TAU; BDI-II) and at follow-up after 4 to 6 months (d = 0.97 BA vs. d = 1.33 CBT-TAU, BDI-II; and d = 1.17 BA vs. d = 1.09 CBT-TAU, QIDS). There were no significant differences between treatment approaches. At least 50% symptom reduction was achieved by 53.7 % and 54.2 % in BA vs. CBT-TAU respectively. Reported activation levels increased from pre- to posttreatment (d = 0.76 BA vs. d = 0.70 TAU), while showing loss of increment between the end of the treatment until follow up in both formats (d = 0.28 BA vs. d = 0.29 CBT-TAU). Discussion: Both modalities led to significant improvement of symptomatology and functioning at the end of the treatment and at follow-up, thus for the first time demonstrating the practicability of BA in rehabilitation clinics. Considering its lower requirements regarding cognitive abilities and its easier implementation, BA proved to be a good alternative to other psychotherapeutic treatments.

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 70 Years(—)
性别
All

入选标准

  • Patients undergoing treatment in one of the two cooperating clinics (Reha-Zentrum Seehof; Lichterfelder Allee 55, 14513 Teltow or [is still outstanding])
  • Age between 18 and 70 years
  • Presence of an unipolar depression according to the clinical impression of the clinical professional (reference physician or reference therapist)
  • Inclusion in the study is based on clinical considerations in accordance with regular clinical procedures (allocation to the group offer by the respective reference physician or therapist with appropriate indication and on the basis of information from routine diagnostics).
  • All patients included according to the above criteria are used to test the hypotheses associated with the questions. In order to increase the severity of the test, only those patients are included in the evaluation in additional analyses for whom the rating in the Quick Inventory of Depressive Symptomatology (QIDS; Rush et al., 2003) reaches a cut-off value in the QIDS of at least 8 (mild depression severity, comparable to BDI-II =14 mild depression).

排除标准

  • current presence of psychotic or manic symptoms
  • current substance abuse or substance dependence
  • Presence of a severe anxiety disorder (e.g. social phobia or agoraphobia with a pronounced avoidance behaviour)
  • acute suicidal tendencies in the context of depression
  • the severity of depression does not allow active participation in group therapy according to clinical assessment
  • brainorganic impairments
  • mental disabilities
  • severe chronic and physical diseases

研究者

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