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临床试验/NCT02992158
NCT02992158已完成不适用

Feasibility of a Behavioral Activation Trial in Community Mental Health

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
percent of BA homework assignments that are completed

研究概览

简要总结

The goal of this project is to train community mental health therapists in behavioral activation (BA) treatment for major depressive disorder and then to conduct a study examining the feasibility of evaluating the effectiveness of BA in this setting.

详细描述

After finalizing a 9-session BA treatment model for major depressive disorder in the Community Mental Health Center (CMHC) setting, the final treatment manual will be used to train clinicians in BA at the CMHC through workshops and training cases.

Upon completion of training and certification of adequate implementation of BA, a total of 80 patients with MDD will be randomly assigned in a 3:1 ratio to 9 sessions of BA or treatment-as-usual (TAU) at the CMHC. Feasibility will be assessed in terms of (1) percent of eligible patients who refuse randomization, (2) percent of patients who complete 9 sessions of BA treatment, (3) percent of BA homework assignments that are completed, (4) percent of monthly assessments obtained, and (5) patient ratings of credibility and alliance in BA treatment. The ability of CMHC therapists to adequately implement BA will be assessed by rating taped sessions on BA adherence and competence scales. In addition to feasibility/acceptability of BA and TAU, this study is designed to test whether theoretically important targets of BA change over the course of BA treatment, and whether such changes are associated with changes in depressive symptoms. The target measures will be assessed at baseline, month 1, month 2, and month 3. To support the potential role of these targets as the mechanisms of change in BA, change in the target variables will be examined in relation to change in depression symptoms. The investigators will also pilot a potential moderator of treatment effects (trait reward processing, as measured at baseline using the Effort-Expenditure for Rewards Task) to include this potential moderator in a subsequent fully-powered study with the long-term goal of identifying the types of patients most responsive to BA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • confirmed diagnosis of MDD based on the SCID for DSM-IV (or DSM-V, if available),
  • ability to read at least at the 4th grade level,
  • willingness to participate in research,
  • willingness to be audio recorded (for both therapists and patient- participants)

排除标准

  • current or past psychotic disorder, seizure disorder, or clinically significant organic pathology
  • acute medical problem requiring immediate inpatient treatment,
  • current substance abuse or dependence requiring primary referral to substance abuse program,
  • significant suicidal risk/ideation requiring immediate referral or suicidal gesture within the last 3 months

结局指标

主要结局

percent of BA homework assignments that are completed

时间窗: 12 weeks

We will calculate this value based on our records of homework assignment completion (tracked weekly by therapist participants and reported to the research staff).

percent of eligible patients who refuse randomization

时间窗: assessed at baseline

We will calculate this value based on our records of patient participation in baseline assessments.

percent of patients who complete 9 sessions of BA treatment

时间窗: 12 weeks

We will calculate this value based on our records of patient attendance of therapy sessions (tracked each week by a research assistant).

Opinions About Treatment questionnaire

时间窗: collected at week 2

This questionnaire measures patient ratings of the credibility of BA treatment.

percent of monthly assessments obtained

时间窗: 12 weeks

We will calculate this value based on our records of patient assessment attendance (tracked by a research assistant).

Brief Alliance Inventory

时间窗: collected at weeks 2, 4, 6, and 8

This questionnaire measures patient ratings of the therapeutic alliance.

次要结局

  • Inventory of Depressive Symptomatology(monthly for 3 months)
  • Quality of Life Index (questionnaire)(monthly for 3 months)
  • Effort Expenditure for Rewards Task (EEfRT)(administered once at baseline and once at month 3)
  • Short Form Health Survey (SF-36)(monthly for 3 months)
  • Behavior and Symptom Identification Scale (BASIS-24)(monthly for 3 months)
  • Dysfunctional Attitudes Scale(monthly for 3 months)
  • Beck Anxiety Inventory(monthly for three months)
  • Reward Probability Index(monthly for 3 months)
  • Hamilton Rating Scale for Depression(monthly for 3 months)
  • Behavioral Activation for Depression Scale(monthly for 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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