跳至主要内容
临床试验/NCT05273983
NCT05273983终止不适用

Pilot Study of a Brief Behavioural Activation Intervention for Depressed Patients in Primary Care

University of Manitoba2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
2
主要终点
Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)

研究概览

简要总结

This study will explore the effectiveness of a brief psychological intervention for depressed outpatients in primary care. Participants will attend two intervention sessions with a psychologist and use a mobile activity/goal setting application for 6 weeks.

详细描述

This study will evaluate the feasibility and effectiveness of a two-session psychologist-led behavioural activation intervention, with adjunctive use of a free activity/goal setting app, for depressed patients in primary care. Outpatients in primary care with Major Depressive Disorder will be recruited to complete two intervention sessions with the primary care psychologist, as well as use the mobile activity scheduling app for 6 weeks. Symptom measures will be administered prior to both intervention sessions and 6-weeks after the first intervention session.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Depression is the primary concern;
  • Score of 10 or greater on a depression screening tool;
  • Have access to an iPhone or iPad.

排除标准

  • Another psychological disorder is the primary concern (e.g., anxiety disorder, personality disorder);
  • Concurrent alcohol or drug use disorder;
  • Unstable dose of psychotropic medication (i.e., any psychotropic medication doses will need to be stable for at least four weeks prior to enrolment);
  • Current participation in other regular psychological treatment (e.g., cognitive behavioral therapy, counselling);
  • At a high risk/emergent risk for suicide.

结局指标

主要结局

Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)

时间窗: Change in score from baseline to 6 weeks.

This survey will be completed online. Participants will answer 9-items assessing symptoms and severity of depression, on a four-option scale from 0 (not at all) to 3 (nearly every day). A sum of the items produces a Total Score from 0 to 27. Higher scores indicate greater depression symptomology.

次要结局

  • Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 item Scale (GAD-7)(Change in score from baseline to 6 weeks)
  • Change in perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS)(Change in score from baseline to 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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