Pilot Study Assessing Acceptability, Feasibility, and Appropriateness of Brief Culturally Adapted Behavioral Activation for Adults With Depression in Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Participant's and Clinical Provider's Perceived Feasibility as Assessed by Feasibility of Intervention Measure (FIM)
研究概览
简要总结
This is a pilot study of culturally adapted behavioral activation for adults with depression in primary care setting. As a pilot study following systematic cultural adaptation process, the purpose of this clinical trial is to understand if brief culturally adapted individual intervention based on behavioral activation, can be an acceptable, feasible, and appropriate intervention to reduce depressive symptoms among adults with depression in primary care setting. The main question it aims to answer is:
Is brief culturally adapted behavioral activation intervention delivered by primary care psychologist acceptable, feasible, and appropriate as an evidence based treatment for reducing depressive symptoms among adults with depression in primary care setting?
详细描述
This is a pilot study using mixed method and single arm design to assess acceptability, feasibility, and appropriateness of brief culturally adapted behavioral activation for adults with depression in primary care setting. In this study, participants will receive three individual sessions of brief culturally adapted behavioral activation intervention delivered by primary care psychologist. The participants and primary care psychologist will be asked to fill standardized questionnaire before and after intervention. In addition, the investigators will ask them after the intervention about their experience in receiving or delivering the intervention using semi-structured interview. The depressive symptom level and quality of life of the participants before and after the intervention will be compared as secondary outcome. The results of this study will serve as reference to revise the intervention manual before testing it in a hybrid effectiveness-implementation trial or the main trial.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scored 10 or above on PHQ-9
- •provide informed consent
排除标准
- •having diagnosed of bipolar disorder, psychotic disorders, or substance abuse disorders
研究组 & 干预措施
Intervention Arm
The intervention arm will receive brief culturally adapted behavioral activation therapy, delivered by primary care psychologist, which consists of three individual face-to-face session. The intervention will include both in session activities and homework activity assignment.
干预措施: brief culturally adapted behavioral activation (Behavioral)
结局指标
主要结局
Participant's and Clinical Provider's Perceived Feasibility as Assessed by Feasibility of Intervention Measure (FIM)
时间窗: Post-intervention (maximum 1 week after intervention completed)
Feasibility is defined as the perceived extent to which the intervention can be successfully used or carried out in primary care setting from participants and clinical providers' perspectives and will be measured by Feasibility of Intervention Measure (FIM). FIM consists of four items with five Likert-type responses. The score of the scale will range from 1 to 20 with higher score indicating higher feasibility of the intervention.
Qualitative Feedback on Acceptability, Feasibility, and Appropriateness from Participants and Clinical Providers as Assessed using Semi-structured Interview
时间窗: Post-intervention (maximum 1 week after intervention completed)
Participants and clinical providers will be asked about their experiences in receiving or providing the intervention through individual qualitative interview to understand their perceived acceptability, feasibility, and appropriateness in a more detailed and comprehensive way.
Participant's and Clinical Provider's Perceived Acceptability as Assessed by Acceptability of Intervention Measure (AIM)
时间窗: Post-intervention (maximum 1 week after intervention)
Acceptability is defined as the participant's and clinical provider's perception that a given treatment is agreeable, palatable, or satisfactory and will be measured by Acceptability of Intervention Measure (AIM). AIM consists of four items with five Likert-based responses. The score of the scale will range from 1 to 20 with higher score indicating higher acceptability to the intervention.
Participant's and Clinical Provider's Perceived Feasibility as Assessed by Feasibility of Intervention Measure (FIM)
时间窗: Post-intervention (maximum 1 week after intervention completed)
Feasibility is defined as the perceived extent to which the intervention can be successfully used or carried out in primary care setting from participants and clinical providers' perspectives and will be measured by Feasibility of Intervention Measure (FIM). FIM consists of four items with five Likert-type responses. The score of the scale will range from 1 to 20 with higher score indicating higher feasibility of the intervention.
Participant's and Clinical Provider's Perceived Appropriateness as Assessed by Intervention Appropriateness Measure (IAM)
时间窗: Post-intervention (maximum 1 week after intervention completed)
Appropriateness is defined as the perceived fit, relevance, or compatibility of brief culturally adapted behavioral activation for adults with depression in primary care setting from participant's and clinical provider's perspectives, and measured by Intervention Appropriateness Measure (IAM). IAM consists of four items with five Likert-based responses. The score of the scale will range from 1 to 20 with higher score indicating higher appropriateness of the intervention.
Qualitative Feedback on Acceptability, Feasibility, and Appropriateness from Participants and Clinical Providers as Assessed using Semi-structured Interview
时间窗: Post-intervention (maximum 1 week after intervention completed)
Participants and clinical providers will be asked about their experiences in receiving or providing the intervention through individual qualitative interview to understand their perceived acceptability, feasibility, and appropriateness in a more detailed and comprehensive way.
次要结局
- Change in Depressive Symptoms as Assessed by Patient Health Questionnaire-9 (PHQ-9)(Baseline (week 0) and post-intervention (1 week after intervention completed))
- Change in Quality of Life as Assessed by WHO Quality of Life Brief Version (WHOQOL-BREF)(Baseline (week 0) and post-intervention (1 week after intervention completed))
- Change in Anxiety as Assessed by Generalized Anxiety Disorder-7 (GAD-7)(Baseline (week 0) and post-intervention (1 week after intervention completed))
- Change in Depression Diagnosis as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)(Baseline (week 0) and post-intervention (1 week after intervention completed))
- Change in Quality of Life as Assessed by WHO Quality of Life Brief Version (WHOQOL-BREF)(Baseline (week 0) and post-intervention (1 week after intervention completed))
- Change in Depressive Symptoms as Assessed by Patient Health Questionnaire-9 (PHQ-9)(Baseline (week 0) and post-intervention (1 week after intervention completed))
- Change in Anxiety as Assessed by Generalized Anxiety Disorder-7 (GAD-7)(Baseline (week 0) and post-intervention (1 week after intervention completed))
- Change in Depression Diagnosis as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)(Baseline (week 0) and post-intervention (1 week after intervention completed))
研究者
Salma Salma
Principal Investigator
Gadjah Mada University