Hybrid Type-2 Effectiveness-Implementation Study of Brief Culturally Adapted Behavioral Activation Therapy Delivered by Primary Care Psychologists for Adults With Depression in Indonesian Primary Care Setting: A Study Protocol of Pragmatic Parallel Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change from Baseline in Depressive Symptoms as Assessed by Patient Health Questionnaire-9 (PHQ-9) at 1 Week after Intervention
研究概览
简要总结
This is a type-2 hybrid effectiveness-implementation study of brief culturally adapted behavioral activation for adults with depression in primary care setting. This clinical trial has two parallel aims: 1) to understand if brief culturally adapted behavioral activation therapy delivered by psychologist in primary care in individual face-to-face session is effective to reduce depressive symptoms among adult patients in Primary Healthcare Centers and 2) to test the outcome of clinical training and supervision on acceptability, feasibility, appropriateness, and fidelity of implementation of brief culturally adapted behavioral activation therapy in Primary Healthcare Centers. The main questions it aims to answer is:
1) Is brief culturally adapted behavioral activation intervention delivered by primary care psychologist effective in reducing depressive symptoms among adult patients with depression in primary care settings and 2) Are training and supervision effective in enhancing acceptability, feasibility, appropriateness and fidelity of implementation of brief culturally adapted behavioral activation therapy for adults with depression in primary care settings?
详细描述
Depression is among global burden of diseases with higher treatment gap in lower- and middle-income countries (LMICs), including Indonesia. Integrating mental health care into primary care is one of recommended strategy to close the treatment gap in LMICs and there has been such integration through the placement of primary care psychologist in one of rural districts in Indonesia. In the other hand, behavioral activation therapy (BAT) is a culturally adaptable evidence-based therapy for adults with depression. However, little is known about implementation strategy to enhance the adoption of BAT as well as its clinical effectiveness in Indonesian primary care.
This study aims to: 1) test clinical effectiveness of BAT with prior systematic cultural adaptation in reducing depressive symptoms among adults with depression in primary care and 2) test the effect of implementation strategies (i.e., training and supervision) on implementation outcomes (i.e., acceptability, feasibility, appropriateness, and fidelity). The results of this study will inform further study to scale up BAT implementation in Indonesian primary care settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •aged 18-65 years old
- •scored 10 or above on PHQ-9
- •provide informed consent
排除标准
- •having diagnosis of bipolar disorder, psychotic disorders, or substance use disorders
研究组 & 干预措施
TAU (Treatment-as-usual)
Six primary health centers will be grouped into control arm using online randomizer. No implementation strategy applied for these clusters. Forty-eight participants (adult patients) from six primary health centers will receive treatment-as-usual for depression from primary care psychologist with no restriction on intervention approach and number of sessions.
结局指标
主要结局
Change from Baseline in Depressive Symptoms as Assessed by Patient Health Questionnaire-9 (PHQ-9) at 1 Week after Intervention
时间窗: Baseline and 1 week post intervention
Participants will fill the PHQ-9 as self-reported questionnaire using paper and pencil format, administered by research assistant. PHQ-9 consists of nine items with four response from 'not at all' (0) to 'nearly every day' (3). The score of the PHQ-9 ranges from 0 to 27 with higher score indicating higher depressive symptoms.
Participant's Acceptability of Intervention as Assessed by Client Satisfaction Questionnaire-8 (CSQ-8)
时间窗: Post intervention (immediately after intervention completed)
Acceptability is defined as the participant's perception that a given treatment is agreeable, palatable, or satisfactory and will be measured using CSQ-8. CSQ-8 consists of 8 items with four optional responses. The score of the questionnaire will range from 1 to 32 with higher score indicating acceptability of intervention.
Clinical Provider's Perceived Acceptability as Assessed by Acceptability of Intervention Measure (AIM)
时间窗: through study completion, an average of 3 months
Acceptability is defined as the 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.
Clinical Provider's Perceived Feasibility as Assessed by Feasibility of Intervention Measure (FIM)
时间窗: through study completion, an average of 3 months
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.
Clinical Provider's Perceived Appropriateness as Assessed by Intervention Appropriateness Measure (IAM)
时间窗: through study completion, an average of 3 months
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: From enrollment to 1 week after intervention completed (for participants) through study completion, an average of 3 months (for clinical providers)
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
- Rate of Remission or Recovery of Depression Diagnosis as Assessed by Structured Clinical Interview for DSM-5 (SCID-5) at 1 Week after Intervention(Post-intervention (1 week after intervention completed))
- Change in Quality of Life from Baseline as Assessed by WHO Quality of Life Brief Version (WHOQOL-BREF) at 1 Week after Intervention(Baseline (week 0) and post-intervention (1 week after intervention completed))
- Change from Baseline in Anxiety as Assessed by Generalized Anxiety Disorder-7 (GAD-7) at 1 Week after Intervention(Baseline (week 0) and post-intervention (1 week after intervention completed))
- Rate of Remission or Recovery in Depression Diagnosis 1-month after Intervention as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)(One month after intervention)
- Change in Depressive Symptoms 1-month after Intervention as Assessed by Patient Health Questionnaire-9 (PHQ-9)(Baseline (week 0) and 1-month after intervention)
- Change in Quality of Life 1-month after Intervention as Assessed by WHO Quality of Life Brief Version (WHOQOL-BREF)(Baseline (week 0) and 1-month after intervention)
- Change in Anxiety 1-month after Intervention as Assessed by Generalized Anxiety Disorder-7 (GAD-7)(Baseline (week 0) and 1-month after intervention)
研究者
Salma Salma
Principal Investigator
Gadjah Mada University
