Brief Culturally Adapted Behavioral Activation Therapy for Adults With Depression in Indonesian Primary Care: A Type-2 Hybrid Effectiveness-Implementation Trial

Официальное название

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

Обзор

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?

Подробное описание

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.

Вмешательства

• Другое Training and supervision on BAT
  Implementation strategy: Training and Supervision Training: Primary care psychologists will receive training which consists of 4-session online training of Behavioral Activation Therapy (BAT), 2-session of booster training focusing on BA principle and therapy protocol, and clinical practice with 2 participants during pilot study. Four-session online training, 1 booster session, and clinical practice with 2 participants have been delivered during pilot study phase. Supervision: Supervision will

Первичные конечные точки

• Change from Baseline in Depressive Symptoms as Assessed by the Patient Health Questionnaire-9 (PHQ-9) at 1 Week after Intervention [Срок оценки: Baseline and 1 week post intervention]
• Participant's Acceptability of Intervention as Assessed by the Client Satisfaction Questionnaire-8 (CSQ-8) [Срок оценки: Post intervention (immediately after intervention completed)]
• Clinical Provider's Perceived Acceptability as Assessed by Acceptability of Intervention Measure (AIM) [Срок оценки: through study completion, an average of 3 months]
• Clinical Provider's Perceived Feasibility as Assessed by Feasibility of Intervention Measure (FIM) [Срок оценки: through study completion, an average of 3 months]
• Clinical Provider's Perceived Appropriateness as Assessed by Intervention Appropriateness Measure (IAM) [Срок оценки: through study completion, an average of 3 months]
• Qualitative Feedback on Acceptability, Feasibility, and Appropriateness from Participants as Assessed using Semi-structured Interview [Срок оценки: From enrollment to 1 week after intervention completed (for participants) through study completion, an average of 3 months (for clinical providers)]
• Qualitative Feedback on Acceptability, Feasibility, and Appropriateness from Clinical Providers as Assessed using Semi-structured Interview [Срок оценки: From enrollment to 1 week after intervention completed (for participants) through study completion, an average of 3 months (for clinical providers)]

Вторичные конечные точки (8)

• Rate of Remission or Recovery of Depression Diagnosis as Assessed by Structured Clinical Interview for DSM-5 (SCID-5) at 1 Week after Intervention [Срок оценки: Post-intervention (1 week after intervention completed)]
• Change in Behavioral Activation as Assessed by Behavioral Activation for Depression Scale - Short Form (BADS-SF) [Срок оценки: Every week during the trial from baseline to post-intervention (week 0, 1, 2, 3, and 4)]
• Change in Quality of Life from Baseline as Assessed by WHO Quality of Life Brief Version (WHOQOL-BREF) at 1 Week after Intervention [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: One month after intervention]
• Change in Depressive Symptoms 1-month after Intervention as Assessed by Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 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) [Срок оценки: Baseline (week 0) and 1-month after intervention]
• Change in Anxiety 1-month after Intervention as Assessed by Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline (week 0) and 1-month after intervention]

Критерии участия

Критерии включения

• aged 18-65 years old
• scored 10 or above on PHQ-9
• provide informed consent

Критерии исключения

• having diagnosis of bipolar disorder, psychotic disorders, or substance use disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Индонезия · 1 центр

• Puskesmas (Primary Healthcare Center) — Sleman

Идентификаторы

NCT: NCT07373080 · 3415/UN1/PS.1/SD/PT.01.04/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗