Integrating an Evidence-based Mental Health Intervention Into Primary Health Care to Improve Outcomes for Refugees With Hypertension, Diabetes, and Epilepsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 308
- Locations
- 1
- Primary Endpoint
- Medication Adherence Report Scale
Study Overview
Brief Summary
The objective of this study is to evaluate the impact of an evidence-based mental health intervention (Common Elements Treatment Approach) on medication adherence, behavioral improvement and clinical outcomesamong adults taking medication for hypertension, diabetes and epilepsy using a two-arm randomized wait-list controlled trial among adult refugees in Mae La camp, Thailand.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •A. Inclusion criteria:
- •Patients who was diagnosed by physician based on ICD 10 to have diabetes, hypertension or diabetes with hypertension comorbidity, or epilepsy.
- •Registered in chronic database system of the camp.
Exclusion Criteria
- •who are younger than 18 years old
- •who have severe physical illness
- •who have severe mental disorders
- •who will not stay in the camp until the end of the program
- •who are not willing to participate in the program
- •Exclusion Criteria:
Arms & Interventions
Intervention Arm
The course of Common Elements Treatment Approach (CETA - the intervention under study) is built to be flexible depending on need. Mild symptoms could result in fewer sessions (e.g., 5), while greater severity may require 8-12 sessions.
Intervention: Common Elements Treatment Approach (Behavioral)
Waitlisted Arm
The waitlisted arm will be offered the CETA approach upon conclusion of the endline data collection.
Outcomes
Primary Outcomes
Medication Adherence Report Scale
Time Frame: Baseline, Endline, Past two weeks
Medication Adherence - Self Report will be assessed using the 5-item Medication Adherence Report Scale (MARS-5). Each item assesses the frequency of deviations in medication use, ranging from never (0) to all days (4) over the past two weeks. The MARS-5 will be scored by calculating the mean of all items to generate a continuous score ranging from 0-4, with higher scores indicating greater problems with medication adherence.
Pill Count Medication Adherence
Time Frame: Baseline, Endline, Past two weeks
Medication Adherence - Pill Count: Measurement: Medication Adherence will also be objectively measured by counting the proportion of pills taken over the past two weeks relative to the number taken if used as prescribed over the same period. Proportions will range from 0-100% with higher proportion indicating greater adherence. Proportions will be used to classify a binary indicator of adherence using an 80% or higher cutoff.
Secondary Outcomes
No secondary outcomes reported