Integrating a Mental Health Intervention Into Primary Health Care for Refugees

Study Overview
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Brief Summary
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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.

Official Title
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Integrating an Evidence-based Mental Health Intervention Into Primary Health Care to Improve Outcomes for Refugees With Hypertension, Diabetes, and Epilepsy

Conditions
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Medication Adherence, Mental Health Issue, Self Efficacy, Hypertension, Epilepsy, Diabetes

Intervention / Treatment
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* Behavioral: Common Elements Treatment Approach


Participation Criteria
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Eligibility Criteria
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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. B. 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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-armed randomized waitlisted control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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. | Behavioral: Common Elements Treatment Approach<br>* For treatment group participants, they will then have weekly meetings with a counselor lasting no more than 1.5 hours per session, and a total of approximately 10 sessions. Both treatment and wait list participants will then complete the assessment instrument at 3 months and 6 months post-enrollment (each lasting no more than 1.5 hours). All total, it is expected that treatment group participants will have up to 13 meetings with a study team member or counselor over the course of their participation. Wait list group participants will have 3 meetings with a study team member over the course of their participation. If the treatment is deemed to be effective these wait list participants will be the first adults to be offered the intervention after trial completion.<br>|
| No Intervention: Waitlisted Arm<br>The waitlisted arm will be offered the CETA approach upon conclusion of the endline data collection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence Report Scale | 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. | Baseline, Endline, Past two weeks | 
| Pill Count Medication Adherence | 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. | Baseline, Endline, Past two weeks |