Integrating a Mental Health Intervention Into Primary Health Care for Refugees

Not Applicable

Recruiting

• Conditions: Epilepsy; Medication Adherence; Self Efficacy; Mental Health Issue; Hypertension; Diabetes
• Interventions: Behavioral: Common Elements Treatment Approach

• Registration Number: NCT05512624
• Lead Sponsor: International Rescue Committee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-15
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-23
• Study Start: 2022-09-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-22
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

• A. Inclusion criteria:

  1. Patients who was diagnosed by physician based on ICD 10 to have diabetes, hypertension or diabetes with hypertension comorbidity, or epilepsy.
  2. Registered in chronic database system of the camp.

B. Exclusion criteria:

1. who are younger than 18 years old
2. who have severe physical illness
3. who have severe mental disorders
4. who will not stay in the camp until the end of the program
5. who are not willing to participate in the program

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Common Elements Treatment Approach	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.

Primary Outcome Measures

Name	Time	Method
Medication Adherence Report Scale	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	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.

Trial Locations

Locations (1)

Mae La Refugee Camp; 🇹🇭 Mae Sot, Thailand