Integrating a Mental Health Intervention Into Primary Health Care for Refugees

NCT05512624 | Unknown

• 1 other identifier: EX175
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence; Mental Health Issue; Self Efficacy; Hypertension; Epilepsy; Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (10)

• Substance use

  Baseline, Endline, Past two weeks

• Physical activity

  Baseline, Endline, Past two weeks

• Diet

  Baseline, Endline, Past two weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Waitlisted Arm

NO INTERVENTION

The waitlisted arm will be offered the CETA approach upon conclusion of the endline data collection.

Interventions

Common Elements Treatment Approach BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• International Rescue Committee: lead
• Khon Kaen University: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Mae La Refugee Camp

Mae Sot, Thailand

RECRUITING

MeSH Terms

Conditions

Medication Adherence; Hypertension; Epilepsy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ye Htut Oo

CONTACT

(202) 822-0043; yehtut.oo@rescue.org

Kathryn Falb

CONTACT

(202) 822-0043; kathryn.falb@rescue.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-armed randomized waitlisted control trial

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: August 23, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)