Integrating a Mental Health Intervention Into Primary Health Care for Refugees

NCT ID: NCT05512624

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-09-01

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.

Detailed Description

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Conditions

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Medication Adherence Mental Health Issue Self Efficacy Hypertension Epilepsy Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-armed randomized waitlisted control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Common Elements Treatment Approach

Intervention Type 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.

Waitlisted Arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Common Elements Treatment Approach

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 Type BEHAVIORAL

Eligibility Criteria

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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.

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


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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Khon Kaen University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

International Rescue Committee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mae La Refugee Camp

Mae Sot, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Ye Htut Oo

Role: CONTACT

(202) 822-0043

Kathryn Falb

Role: CONTACT

(202) 822-0043

Facility Contacts

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Ye Htut Oo

Role: primary

Other Identifiers

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EX175

Identifier Type: -

Identifier Source: org_study_id

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