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Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan

NCT ID: NCT03760627

Last Updated: 2021-10-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2020-03-30

Brief Summary

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To estimate the efficacy of a structured, scalable and replicable psychosocial intervention targeting refugees living in Jordan, Amman who have been forced to flee their homes due to regional conflicts.

Detailed Description

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The study is designed to examine the effects of the Mindfulness Resiliency Training Program (MRTP) conducted at Collateral Repair Project (CRP) on the resilience of refugees. The study group and the control group will be recruited from refugees currently residing in Amman, Jordan who are participating in the MRTP at CRP, an ongoing program independent of our study.

In order to assess the effect of the MRTP on participant resiliency, the three survey tools described above will be used:

1. the Strength and Difficulties Questionnaire (SDQ) as a measure of the individual's degree of traumatization and
2. the Child and Youth Resiliency Measure (CYRM-12) (for adolescents) or the Adult Resiliency Measure (ARM-12) (for adults) as a measure of resiliency

Conditions

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Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) Mental Health Wellness 1 War-Related Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a stepped wedge cluster randomized trial design. The design involves random and sequential crossover of clusters from control to intervention until all clusters are exposed. The controls from the previous session who were available for the parallel portion of the study, will later become the treatment group while another control group is recruited for them, which in turn will become an intervention group and so forth.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Refugees Mindfulness Resiliency Training

The Collateral Repair Project (CRP) will conduct a Mindfulness Resiliency Training Program (MRTP) for refugees residing in Amman, Jordan. A small support group will demonstrate to participants techniques that they can use to self-manage their own stress and trauma.

Group Type EXPERIMENTAL

Refugees Mindfulness Resiliency Training

Intervention Type BEHAVIORAL

The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.

Control arm

The control group will receive the training after the study group at 2 months and the control group will then become the study group for the new session. A new group of 20 participants will be recruited who will act as a control for that session. The surveys from the control group will be compared with the study group at 0 and 2 months. Each session will last for two months. The control group will receive the training at the end of the two months. This process will be repeated for a total of nine sessions over a total period of 12 months.

Group Type PLACEBO_COMPARATOR

Mindfulness Resiliency Training

Intervention Type BEHAVIORAL

The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.

Interventions

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Refugees Mindfulness Resiliency Training

The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.

Intervention Type BEHAVIORAL

Mindfulness Resiliency Training

The intervention consists of meditation, guided imagery, yoga and exercise, biofeedback; self-expression in words, drawings, and movement; and small group support to demonstrate to participants techniques that they can use to self-manage their own stress and trauma.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participants who will be recruited in the study are adult and adolescent (13-19 years) refugees, Syrian and non-Syrians, who are currently residing in Amman, Jordan who will be participating in the MRTP at CRP.

Exclusion Criteria

* Jordanian refugees residing in Amman, Jordan.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saquib Lakhani, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Prachi Syngal, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Collateral repair Project

Amman, , Jordan

Site Status

Countries

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Jordan

Other Identifiers

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2000024279

Identifier Type: -

Identifier Source: org_study_id