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

NCT03760627 | Completed

• 1 other identifier: 2000024279
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Assess Mindfulness Resiliency Adolescents

  In order to assess the effect of the Mindfulness Resiliency Training Program (MRTP) on participant resiliency, the Child and Youth Resiliency Measurement (CYRM-12) 12 question assessment tool for adolescents will be used to measure an increase in scores from baseline.

  2 months

• Assess Mindfulness Resiliency Adolescents

  In order to assess the effect of the MRTP on participant resiliency, the CYRM-12 for adolescents will be used to measure an increase in scores from baseline.

  6 months

• Assess Mindfulness Resiliency Adults

  In order to assess the effect of the MRTP on participant resiliency, the Adult Resiliency Measurement 12 question assessment tool (ARM-12) will be used to measure an improvement in score from pre-intervention baseline.

  2 months

• Assess Mindfulness Resiliency Adults

  In order to assess the effect of the MRTP on participant resiliency, the Adult Resiliency Measurement tool (ARM-12) will be used to measure an improvement in score from pre-intervention baseline.

  6 months

Study Arms (2)

Refugees Mindfulness Resiliency Training

EXPERIMENTAL

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.

Behavioral: Refugees Mindfulness Resiliency Training

Control arm

PLACEBO COMPARATOR

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.

Behavioral: Mindfulness Resiliency Training

Interventions

Refugees Mindfulness Resiliency Training 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.

Refugees Mindfulness Resiliency Training

Mindfulness Resiliency Training 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

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Jordanian refugees residing in Amman, Jordan.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Collateral repair Project

Amman, Jordan

Location

MeSH Terms

Conditions

Depression; Psychotic Disorders; Personality Disorders; Substance-Related Disorders; War-Related Injuries

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Saquib Lakhani, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Prachi Syngal, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 30, 2018
• Study Start: November 30, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

JO (1)