Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)NCT03760627
Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan
A study testing Refugees Mindfulness Resiliency Training and Mindfulness Resiliency Training in people with Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) and Mental Health Wellness 1, run by Yale University at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Mental Health Wellness 1, War-Related Trauma
- What is being tested?
- Refugees Mindfulness Resiliency Training and Mindfulness Resiliency Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteJordan
- Study dates
- 30 Nov 2018to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Jordanian refugees residing in Amman, Jordan.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- the Strength and Difficulties Questionnaire (SDQ) as a measure of the individual's degree of traumatization and
- 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
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Mental Health Wellness 1, War-Related Trauma
- Being tested
- Refugees Mindfulness Resiliency Training, Mindfulness Resiliency Training
- Medical subject headings
- Depression, Psychotic Disorders, Personality Disorders, Substance-Related Disorders, War-Related Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refugees Mindfulness Resiliency TrainingBehavioural
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.
Mindfulness Resiliency TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness Resiliency Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start30 Nov 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saquib Lakhani, MD, Principal investigator, Yale UniversityPrachi Syngal, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760627
- Sponsor's protocol ID
- 2000024279
- Status last verified
- Oct 2021
- First submitted
- 16 Nov 2018
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan
- ClinicalTrials.gov ID
- NCT03760627
- Acronym / sponsor ID
- 2000024279
- Conditions
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Mental Health Wellness 1, War-Related Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- the Strength and Difficulties Questionnaire (SDQ) as a measure of the individual's degree of traumatization and
- the Child and Youth Resiliency Measure (CYRM-12) (for adolescents) or the Adult Resiliency Measure (ARM-12) (for adults) as a measure of resiliency
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Refugees Mindfulness Resiliency Training | Experimental | Behavioral: Refugees Mindfulness Resiliency TrainingThe 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. |
| Control arm | Placebo comparator | Behavioral: Mindfulness Resiliency TrainingThe 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Jordanian refugees residing in Amman, Jordan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Refugees Mindfulness Resiliency TrainingThe 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. | Behavioural | Refugees Mindfulness Resiliency Training |
| Mindfulness Resiliency TrainingThe 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. | Behavioural | Control arm |
Primary outcome
Assess Mindfulness Resiliency Adolescents
Time frame: 2 months
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.
Assess Mindfulness Resiliency Adolescents
Time frame: 6 months
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.
Assess Mindfulness Resiliency Adults
Time frame: 2 months
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.
Assess Mindfulness Resiliency Adults
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saquib Lakhani, MD principal investigator
Yale University
Prachi Syngal, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Refugees Mindfulness Resiliency Training and Mindfulness Resiliency Training in people with Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) and Mental Health Wellness 1, run by Yale University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess Mindfulness Resiliency Adolescents (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.