Mindfulness-SOS for Refugees

NCT05616286 | Unknown

• 1 other identifier: Mindfulness-SOS RCT
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Worldwide, refugees and asylum seekers suffer at high rates from trauma and stress-related mental health problems. The research group therefore developed, and initially piloted in a single-site open trial, a novel mindfulness- and compassion-based digital intervention program - Mindfulness-SOS for refugees (Mindfulness-SOS). The pilot study had promising preliminary findings of utilization, feasibility and related dose-response effects of intervention program engagement with mental health outcomes. The digital intervention program was developed based on randomized control trial data of a group-based mindfulness- and compassion-based program for forcibly displaced people. To address common limitations of mobile health interventions such as attrition, engagement and adherence, the investigators will implement a personalized stepped-care adaptation and augmentation of Mindfulness-SOS, that entails providing intensified (remote) guidance for FDPs that do not respond to the intervention, to optimize capacity to therapeutically benefit from Mindfulness-SOS. To do so, the investigators propose to carry out a randomized controlled Sequential Multiple Assignment Randomized Trial (SMART) study to test and optimize the therapeutic outcomes of Mindfulness-SOS, using an adaptive intervention sequence of guidance format intensities among N ≅ 170 (50% female) adult trauma-affected Eritrean asylum-seekers residing in Israel.

Conditions

Stress Disorders, Post-Traumatic; Stress Related Disorder

Keywords

Forcibly Displaced Persons; Post-Migration Stress; Trauma; Depression; Anxiety; Stress; Online Mental Health Intervention Program; Mindfulness; Compassion; Treatment Adherence

Outcome Measures

Primary Outcomes (4)

• Harvard Trauma Questionnaire

  The Harvard Trauma Questionnaire (HTQ) is a 16-item self-report questionnaire to assess post-traumatic stress symptom severity (5-point Likert scale) with higher scores indicating greater post-traumatic stress severity (minimum scale score 1 and maximum scale score 5), HTQ mean cut-off score ≥ 2 is commonly used to identify categorical (diagnostic) symptom status of post-traumatic stress disorder

  Change from immediately pre-intervention to 1-week post-intervention

• Brief Patient Health Questionnaire (PHQ-9)

  A 9-item self-report questionnaire to assess depression symptom severity (5-point Likert scale) with higher scores indicating greater depression symptom severity (minimum scale score 0 and maximum scale score 36), PHQ-9 mean cut-off score ≥10 is commonly used to identify categorical (diagnostic) symptom status of depression.

  Change from immediately pre-intervention to 1-week post-intervention

• Beck's Anxiety Inventory (BAI)

  The Beck's Anxiety Inventory (BAI) is a 21-item self-report questionnaire to assess anxiety symptom severity (4-point Likert scale) with higher scores indicating greater anxiety symptom severity (minimum scale score 0 and maximum scale score 63), BAI total cut-off score ≥ 16 is commonly used to identify categorical (diagnostic) symptom status of anxiety disorder.

  Change from immediately pre-intervention to 1-week post-intervention

• Positive and Negative Affect Schedule (PANAS)

  PANAS-SF is a 10-item self-report questionnaire measuring state positive and negative affect (5-point Likert scale ranging from 1 to 5) with higher scores indicating greater state positive and negative affect. The PANAS-SF includes 2 subscales, one measuring positive affect and the other measuring negative affect. Each subscale score is the sum of its items.

  Change from immediately pre-intervention to mid-assessment (3 weeks in) to 1-week post-intervention

Secondary Outcomes (13)

• Post-Migration Living Difficulties (PMLD) scale

  Change from immediately pre-intervention to 1-week post-intervention

• Brief Inventory of Thriving (BIT)

  Change from immediately pre-intervention to 1-week post-intervention

• The State Shame and Guilt Scale

  Change from immediately pre-intervention to 1-week post-intervention

• Brief Five-Facet-Mindfulness Scale

  Change from immediately pre-intervention to 1-week post-intervention

• Short Form of the Conflict Tactic Scale

  Change from immediately pre-intervention to 1-week post-intervention

Study Arms (2)

Mindfulness-SOS

EXPERIMENTAL

Mindfulness-SOS for Refugees is a brief internet-based mobile-supported intervention program which is a mobile health adaptation of MBTR-R, mindfulness- and compassion-based, trauma-sensitive, and socio-culturally adapted group intervention program designed for FDPs. Mindfulness-SOS for Refugees entails 8 brief sessions and 9 mindfulness meditation practice exercises - delivered via audio recordings using participants' smartphones. Mid-intervention, 3-weeks following randomization, all participants will be re-assessed. Participants initially randomized to MG-Mindfulness-SOS will be identified as either responders or non-responders. Responders will be assigned to continue MG-Mindfulness-SOS. Non-responders will be re-randomized to either Intensified-Guidance Mindfulness-SOS (IG-Mindfulness-SOS), an adaptive intervention sequence condition, or to continue with the MG-Mindfulness-SOS, a non-adaptive intervention sequence condition.

Behavioral: Mindfulness-SOS for Refugees

Waitlist-Control

NO INTERVENTION

Following the 7-week waitlist period and another assessment, participants randomized to waitlist-control will be assigned to Minimally-Guided Mindfulness-SOS (MG-Mindfulness-SOS) and then re-assessed following 3-weeks and, as described above, assigned to either continue in the MG-Mindfulness-SOS group or to move to the Intensified-Guidance Mindfulness-SOS (IG-Mindfulness-SOS).

Interventions

Mindfulness-SOS for Refugees BEHAVIORAL

Mindfulness-SOS for Refugees is a brief internet-based mobile-supported intervention program which is a mobile health adaptation of MBTR-R, mindfulness- and compassion-based, trauma-sensitive, and socio-culturally adapted group intervention program designed for FDPs. Mindfulness-SOS for Refugees entails 8 brief sessions and 9 mindfulness meditation practice exercises - delivered via audio recordings using participants' smartphones. The Mindfulness-SOS for Refugees intervention program is specifically designed to mitigate acute stress and related mental health symptoms among FDPs.

Mindfulness-SOS

Eligibility Criteria

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

You may qualify if:

• East African refugee or asylum seeker living in Israel
• Tigrinya fluency and literacy
• Owns a personal smartphone

You may not qualify if:

• Active suicidal ideation or/and past suicide attempt in the last year or/and passive suicidal ideation with clinical indicators of imminent suicide risk (e.g. severe paranoia)
• Current mental health treatment (i.e. psychotherapy or/and group therapy at least twice a month)
• Participation in the MBTR-R group in a previous study

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

Central Bus Station

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries; Depression; Anxiety Disorders; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Health Behavior

Study Design

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

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 15, 2022
• Study Start: December 15, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-09

Locations

IL (1)