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Mindfulness-SOS for Refugees

Primary Purpose

Stress Disorders, Post-Traumatic, Stress Related Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Mindfulness-SOS for Refugees
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Forcibly Displaced Persons, Post-Migration Stress, Trauma, Depression, Anxiety, Stress, Online Mental Health Intervention Program, Mindfulness, Compassion, Treatment Adherence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: East African refugee or asylum seeker living in Israel Tigrinya fluency and literacy Owns a personal smartphone Exclusion Criteria: 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

Sites / Locations

  • Central Bus StationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness-SOS

Waitlist-Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

Post-Migration Living Difficulties (PMLD) scale
The Post-Migration-Living-Difficulties Checklist (PMLD) is a 9-item self-report questionnaire to assess post-migration stress (5-point Likert scale) with higher scores indicating greater post-migration stress (minimum scale score 1 and maximum scale score 5).
Brief Inventory of Thriving (BIT)
One item of the 9-item self-report questionnaire Brief Inventory of Thriving (BIT) was used to assess subjective wellbeing (5-point Likert scale) with higher scores indicating greater subjective well-being (minimum score 1 and maximum score 5).
The State Shame and Guilt Scale
The State Shame and Guilt Scale (SSGS) is a 15-item self-report questionnaire to assess state shame and guilt (5- point Likert scale) with higher scores indicating greater levels of state shame, guilt and pride (minimum scale score 15 and maximum scale score 75).
Brief Five-Facet-Mindfulness Scale
The Five Facets of Mindfulness Questionnaire (FFMQ) is a self-report questionnaire to assess different facets of trait mindfulness (5-point Likert scale) with higher scores indicating greater levels of trait mindfulness (minimum scale score 1 and maximum scale score 5).
Short Form of the Conflict Tactic Scale
The Conflict Tactics Scales (CTS2) is the most widely used instrument for measuring intimate partner violence. The scale presents various cases of intimate partner violence and measures the frequency of these instances. The scale consists of 16 items measured on a 5-point scale ranging from (1)This has never happened to (5) 3-5 times in the last week.
Revised Social Capital Scale
The social capital scale is used to measure the resources available to an individual through relational networks. The scale consists of 11 items on a 5-point Likert scale ( 1- Not at all - 5-Very often).
Sussex-Oxford Compassion for Self Scale
The Self-Compassion Scale SOCS is a 20-item self-report questionnaire to assess different facets of compassion for others (5-point Likert scale) with higher scores indicating greater levels of compassion for others (minimum scale score 1 and maximum scale score 5).
Challenged Sense of Belonging Scale (CSBS)
The CSBS assess a challenged or eroded sense of belonging that provides insight into how individuals relate to their environment and how socially connected they feel. The scale consists of four key elements connection, participation, identification, and congruence. The CSBS is a 4-item scale measured in a 5-point Likert scale ranging from 1(Strongly agree)-5(Strongly disagree).
Metacognitive Processes of Decentering Scale-Trait (MPoD-T)
MPod-s is a 3-item self-report questionnaire measuring state levels of the 3 metacognitive processes of decentering (11-point Likert scale ranging from 0 to 10) with higher scores indicating greater levels of decentering (minimum scale score 0 and maximum scale score 10). Each of the 3 MPoD-s items measures a metacognitive process of decentering: meta-awareness, disidentification from internal experience, and non-reactivity to internal experience. MPod-s will be used to measure change, from pre-to post-intervention, instate decentering during the MAT mindfulness meditation.
Alliance with an Unguided Smartphone App
The measure consists of 6 items on a 5-point Likert scale 1(strongly agree)-5(strongly disagree). The measure aims to determine the quality of the alliance between the app-user and the smartphone app.
Child Behavior Checklist (CBCL)
The CBCL includes 21 items measured on a 3-point Likert scale (0-Never true - 2-Often true). The measure is used to detect behavioral and emotional problems in children and adolescents.
Hostile/Warm Parenting styles
This measure consists of items that measure parental warmth and parental hostility. The measure consists of 11 items on a 5-point Likert scale 1(never)-5(always).
Brief Problem monitoring (BPM)
The BPM provides a uniformed problem scale to assess attentional, behavioral, and internalizing problems in children and adolescents aged from 6-18 years old. The BPM includes 19 items measured on a 3-point Likert scale (0-Not true - 2-Very true).

Full Information

First Posted
November 6, 2022
Last Updated
December 1, 2022
Sponsor
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT05616286
Brief Title
Mindfulness-SOS for Refugees
Official Title
Mindfulness-SOS for Refugees: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Haifa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Over 100 million Forcibly Displaced Persons (FDPs), including refugees and asylum-seekers, are forcibly displaced due to conflict, persecution, and natural disaster. Forced displacement is often associated with severe and chronic forms of trauma- and stress-related mental health difficulties, with destructive generational and inter-generational consequences for forcibly displaced families including spouses or partners, children, as well as communities. To address this fast-growing crisis and the public health challenge, field-wide efforts have emerged to develop and test interventions tailored to the complex needs and post-displacement settings of FDPs. Among such efforts, the research group developed Mindfulness-Based Trauma Recovery for Refugees (MBTR-R) - a Mindfulness-Based Intervention (MBI) that is group-based, trauma-sensitive and socio-culturally adapted for diverse populations of FDPs. MBTR-R demonstrated waitlist-controlled evidence of efficacy and safety to improve stress- and trauma-related mental health outcomes among African asylum-seekers in Israel. Yet, the potential reach, access, scalability, and therefore impact of such interventions is systematically limited by their relatively rigid, group-based in-person delivery format. Behavioral Intervention Technologies (BITs), notably via mobile health interventions (mHealth), may be one promising implementation approach to help facilitate the dissemination and scalability of MBTR-R among FDPs. The research group therefore developed, and initially piloted a novel mHealth adaptation of MBTR-R - Mindfulness-SOS for refugees (Mindfulness-SOS) with promising preliminary findings of utilization, related feasibility and effects of engagement with the program on several individual mental health outcomes (i.e., modest protective dose-response effects). Yet, to improve their impact and efficacy, the development and delivery of BIT adaptations of MBIs broadly, and among FDPs specifically, must address well-documented limitations of BITs, most notably, high attrition, low engagement and adherence. One way to do so is through personalized stepped-care adaptation and augmentation of Mindfulness-SOS, that entails providing intensified (remote) guidance for FDPs that do not respond to the intervention, as a means of reducing attrition, increasing engagement and adherence, and optimizing capacity to therapeutically benefit from Mindfulness-SOS. The research group argues that a Sequential Multiple Assignment Randomized Trial (SMART), a multistage randomized trials design, is particularly well-suited to experimentally deliver, test, and optimize such a personalized adaptive stepped-care approach to Mindfulness-SOS for FDPs. The research group therefore propose to carry out a 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 Eritrean asylum-seekers residing in Israel. Following baseline assessment (pre-intervention), participants will be randomly assigned to Minimally-Guided Mindfulness-SOS (MG-Mindfulness-SOS) or to Wait-List Control. 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. Following the 7-week wait-list period and after re-assessment, Wait-List Control participants will initiate MG-Mindfulness-SOS intervention, receive MG-Mindfulness-SOS. Then, like participants initially randomized to MG-Mindfulness-SOS, 3-weeks following the wait-list period, participants will be re-randomized to either Intensified-Guidance Mindfulness-SOS (IG-Mindfulness-SOS), the adaptive intervention sequence condition, or to continue with the MG-Mindfulness-SOS, the non-adaptive intervention sequence condition. All participants will be re-assessed at post-intervention, and then at 8-week follow-up assessment. Primary outcomes will include subjective self-report measures of individual mental health outcomes. Secondary outcomes will include subjective self-report and/or parental report measures of pro-social family outcomes, child outcomes, inter-personal and community outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-SOS
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist-Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-SOS for Refugees
Intervention Description
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.
Primary Outcome Measure Information:
Title
Harvard Trauma Questionnaire
Description
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
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Brief Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Beck's Anxiety Inventory (BAI)
Description
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.
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Positive and Negative Affect Schedule (PANAS)
Description
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.
Time Frame
Change from immediately pre-intervention to mid-assessment (3 weeks in) to 1-week post-intervention
Secondary Outcome Measure Information:
Title
Post-Migration Living Difficulties (PMLD) scale
Description
The Post-Migration-Living-Difficulties Checklist (PMLD) is a 9-item self-report questionnaire to assess post-migration stress (5-point Likert scale) with higher scores indicating greater post-migration stress (minimum scale score 1 and maximum scale score 5).
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Brief Inventory of Thriving (BIT)
Description
One item of the 9-item self-report questionnaire Brief Inventory of Thriving (BIT) was used to assess subjective wellbeing (5-point Likert scale) with higher scores indicating greater subjective well-being (minimum score 1 and maximum score 5).
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
The State Shame and Guilt Scale
Description
The State Shame and Guilt Scale (SSGS) is a 15-item self-report questionnaire to assess state shame and guilt (5- point Likert scale) with higher scores indicating greater levels of state shame, guilt and pride (minimum scale score 15 and maximum scale score 75).
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Brief Five-Facet-Mindfulness Scale
Description
The Five Facets of Mindfulness Questionnaire (FFMQ) is a self-report questionnaire to assess different facets of trait mindfulness (5-point Likert scale) with higher scores indicating greater levels of trait mindfulness (minimum scale score 1 and maximum scale score 5).
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Short Form of the Conflict Tactic Scale
Description
The Conflict Tactics Scales (CTS2) is the most widely used instrument for measuring intimate partner violence. The scale presents various cases of intimate partner violence and measures the frequency of these instances. The scale consists of 16 items measured on a 5-point scale ranging from (1)This has never happened to (5) 3-5 times in the last week.
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Revised Social Capital Scale
Description
The social capital scale is used to measure the resources available to an individual through relational networks. The scale consists of 11 items on a 5-point Likert scale ( 1- Not at all - 5-Very often).
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Sussex-Oxford Compassion for Self Scale
Description
The Self-Compassion Scale SOCS is a 20-item self-report questionnaire to assess different facets of compassion for others (5-point Likert scale) with higher scores indicating greater levels of compassion for others (minimum scale score 1 and maximum scale score 5).
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Challenged Sense of Belonging Scale (CSBS)
Description
The CSBS assess a challenged or eroded sense of belonging that provides insight into how individuals relate to their environment and how socially connected they feel. The scale consists of four key elements connection, participation, identification, and congruence. The CSBS is a 4-item scale measured in a 5-point Likert scale ranging from 1(Strongly agree)-5(Strongly disagree).
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Metacognitive Processes of Decentering Scale-Trait (MPoD-T)
Description
MPod-s is a 3-item self-report questionnaire measuring state levels of the 3 metacognitive processes of decentering (11-point Likert scale ranging from 0 to 10) with higher scores indicating greater levels of decentering (minimum scale score 0 and maximum scale score 10). Each of the 3 MPoD-s items measures a metacognitive process of decentering: meta-awareness, disidentification from internal experience, and non-reactivity to internal experience. MPod-s will be used to measure change, from pre-to post-intervention, instate decentering during the MAT mindfulness meditation.
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Alliance with an Unguided Smartphone App
Description
The measure consists of 6 items on a 5-point Likert scale 1(strongly agree)-5(strongly disagree). The measure aims to determine the quality of the alliance between the app-user and the smartphone app.
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Child Behavior Checklist (CBCL)
Description
The CBCL includes 21 items measured on a 3-point Likert scale (0-Never true - 2-Often true). The measure is used to detect behavioral and emotional problems in children and adolescents.
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Hostile/Warm Parenting styles
Description
This measure consists of items that measure parental warmth and parental hostility. The measure consists of 11 items on a 5-point Likert scale 1(never)-5(always).
Time Frame
Change from immediately pre-intervention to 1-week post-intervention
Title
Brief Problem monitoring (BPM)
Description
The BPM provides a uniformed problem scale to assess attentional, behavioral, and internalizing problems in children and adolescents aged from 6-18 years old. The BPM includes 19 items measured on a 3-point Likert scale (0-Not true - 2-Very true).
Time Frame
Change from immediately pre-intervention to 1-week post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: East African refugee or asylum seeker living in Israel Tigrinya fluency and literacy Owns a personal smartphone Exclusion Criteria: 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
Facility Information:
Facility Name
Central Bus Station
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Aizik, phD
Phone
053-2249339
Email
anna.aizikreebs@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Mindfulness-SOS for Refugees

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