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| Name | Class |
|---|---|
| Vanderbilt University | OTHER |
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Goal: The long-term goal of the proposed research program is to test the effectiveness of a preventative behavioral intervention and to scale it up for use with broader immigrant populations to reduce stress and mental health disorders.
Intervention: This study plan to adapt the World Health Organization developed Problem Management Plus (PMP), an evidence based, multi-component, behavioral intervention including breathing, problem solving, behavioral activation, and social support for immigrants.
Hypothesis: Immigrants in the Problem Management Plus for Immigrants (PMP-I) will have significantly lower levels of stress and anxious/depressive symptoms as compared to immigrants in the talk program with Community Support Service pamphlets (CSS).
Objective: The current study aims to pilot test the feasibility and acceptability of PMP-I among Bhutanese immigrants 18 years and older living in the Massachusetts.
Problem Management Plus (PMP) is a low-intensity evidence-based psychological intervention developed by World Health Organization that can be delivered by trained lay people. PMP systematically teaches four strategies: stress management through breathing exercises, problem solving, behavioral activation, and skills to strengthen social support at individual level. The current study plans to adapt PMP to develop the PMP for Immigrants (PMP-I) for a family setting to address immigrant's multiple social and emotional stressors while adjusting into the new multi-cultural environment of the United States. The rationale to adapt PMP is based on our intervention model that demands integration of social and emotional stressors; promising results of PMP; strong evidence of family and community ties in health care process; and growing consensus among community, scientists, and policymakers on the need for family-based care models that are sustainable. PMP-I is a 5-week, peer-led, culturally tailored mental health promotion program that includes psychoeducation, behavioral activation, and problem solving (90 minutes/session/weekly), and breathing exercises and yoga (90 minutes/session/weekly) in a family setting. Participating families will be randomly allocated into two groups (N=116 families (232 participants: two eligible members per family); 58 families per intervention (PMP-I) and control (CSS)) with assessments at baseline, post-intervention, and 3-month post-intervention with trained community facilitators in collaboration with church leaders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Problem Management Plus for Immigrants at family settings | Experimental | PMP-I intervention aims to develop skills in coping adaptively in a new culture, seeking help and support for mental health problems, and other life skills opportunities that can help to improve their quality of life. PMP-I intervention includes stress management through breathing exercises and yoga, problem solving, behavioral activation, and skills to strengthen social support. |
|
| Talk program with Community Support Service Pamphlet (CSS) | Active Comparator | Family receives pamphlet including list of community support service institutions that provide various health and well-being services. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem Management Plus for Immigrants at family settings | Behavioral | PMP-I is a 5-week, peer-led, culturally tailored psychoeducation, behavioral activation (90 minutes), breathing and yoga intervention (90 minutes) in a family setting. PMP-I will use a structured approach, including once a week face-to-face sessions, breathing and yoga practices.
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohen Perceived Stress Scale to Measure Stress | The 10-item Cohen Perceived Stress Scale will be used to assess perceived stress at baseline, post-intervention, and 12-week post-intervention. The Cohen Perceived Stress Scale uses a 5-point Likert scale (ranging from 0, "never" to 4, "very often") to assess psychological stress experienced during the past four weeks, including the extent to which situations felt unpredictable, uncomfortable, and overwhelming. The total high scores indicate a worse outcome. The score range is between 0 and 40. | Baseline |
| Hopkins Symptom Checklist-25 to Measure Anxiety | The Hopkins Symptom Checklist-25 (HSCL-25) will be used to measure anxiety and depressive symptoms experienced over the past four weeks at baseline, post-intervention, and 12-week post-intervention. It is composed of a 10-item subscale for anxiety and a 15-item subscale for depression, with each item scored on a Likert scale from 1 (not at all) to 4 (extremely). The higher scores indicate high anxiety or depressive symptoms. The scores range for anxiety between 10 and 40 and depressive symptoms between 15 and 60. | Baseline |
| Hopkins Symptom Checklist-25 to Measure Depressive Symptoms | The Hopkins Symptom Checklist-25 (HSCL-25) will be used to measure anxiety and depressive symptoms experienced over the past four weeks at baseline, post-intervention, and 12-week post-intervention. It is composed of a 10-item subscale for anxiety and a 15-item subscale for depression, with each item scored on a Likert scale from 1 (not at all) to 4 (extremely). The higher scores indicate high anxiety or depressive symptoms. The scores range for anxiety between 10 and 40 and depressive symptoms between 15 and 60. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Hair Cortisol Concentrations (pg/mg) | Cortisol hair test (average hormone levels over the past 3 months) will be used as a biomarker to measure physiological stress. Higher hair cortisol concentrations indicate a higher level of biological stress in the body. The range of values is between 0.799 and 2554.68 pg/mg. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Amherst | Amherst | Massachusetts | 01003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35504635 | Derived | Poudel-Tandukar K, Jacelon CS, Martell CR, Poudel KC, Rai S, Ramdam R, Laws H, Meyer JS, Bertone-Johnson ER, Hollon SD. Peer-led family-centred problem management plus for immigrants (PMP-I) for mental health promotion among immigrants in USA: protocol for a pilot, randomised controlled feasibility trial. BMJ Open. 2022 May 3;12(5):e061353. doi: 10.1136/bmjopen-2022-061353. |
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Individual participant data that underlies published results will be shared after deidentification.
IPD will be made available after the main findings from the final research data set have been accepted for publication. No end date.
Access to IPD can be requested by qualified researchers engaging in independent scientific research, and will be disseminated in accordance with University/Participating institutional and NIH policies, including entering into a Data Sharing Agreement. Inquiries for should be sent to the Principal Investigator.
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| ID | Title | Description |
|---|---|---|
| FG000 | Problem Management Plus for Immigrants at Family Settings | PMP-I intervention aims to develop skills in coping adaptively in a new culture, seeking help and support for mental health problems, and other life skills opportunities that can help to improve their quality of life. PMP-I intervention includes stress management through breathing exercises and yoga, problem solving, behavioral activation, and skills to strengthen social support. Problem Management Plus for Immigrants at family settings: PMP-I is a 5-week, peer-led, culturally tailored psychoeducation, behavioral activation (90 minutes), breathing and yoga intervention (90 minutes) in a family setting. PMP-I will use a structured approach, including once a week face-to-face sessions, breathing and yoga practices.
|
| FG001 | Talk Program With Community Support Service Pamphlet (CSS) | Family receives pamphlet including list of community support service institutions that provide various health and well-being services. Talk program with Community Support Service Pamphlet (CSS): Pamphlet including list of community support service institutions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Problem Management Plus for Immigrants at Family Settings | PMP-I intervention aims to develop skills in coping adaptively in a new culture, seeking help and support for mental health problems, and other life skills opportunities that can help to improve their quality of life. PMP-I intervention includes stress management through breathing exercises and yoga, problem solving, behavioral activation, and skills to strengthen social support. Problem Management Plus for Immigrants at family settings: PMP-I is a 5-week, peer-led, culturally tailored psychoeducation, behavioral activation (90 minutes), breathing and yoga intervention (90 minutes) in a family setting. PMP-I will use a structured approach, including once a week face-to-face sessions, breathing and yoga practices.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cohen Perceived Stress Scale to Measure Stress | The 10-item Cohen Perceived Stress Scale will be used to assess perceived stress at baseline, post-intervention, and 12-week post-intervention. The Cohen Perceived Stress Scale uses a 5-point Likert scale (ranging from 0, "never" to 4, "very often") to assess psychological stress experienced during the past four weeks, including the extent to which situations felt unpredictable, uncomfortable, and overwhelming. The total high scores indicate a worse outcome. The score range is between 0 and 40. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
41/2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Problem Management Plus for Immigrants at Family Settings | PMP-I intervention aims to develop skills in coping adaptively in a new culture, seeking help and support for mental health problems, and other life skills opportunities that can help to improve their quality of life. PMP-I intervention includes stress management through breathing exercises and yoga, problem solving, behavioral activation, and skills to strengthen social support. Problem Management Plus for Immigrants at family settings: PMP-I is a 5-week, peer-led, culturally tailored psychoeducation, behavioral activation (90 minutes), breathing and yoga intervention (90 minutes) in a family setting. PMP-I will use a structured approach, including once a week face-to-face sessions, breathing and yoga practices.
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kalpana Poudel-Tandukar, Associate Professor | University of Massachusetts Amherst | 413-545-5095 | kalpana@umass.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2021 | Nov 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| Talk program with Community Support Service Pamphlet (CSS) | Behavioral | Pamphlet including list of community support service institutions |
|
| BG001 | Talk Program With Community Support Service Pamphlet (CSS) | Family receives pamphlet including list of community support service institutions that provide various health and well-being services. Talk program with Community Support Service Pamphlet (CSS): Pamphlet including list of community support service institutions |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ever Married | Count of Participants | Participants |
|
| Ever Been to School | Count of Participants | Participants |
|
| Employed | Count of Participants | Participants |
|
| Ever Drunk Alcohol | Count of Participants | Participants |
|
| Ever Smoked | Count of Participants | Participants |
|
| History of Chronic Disease | Count of Participants | Participants |
|
| Duration of living in US | Mean | Standard Deviation | years |
|
| Body weight in kg | Mean | Standard Deviation | kg |
|
| Body height in cms | Mean | Standard Deviation | cms |
|
| Body waist in inches | Mean | Standard Deviation | inches |
|
| Systolic Blood Pressure | Mean | Standard Deviation | millimeters of mercury |
|
| Dystolic Blood Pressure | Mean | Standard Deviation | millimeters of mercury |
|
| OG001 | Talk Program With Community Support Service Pamphlet (CSS) | Family receives pamphlet including list of community support service institutions that provide various health and well-being services. Talk program with Community Support Service Pamphlet (CSS): Pamphlet including list of community support service institutions |
|
|
| Primary | Hopkins Symptom Checklist-25 to Measure Anxiety | The Hopkins Symptom Checklist-25 (HSCL-25) will be used to measure anxiety and depressive symptoms experienced over the past four weeks at baseline, post-intervention, and 12-week post-intervention. It is composed of a 10-item subscale for anxiety and a 15-item subscale for depression, with each item scored on a Likert scale from 1 (not at all) to 4 (extremely). The higher scores indicate high anxiety or depressive symptoms. The scores range for anxiety between 10 and 40 and depressive symptoms between 15 and 60. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Hopkins Symptom Checklist-25 to Measure Depressive Symptoms | The Hopkins Symptom Checklist-25 (HSCL-25) will be used to measure anxiety and depressive symptoms experienced over the past four weeks at baseline, post-intervention, and 12-week post-intervention. It is composed of a 10-item subscale for anxiety and a 15-item subscale for depression, with each item scored on a Likert scale from 1 (not at all) to 4 (extremely). The higher scores indicate high anxiety or depressive symptoms. The scores range for anxiety between 10 and 40 and depressive symptoms between 15 and 60. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Hair Cortisol Concentrations (pg/mg) | Cortisol hair test (average hormone levels over the past 3 months) will be used as a biomarker to measure physiological stress. Higher hair cortisol concentrations indicate a higher level of biological stress in the body. The range of values is between 0.799 and 2554.68 pg/mg. | Intervention Group: Only 84 participants provided hair samples out of 116 total participants. Control Group: Only 71 participants provided hair samples out of 116 total participants. | Posted | Mean | Standard Deviation | pg/mg | Baseline |
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|
| 0 |
| 116 |
| 0 |
| 116 |
| 0 |
| 116 |
| EG001 | Talk Program With Community Support Service Pamphlet (CSS) | Family receives pamphlet including list of community support service institutions that provide various health and well-being services. Talk program with Community Support Service Pamphlet (CSS): Pamphlet including list of community support service institutions | 0 | 116 | 0 | 116 | 0 | 116 |
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