Anxiety, Depression, Stress, Physiological, Stress, Psychological
Conditions
Keywords
Stress, Anxiety, Depression, Preventative Intervention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALProblem 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. 1. Managing Stress: Breathing and yoga practices, stress-management sessions, and behavioral activation exercises to strengthen positive coping strategies. 2. Managing Problems: Practice exercises to identify the problems, develop solutions, and plan a strategy to carry out those solutions. 3. Get Going, Keep Doing: Communication skill sessions and practice exercises to identify and carry out pleasant tasks. 4. Strengthening Social Support: Social skills session and practice exercise to identify social support. 5. Staying Well: Make a plan that helps to create supportive family environment.
BEHAVIORALTalk program with Community Support Service Pamphlet (CSS)
Pamphlet including list of community support service institutions
Sponsors
Vanderbilt University
University of Massachusetts, Amherst
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Bhutanese adult 18 years or older resettled in Massachusetts * Have a score of 14 or below on the Patient Health Questionnaire (PHQ-9)
Exclusion criteria
* Have a PHQ-9 score of 15 or above * Clinically diagnosed mental health disorders * Taking psychiatric medications for any mental health problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohen Perceived Stress Scale to Measure Stress | Baseline | 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. |
| Hopkins Symptom Checklist-25 to Measure Anxiety | Baseline | 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. |
| Hopkins Symptom Checklist-25 to Measure Depressive Symptoms | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hair Cortisol Concentrations (pg/mg) | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
1. Managing Stress: Breathing and yoga practices, stress-management sessions, and behavioral activation exercises to strengthen positive coping strategies.
2. Managing Problems: Practice exercises to identify the problems, develop solutions, and plan a strategy to carry out those solutions.
3. Get Going, Keep Doing: Communication skill sessions and practice exercises to identify and carry out pleasant tasks.
4. Strengthening Social Support: Social skills session and practice exercise to identify social support.
5. Staying Well: Make a plan that helps to create supportive family environment. | 116 |
| 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 | 116 |
| Total | 232 |
Baseline characteristics
| Characteristic | Problem Management Plus for Immigrants at Family Settings | Talk Program With Community Support Service Pamphlet (CSS) | Total |
|---|---|---|---|
| Age, Continuous | 43.60 years STANDARD_DEVIATION 16.35 | 39.98 years STANDARD_DEVIATION 15.46 | 41.79 years STANDARD_DEVIATION 15.98 |
| Body height in cms | 156.2 cms STANDARD_DEVIATION 13.34 | 157.7 cms STANDARD_DEVIATION 11.21 | 156.9 cms STANDARD_DEVIATION 12.32 |
| Body waist in inches | 36.78 inches STANDARD_DEVIATION 3.88 | 35.35 inches STANDARD_DEVIATION 4.02 | 36.10 inches STANDARD_DEVIATION 4.03 |
| Body weight in kg | 66.93 kg STANDARD_DEVIATION 11.33 | 64.88 kg STANDARD_DEVIATION 11.8 | 65.91 kg STANDARD_DEVIATION 11.59 |
| Duration of living in US | 9.45 years STANDARD_DEVIATION 1.89 | 8.77 years STANDARD_DEVIATION 2.26 | 9.11 years STANDARD_DEVIATION 2.1 |
| Dystolic Blood Pressure | 84.25 millimeters of mercury STANDARD_DEVIATION 7.69 | 81.85 millimeters of mercury STANDARD_DEVIATION 7.85 | 83.05 millimeters of mercury STANDARD_DEVIATION 7.85 |
| Employed | 59 Participants | 58 Participants | 117 Participants |
| Ever Been to School | 63 Participants | 62 Participants | 125 Participants |
| Ever Drunk Alcohol | 23 Participants | 17 Participants | 40 Participants |
| Ever Married | 104 Participants | 94 Participants | 198 Participants |
| Ever Smoked | 25 Participants | 24 Participants | 49 Participants |
| History of Chronic Disease | 31 Participants | 15 Participants | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 116 Participants | 116 Participants | 232 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 116 participants | 116 participants | 232 participants |
| Sex: Female, Male Female | 64 Participants | 65 Participants | 129 Participants |
| Sex: Female, Male Male | 52 Participants | 51 Participants | 103 Participants |
| Systolic Blood Pressure | 127.8 millimeters of mercury STANDARD_DEVIATION 11.9 | 126 millimeters of mercury STANDARD_DEVIATION 14.7 | 126.8 millimeters of mercury STANDARD_DEVIATION 13.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 116 | 0 / 116 |
| other Total, other adverse events | 0 / 116 | 0 / 116 |
| serious Total, serious adverse events | 0 / 116 | 0 / 116 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Management Plus for Immigrants at Family Settings | Cohen Perceived Stress Scale to Measure Stress | 23.28 score on a scale | Standard Deviation 3.7 |
| Talk Program With Community Support Service Pamphlet (CSS) | Cohen Perceived Stress Scale to Measure Stress | 19.31 score on a scale | Standard Deviation 4.87 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Management Plus for Immigrants at Family Settings | Hopkins Symptom Checklist-25 to Measure Anxiety | 21.57 score on a scale | Standard Deviation 3.25 |
| Talk Program With Community Support Service Pamphlet (CSS) | Hopkins Symptom Checklist-25 to Measure Anxiety | 15.37 score on a scale | Standard Deviation 5.08 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Management Plus for Immigrants at Family Settings | Hopkins Symptom Checklist-25 to Measure Depressive Symptoms | 32.11 score on a scale | Standard Deviation 4.89 |
| Talk Program With Community Support Service Pamphlet (CSS) | Hopkins Symptom Checklist-25 to Measure Depressive Symptoms | 22.56 score on a scale | Standard Deviation 6.24 |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Management Plus for Immigrants at Family Settings | Hair Cortisol Concentrations (pg/mg) | 349.37 pg/mg | Standard Deviation 2627.98 |
| Talk Program With Community Support Service Pamphlet (CSS) | Hair Cortisol Concentrations (pg/mg) | 78.35 pg/mg | Standard Deviation 324.36 |