Trial Outcomes & Findings for Family-centered Mental Health Promotion Intervention (NCT NCT04453709)
NCT ID: NCT04453709
Last Updated: 2024-10-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
232 participants
Primary outcome timeframe
Baseline
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
116
|
|
Overall Study
COMPLETED
|
116
|
116
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Family-centered Mental Health Promotion Intervention
Baseline characteristics by cohort
| Measure |
Problem Management Plus for Immigrants at Family Settings
n=116 Participants
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.
|
Talk Program With Community Support Service Pamphlet (CSS)
n=116 Participants
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
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.60 years
STANDARD_DEVIATION 16.35 • n=5 Participants
|
39.98 years
STANDARD_DEVIATION 15.46 • n=7 Participants
|
41.79 years
STANDARD_DEVIATION 15.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
116 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
116 participants
n=5 Participants
|
116 participants
n=7 Participants
|
232 participants
n=5 Participants
|
|
Ever Married
|
104 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Ever Been to School
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Employed
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Ever Drunk Alcohol
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ever Smoked
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
History of Chronic Disease
|
31 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Duration of living in US
|
9.45 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
8.77 years
STANDARD_DEVIATION 2.26 • n=7 Participants
|
9.11 years
STANDARD_DEVIATION 2.10 • n=5 Participants
|
|
Body weight in kg
|
66.93 kg
STANDARD_DEVIATION 11.33 • n=5 Participants
|
64.88 kg
STANDARD_DEVIATION 11.80 • n=7 Participants
|
65.91 kg
STANDARD_DEVIATION 11.59 • n=5 Participants
|
|
Body height in cms
|
156.2 cms
STANDARD_DEVIATION 13.34 • n=5 Participants
|
157.7 cms
STANDARD_DEVIATION 11.21 • n=7 Participants
|
156.9 cms
STANDARD_DEVIATION 12.32 • n=5 Participants
|
|
Body waist in inches
|
36.78 inches
STANDARD_DEVIATION 3.88 • n=5 Participants
|
35.35 inches
STANDARD_DEVIATION 4.02 • n=7 Participants
|
36.10 inches
STANDARD_DEVIATION 4.03 • n=5 Participants
|
|
Systolic Blood Pressure
|
127.8 millimeters of mercury
STANDARD_DEVIATION 11.9 • n=5 Participants
|
126 millimeters of mercury
STANDARD_DEVIATION 14.7 • n=7 Participants
|
126.8 millimeters of mercury
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Dystolic Blood Pressure
|
84.25 millimeters of mercury
STANDARD_DEVIATION 7.69 • n=5 Participants
|
81.85 millimeters of mercury
STANDARD_DEVIATION 7.85 • n=7 Participants
|
83.05 millimeters of mercury
STANDARD_DEVIATION 7.85 • n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Problem Management Plus for Immigrants at Family Settings
n=116 Participants
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.
|
Talk Program With Community Support Service Pamphlet (CSS)
n=116 Participants
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
|
|---|---|---|
|
Cohen Perceived Stress Scale to Measure Stress
|
23.28 score on a scale
Standard Deviation 3.70
|
19.31 score on a scale
Standard Deviation 4.87
|
PRIMARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Problem Management Plus for Immigrants at Family Settings
n=116 Participants
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.
|
Talk Program With Community Support Service Pamphlet (CSS)
n=116 Participants
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
|
|---|---|---|
|
Hopkins Symptom Checklist-25 to Measure Anxiety
|
21.57 score on a scale
Standard Deviation 3.25
|
15.37 score on a scale
Standard Deviation 5.08
|
PRIMARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Problem Management Plus for Immigrants at Family Settings
n=116 Participants
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.
|
Talk Program With Community Support Service Pamphlet (CSS)
n=116 Participants
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
|
|---|---|---|
|
Hopkins Symptom Checklist-25 to Measure Depressive Symptoms
|
32.11 score on a scale
Standard Deviation 4.89
|
22.56 score on a scale
Standard Deviation 6.24
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
Problem Management Plus for Immigrants at Family Settings
n=84 Participants
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.
|
Talk Program With Community Support Service Pamphlet (CSS)
n=71 Participants
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
|
|---|---|---|
|
Hair Cortisol Concentrations (pg/mg)
|
349.37 pg/mg
Standard Deviation 2627.98
|
78.35 pg/mg
Standard Deviation 324.36
|
Adverse Events
Problem Management Plus for Immigrants at Family Settings
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Talk Program With Community Support Service Pamphlet (CSS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kalpana Poudel-Tandukar, Associate Professor
University of Massachusetts Amherst
Phone: 413-545-5095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place