<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04453709</url>
  </required_header>
  <id_info>
    <org_study_id>1837</org_study_id>
    <nct_id>NCT04453709</nct_id>
  </id_info>
  <brief_title>Family-centered Mental Health Promotion Intervention</brief_title>
  <official_title>Reducing Stress, Anxiety, and Depressive Symptoms Via a Family-centered Preventative Intervention for Immigrants: A Randomized Controlled Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Amherst</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Massachusetts, Amherst</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Goal: The long-term goal of the proposed research program is to test the effectiveness of a&#xD;
      preventative behavioral intervention and to scale it up for use with broader immigrant&#xD;
      populations to reduce stress and mental health disorders.&#xD;
&#xD;
      Intervention: This study plan to adapt the World Health Organization developed Problem&#xD;
      Management Plus (PMP), an evidence based, multi-component, behavioral intervention including&#xD;
      breathing, problem solving, behavioral activation, and social support for immigrants.&#xD;
&#xD;
      Hypothesis: Immigrants in the Problem Management Plus for Immigrants (PMP-I) will have&#xD;
      significantly lower levels of stress and anxious/depressive symptoms as compared to&#xD;
      immigrants in the talk program with Community Support Service pamphlets (CSS).&#xD;
&#xD;
      Objective: The current study aims to pilot test the feasibility and acceptability of PMP-I&#xD;
      among Bhutanese immigrants 18 years and older living in the Massachusetts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Problem Management Plus (PMP) is a low-intensity evidence-based psychological intervention&#xD;
      developed by World Health Organization that can be delivered by trained lay people. PMP&#xD;
      systematically teaches four strategies: stress management through breathing exercises,&#xD;
      problem solving, behavioral activation, and skills to strengthen social support at individual&#xD;
      level. The current study plans to adapt PMP to develop the PMP for Immigrants (PMP-I) for a&#xD;
      family setting to address immigrant's multiple social and emotional stressors while adjusting&#xD;
      into the new multi-cultural environment of the United States. The rationale to adapt PMP is&#xD;
      based on our intervention model that demands integration of social and emotional stressors;&#xD;
      promising results of PMP; strong evidence of family and community ties in health care&#xD;
      process; and growing consensus among community, scientists, and policymakers on the need for&#xD;
      family-based care models that are sustainable. PMP-I is a 5-week, peer-led, culturally&#xD;
      tailored mental health promotion program that includes psychoeducation, behavioral&#xD;
      activation, and problem solving (90 minutes/session/weekly), and breathing exercises and yoga&#xD;
      (90 minutes/session/weekly) in a family setting. Participating families will be randomly&#xD;
      allocated into two groups (N=116 families (232 participants: two eligible members per&#xD;
      family); 58 families per intervention (PMP-I) and control (CSS)) with assessments at&#xD;
      baseline, post-intervention, and 3-month post-intervention with trained community&#xD;
      facilitators in collaboration with church leaders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 17, 2021</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Perceived Stress Scores</measure>
    <time_frame>Baseline, immediate post-intervention and 12-week post intervention</time_frame>
    <description>The 10-item Cohen Perceived Stress Scale (PSS) will be used to assess perceived stress at baseline, post-intervention, and 12-week post-intervention. The PSS uses a 5-point Likert scale (ranging from 0, &quot;never&quot; to 4, &quot;very often&quot;) to assess psychological stress experienced during the past four weeks, including the extent to which situations felt unpredictable, uncomfortable, and overwhelming.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Anxiety and Depressive Symptoms Scores</measure>
    <time_frame>Baseline, immediate post-intervention and 12-week post intervention</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Hair Cortisol Concentrations</measure>
    <time_frame>Baseline and 12-week post intervention</time_frame>
    <description>Cortisol hair-test (average hormone levels over the past 3 months) will be used as a biomarker to measure physiological stress.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">232</enrollment>
  <condition>Stress, Psychological</condition>
  <condition>Stress, Physiological</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Problem Management Plus for Immigrants at family settings</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Talk program with Community Support Service Pamphlet (CSS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Family receives pamphlet including list of community support service institutions that provide various health and well-being services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Problem Management Plus for Immigrants at family settings</intervention_name>
    <description>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.&#xD;
Managing Stress: Breathing and yoga practices, stress-management sessions, and behavioral activation exercises to strengthen positive coping strategies.&#xD;
Managing Problems: Practice exercises to identify the problems, develop solutions, and plan a strategy to carry out those solutions.&#xD;
Get Going, Keep Doing: Communication skill sessions and practice exercises to identify and carry out pleasant tasks.&#xD;
Strengthening Social Support: Social skills session and practice exercise to identify social support.&#xD;
Staying Well: Make a plan that helps to create supportive family environment.</description>
    <arm_group_label>Problem Management Plus for Immigrants at family settings</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Talk program with Community Support Service Pamphlet (CSS)</intervention_name>
    <description>Pamphlet including list of community support service institutions</description>
    <arm_group_label>Talk program with Community Support Service Pamphlet (CSS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bhutanese adult 18 years or older resettled in Massachusetts&#xD;
&#xD;
          -  Have a score of 14 or below on the Patient Health Questionnaire (PHQ-9)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a PHQ-9 score of 15 or above&#xD;
&#xD;
          -  Clinically diagnosed mental health disorders&#xD;
&#xD;
          -  Taking psychiatric medications for any mental health problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kalpana Poudel-Tandukar, PhD</last_name>
    <phone>4135455095</phone>
    <email>kalpana@umass.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cynthia S Jacelon</last_name>
    <phone>4135459576</phone>
    <email>jacelon@nursing.umass.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Massachusetts Amherst</name>
      <address>
        <city>Amherst</city>
        <state>Massachusetts</state>
        <zip>01003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kalpana Poudel-Tandukar, Ph.D</last_name>
      <phone>413-545-5095</phone>
      <email>kalpana@umass.edu</email>
    </contact>
    <contact_backup>
      <last_name>Cynthia S Jacelon</last_name>
      <phone>413 545 9576</phone>
      <email>jacelon@nursing.umass.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Amherst</investigator_affiliation>
    <investigator_full_name>Kalpana Poudel-Tandukar</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Stress</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>Preventative Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlies published results will be shared after deidentification.</ipd_description>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>IPD will be made available after the main findings from the final research data set have been accepted for publication. No end date.</ipd_time_frame>
    <ipd_access_criteria>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.</ipd_access_criteria>
    <ipd_url>https://grants.nih.gov/grants/policy/data_sharing/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04453709
org study id: 1837
nct id: NCT04453709
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in the Perceived Stress Scores
time frame: Baseline, immediate post-intervention and 12-week post intervention
description: The 10-item Cohen Perceived Stress Scale (PSS) will be used to assess perceived stress at baseline, post-intervention, and 12-week post-intervention. The PSS 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.
measure: Change in the Anxiety and Depressive Symptoms Scores
time frame: Baseline, immediate post-intervention and 12-week post intervention
description: 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).
measure: Change in the Hair Cortisol Concentrations
time frame: Baseline and 12-week post intervention
description: Cortisol hair-test (average hormone levels over the past 3 months) will be used as a biomarker to measure physiological stress.
arm group label: Problem Management Plus for Immigrants at family settings
arm group type: Experimental
description: 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.
arm group label: Talk program with Community Support Service Pamphlet (CSS)
arm group type: Active Comparator
description: Family receives pamphlet including list of community support service institutions that provide various health and well-being services.
intervention type: Behavioral
intervention name: Problem Management Plus for Immigrants at family settings
description: 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.
Managing Stress: Breathing and yoga practices, stress-management sessions, and behavioral activation exercises to strengthen positive coping strategies.
Managing Problems: Practice exercises to identify the problems, develop solutions, and plan a strategy to carry out those solutions.
Get Going, Keep Doing: Communication skill sessions and practice exercises to identify and carry out pleasant tasks.
Strengthening Social Support: Social skills session and practice exercise to identify social support.
Staying Well: Make a plan that helps to create supportive family environment.
arm group label: Problem Management Plus for Immigrants at family settings
intervention type: Behavioral
intervention name: Talk program with Community Support Service Pamphlet (CSS)
description: Pamphlet including list of community support service institutions
arm group label: Talk program with Community Support Service Pamphlet (CSS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kalpana Poudel-Tandukar, PhD
phone: 4135455095
email: kalpana@umass.edu
last name: Cynthia S Jacelon
phone: 4135459576
email: jacelon@nursing.umass.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Amherst
investigator full name: Kalpana Poudel-Tandukar
investigator title: Assistant Professor
mesh term: Depression
mesh term: Anxiety Disorders
mesh term: Stress, Psychological
sharing ipd: Yes
ipd description: Individual participant data that underlies published results will be shared after deidentification.
ipd info type: Informed Consent Form (ICF)
ipd time frame: IPD will be made available after the main findings from the final research data set have been accepted for publication. No end date.
ipd access criteria: 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.
ipd url: https://grants.nih.gov/grants/policy/data_sharing/