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The Roshni Project - Developing a Psychosocial Intervention

Primary Purpose

Mood Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychosocial therapy for South Asian women experiencing mood disorders
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Disorders focused on measuring Cultural Relevance, Cultural Adaptation, South Asian, Gender

Eligibility Criteria

16 Years - 24 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  • aged 16-24 years
  • identify as a woman
  • ancestry connected to India, Pakistan, Bangladesh and Sri Lanka
  • formal diagnosis of mood or anxiety disorder
  • completed high-school in Canada
  • reside in the Greater Toronto Area
  • speak conversational English

Exclusion criteria:

• individuals with developmental disabilities and serious mental illness e.g. schizophrenia spectrum, bipolar and personality disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Depression, Anxiety & Stress Scale (Lovibond & Lovibond, 1995)
    The Depression, Anxiety & Stress Scale (Lovibond & Lovibond, 1995) is a 42 item scale questionnaire with a 4 point likert scale from 0 to 4 measuring across three domains of depression, anxiety and stress. Total scores range from 0-168, with higher scores indicating greater symptom severity.

    Secondary Outcome Measures

    Emotion Regulation Questionnaire (Gross & John, 2003)
    Emotion Regulation Questionnaire (Gross & John, 2003) is a 10 item survey assessing emotion regulatory processes including subscales for cognitive reappraisal and expressive suppression. The survey has a 7 point likert scale ranging from 0 (strongly disagree) to 7 (strongly agree), with total range from 0-70 with higher scores indicating better emotion regulation.

    Full Information

    First Posted
    March 20, 2020
    Last Updated
    April 6, 2020
    Sponsor
    Centre for Addiction and Mental Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04338464
    Brief Title
    The Roshni Project - Developing a Psychosocial Intervention
    Official Title
    The Roshni Project Phase 3: Developing a Culturally Driven Approach to Enhancing the Mental Well-being of Young South Asian Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2020 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centre for Addiction and Mental Health

    4. Oversight

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

    5. Study Description

    Brief Summary
    The mental health sector is being called upon to develop and implement interventions for youth that attend to gender, age and cultural diversity (Mental Health Commission of Canada, 2016). The proposed project outlines the development and feasibility testing of a culturally driven transdiagnostic psychosocial intervention for South Asian women aged 16-24 years. We will recruit 30 participants to complete the 12 week psychosocial intervention. Pre, midpoint and post evaluations will be completed to asses change in mental health, self esteem and values, and also qualitative feedback on participant experiences of the intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mood Disorders
    Keywords
    Cultural Relevance, Cultural Adaptation, South Asian, Gender

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychosocial therapy for South Asian women experiencing mood disorders
    Intervention Description
    The 12 week intervention has four major components: Relational theory (Belgrave, 2002) & South Asian identity development (Inman et al., 2001). These foundational components focus on strengthening cultural identity through the exploration of values, navigation and reconciliation of two cultures. Transdiagnostic treatment of mood disorders (Ehrenreich-May et al., 2017). This component will focus on skill building in the areas of emotion awareness, resilience, adaptability, self-compassion and healthy coping strategies (Farchione et al., 2012; Bilek & Ehrenriech-May, 2012; Ritschel, Noriel & Lindsay, 2015). Psychoeducation on mental health, sexual health, and substance use. Peer support is a critical component of the intervention and will be provided by the peer researcher on the team. Participants will have access to optional individual peer support for 30 minutes to one hour per week for the duration of the intervention, this can be in person or telephone support.
    Primary Outcome Measure Information:
    Title
    Depression, Anxiety & Stress Scale (Lovibond & Lovibond, 1995)
    Description
    The Depression, Anxiety & Stress Scale (Lovibond & Lovibond, 1995) is a 42 item scale questionnaire with a 4 point likert scale from 0 to 4 measuring across three domains of depression, anxiety and stress. Total scores range from 0-168, with higher scores indicating greater symptom severity.
    Time Frame
    Change from baseline depression, anxiety and stress at 12 weeks
    Secondary Outcome Measure Information:
    Title
    Emotion Regulation Questionnaire (Gross & John, 2003)
    Description
    Emotion Regulation Questionnaire (Gross & John, 2003) is a 10 item survey assessing emotion regulatory processes including subscales for cognitive reappraisal and expressive suppression. The survey has a 7 point likert scale ranging from 0 (strongly disagree) to 7 (strongly agree), with total range from 0-70 with higher scores indicating better emotion regulation.
    Time Frame
    Change from baseline emotion regulation at 12 weeks
    Other Pre-specified Outcome Measures:
    Title
    Rosenberg Self Esteem Scale (Rosenberg, 1965)
    Description
    Rosenberg Self Esteem Scale (Rosenberg, 1965) is a 10 item self report measure used globally to assess self esteem amongst young adults. Scores on a 4 point likert scale with total scores ranging from 0-40, with higher scores indicating high self esteem.
    Time Frame
    Change from baseline self esteem at 12 weeks
    Title
    Connor-Davidson Resilience Scale (Campbell Sills & Stein, 2007)
    Description
    Connor-Davidson Resilience Scale (Campbell Sills & Stein, 2007) is a 25-item self report form including key features of resilience found across cultures including self-efficacy, action oriented approach, viewing change or stress as a challenge or opportunity, recognizing limits to control, faith and past successes. Scores range from 0-4, with full range from 0-100, and higher scores reflecting greater resilience.
    Time Frame
    Change from baseline resilience at 12 weeks
    Title
    Culture and Identity Schedule (Bhugra et al., 1999)
    Description
    Culture and Identity Schedule (Bhugra et al., 1999) is a 106 item survey which explores adherence to traditional cultural values amongst immigrant South Asians in high income contexts. Items are scored 0 indicating more Eurocentric values and 1 indicating alliance with South Asian values. Higher total scores reflect greater overall affiliation with South Asian culture and identity.
    Time Frame
    Change from baseline cultural identity at 12 weeks
    Title
    Cultural Values Conflict Scale for South Asian women (Inman et al., 2001)
    Description
    Cultural Values Conflict Scale for South Asian women (Inman et al., 2001) measures cultural adjustment among North American South Asian women specifically in the areas of family relations, sex role expectations, dating and premarital practices, and marriage. This 40 item scales scored on a 6 point likert scale, with total range from 0-240 and higher overall scores indicating greater conflict.
    Time Frame
    Change from baseline cultural values conflict at 12 weeks
    Title
    World Health Organization Quality of Life Scale (WHOQOL-BREF) (Skevington, Lofty, O'Connell, 2004)
    Description
    World Health Organization Quality of Life Scale (WHOQOL-BREF) (Skevington, Lofty, O'Connell, 2004) is a 26 item cross culturally valid measure of quality of life. Scores range from 0-100 with higher scores indicating better quality of life.
    Time Frame
    Change from baseline quality of life at 12 weeks
    Title
    Working Alliance Inventory (Horvath & Greenberg, 1989)
    Description
    Working Alliance Inventory (Horvath & Greenberg, 1989) is a 36 item questionnaire that assesses the relationship between client and clinician, measuring working, therapeutic and helping alliance. Items are scored on a 7 point likert scale, with three 12-item sub scales measuring task, bond and goal.
    Time Frame
    12 weeks
    Title
    Demographics
    Description
    A detailed demographic profile will be developed including age, gender, ethnicity, sexual orientation/identity, religion, family composition, immigration history, mental health history, school and employment history, characteristics of neighbourhoods.
    Time Frame
    Baseline
    Title
    Service Use & Access
    Description
    We will record participants use of services related to their mental health.
    Time Frame
    Baseline
    Title
    Service Use & Access
    Description
    We will record participants use of services related to their mental health.
    Time Frame
    6 weeks
    Title
    Service Use & Access
    Description
    We will record participants use of services related to their mental health.
    Time Frame
    12 weeks
    Title
    Qualitative Interviews
    Description
    Mid-point interview (week 6): Participants will be asked about their experiences of the intervention including access to the group, content, facilitation and out of session practice.
    Time Frame
    6 weeks
    Title
    Qualitative Interviews
    Description
    Post-treatment interview (week 12): In this interview participants will be asked about their total experience of the intervention including access to the group, content, facilitation and out of session practice, perceived impacts, probing what aspects of the intervention were helpful and those that weren't as helpful, and thoughts about how we can improve the intervention.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Self define as female
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: aged 16-24 years identify as a woman ancestry connected to India, Pakistan, Bangladesh and Sri Lanka formal diagnosis of mood or anxiety disorder completed high-school in Canada reside in the Greater Toronto Area speak conversational English Exclusion criteria: • individuals with developmental disabilities and serious mental illness e.g. schizophrenia spectrum, bipolar and personality disorders.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gursharan Virdee, Doctorate
    Phone
    416-535-8501
    Ext
    34065
    Email
    gursharan.virdee@camh.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sidney Lichtenstein, Bachelors
    Phone
    416-535-8501
    Email
    sidney.lichtenstein@camh.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gursharan Virdee, Doctorate
    Organizational Affiliation
    Centre for Addiction and Mental Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Roshni Project - Developing a Psychosocial Intervention

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