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
About this trial
This is an interventional treatment trial for Mood Disorders focused on measuring Cultural Relevance, Cultural Adaptation, South Asian, Gender
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.
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
NCT ID
NCT04338464
First Posted
March 20, 2020
Last Updated
April 6, 2020
Sponsor
Centre for Addiction and Mental Health
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
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The Roshni Project - Developing a Psychosocial Intervention
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