The Roshni Project - Developing a Psychosocial Intervention

NCT04338464 | Withdrawn DMC

• 1 other identifier: 022/2019
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mood Disorders

Keywords

Cultural Relevance; Cultural Adaptation; South Asian; Gender

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline depression, anxiety and stress at 12 weeks

Secondary Outcomes (1)

• Emotion Regulation Questionnaire (Gross & John, 2003)

  Change from baseline emotion regulation at 12 weeks

Other Outcomes (12)

• Rosenberg Self Esteem Scale (Rosenberg, 1965)

  Change from baseline self esteem at 12 weeks

• Connor-Davidson Resilience Scale (Campbell Sills & Stein, 2007)

  Change from baseline resilience at 12 weeks

• Culture and Identity Schedule (Bhugra et al., 1999)

  Change from baseline cultural identity at 12 weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

Behavioral: Psychosocial therapy for South Asian women experiencing mood disorders

Interventions

Psychosocial therapy for South Asian women experiencing mood disorders BEHAVIORAL

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.

Treatment Group

Eligibility Criteria

• Age: 16 Years - 24 Years
• Gender Eligibility Details: Self define as female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

MeSH Terms

Conditions

Mood Disorders; Coitus

Condition Hierarchy (Ancestors)

Mental Disorders; Sexual Behavior; Behavior

Study Officials

• Gursharan Virdee, Doctorate

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: April 8, 2020
• Study Start: August 4, 2020
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share