The Roshni Project - Developing a Psychosocial Intervention

April 7, 2026 updated by: Centre for Addiction and Mental Health

The Roshni Project Phase 3: Developing a Culturally Driven Approach to Enhancing the Mental Well-being of Young South Asian Women

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group
Behavioral: Psychosocial therapy for South Asian women experiencing mood disorders

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depression, Anxiety & Stress Scale (Lovibond & Lovibond, 1995)
Time Frame: Change from baseline depression, anxiety and stress at 12 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emotion Regulation Questionnaire (Gross & John, 2003)
Time Frame: Change from baseline emotion regulation at 12 weeks
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.
Change from baseline emotion regulation at 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rosenberg Self Esteem Scale (Rosenberg, 1965)
Time Frame: Change from baseline self esteem at 12 weeks
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.
Change from baseline self esteem at 12 weeks
Connor-Davidson Resilience Scale (Campbell Sills & Stein, 2007)
Time Frame: Change from baseline resilience at 12 weeks
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.
Change from baseline resilience at 12 weeks
Culture and Identity Schedule (Bhugra et al., 1999)
Time Frame: Change from baseline cultural identity at 12 weeks
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.
Change from baseline cultural identity at 12 weeks
Cultural Values Conflict Scale for South Asian women (Inman et al., 2001)
Time Frame: Change from baseline cultural values conflict at 12 weeks
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.
Change from baseline cultural values conflict at 12 weeks
World Health Organization Quality of Life Scale (WHOQOL-BREF) (Skevington, Lofty, O'Connell, 2004)
Time Frame: Change from baseline quality of life at 12 weeks
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.
Change from baseline quality of life at 12 weeks
Working Alliance Inventory (Horvath & Greenberg, 1989)
Time Frame: 12 weeks
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.
12 weeks
Demographics
Time Frame: Baseline
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.
Baseline
Service Use & Access
Time Frame: Baseline
We will record participants use of services related to their mental health.
Baseline
Service Use & Access
Time Frame: 6 weeks
We will record participants use of services related to their mental health.
6 weeks
Service Use & Access
Time Frame: 12 weeks
We will record participants use of services related to their mental health.
12 weeks
Qualitative Interviews
Time Frame: 6 weeks
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.
6 weeks
Qualitative Interviews
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for Addiction and Mental Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gursharan Virdee, Doctorate, Centre for Addiction and Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 022/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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