Mood DisordersNCT04338464
The Roshni Project - Developing a Psychosocial Intervention
A study testing Psychosocial therapy for South Asian women experiencing mood disorders in people with Mood Disorders, run by Centre for Addiction and Mental Health.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 24 years, women only
- Conditions the study is for
- Mood Disorders
- What is being tested?
- Psychosocial therapy for South Asian women experiencing mood disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2020to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- individuals with developmental disabilities and serious mental illness e.g. schizophrenia spectrum, bipolar and personality disorders.
About this study
Official title: 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.
- Conditions
- Mood Disorders
- Being tested
- Psychosocial therapy for South Asian women experiencing mood disorders
- Keywords
- Cultural Relevance, Cultural Adaptation, South Asian, Gender
- Medical subject headings
- Mood Disorders, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial therapy for South Asian women experiencing mood disordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Behavioral: Psychosocial therapy for South Asian women experiencing mood disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline depression, anxiety and stress at 12 weeks
Secondary outcomes (1)
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.
Measured: Change from baseline emotion regulation at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start4 Aug 2020
- Primary completion30 Aug 2025
- Study completion30 Sep 2025
Why it stopped: Study closed prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gursharan Virdee, Doctorate, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338464
- Sponsor's protocol ID
- 022/2019
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Roshni Project Phase 3: Developing a Culturally Driven Approach to Enhancing the Mental Well-being of Young South Asian Women
- ClinicalTrials.gov ID
- NCT04338464
- Acronym / sponsor ID
- 022/2019
- Conditions
- Mood Disorders
- Keywords
- Cultural Relevance, Cultural Adaptation, South Asian, Gender
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed prematurely
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Psychosocial therapy for South Asian women experiencing mood disorders |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- individuals with developmental disabilities and serious mental illness e.g. schizophrenia spectrum, bipolar and personality disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial therapy for South Asian women experiencing mood disordersThe 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. | Behavioural | Treatment Group |
Primary outcome
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.
1 secondary outcome
Emotion Regulation Questionnaire (Gross & John, 2003)
Time frame: Change from baseline emotion regulation at 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gursharan Virdee, Doctorate principal investigator
Centre for Addiction and Mental Health
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial therapy for South Asian women experiencing mood disorders in people with Mood Disorders, run by Centre for Addiction and Mental Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety & Stress Scale (Lovibond & Lovibond, 1995) (time frame: Change from baseline depression, anxiety and stress at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.