Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
564 participants
INTERVENTIONAL
2025-05-01
2025-12-30
Brief Summary
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According to a recent study, 34% of young people worldwide (aged 10-19) suffer from depression and more than half of this population belongs to Southeast Asia such as Pakistan, India, and China.
Existing evidence shows that the access to mental health services in LMICs is limited and even fewer child psychiatric services are available.
One approach to overcome barriers such as limited availability of trained mental health professionals and risk of stigma may involve the use of simple, brief, scalable interventions based on basic psychological principles rather than treatment of psychopathology.
This study adapts and evaluates two brief interventions called behavioral activation single session intervention (BA-SSI) and 4-session Mindset intervention (MI) for teenage depression and anxiety in Pakistan, where access to mental health care is constrained by societal stigma and a shortage of clinicians.
Detailed Description
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Proposed study is designed using the updated Medical Research Council (MRC) Framework for the development and evaluation of complex interventions.
Three public schools will be recruited from each of 10 cities across Pakistan: Karachi, Hyderabad, Nawabshah, Thatta, Lahore, Gujrat, Rawalpindi, Multan, Quetta, and Peshawar.
All the participants, regardless of their treatment arm, will be assessed at baseline, 1 month post-baseline and at 3-month.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Behavioral Activation - single session intervention (BA-SSI)
This is comprised of 5 five components:
1. Discussion on the rationale of the behavioral activation
2. Awareness raising about distress, including how behavior shapes feelings and thoughts;
3. a life values assessment
4. the creation of an activity action plan
5. an exercise in which youths write about benefits that might result from engaging in each activity, an obstacle that might keep them from doing the activities and a strategy for overcoming the identified obstacles.
Behavioral Activation - single session intervention (BA-SSI)
Single session intervention
4-session Mindset intervention
This is comprised of a growth mindset module (2 sessions), a gratitude module (1 session) and a value affirmations module (1 session). Sessions are delivered weekly (over 4 weeks) and each session lasts for an hour. Reading and writing activities and group discussions are included in each session. Participants are supposed to complete homework exercises are assigned between sessions.
4-session Mindset intervention
This is comprised of 4 sessions.
Waiting list control group
At end of the study, this group will be offered to choose one intervention from two active interventions mentioned above.
No interventions assigned to this group
Interventions
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Behavioral Activation - single session intervention (BA-SSI)
Single session intervention
4-session Mindset intervention
This is comprised of 4 sessions.
Eligibility Criteria
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Inclusion Criteria
* Youth has one parent or legal guardian to give consent.
* Youth speaks Urdu well enough to complete the paper based intervention.
Schools in the study areas are eligible to participate if they meet all the following criteria:
1. the school authority agrees to participate;
2. the schools shall be non-specialist public schools;
Exclusion Criteria
* Adolescent with history of hospitalization or those who received inpatient treatment for a mental health problem within the past two months as the intervention being tested and this study is not designed for adolescent with acute medical and/or psychiatric treatment needs (if identified with any acute medical and/or psychiatric problem, they would be referred to appropriate health services through parents).
1. the school authority refuses to participate;
2. a specialist and/or independent or private school;
12 Years
15 Years
ALL
Yes
Sponsors
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Fatima Jinnah Women University
OTHER
Pakistan Institute of Living and Learning
OTHER
Responsible Party
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Locations
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Public school for boys 1
Rawalpindi, Punjab Province, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Tayyeba Kiran, PhD
Role: primary
Other Identifiers
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Mindset-PK
Identifier Type: -
Identifier Source: org_study_id