- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468994
Effect of the MindUP Program on Depression, Anxiety, and Stress in Pakistani Orphan Adolescents (MINDUP-PAK)
Does MindUP Work With Pakistani Orphan Adolescents? Assessing Its Efficacy in Lowering Depression, Anxiety and Stress
This study evaluates the effectiveness of the MindUP mindfulness-based program in reducing depression, anxiety, and stress among orphan adolescents in Pakistan. Adolescents living in orphan care institutions often experience significant psychological distress due to early life adversity, loss of parental support, and institutional living conditions.
A school-based quasi-experimental design was used to examine whether participation in the MindUP program improves mental health outcomes among orphan adolescents. Participants were adolescents residing in orphanages in Pakistan who were assigned to either an intervention group receiving the MindUP program or a comparison group receiving routine institutional activities.
The MindUP intervention consisted of structured mindfulness and social-emotional learning sessions designed to enhance emotional regulation, attention, and psychological well-being. The program was delivered over several weeks by trained facilitators.
Psychological outcomes including depression, anxiety, and stress were measured using standardized self-report scales before and after the intervention. The study aims to determine whether the MindUP program is effective in improving mental health among orphan adolescents in low-resource institutional settings.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Islamabad
-
Islamabad, Islamabad, Pakistan, 44000
- Aghosh Alkhidmat Foundation College Murree
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male adolescents aged 11-16 years.
Residing in an orphan care institution.
Currently enrolled in school (grades 7-8).
Able to understand and participate in the MindUP program sessions.
Provided assent to participate and permission obtained from the institutional authorities/guardians.
Exclusion Criteria:
- Adolescents currently receiving psychological or psychiatric treatment.
Adolescents with severe cognitive or developmental disorders that would interfere with participation in the intervention.
Adolescents who did not complete baseline assessments or were absent for most intervention sessions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MindUP Intervention Group
Participants in this group received the MindUP mindfulness-based intervention program designed to improve emotional regulation, attention, and psychological well-being.
The program consisted of structured sessions focusing on mindfulness practices, social-emotional learning, and awareness exercises delivered over several weeks.
|
MindUP is a mindfulness-based social and emotional learning program that teaches participants skills related to mindful awareness, emotional regulation, attention, and stress management through structured exercises and activities.
|
|
No Intervention: Control Group
Participants in this group continued their routine institutional activities and did not receive the MindUP intervention during the study period.
Psychological outcomes were assessed at the same time points as the intervention group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Depression Symptoms (DASS-21 Depression Subscale)
Time Frame: Baseline to Post-Intervention (15 weeks)
|
Depression symptoms were measured using the Depression subscale of the Depression Anxiety Stress Scales (DASS-21).
Higher scores indicate greater levels of depressive symptoms.
Changes from baseline to post-intervention were assessed to evaluate the effectiveness of the MindUP program.
|
Baseline to Post-Intervention (15 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Stress Levels (DASS-21 Stress Subscale)
Time Frame: Baseline to Post-Intervention (15 weeks)
|
Baseline to Post-Intervention (15 weeks)
|
|
Change in Anxiety Symptoms (DASS-21 Anxiety Subscale)
Time Frame: Baseline to Post-Intervention (15 weeks)
|
Baseline to Post-Intervention (15 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rubina Hanif, PhD, Quaid-i-Azam University, Islamabad.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIP-MINDUP-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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