- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07239388
Structured Group Therapy in Reducing Depression and Anxiety in Pakistan
Effectiveness of Structured Group Therapy in Reducing Depression and Anxiety Symptoms in Pakistan: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mental health disorders, particularly depression and anxiety, are prevalent in Pakistan and significantly affect the emotional, social, and occupational well-being of individuals. According to the World Health Organisation (WHO), depression is the leading cause of disability globally, and anxiety disorders are among the most common mental health conditions in Pakistan, affecting millions.
In the Pakistani context, stigma surrounding mental illness, lack of awareness, and limited access to mental health services create substantial barriers to care. Group therapy, which provides a collective support system and skill-building strategies, can be an effective modality in addressing these challenges. Structured group therapy offers participants a sense of community, reduces feelings of isolation, and provides a platform for learning coping strategies within a culturally sensitive framework.
This study aims to assess the effectiveness of Cognitive Behavioural Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) in group settings to reduce symptoms of depression and anxiety, enhance emotional resilience, and improve social support among Pakistani individuals struggling with these conditions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Pakistan Association of Cognitive Therapists
-
Contact:
- Laiba Qayyum
- Phone Number: +923021474287
- Email: laiba90012@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (18-65 years)
- Diagnosed with moderate to severe depression
- Residing in urban or rural areas of Pakistan
- Willingness to attend 12 weekly group therapy sessions and comply with the study protocol
Exclusion Criteria:
- Severe psychiatric disorders (e.g., psychosis, bipolar disorder)
- Ongoing substance abuse or severe substance use disorder
- Participation in other therapeutic interventions (e.g., individual therapy or group therapy) during the study period
- Cognitive impairments that would interfere with participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Structured group therapy
This group will receive Cognitive Behavioural Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) therapy techniques in group settings. The intervention will cover contents like: (1) Introduction to Depression and Anxiety: Understanding symptoms and causes; (2) Cognitive Restructuring: Identifying and challenging negative thoughts; (3) Stress Management: Techniques for managing physiological and psychological stress; (4) Mindfulness Practices: Meditation, breathing exercises, and body scanning; (5) Behavioural Activation: Planning and engaging in pleasurable and meaningful activities; (6) Social Support: Building and enhancing relationships; (7) Relapse Prevention: Strategies for maintaining progress after the intervention. Each group will consist of 8-10 participants to allow for optimal interaction and support. Twelve weekly group sessions, each lasting 90 minutes, will be conducted. |
Participants will receive Cognitive Behavioural Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) therapy techniques in group settings. The intervention will cover contents like: (1) Introduction to Depression and Anxiety: Understanding symptoms and causes; (2) Cognitive Restructuring: Identifying and challenging negative thoughts; (3) Stress Management: Techniques for managing physiological and psychological stress; (4) Mindfulness Practices: Meditation, breathing exercises, and body scanning; (5) Behavioural Activation: Planning and engaging in pleasurable and meaningful activities; (6) Social Support: Building and enhancing relationships; (7) Relapse Prevention: Strategies for maintaining progress after the intervention. Each group will consist of 8-10 participants to allow for optimal interaction and support. Twelve weekly group sessions, each lasting 90 minutes, will be conducted. |
|
No Intervention: Treatment as usual
Participants will receive standard treatment or usual care, which may include individual therapy or medication, depending on their current treatment regimen.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression and anxiety
Time Frame: 12 weeks
|
As measured through the participants' scores on the Hospital Anxiety & Depression Scale (HADS)
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social support
Time Frame: 12 weeks
|
As measured through participants' scores on the Multidimensional Scale of Perceived Social Support (MSPSS)
|
12 weeks
|
|
Functionality of participants
Time Frame: 12 weeks
|
As measured through participants' scores on the WHO Disability Assessment Schedule (WHODAS 2.0)
|
12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- RCT_D_A_GT_2025
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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