Structured Group Therapy in Reducing Depression and Anxiety in Pakistan

November 15, 2025 updated by: Pakistan Association of Cognitive Therapists

Effectiveness of Structured Group Therapy in Reducing Depression and Anxiety Symptoms in Pakistan: A Randomised Controlled Trial

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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

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

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

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 Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Pakistan Association of Cognitive Therapists
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: 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.
Other: Structured group therapy

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

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 and anxiety
Time Frame: 12 weeks
As measured through the participants' scores on the Hospital Anxiety & Depression Scale (HADS)
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
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

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.
Pakistan Association of Cognitive Therapists

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 (Estimated)

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.
November 1, 2025

Primary Completion (Estimated)

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.
February 1, 2026

Study Completion (Estimated)

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.
February 1, 2026

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).
November 15, 2025

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.
November 15, 2025

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.
November 20, 2025

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.
November 20, 2025

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.
November 15, 2025

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.
November 1, 2025

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.
  • RCT_D_A_GT_2025

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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