Depression in AdultsNCT07239388
Structured Group Therapy in Reducing Depression and Anxiety in Pakistan
A study testing Structured group therapy in people with Depression in Adults and Anxiety, run by Pakistan Association of Cognitive Therapists at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression in Adults, Anxiety
- What is being tested?
- Structured group therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Pakistan Association of Cognitive Therapists
Lahore, Punjab Province
Laiba Qayyum, +923021474287, laiba90012@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression in Adults, Anxiety
- Being tested
- Structured group therapy
- Keywords
- Depression, Anxiety, Group therapy, Social support
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured group therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Structured group therapy | Experimental | 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. Receives: Other: Structured group therapy |
| Treatment as usual | No intervention | Participants will receive standard treatment or usual care, which may include individual therapy or medication, depending on their current treatment regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression and anxiety
As measured through the participants' scores on the Hospital Anxiety \& Depression Scale (HADS)
Measured: 12 weeks
Secondary outcomes (2)
Social support
As measured through participants' scores on the Multidimensional Scale of Perceived Social Support (MSPSS)
Measured: 12 weeks
Functionality of participants
As measured through participants' scores on the WHO Disability Assessment Schedule (WHODAS 2.0)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdultsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Association of Cognitive Therapists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239388
- Sponsor's protocol ID
- RCT_D_A_GT_2025
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Structured Group Therapy in Reducing Depression and Anxiety Symptoms in Pakistan: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07239388
- Acronym / sponsor ID
- RCT_D_A_GT_2025
- Conditions
- Depression in Adults, Anxiety
- Keywords
- Depression, Anxiety, Group therapy, Social support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Pakistan Association of Cognitive TherapistsUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 20 Nov 2025 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured group therapy | Experimental | Other: Structured group therapyThis 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. |
| Treatment as usual | No intervention | –Participants will receive standard treatment or usual care, which may include individual therapy or medication, depending on their current treatment regimen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Structured group therapyParticipants 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 |
Primary outcome
Depression and anxiety
Time frame: 12 weeks
As measured through the participants' scores on the Hospital Anxiety \& Depression Scale (HADS)
2 secondary outcomes
Social support
Time frame: 12 weeks
Functionality of participants
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured group therapy in people with Depression in Adults and Anxiety, run by Pakistan Association of Cognitive Therapists at 1 site in Pakistan.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression and anxiety (time frame: 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 20 Nov 2025.