NCT07239388

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 15, 2025

Last Update Submit

November 15, 2025

Conditions

Depression in AdultsAnxiety

Keywords

DepressionAnxietyGroup therapySocial support

Outcome Measures

Primary Outcomes (1)

  • Depression and anxiety

    As measured through the participants' scores on the Hospital Anxiety \& Depression Scale (HADS)

    12 weeks

Secondary Outcomes (2)

  • Social support

    12 weeks

  • Functionality of participants

    12 weeks

Study Arms (2)

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.

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.

Interventions

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.

Structured group therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Association of Cognitive Therapists

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 20, 2025

Study Start

November 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)