NCT06840184

Culturally Adapted Cognitive Behavioral Therapy Based Self Help Intervention for Mental Health of Caregivers of Individuals With Substance Use: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Fatima Jinnah Women University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to investigate whether Cognitive Behavioral Therapy based Self- Help Intervention can significantly reduce emotional problems as well as improve the mental well being and quality of life among the caregivers of individuals with substance use. The study aims to contribute to the existing literature by providing evidence on the efficacy of the above mentioned therapy. This can be helpful in improving clinical practices and treatment outcomes.

Detailed description

The current quantitative study comprises of two phases. Pilot study for translation and validation of scales were done as a preliminary step. The first phase was a cross-sectional survey to screen out potential caregivers of substance users, with depression, anxiety and stress, higher than the normal level. A randomized controlled trial (RCT) was done in the second phase, where caregivers of substance users who had higher level of psychological distress, were categorized into two groups; control group and intervention group through randomization. Cognitive Behavioral Therapy based intervention (Self- Help Manuel named, "Khushi aur Khatoon") was provided to the intervention group in 4-6 individual and face to face sessions. Control group did not receive therapy ( on request of some of the members of control group, therapy was provided after the completion of the study). Pre and post- assessment of the study variables were done for both control and intervention groups. Difference between pre and post assessment was compared to investigate the effectiveness of Cognitive Behavioral Therapy based intervention ("Khushi aur Khatoon") among caregivers of substance users.

Conditions

• Psychological Stress
• Quality of Life (QOL)
• Mental Health

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy based Intervention	Session 1: Introduction of CBT, Relationship between events, thoughts and behavior. Session 2: Psychoeducation about the vicious circle of inactivity and depression, Ladder technique for task management. Session 3: Problem solving techniques and discussion about them, Decision making techniques through "Advantages/ Disadvantages" chart. Session 4: Identifying positive and negative emotions, Cognitive errors were explained. Session 5: Identifying negative thoughts through Socratic questioning, Finding evidence for and against the thoughts, Challenging negative thought, Cracking firm irrational beliefs. Session 6: Cognitive restructuring techniques, Finding alternative thoughts.
OTHER	No intervention	No intervention was provided to the control group, except for a few members who requested for the therapy, that too after the post assessment.

Timeline

• Start date: 2024-08-20
• Primary completion: 2024-12-15
• Completion: 2024-12-15
• First posted: 2025-02-21
• Last updated: 2025-02-21

Locations

1 site across 1 country: Pakistan