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

Fatima Jinnah Women University

Status: Completed

Conditions: Psychological Stress; Quality of Life (QOL); Mental Health

Treatments: Other: No intervention; Behavioral: Cognitive Behavioral Therapy based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06840184

FJWU/EC/2025/103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals aged 18 and above.
• Those who will have burden and distress above the normal levels on respective scales during baseline assessment.
• Capable of providing written informed consent.
• Residing within the catchment areas of the participating rehabilitation center.

Exclusion criteria

• Individuals unable to provide consent due to severe mental or physical illness.
• Individuals not capable of reading and comprehending Urdu versions of the intervention manual and scales.
• Unlikely to be accessible for outcome assessments due to temporary residence.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups

Experimental Group which received intervention

Experimental group

Description:

The experimental group was provided with CBT Self- help Intervention (Khushi aur Khatoon), a 4-6 weeks program for improvement of emotional resilience and mental well- being.

Treatment:

Behavioral: Cognitive Behavioral Therapy based Intervention

Control Group

Active Comparator group

Description:

No intervention was provided to the control group, except for a few members who requested for the therapy, that too after the post assessment.

Treatment:

Other: No intervention