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

Not Applicable

Completed

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

• Registration Number: NCT06840184
• Lead Sponsor: Fatima Jinnah Women University

Brief 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.

Study Timeline

• Study Start: 2024-08-20
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15
• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
DASS- 21 (Urdu)	3 months	This scale has 21- Items comprising of 3 subscales, designed to assess emotional states related to depression, anxiety, and stress (7 items each). Higher scores on the scale indicate higher levels of psychological distress and low scores indicate low psychological distress.
Caregivers' Burden Questionnaire (Urdu)	3 months	This scale measures two aspects of burden (objective and subjective) comprising of 6 items each. This scale encompasses financial burden, disruption of routine family activities, family leisure, family interactions, and effect on physical and mental health of caregivers. Higher score on Caregivers' Burden Questionnaire represents higher level of burden caregivers, whereas low scores depict low caregivers' burden
Quality of Life Questionnaire (Urdu)	3 months	It is a 15-item instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health; it also contains QOL and general health items. Higher score on QOLQ represents higher quality of life, whereas low scores depict low quality of life.
Warwick- Edinburgh Mental Well- Being Scale (Urdu)	3 months	The 14- items scale covers subjective well- being and psychological functioning. Higher score on the scale represents higher level of mental well- being, whereas low scores depict low mental well- being.

Secondary Outcome Measures

Name	Time	Method
Role Burden Scale (Urdu)	3 months	It measures the psychological as well as physical burden on a person due to performing multiple roles in their daily routine. Only "Item # 1" has to be scored in reverse manner. Higher score on Role Burden Scale represents higher burden on the participant due to holding multiple roles, whereas low scores depict low role burden

Trial Locations

Locations (1)

Islah drug Rehabilitation Center; 🇵🇰 Rawalpindi, Punjab, Pakistan