Clinical trial NCT06840184: Culturally Adapted Cognitive Behavioral Therapy Based Self Help Intervention for Mental Health of Caregivers of Individuals With Substance Use: A Randomized Controlled Trial
Official title: Culturally Adapted Cognitive Behavioral Therapy Based Self Help Intervention for Mental Health of Caregivers of Individuals With Substance Use: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Quality of Life (QOL)
Mental Health
Keywords: Khushi Aur Khatoon
CBT Self Help intervention
Lead sponsor: Fatima Jinnah Women University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: DASS- 21 (Urdu)
timeFrame: 3 months
measure: Quality of Life Questionnaire (Urdu)
timeFrame: 3 months
measure: Caregivers' Burden Questionnaire (Urdu)
timeFrame: 3 months
measure: Warwick- Edinburgh Mental Well- Being Scale (Urdu)
timeFrame: 3 months
Secondary outcomes:
measure: Role Burden Scale (Urdu)
timeFrame: 3 months
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Islah drug Rehabilitation Center
state: Punjab
Study officials:
affiliation: Fatima Jinnah Women University
name: Jawairia Zia, M Phil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amin R, Iqbal A, Naeem F, Irfan M. Effectiveness of a culturally adapted cognitive behavioural therapy-based guided self-help (CACBT-GSH) intervention to reduce social anxiety and enhance self-esteem in adolescents: a randomized controlled trial from Pakistan. Behav Cogn Psychother. 2020 Sep;48(5):503-514. doi: 10.1017/S1352465820000284. Epub 2020 May 26.