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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2024-12-15

Brief Summary

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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.

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Detailed Description

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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

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Psychological Stress Quality of Life (QOL) Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental Group which received intervention

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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy based Intervention

Intervention Type BEHAVIORAL

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.

Control Group

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

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No