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

February 17, 2025 updated by: Jawairia Zia, Fatima Jinnah Women University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Islah drug Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASS- 21 (Urdu)
Time Frame: 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.
3 months
Quality of Life Questionnaire (Urdu)
Time Frame: 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.
3 months
Caregivers' Burden Questionnaire (Urdu)
Time Frame: 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
3 months
Warwick- Edinburgh Mental Well- Being Scale (Urdu)
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role Burden Scale (Urdu)
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatima Jinnah Women University

Investigators

  • Principal Investigator: Jawairia Zia, M Phil, Fatima Jinnah Women University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2024

Primary Completion (Actual)

December 15, 2024

Study Completion (Actual)

December 15, 2024

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJWU/EC/2025/103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to ethical concerns, data will not be shared. All research findings will be published in aggregate form maintaining anonymity of the participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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