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

NCT06840184 | Completed DMC

• 1 other identifier: FJWU/EC/2025/103
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Khushi Aur Khatoon; CBT Self Help intervention

Outcome Measures

Primary Outcomes (4)

• DASS- 21 (Urdu)

  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)

  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)

  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)

  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 Outcomes (1)

• Role Burden Scale (Urdu)

  3 months

Study Arms (2)

Experimental Group which received intervention

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Cognitive Behavioral Therapy based Intervention 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.

Experimental Group which received intervention

No intervention 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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatima Jinnah Women University: lead

Study Sites (1)

Islah drug Rehabilitation Center

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 32450939 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Stress, Psychological; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Jawairia Zia, M Phil

  Fatima Jinnah Women University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: August 20, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)