Culturally Adapted Group Cognitive Behavior Therapy (CaGCBT-SUDs) for Substance Use Disorders and Their Caregivers

NCT06462131 | Completed

• 1 other identifier: Ref No.20-16628/NRPU/R&D/HEC/
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

Pakistan is facing a massive rise in drug abuse. According to recent estimates, there are 6.7 million drug abusers, of which 4.25 million are drug dependents who need long-term treatments in residential setups. Despite these shocking statistics, there is a severe lack of evidence-based treatment, preventive measures, and drug indictment policies. Consequently, the number of drug dependents continues to increase at an alarming rate of 40,000 per year, making Pakistan one of the most drug-affected countries in the world. The ever-increasing rise in drug abuse can be devastating for a country such as Pakistan where the youth population (aged \<30 years) makes up a substantial 64% of the total population. It not only affects the individual's physical and mental health but also casts devastating effects on the psycho-social and economic aspects of their lives. Adults with Substance Use Disorders (SUDs) usually come across aggravated interpersonal and family problems, loss of productivity and unemployment, poverty and crimes, overall financial problems, deaths, and accidents. Furthermore, it also destroys the norms, morality, worth, and dignity of the person's well-being and effectiveness in the growth of society. Numerous studies in Pakistan showed a lack of evidence-based treatment altogether for adults suffering from SUDs. Thus, effective interventions for SUDs that also meet the clinical reality of open treatment groups are much needed to reduce the treatment gap. Further, the implementation of evidence-based approaches like Cognitive Behavior Therapy (CBT) has an advantage with SUDs clients who are motivated. The proposed project aims at the cultural adaptation of CBT-based group intervention for adults with substance use disorders (SUDs) in Pakistan by employing a Quasi-Experimental research design, followed by Randomized Control Trials to test its effectiveness in Pakistan.

Conditions

Treatment; Waitlist

Keywords

Group CBT; SUDs; Cultural Adaptation

Outcome Measures

Primary Outcomes (3)

• Addiction Severity Index-Lite Version

  The ASI covers the following areas: medical, employment/support, drug and alcohol use, legal, family/social, and psychiatric. The ASI obtains lifetime information about problem behaviors, as well as problems within the previous 30 days. The ASI-Lite contains 22 fewer questions than the ASI, and omits items relating to severity ratings, and a family history grid. The higher a subject scores on the ASI, the greater the indication of a need for treatment.

  Upto 8-12 weeks

• Revised Mental Health Inventory- 5

  The MHI-5 was developed for its use with the general population, and it includes items on psychological well-being. The total score ranges from 0 to 15, with higher scores indicating better mental health.

  Upto 8-12 weeks

• The Readiness to Change Questionnaire

  designed to assess stages of change in substance abusers, in terms of the Prochaska and DiClemente stages of change model. The score ranges for each scale is -10 through 0 to +10. Score towards positive end indicates patients' readiness to change.

  Upto 8-12 weeks

Secondary Outcomes (5)

• Relapse Risk Scale

  Upto 8-12 weeks

• Coping Strategies Scale

  Upto 8-12 weeks

• WHO Quality of Life- Brief version

  Upto 8-12 weeks

• Subjective Well-being Scale

  Upto 8-12 weeks

• Family Burden Interview Schedule

  Upto 8-12 weeks

Study Arms (3)

CaGCBT with TAU

EXPERIMENTAL

In this group, CaGCBT-SUD along with TAU will be provided.

Behavioral: Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT)

CBTAG with TAU and with caregivers

ACTIVE COMPARATOR

In this group, CaGCBT-SUD along with TAU will be provided. Moreover caregivers will be provided psychoeducation

Behavioral: Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT)

No intervention only TAU

NO INTERVENTION

Treatment as usual

Interventions

Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT) BEHAVIORAL

In first session, introduction of the therapist/facilitator and group members will be made. Group rules will be discussed with members. Group members' introduction primarily focuses on participant/clients' expectations, addictive behaviors and its status, and goals. Moreover, it also emphasize on identification of any other significant issue that is contributing in burden of disease.

CBTAG with TAU and with caregivers; CaGCBT with TAU

Eligibility Criteria

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

You may qualify if:

• Diagnosed individuals with substance use disorder within the age bracket of 18-64 years.
• In-patient of rehabilitation center and detoxified for 2 months
• Able to give written informed consent
• Able to read and speak Urdu

You may not qualify if:

• Presence of a diagnosed physical or intellectual disability as it can prevent individuals from engaging with the intervention. This will be assessed by the research team at screening stage. Any disabilities will be identified by a relevant clinician (e.g., Psychiatrist).
• Temporary resident unlikely to be available for follow-up
• Being detoxified less than 2 months
• Individuals with substance use disorder having follow up with rehabilitation center
• Having Comorbidity with psychological disturbances like depression, anxiety etc.

Sponsors & Collaborators

• National University of Modern Languages: lead

Study Sites (5)

BMC Psychiatry

Quetta, Balochistan, 87300, Pakistan

Location

ANF rehabilitation Centre

Islamabad, Islamabad, 45000, Pakistan

Location

Dr. Mian Iftekhar Psychiatry Hospital

Peshawar, KPK, 25000, Pakistan

Location

Life Care International Hospital

Lahore, Punjab Province, 05450, Pakistan

Location

Parwarish Rehabilitation centre

Karachi, Sindh, 05444, Pakistan

Location

Study Officials

• Anila Sadaf, PhD

  NUML

  PRINCIPAL INVESTIGATOR

• Rizwana Amin

  Bahria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 17, 2024
• Study Start: December 21, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (5)