CompletedNot Applicable

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

Pakistan30 participantsStarted 2022-12-21

Plain-language 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.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Addiction Severity Index-Lite Version

Timeframe: Upto 8-12 weeks

Revised Mental Health Inventory- 5

Timeframe: Upto 8-12 weeks

The Readiness to Change Questionnaire

Timeframe: Upto 8-12 weeks

Trial details

NCT IDNCT06462131

SponsorNational University of Modern Languages

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Treatment trials

Plain-language summary

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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