Culturally Adapted Group Cognitive Behavior Therapy (CaGCBT-SUDs) for Substance Use Disorders and Their Caregivers
NCT Number: NCT06462131
Acronym: CaGCBT-SUDs
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Treatment|Waitlist
Interventions: BEHAVIORAL: Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT)
Sponsor: National University of Modern Languages
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-12-21
Completion Date: 2024-12-31
Locations: BMC Psychiatry, Quetta, Balochistan, 87300, Pakistan|ANF rehabilitation Centre, Islamabad, Federal Capital Area, 45000, Pakistan|Dr. Mian Iftekhar Psychiatry Hospital, Peshawar, KPK, 25000, Pakistan|Life Care International Hospital, Lahore, Punjab, 05450, Pakistan|Parwarish Rehabilitation centre, Karachi, Sindh, 05444, Pakistan

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.

Primary Outcome Measures: 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 Outcome Measures: Relapse Risk Scale, It is a 44-item self-report multidimensional instrument, which proposes to measure relapse risk among substance dependents. Lower scores indicate low risk of relapse while high scores are indicative of higher risk of relapse., Upto 8-12 weeks|Coping Strategies Scale, The CSS is comprised of 48 items intended to tap potential coping strategies that might be used by patients in to remain abstinent. Respondents rate the frequency (from 1 = never to 4 = frequently) of using specific strategies in the past 3 months. Total coping on the CSS was calculated by taking the mean across all 48 items., Upto 8-12 weeks|WHO Quality of Life- Brief version, It consists of 24 items to assess perception of quality of life in four domains, including physical health, psychological, social relationships and environment, and two items on overall QOL and general health. A higher score indicated a better quality of life., Upto 8-12 weeks|Subjective Well-being Scale, Subjective well-being will be measured by using following three scales: 1. PANAS (Use 5 point Likert scale to identify the positive or negative emotion experienced across week); 2. SWL(measures individuals' global cognitive judgments of their life as a whole in relation to a self-imposed ideal using five items (e.g., "In most ways my life is close to my ideal") and a seven point Likert scale (1 = strongly disagree, 7 = strongly agree); 3. HLS (assess a person's global sense of harmony in life and consists of five statements (e.g., "My lifestyle allows me to be in harmony") for which respondents are asked to indicate degree of agreement on a seven-point Likert scale (1 = strongly disagree, 7 = strongly agree)., Upto 8-12 weeks|Family Burden Interview Schedule, It has 24 items each rated on a three-point scale: 0, no burden; 1. moderate burden; and 2, severe burden., Upto 8-12 weeks