Cognitive Behavior Therapy for Depression, Stigmatization, Criminogenic Cognition, and Quality of Life Among Patients With Opioid Use Disorder (OUD): A Randomized Control Trial. (CBT with OUD)

Government College University Faisalabad

Status: Active, not recruiting

Conditions: Psychoeducation

Treatments: Behavioral: Stigma Reduction and Relapse Management; Behavioral: psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT06326515

Government College University

Details and patient eligibility

About

to investigate the impact of cognitive behavior therapy for psychiatric problems among patients with opioid use disorder with relapse condition.

In this randomize control trail (RCT), N=120 patients with relapse condition would be taken. After enrolment patients' eligibility assessment would be completed and then n=60 patients would be allocated to experimental (n=30) and waitlist control (n=30) through random assignment. Patient's age range would be between 20 to 30 years.

Full description

Background: Opioid use disorder causes severe mental health problems with high mortality and morbidity (Harford, Yi, & Grant, 2013). Cognitive behavior therapy is found an evidence-based treatment modality to address psychiatric problems among individuals with substance use disorders (Cosci et al., 2007).

Objectives: to investigate the impact of cognitive behavior therapy for psychiatric problems among patients with opioid use disorder with relapse condition.

Hypothesis: After review of literature, cognitive behavior therapy would reduce criminogenic cognition, depressive symptoms, stigma and addiction severity and will improve coping strategies and the quality of life between experimental and waitlist control.

Methods: In this randomize control trail (RCT), N=120 patients with relapse condition would be taken. After enrolment patients' eligibility assessment would be completed and then n=60 patients would be allocated to experimental (n=30) and waitlist control (n=30) through random assignment. Patient's age range would be between 20 to 30 years.

Measures: Demographic form and in-depth clinical interview would be used conducted to take history of the participants' problems. Moreover, Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; Henry-Edwards et al., 2003; Hussain et al., 2022), Criminogenic Cognition Scale (CCS;Tangney, at el, 2012; Jamil & Fatima, 2018) Perceived Stigma of Addiction Scale (PSAS; Luoma et al, 2010; Shahzad et al., 2021), Patient Health Questionnaire (PHQ-9; Robert et al. 1999; Ahmad et al, 2018), Relapse Risk Scale (RRS; Marlatt & Gordon, 1985; Hussain et al., 2016), Brief Cope Inventory (BCI; Carver, 1997; Shahzad et al., 2020) and World Health Organization Quality-of-Life Scale (WHOQOL; WHO, 2004; Khalid & Kausar, 2006) would be used as secondary measures.

Interventions: The treatment protocol would be prepared on the base of CBT with specific goals including short term and long term. 8-12 therapeutic sessions would be given with twice a week interval in one-on-one sitting.

Procedure: After approval from the BOS and Advance Studies and Research (ASR), G. C. University Faisalabad, study proposal would be submitted in the Institutional Review Board (IRB), G. C. University Faisalabad for further approval. Furthermore, study protocol would be registered in WHO recognised registry for further approval to conduct RCT. Then data would be collected after getting consent from the institutions as well as from the participants. In RCT, participants eligibility assessment would be completed after enrolment then they will be allocated to experimental and control groups through random assignment. CBT based 8-12 therapeutic sessions would be given with twice a week interval in one-on-one sitting.

Statistical analysis: Study-I: Descriptive statistics (i.e., M, SD & f) will be used to calculate demographic characteristics of the sample. Correlation statistics, t-test, and mediation analysis using PROCESS would be used. Study-II: Descriptive statistics (i.e., M & SD), chi-square statistics, power analysis, and repeated measure ANOVA statistics would be used. All statistical computation would be calculated by using SPSS 26.0. sample size would be calculated using G-Power Software.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

In this study, only patients they have history of relapse would be taken. Patient's age range would be between 20 to 30 years. Patients would be taken who are un-married and belong from middle social economic status. Participants would be diagnosed according to the DSM-V.

Exclusion criteria

Participants with more than 4-time history of relapse and more than 5 years of history of illness would be excluded from the study. Participants with different medical comorbidities, and intellectual disability would be excluded. Participants who would not sign the consent form or would not complete all the research procedures would also exclude from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Experimental: Treatment Group

Experimental group

Description:

Experimental: Treatment Group Experimental Group: Participants in the experimental group would receive 8-10 session of psychoeducational based Program. Waitlist control Group: Participants in the Control group would not receive psychoeducational Intervention

Treatment:

Behavioral: Stigma Reduction and Relapse Management

Behavioral: psychoeducation

No Intervention: Control Group

No Intervention group

Description:

No Intervention: Control Group Control Group: Participants in the control group did not receive the said psychoeducational intervention