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

NCT ID: NCT06326515

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-09-10

Brief Summary

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.

Detailed 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.

Conditions

Psychoeducation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Treatment Group

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

Group Type: EXPERIMENTAL

psychoeducation

Intervention Type: BEHAVIORAL

To identify and recognize the cognitive distortions To explore the automatic thoughts and emotions about illness Evaluate and respond to thoughts, emotions, and beliefs Automatic thought records were used by patients with some help from therapist (Chattopadhyay et al., 2017).

The cognitive errors were corrected using individual cognitive strategies (Chattopadhyay et al., 2017).

Stigma Reduction and Relapse Management

Intervention Type: BEHAVIORAL

To improve ability to effectively cope with lapse and relapse (Brown & Vanable, 2008).

To improve relapse management skills (Brown & Vanable, 2008). Emphasized skill development to cope with OUD-related stressors (Zhang, 2021). To change their conception of OUD (Tshabalala & Visser, 2011). To change their sense of self-worth and to empower them with more adaptive ways of thinking (Tshabalala & Visser, 2011).

To deal with their experience of stigma (Tshabalala & Visser, 2011).

No Intervention: Control Group

No Intervention: Control Group

Control Group:

Participants in the control group did not receive the said psychoeducational intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

psychoeducation

To identify and recognize the cognitive distortions To explore the automatic thoughts and emotions about illness Evaluate and respond to thoughts, emotions, and beliefs Automatic thought records were used by patients with some help from therapist (Chattopadhyay et al., 2017).

The cognitive errors were corrected using individual cognitive strategies (Chattopadhyay et al., 2017).

Intervention Type: BEHAVIORAL

Stigma Reduction and Relapse Management

To improve ability to effectively cope with lapse and relapse (Brown & Vanable, 2008).

To improve relapse management skills (Brown & Vanable, 2008). Emphasized skill development to cope with OUD-related stressors (Zhang, 2021). To change their conception of OUD (Tshabalala & Visser, 2011). To change their sense of self-worth and to empower them with more adaptive ways of thinking (Tshabalala & Visser, 2011).

To deal with their experience of stigma (Tshabalala & Visser, 2011).

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive Conceptualization and Cognitive Restructuring

Eligibility Criteria

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.

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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.

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• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government College University Faisalabad

OTHER

Sponsor Role: lead

Responsible Party

Qasir Abbas

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dr Khalid Mahmood

Faisalābad, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Government College University

Identifier Type: -

Identifier Source: org_study_id