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

NCT06326515 | Active Not Recruiting

• 1 other identifier: Government College University
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychoeducation

Keywords

Opioid use disorder, Cognitive behaviour therapy, Primary symptoms, Secondary symptoms

Outcome Measures

Primary Outcomes (6)

• The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; Henry-Edwards et al., 2003; Hussain et al., 2022).

  It was developed by the World Health Organization (WHO) and adopted by Hussain et al. (2022) to screen out people's use of psychoactive substances.

  1-2 weeks

• Criminogenic Cognition Scale (CCS;Tangney, at el, 2012; Jamil & Fatima, 2018):

  measure that has been reported to have statistically sound psychometric properties (Tangney etal., 2012). The 25 item Criminogenic Cognitions Scale (CCS) was designed to tap 5 dimensions

  after Allocation 1 week

• Patient Health Questionnaire (PHQ-9; Robert et al. 1999; Ahmad et al, 2018).

  It is a depression screening instruments that can be self-administered.

  after Allocation 1 week

• Relapse Risk Scale (RRS; Marlatt & Gordon, 1985; Hussain et al., 2016):

  The RRS was developed by Marlatt and Gordon (1985) and adopted by Hussain et al. (2016) to assess the cognitive and behavioral triggers toward relapse.

  after Allocation 1 week

• Perceived Stigma of Addiction Scale

  The PSAS developed by Luoma et al. (2010) and adopted by Shahzad et al. (2021) to assess perceived stigma among substance users and patients with OUD specifically.

  after Allocation 1 week

• Brief Cope Inventory (BCI)

  The Brief COPE is a 28-item multidimensional measure of strategies used for coping or regulating cognitions in response to stressors

  after Allocation 1 week

Secondary Outcomes (1)

• World Health Organization Quality-of-Life Scale

  after Allocation 1 week

Study Arms (2)

Experimental: Treatment Group

EXPERIMENTAL

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

Behavioral: psychoeducation; Behavioral: Stigma Reduction and Relapse Management

No Intervention: Control Group

NO INTERVENTION

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

Interventions

psychoeducation 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).

Also known as: Cognitive Conceptualization and Cognitive Restructuring

Experimental: Treatment Group

Stigma Reduction and Relapse Management 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).

Experimental: Treatment Group

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government College University Faisalabad: lead

Study Sites (1)

Dr Khalid Mahmood

Faisalābad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Cognitive Restructuring

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomized control trial design would be used in this study. It would be two arm study and there would be two groups an experimental and wait-list control group. Experimental group will receive intervention and another group would be placed in waitlist. In this research, parallel group design would be used. We will give treatment to all participants in a parallel way. Allocation ratio and framework would be equivalence i.e., treatment group and control group would be equal number of participants

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 22, 2024
• Study Start: January 1, 2024
• Primary Completion: July 20, 2024
• Study Completion: September 10, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)