Cognitive Behavior Therapy for Depression, Stigmatization, Criminogenic Cognition, and Quality of Life Among Patients With Opioid Use Disorder (OUD): A Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Brief Cope Inventory (BCI)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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
Intervention: psychoeducation (Behavioral)
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
Intervention: Stigma Reduction and Relapse Management (Behavioral)
No Intervention: Control Group
No Intervention: Control Group
Control Group:
Participants in the control group did not receive the said psychoeducational intervention
Outcomes
Primary Outcomes
Brief Cope Inventory (BCI)
Time Frame: after Allocation 1 week
The Brief COPE is a 28-item multidimensional measure of strategies used for coping or regulating cognitions in response to stressors
Relapse Risk Scale (RRS; Marlatt & Gordon, 1985; Hussain et al., 2016):
Time Frame: after Allocation 1 week
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.
Criminogenic Cognition Scale (CCS;Tangney, at el, 2012; Jamil & Fatima, 2018):
Time Frame: after Allocation 1 week
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
Patient Health Questionnaire (PHQ-9; Robert et al. 1999; Ahmad et al, 2018).
Time Frame: after Allocation 1 week
It is a depression screening instruments that can be self-administered.
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; Henry-Edwards et al., 2003; Hussain et al., 2022).
Time Frame: 1-2 weeks
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.
Perceived Stigma of Addiction Scale
Time Frame: after Allocation 1 week
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.
Secondary Outcomes
- World Health Organization Quality-of-Life Scale(after Allocation 1 week)
Investigators
Qasir Abbas
Principle Investigator
Government College University Faisalabad