Clinical trial NCT06326515: Cognitive Behavior Therapy for Depression, Stigmatization, Criminogenic Cognition, and Quality of Life Among Patients With Opioid Use Disorder (OUD): A Randomized Control Trial.
Official title: Cognitive Behavior Therapy for Depression, Stigmatization, Criminogenic Cognition, and Quality of Life Among Patients With Opioid Use Disorder (OUD): A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychoeducation
Keywords: Opioid use disorder, Cognitive behaviour therapy, Primary symptoms, Secondary symptoms
Lead sponsor: Government College University Faisalabad
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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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Primary outcomes:
measure: The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; Henry-Edwards et al., 2003; Hussain et al., 2022).
timeFrame: 1-2 weeks
measure: Criminogenic Cognition Scale (CCS;Tangney, at el, 2012; Jamil & Fatima, 2018):
timeFrame: after Allocation 1 week
measure: Patient Health Questionnaire (PHQ-9; Robert et al. 1999; Ahmad et al, 2018).
timeFrame: after Allocation 1 week
measure: Relapse Risk Scale (RRS; Marlatt & Gordon, 1985; Hussain et al., 2016):
timeFrame: after Allocation 1 week
measure: Perceived Stigma of Addiction Scale
timeFrame: after Allocation 1 week
measure: Brief Cope Inventory (BCI)
timeFrame: after Allocation 1 week
Secondary outcomes:
measure: World Health Organization Quality-of-Life Scale
timeFrame: after Allocation 1 week
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Dr Khalid Mahmood
state: Punjab
Study officials:
References: