Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326515
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-17
Brief Title:
Cognitive Behavior Therapy for Depression Stigmatization Criminogenic Cognition and Quality of Life Among Patients With Opioid Use Disorder OUD A Randomized Control Trial
Sponsor:
Government College University Faisalabad
Organization:
Government College University Faisalabad
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBT with OUD
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 N120 patients with relapse condition would be taken After enrolment patients eligibility assessment would be completed and then n60 patients would be allocated to experimental n30 and waitlist control n30 through random assignment Patients age range would be between 20 to 30 years
In this randomize control trail RCT N120 patients with relapse condition would be taken After enrolment patients eligibility assessment would be completed and then n60 patients would be allocated to experimental n30 and waitlist control n30 through random assignment Patients 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 N120 patients with relapse condition would be taken After enrolment patients eligibility assessment would be completed and then n60 patients would be allocated to experimental n30 and waitlist control n30 through random assignment Patients 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 CCSTangney 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 ie 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 ie M SD chi-square statistics power analysis and repeated measure ANOVA statistics would be used All statistical computation would be calculated by using SPSS 260 sample size would be calculated using G-Power Software
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 N120 patients with relapse condition would be taken After enrolment patients eligibility assessment would be completed and then n60 patients would be allocated to experimental n30 and waitlist control n30 through random assignment Patients 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 CCSTangney 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 ie 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 ie M SD chi-square statistics power analysis and repeated measure ANOVA statistics would be used All statistical computation would be calculated by using SPSS 260 sample size would be calculated using G-Power Software
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None