PsychoeducationCBT with OUDNCT06326515
Cognitive Behavior Therapy for Depression, Stigmatization, Criminogenic Cognition, and Quality of Life Among Patients With Opioid Use Disorder (OUD): A Randomized Control Trial.
A study testing psychoeducation and Stigma Reduction and Relapse Management in people with Psychoeducation, run by Government College University Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychoeducation
- What is being tested?
- psychoeducation and Stigma Reduction and Relapse Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- psychoeducation, Stigma Reduction and Relapse Management
- Keywords
- Opioid use disorder, Cognitive behaviour therapy, Primary symptoms, Secondary symptoms
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducationBehavioural
Also called Cognitive Conceptualization and Cognitive Restructuring
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 ManagementBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: after Allocation 1 week
Secondary outcomes (1)
World Health Organization Quality-of-Life Scale
it assesses impact of negative events on subjective well-being across four areas of an individual's life that is, physical, psychological, social, and environmental domains.
Measured: after Allocation 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Jan 2024
- Primary completion20 Jul 2024 (estimated)
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychoeducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Government College University Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qasir Abbas, Government College University Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326515
- Sponsor's protocol ID
- Government College University
- Acronym
- CBT with OUD
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06326515
- Acronym / sponsor ID
- CBT with OUD / Government College University
- Conditions
- Psychoeducation
- Keywords
- Opioid use disorder, Cognitive behaviour therapy, Primary symptoms, Secondary symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Government College University FaisalabadUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment Group | Experimental | Behavioral: psychoeducation, Behavioral: Stigma Reduction and Relapse ManagementExperimental: 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 |
| No Intervention: Control Group | No intervention | –No Intervention: Control Group Control Group: Participants in the control group did not receive the said psychoeducational intervention |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychoeducationAlso: Cognitive Conceptualization and Cognitive RestructuringTo 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). | Behavioural | Experimental: Treatment Group |
| Stigma Reduction and Relapse ManagementTo 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). | Behavioural | Experimental: Treatment Group |
Primary outcome
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.
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.
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.
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.
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
1 secondary outcome
World Health Organization Quality-of-Life Scale
Time frame: after Allocation 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducation and Stigma Reduction and Relapse Management in people with Psychoeducation, run by Government College University Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; Henry-Edwards et al., 2003; Hussain et al., 2022). (time frame: 1-2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.