UnknownNot Applicable

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

Pakistan120 participantsStarted 2024-01-01

Plain-language 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.

Who can participate

Age range

20 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1-2 weeks

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

Timeframe: after Allocation 1 week

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

Timeframe: after Allocation 1 week

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

Timeframe: after Allocation 1 week

Perceived Stigma of Addiction Scale

Timeframe: after Allocation 1 week

Brief Cope Inventory (BCI)

Timeframe: after Allocation 1 week

Trial details

NCT IDNCT06326515

SponsorGovernment College University Faisalabad

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-20

View on ClinicalTrials.gov More Psychoeducation trials

Plain-language summary

Who can participate

Age range

20 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 1-2 weeks

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

Timeframe: after Allocation 1 week

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

Timeframe: after Allocation 1 week

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

Timeframe: after Allocation 1 week

Perceived Stigma of Addiction Scale

Timeframe: after Allocation 1 week

Brief Cope Inventory (BCI)

Timeframe: after Allocation 1 week