- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07364240
Effect of Person-Centered Occupational Therapy Interventions for Substance Use Disorder
The Effect of Person-Centered Occupational Therapy Interventions on Occupational Performance, Self-Efficacy and Psychological Resilience in Substance Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants aged 18-65 with a DSM-5 diagnosis of substance use disorder will be recruited from the Erenköy AMATEM unit. The study employs an experimental design with 34 participants (17 in the study group, 17 in the control group). The study group will receive person-centered occupational therapy interventions 3 times per week for a total of 8 weeks.
The intervention process is based on the four stages of person-centered practice: identifying occupational performance problems using the Canadian Occupational Performance Measure (COPM), brainstorming realistic goals, implementing tailored strategies (e.g., time management, vocational skills, or healthy habits), and revising the process based on feedback . Assessment tools including the COPM, Self-Efficacy Scale, and Brief Resilience Scale will be administered at baseline and after the 8-week intervention to measure changes in performance and psychological factors.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Büşra Yuvalı, PhD Cand
- Phone Number: +90 532 772 43 34
- Email: busra.atmaca@hacettepe.edu.tr
Study Contact Backup
- Name: Onur Altuntaş, Assoc Prof
- Phone Number: 305 25 60 / 121
- Email: fztonurb@hotmail.com
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Recruiting
- Erenköy Mental and Neurological Diseases Training and Research Hospital
-
Contact:
- Büşra Yuvalı, PhD Cand
- Phone Number: +90 532 772 43 34
- Email: busra.atmaca@hacettepe.edu.tr
-
Principal Investigator:
- Büşra Yuvalı, PhD Cand
-
Sub-Investigator:
- Onur Altuntaş, Assoc Prof
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being diagnosed with substance use disorder according to DSM-5 criteria.
- Having completed the detoxification process.
- Being between the ages of 18-65.
- Having at least a primary school education.
- Volunteering to participate and signing the informed consent.
Exclusion Criteria:
- Being in an acute psychotic episode.
- Having severe neurological deficits that prevent responding to assessments. -Having severe visual or hearing loss that prevents completing the test batteries
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
Participants in this group will receive person-centered occupational therapy interventions in addition to their routine treatment.
|
An 8-week person-centered program (3 sessions per week) focusing on daily life activities, productivity, and leisure goals identified through the COPM.
|
|
Active Comparator: Control Group
Participants in this group will receive a one-time awareness training session about substance use disorder and its effects, in addition to their routine clinical follow-up.
|
A single-session educational program designed to increase awareness about the consequences of substance use and the recovery process.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Canadian Occupational Performance Measure (COPM)
Time Frame: Change from baseline at 8 weeks.
|
A semi-structured interview used to identify and prioritize everyday activities that the individual finds difficult to perform.
It measures two components: Occupational Performance and Satisfaction.
Both are scored on a scale of 1 to 10, where higher scores indicate better performance and higher satisfaction.
|
Change from baseline at 8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy Scale
Time Frame: Change from baseline at 8 weeks.
|
A 23-item scale measuring the individual's self-judgment of their ability to achieve intended goals.
Scores range from 23 to 115, with higher scores indicating higher self-efficacy.
|
Change from baseline at 8 weeks.
|
|
Brief Resilience Scale
Time Frame: Change from baseline at 8 weeks
|
A 6-item self-report scale measuring the individual's ability to bounce back or recover from stress.
Higher scores indicate higher psychological resilience.
|
Change from baseline at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Onur Altuntaş, Assoc Prof, Hacettepe University
- Principal Investigator: Büşra Yuvalı, PhD Cand, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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