- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05531318
Emotional Regulation in People With Co-occurring Posttraumatic Stress Disorder and Substance Use Disorder
Emotional Regulation in People With Co-occurring Posttraumatic Stress Disorder and Substance Use Disorder: A Qualitative Study of Individuals Receiving Community Substance Misuse Treatment
The aim of this project is to look at emotional regulation in people with posttraumatic stress disorder (PTSD) and substance use disorder (SUD). This study will explore how people with PTSD-SUD regulate their emotions and how this might explain the relationship between these two disorders. In turn, this may inform effective treatment strategies for people with comorbid PTSD-SUD.
Emotional regulation refers to the way in which people process and respond to their emotions. PTSD and SUD commonly cooccur and this is associated with adverse outcomes including high rates of relapse, overdose, and suicide. We therefore need effective treatments to address this clinical concern. Evidence suggests emotional regulation might be important in the development and maintenance of PTSD and SUD and therefore it might be a useful target for treatment. However, most research in this area has been quantitative and has not considered how gender, social circumstances and trauma or substance type might affect the way people regulate their emotions. This study will recruit 40 adults with trauma histories and PTSD who are currently receiving treatment in a community drug and alcohol service for their substance use. Participants will be interviewed to explore how they regulate their emotions and how this relates to their social circumstances. This study will also explore whether gender, substance or trauma type affect the way people regulate their emotions. We hope this will help to improve treatment for people with PTSD and SUD.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Alice Bowen
- Phone Number: 07511319855
- Email: alice.m.bowen@kcl.ac.uk
Study Contact Backup
- Name: Joanne Neale
- Phone Number: 020 7848 0835
- Email: Joanne.neale@kcl.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• Adults aged 18+
- Receiving treatment from a community substance use service at the time of the study.
- Experienced, witnessed or been confronted with at least one traumatic event (according to PTSD Diagnostic Scale for DSM-5) (PDS-5) (Foa, 2016).
- Participant endorses at least 3 PTSD symptoms from criterion B-E, measured using the PDS-5.
- Able to communicate and understand English sufficiently to engage in a qualitative interview.
Exclusion Criteria:
• Staff recommend the individual should not take part in the study
- The individual is unable to provide informed consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative interview accounts
Time Frame: November 2022 - October 2024
|
Semi-structured interviews will be used
|
November 2022 - October 2024
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bowen2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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