Emotional Regulation in People With Co-occurring Posttraumatic Stress Disorder and Substance Use Disorder

September 6, 2022 updated by: King's College London

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

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A sample of approximately 40 people with posttraumatic stress disorder who are accessing substance use services in the community will be recruited and interviewed.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2022

Primary Completion (ANTICIPATED)

October 1, 2024

Study Completion (ANTICIPATED)

October 1, 2024

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (ACTUAL)

September 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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