NCT05531318

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2024

Completed
Last Updated

May 2, 2025

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

September 2, 2022

Last Update Submit

May 1, 2025

Conditions

Keywords

PTSDPosttraumatic Stress DisorderSubstance Use DisordersTraumaEmotional regulation

Outcome Measures

Primary Outcomes (1)

  • Qualitative interview accounts

    Semi-structured interviews will be used

    November 2022 - October 2024

Interventions

Participants will be interviewed about their experiences of substance use, post-traumatic stress and the way they regulate their emotions.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Staff recommend the individual should not take part in the study
  • The individual is unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Addiction Centre

London, SE5 8AF, United Kingdom

Location

Related Publications (1)

  • Foa EB, McLean CP, Zang Y, Zhong J, Powers MB, Kauffman BY, Rauch S, Porter K, Knowles K. Psychometric properties of the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5). Psychol Assess. 2016 Oct;28(10):1166-1171. doi: 10.1037/pas0000258. Epub 2015 Dec 21.

    PMID: 26691504BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSubstance-Related DisordersEmotional RegulationWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersChemically-Induced DisordersSelf-ControlSocial BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

June 7, 2023

Primary Completion

July 9, 2024

Study Completion

July 9, 2024

Last Updated

May 2, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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

Locations