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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05531318
Other study ID # Bowen2022
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2023
Est. completion date October 2024

Study information

Verified date September 2022
Source King's College London
Contact Alice Bowen
Phone 07511319855
Email alice.m.bowen@kcl.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
King's College London Society for the Study of Addiction

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative interview accounts Semi-structured interviews will be used November 2022 - October 2024
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