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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05531318
Recruitment Status : Not yet recruiting
First Posted : September 7, 2022
Last Update Posted : March 8, 2023
Sponsor:
Collaborator:
Society for the Study of Addiction
Information provided by (Responsible Party):
King's College London

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Posttraumatic Stress Disorder Substance Use Disorders Emotional Regulation Other: Qualitative Interview

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Emotional Regulation in People With Co-occurring Posttraumatic Stress Disorder and Substance Use Disorder: A Qualitative Study of Individuals Receiving Community Substance Misuse Treatment
Estimated Study Start Date : March 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


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

Outcome Measures
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Primary Outcome Measures :
  1. Qualitative interview accounts [ Time Frame: November 2022 - October 2024 ]
    Semi-structured interviews will be used


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05531318


Contacts
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Contact: Alice Bowen 07511319855 alice.m.bowen@kcl.ac.uk
Contact: Joanne Neale 020 7848 0835 Joanne.neale@kcl.ac.uk

Sponsors and Collaborators
King's College London
Society for the Study of Addiction
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT05531318    
Other Study ID Numbers: Bowen2022
First Posted: September 7, 2022    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will not be made available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
PTSD
Posttraumatic Stress Disorder
Substance Use Disorders
Trauma
Emotional regulation
Additional relevant MeSH terms:
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Substance-Related Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
 Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders