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Randomised controlled trial to compare the efficacy of integrated cognitive-behavioural therapy (COPE-A) for substance use and traumatic stress among adolescents and young adults delivered via telehealth versus in person: trial protocol

Mills, Katherine ; Winter, Virginia ; Cobham, Vanessa ; Peach, Natalie ; Arunogiri, Shalini ; Chatterton, Mary Lou ; Bendall, Sarah ; Back, Sudie ; Perrin, Sean LU orcid and Brady, Kathleen (2025) In BMJ Open p.1-11
Abstract
Introduction Emerging research indicates that integrated treatment of co-occurring post-traumatic stress disorder (PTSD) and substance use disorder can be effective among adolescents and young people. However, various barriers exist to young people accessing evidence-based treatments. Telehealth offers an opportunity to address these barriers and provide a scalable and accessible alternative to in person treatment. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy, safety and cost-effectiveness of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents and young adults (Concurrent Treatment of PTSD and Substance Use Disorders... (More)
Introduction Emerging research indicates that integrated treatment of co-occurring post-traumatic stress disorder (PTSD) and substance use disorder can be effective among adolescents and young people. However, various barriers exist to young people accessing evidence-based treatments. Telehealth offers an opportunity to address these barriers and provide a scalable and accessible alternative to in person treatment. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy, safety and cost-effectiveness of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents and young adults (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure – Adolescent and Young Adult version (COPE-A)) when delivered in person compared with via telehealth. Methods and analysis A two-arm, parallel group, single-blind, non-inferiority RCT with follow-up at 4 months and 12 months post study entry will be conducted in Sydney, Australia. Participants (170 adolescents and young adults aged 12–25 years) will be allocated to receive COPE-A either in person or via telehealth (allocation ratio 1:1) using minimisation. Project psychologists will administer treatment via both modes of delivery over a maximum of 16 sessions of 60–90 min. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

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author
; ; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Posttraumatic stress disorder, Substance use disorder, Adolesents, Young Adults, Randomised clinical trial, Telehealth
in
BMJ Open
article number
15:e102710
pages
1 - 11
publisher
BMJ Publishing Group
external identifiers
  • pmid:40523782
ISSN
2044-6055
DOI
10.1136/bmjopen-2025-102710
project
Scalable approaches to reducing alcohol and other drug use among traumatised young people: A RCT examining the safety, effectiveness, and cost-effectiveness of an integrated cognitive-behavioural therapy delivered via telehealth
language
English
LU publication?
yes
id
fb90cfe9-3939-4e57-843c-e6506fc5078e
date added to LUP
2025-06-17 10:20:35
date last changed
2025-06-25 03:00:02
@article{fb90cfe9-3939-4e57-843c-e6506fc5078e,
  abstract     = {{Introduction Emerging research indicates that integrated treatment of co-occurring post-traumatic stress disorder (PTSD) and substance use disorder can be effective among adolescents and young people. However, various barriers exist to young people accessing evidence-based treatments. Telehealth offers an opportunity to address these barriers and provide a scalable and accessible alternative to in person treatment. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy, safety and cost-effectiveness of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents and young adults (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure – Adolescent and Young Adult version (COPE-A)) when delivered in person compared with via telehealth. Methods and analysis A two-arm, parallel group, single-blind, non-inferiority RCT with follow-up at 4 months and 12 months post study entry will be conducted in Sydney, Australia. Participants (170 adolescents and young adults aged 12–25 years) will be allocated to receive COPE-A either in person or via telehealth (allocation ratio 1:1) using minimisation. Project psychologists will administer treatment via both modes of delivery over a maximum of 16 sessions of 60–90 min. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.<br/><br/>}},
  author       = {{Mills, Katherine and Winter, Virginia and Cobham, Vanessa and Peach, Natalie and Arunogiri, Shalini and Chatterton, Mary Lou and Bendall, Sarah and Back, Sudie and Perrin, Sean and Brady, Kathleen}},
  issn         = {{2044-6055}},
  keywords     = {{Posttraumatic stress disorder; Substance use disorder; Adolesents; Young Adults; Randomised clinical trial; Telehealth}},
  language     = {{eng}},
  month        = {{06}},
  pages        = {{1--11}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{Randomised controlled trial to compare the efficacy of integrated cognitive-behavioural therapy (COPE-A) for substance use and traumatic stress among adolescents and young adults delivered via telehealth versus in person: trial protocol}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2025-102710}},
  doi          = {{10.1136/bmjopen-2025-102710}},
  year         = {{2025}},
}