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
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 off...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-06-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/6/e102710.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849690145869004800 |
|---|---|
| author | Maree Teesson Sarah Bendall Katherine Mills Frances Kay-Lambkin Emma L Barrett Jackie Curtis Sudie E Back Sean Perrin Natalie Peach Blake Hamilton Bronwyn Milne Virginia Winter Vanessa Cobham Shalini Arunogiri Mary Lou Chatterton Kathleen Brady Timothy Slade Debra Rickwood Sophie Reid Steven Leicester Logan Harvey |
| author_facet | Maree Teesson Sarah Bendall Katherine Mills Frances Kay-Lambkin Emma L Barrett Jackie Curtis Sudie E Back Sean Perrin Natalie Peach Blake Hamilton Bronwyn Milne Virginia Winter Vanessa Cobham Shalini Arunogiri Mary Lou Chatterton Kathleen Brady Timothy Slade Debra Rickwood Sophie Reid Steven Leicester Logan Harvey |
| collection | DOAJ |
| description | 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 inperson 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.Ethics and dissemination This study has been approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee (2024/ETH01050). Research findings will be published in peer-reviewed journals and presented at scientific conferences.Trial registration number ACTRN12624000776505.Protocol version V.2.3, 20 March 2025. |
| format | Article |
| id | doaj-art-fa71cd520e334876ac3f5faae53e61de |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-fa71cd520e334876ac3f5faae53e61de2025-08-20T03:21:24ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2025-102710Randomised 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 Maree TeessonSarah Bendall0Katherine Mills1Frances Kay-LambkinEmma L BarrettJackie CurtisSudie E Back2Sean Perrin3Natalie Peach4Blake HamiltonBronwyn MilneVirginia Winter5Vanessa Cobham6Shalini Arunogiri7Mary Lou Chatterton8Kathleen Brady9Timothy SladeDebra RickwoodSophie ReidSteven LeicesterLogan Harvey6 The University of Melbourne Centre for Youth Mental Health, Melbourne, Victoria, Australia1 The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia8 Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA9 Department of Psychology, Lund University, Lund, Sweden1 The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia1 The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia2 School of Psychology, The University of Queensland, Brisbane, Queensland, Australia4 Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia5 School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia8 Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USAIntroduction 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 inperson 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.Ethics and dissemination This study has been approved by the Sydney Children’s Hospitals Network Human Research Ethics Committee (2024/ETH01050). Research findings will be published in peer-reviewed journals and presented at scientific conferences.Trial registration number ACTRN12624000776505.Protocol version V.2.3, 20 March 2025.https://bmjopen.bmj.com/content/15/6/e102710.full |
| spellingShingle | Maree Teesson Sarah Bendall Katherine Mills Frances Kay-Lambkin Emma L Barrett Jackie Curtis Sudie E Back Sean Perrin Natalie Peach Blake Hamilton Bronwyn Milne Virginia Winter Vanessa Cobham Shalini Arunogiri Mary Lou Chatterton Kathleen Brady Timothy Slade Debra Rickwood Sophie Reid Steven Leicester Logan Harvey 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 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 | https://bmjopen.bmj.com/content/15/6/e102710.full |
| work_keys_str_mv | AT randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT mareeteesson randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT sarahbendall randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT katherinemills randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT franceskaylambkin randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT emmalbarrett randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT jackiecurtis randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT sudieeback randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT seanperrin randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT nataliepeach randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT blakehamilton randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT bronwynmilne randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT virginiawinter randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT vanessacobham randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT shaliniarunogiri randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT marylouchatterton randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT kathleenbrady randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT timothyslade randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT debrarickwood randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT sophiereid randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT stevenleicester randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol AT loganharvey randomisedcontrolledtrialtocomparetheefficacyofintegratedcognitivebehaviouraltherapycopeaforsubstanceuseandtraumaticstressamongadolescentsandyoungadultsdeliveredviatelehealthversusinpersontrialprotocol |