TY - JOUR
T1 - Therapist-supported online cognitive therapy for post-traumatic stress disorder (PTSD) in young people
T2 - protocol for an early-stage, parallel-group, randomised controlled study (OPTYC trial)
AU - Smith, Patrick
AU - Ehlers, Anke
AU - Carr, Ewan
AU - Clark, David
AU - Dalgleish, Tim
AU - Forbes, Gordon
AU - Goldsmith, Kimberley
AU - Griffiths, Helena
AU - Gupta, Monica
AU - King, Dorothy
AU - Miles, Sarah
AU - Plant, Dominic
AU - Yule, William
AU - Meiser-Stedman, Richard
N1 - Funding Information:
Funding OPTYC is funded by the UK Medical Research Council’s Developmental Pathway Funding Scheme (Grant reference: MR/P017355/1). TD was funded by the UK Medical Research Council (Grant Reference: SUAG/043 G101400). KG receives funding from the NIHR Applied Research Collaboration South London (King’s College Hospital NHS Foundation Trust).
Funding Information:
Acknowledgements We are very grateful to the young people who helped to shape the project and made key contributions to the design of the intervention, and to the young people and carers who participate in the trial. We are very grateful to the Trial Steering Committee (Cathy Creswell, Andrew Brand, Rachel Calam and Paul Stallard) for their advice and support. EC, GF and KG’s contributions represent independent research part funded by the NIHR Biomedical Research Centre (South London and Maudsley NHS Foundation Trust and King’s College London). KG receives funding from the NIHR Applied Research Collaboration South London (King’s College Hospital NHS Foundation Trust). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, the Department of Health and Social Care.
Publisher Copyright:
©
PY - 2022/3/21
Y1 - 2022/3/21
N2 - INTRODUCTION: Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition that affects a significant minority of young people exposed to traumatic events. Effective face-to-face psychological treatments for PTSD exist. However, most young people with PTSD do not receive evidence-based treatment. Remotely delivered digital interventions have potential to significantly improve treatment accessibility. Digital interventions have been successfully employed for young people with depression and anxiety, and for adults with PTSD. However, digital interventions to treat PTSD in young people have not been evaluated. The Online PTSD Treatment for Young People & Carers (OPTYC) trial will evaluate the feasibility, acceptability and initial indications of clinical efficacy of a novel internet-delivered Cognitive Therapy for treatment of PTSD in young people (iCT-PTSD-YP). METHODS AND ANALYSIS: This protocol describes a two-arm, parallel-groups, single-blind (outcome assessor), early-stage randomised controlled trial, comparing iCT-PTSD-YP with a waiting list (WL) comparator. N=34 adolescents (12-17 years old), whose primary problem is PTSD after exposure to a single traumatic event, will be recruited from 14 NHS Child and Adolescent Mental Health Services in London and southeast England, from secondary schools and primary care in the same region, or via self-referral from anywhere in the UK using the study website. Individual patient-level randomisation will allocate participants in a 1:1 ratio, randomised using minimisation according to sex and baseline symptom severity. The primary study outcomes are data on feasibility and acceptability, including recruitment, adherence, retention and adverse events (AEs). The primary clinical outcome is PTSD diagnosis 16 weeks post-randomisation. Secondary clinical outcomes include continuous measures of PTSD, anxiety and depression symptoms. Regression analyses will provide preliminary estimates of the effect of iCT-PTSD-YP on PTSD diagnosis, symptoms of PTSD, anxiety and depression relative to WL. Process-outcome evaluation will consider which mechanisms mediate recovery. Qualitative interviews with young people, families and therapists will evaluate acceptability. ETHICS AND DISSEMINATION: The study was approved by a UK Health Research Authority Research Ethics Committee (19/LO/1354). For participants aged under 16, informed consent will be provided by carers and the young person will be asked for their assent; participants aged 16 years or older can provide informed consent without their parent or caregiver's involvement. Findings will be disseminated broadly to participants, healthcare professionals, the public and other relevant groups. Study findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN16876240.
AB - INTRODUCTION: Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition that affects a significant minority of young people exposed to traumatic events. Effective face-to-face psychological treatments for PTSD exist. However, most young people with PTSD do not receive evidence-based treatment. Remotely delivered digital interventions have potential to significantly improve treatment accessibility. Digital interventions have been successfully employed for young people with depression and anxiety, and for adults with PTSD. However, digital interventions to treat PTSD in young people have not been evaluated. The Online PTSD Treatment for Young People & Carers (OPTYC) trial will evaluate the feasibility, acceptability and initial indications of clinical efficacy of a novel internet-delivered Cognitive Therapy for treatment of PTSD in young people (iCT-PTSD-YP). METHODS AND ANALYSIS: This protocol describes a two-arm, parallel-groups, single-blind (outcome assessor), early-stage randomised controlled trial, comparing iCT-PTSD-YP with a waiting list (WL) comparator. N=34 adolescents (12-17 years old), whose primary problem is PTSD after exposure to a single traumatic event, will be recruited from 14 NHS Child and Adolescent Mental Health Services in London and southeast England, from secondary schools and primary care in the same region, or via self-referral from anywhere in the UK using the study website. Individual patient-level randomisation will allocate participants in a 1:1 ratio, randomised using minimisation according to sex and baseline symptom severity. The primary study outcomes are data on feasibility and acceptability, including recruitment, adherence, retention and adverse events (AEs). The primary clinical outcome is PTSD diagnosis 16 weeks post-randomisation. Secondary clinical outcomes include continuous measures of PTSD, anxiety and depression symptoms. Regression analyses will provide preliminary estimates of the effect of iCT-PTSD-YP on PTSD diagnosis, symptoms of PTSD, anxiety and depression relative to WL. Process-outcome evaluation will consider which mechanisms mediate recovery. Qualitative interviews with young people, families and therapists will evaluate acceptability. ETHICS AND DISSEMINATION: The study was approved by a UK Health Research Authority Research Ethics Committee (19/LO/1354). For participants aged under 16, informed consent will be provided by carers and the young person will be asked for their assent; participants aged 16 years or older can provide informed consent without their parent or caregiver's involvement. Findings will be disseminated broadly to participants, healthcare professionals, the public and other relevant groups. Study findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN16876240.
KW - PTSD, young people, cognitive therapy, trial, digital mental health
UR - http://www.scopus.com/inward/record.url?scp=85126851077&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-054852
DO - 10.1136/bmjopen-2021-054852
M3 - Article
SN - 2044-6055
VL - 12
SP - e054852
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e054852
ER -
