PMID- 35314471 OWN - NLM STAT- MEDLINE DCOM- 20220414 LR - 20230322 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 12 IP - 3 DP - 2022 Mar 21 TI - Therapist-supported online cognitive therapy for post-traumatic stress disorder (PTSD) in young people: protocol for an early-stage, parallel-group, randomised controlled study (OPTYC trial). PG - e054852 LID - 10.1136/bmjopen-2021-054852 [doi] LID - e054852 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. CI - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. FAU - Smith, Patrick AU - Smith P AUID- ORCID: 0000-0002-0743-7972 AD - Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK patrick.smith@kcl.ac.uk. AD - South London & Maudsley NHS Foundation Trust, London, UK. FAU - Ehlers, Anke AU - Ehlers A AD - Department of Experimental Psychology, University of Oxford, Oxford, UK. FAU - Carr, Ewan AU - Carr E AUID- ORCID: 0000-0002-1146-4922 AD - Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Clark, David AU - Clark D AD - Department of Experimental Psychology, University of Oxford, Oxford, UK. FAU - Dalgleish, Tim AU - Dalgleish T AD - Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK. AD - Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK. FAU - Forbes, Gordon AU - Forbes G AD - Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Goldsmith, Kimberley AU - Goldsmith K AD - Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Griffiths, Helena AU - Griffiths H AD - Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Gupta, Monica AU - Gupta M AD - Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - King, Dorothy AU - King D AD - Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Miles, Sarah AU - Miles S AD - Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. AD - South London & Maudsley NHS Foundation Trust, London, UK. FAU - Plant, Dominic AU - Plant D AD - Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Yule, William AU - Yule W AD - Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. FAU - Meiser-Stedman, Richard AU - Meiser-Stedman R AUID- ORCID: 0000-0002-0262-623X AD - Department of Clinical Psychology and Psychological Therapies, University of East Anglia, Norwich, Norfolk, UK. LA - eng GR - MC_UU_00030/5/MRC_/Medical Research Council/United Kingdom GR - DH_/Department of Health/United Kingdom PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220321 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Adolescent MH - Adult MH - Anxiety MH - Anxiety Disorders MH - Child MH - *Cognitive Behavioral Therapy/methods MH - Humans MH - Randomized Controlled Trials as Topic MH - Single-Blind Method MH - *Stress Disorders, Post-Traumatic/therapy PMC - PMC8938692 OTO - NOTNLM OT - anxiety disorders OT - child & adolescent psychiatry OT - mental health COIS- Competing interests: Some authors (DC, TD, AE, RM-S, DP and PS) provide training in the delivery of CT-PTSD, for which they may sometimes receive payment. PS, DC and WY are coauthors on a published treatment manual of CT-PTSD for children and young people and receive royalties from sales. EDAT- 2022/03/23 06:00 MHDA- 2022/04/15 06:00 PMCR- 2022/03/21 CRDT- 2022/03/22 05:35 PHST- 2022/03/22 05:35 [entrez] PHST- 2022/03/23 06:00 [pubmed] PHST- 2022/04/15 06:00 [medline] PHST- 2022/03/21 00:00 [pmc-release] AID - bmjopen-2021-054852 [pii] AID - 10.1136/bmjopen-2021-054852 [doi] PST - epublish SO - BMJ Open. 2022 Mar 21;12(3):e054852. doi: 10.1136/bmjopen-2021-054852.