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The DECRYPT trial: Study protocol for a phase II randomised controlled trial of cognitive therapy for post-traumatic stress disorder (PTSD) in youth exposed to multiple traumatic stressors

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Leila Allen, Polly-Anna Ashford, Ella Beeson, Sarah Byford, Jessica Chow, Tim Dalgleish, Andrea Danese, Jack Finn, Ben Goodall, Lauren Grainger, Matt Hammond, Ayla Humphrey, Gerwyn Mahoney-Davies, Nicola Morant, Lee Shepstone, Erika Sims, Patrick Smith, Paul Stallard, Annie Swanepoel, David Trickey & 3 more Katie Trigg, Jon Wilson, Richard Meiser-Stedman

Original languageEnglish
JournalBMJ Open
Accepted/In press18 Jun 2021

King's Authors

Abstract

Background: Post-traumatic stress disorder (PTSD) is a distressing and disabling condition that affects significant numbers of children and adolescents. Youth exposed to multiple traumas (e.g. abuse, domestic violence) are at particular risk of developing PTSD. Cognitive-Therapy for PTSD (CT-PTSD), derived from adult work, is a theoretically-informed, disorder-specific form of trauma-focused cognitive-behavioural therapy (TF-CBT). While efficacious for child and adolescent single-event trauma samples, its effectiveness in routine settings with more complex, multiple-trauma exposed youth has not been established. The Delivery of Cognitive Therapy for Young People after Trauma (DECRYPT) randomised controlled trial (RCT) examines the effectiveness of CT-PTSD for treating PTSD following multiple trauma exposure in children and young people in comparison to treatment as usual (TAU).
Methods/Design: This protocol describes a two-arm, patient-level, single blind, superiority RCT comparing CT-PTSD (n=60) to TAU (n=60) in children and young people aged 8-17 years with a diagnosis of PTSD following multiple trauma exposure. The primary outcome is PTSD severity assessed using the Children’s Revised Impact of Event Scale (8-item version) at post-treatment (i.e. approximately five months post-randomisation). Secondary outcomes include structured interview assessment for PTSD, complex PTSD symptoms, depression and anxiety, overall functioning and parent-rated mental health. Mid-treatment and 11- and 29-month post-randomisation assessments will also be completed. Process-outcome evaluation will consider which mechanisms underpin or moderate recovery. Qualitative interviews with the young people, their families and their therapists will be undertaken. Cost-effectiveness of CT-PTSD relative to TAU will be also be assessed.
Ethics and dissemination: This trial protocol has been approved by a UK Health Research Authority (HRA) Research Ethics Committee (East of England – Cambridge South, 16/EE/0233). Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations, and clinical workshops.
Trial registration: ISRCTN, ISRCTN12077707. Registered 24th October 2016

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