TY - JOUR
T1 - DECRYPT trial
T2 - 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
AU - Allen, Leila
AU - Ashford, Polly Anna
AU - Beeson, Ella
AU - Byford, Sarah
AU - Chow, Jessica
AU - Dalgleish, Tim
AU - Danese, Andrea
AU - Finn, Jack
AU - Goodall, Ben
AU - Grainger, Lauren
AU - Hammond, Matthew
AU - Humphrey, Ayla
AU - Mahoney-Davies, Gerwyn
AU - Morant, Nicola
AU - Shepstone, Lee
AU - Sims, Erika
AU - Smith, Patrick
AU - Stallard, Paul
AU - Swanepoel, Annie
AU - Trickey, David
AU - Trigg, Katie
AU - Wilson, Jon
AU - Meiser-Stedman, Richard
PY - 2021/7/1
Y1 - 2021/7/1
N2 - 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 (eg, 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. 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 randomised controlled trial (RCT) examines the effectiveness of CT-PTSD for treating PTSD following multiple trauma exposure in children and young people in comparison with treatment as usual (TAU). METHODS/DESIGN: This protocol describes a two-arm, patient-level, single blind, superiority RCT comparing CT-PTSD (n=60) with 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 (ie, approximately 5 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-month 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 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: ISRCTN12077707. Registered 24 October 2016 (http://www.isrctn.com/ISRCTN12077707). Trial recruitment commenced on 1 February 2017. It is anticipated that recruitment will continue until June 2021, with 11-month assessments being concluded in May 2022.
AB - 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 (eg, 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. 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 randomised controlled trial (RCT) examines the effectiveness of CT-PTSD for treating PTSD following multiple trauma exposure in children and young people in comparison with treatment as usual (TAU). METHODS/DESIGN: This protocol describes a two-arm, patient-level, single blind, superiority RCT comparing CT-PTSD (n=60) with 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 (ie, approximately 5 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-month 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 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: ISRCTN12077707. Registered 24 October 2016 (http://www.isrctn.com/ISRCTN12077707). Trial recruitment commenced on 1 February 2017. It is anticipated that recruitment will continue until June 2021, with 11-month assessments being concluded in May 2022.
KW - anxiety disorders
KW - child & adolescent psychiatry
KW - depression & mood disorders
UR - http://www.scopus.com/inward/record.url?scp=85110274937&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-047600
DO - 10.1136/bmjopen-2020-047600
M3 - Article
C2 - 34210731
AN - SCOPUS:85110274937
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e047600
ER -