Pragmatic RAndomised controlled trial of a trauma-focused guided self-help Programme versus InDividual trauma-focused cognitive Behavioural therapy for post-traumatic stress disorder (RAPID): trial protocol

Nollett, Claire; Lewis, Catrin; Kitchiner, Neil J; Roberts, Neil P.; Addison, Katherine; Brookes‐Howell, Lucy; Cosgrove, Sarah J.; Cullen, Katherine; Ehlers, Anke; Heke, Sarah; Kelson, Mark; Lovell, Karina; Madden, Kim; McEwan, Kirsten; McNamara, Rachel; Phillips, Ceri; Pickles, Timothy; Simon, Natalie; Bisson, Jonathan I.

doi:10.1186/s12888-018-1665-3

Cited by 13 publications

(9 citation statements)

References 52 publications

(40 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Despite the observed efficacy of i‐CBT for PTSD in comparison with no intervention post‐treatment, there have been no studies drawing comparisons with therapist‐administered treatments. Carefully designed non‐inferiority trials with nested process evaluation are required in order to establish the efficacy of these novel interventions in comparison with the current first‐line interventions . Given the lack of evidence for the longer‐term effect of i‐CBT, there is an urgent need for future trials to collect follow‐up data, ideally spanning a longer term than previous studies.…”

Section: Discussionmentioning

confidence: 99%

Internet‐delivered cognitive behavioural therapy for post‐traumatic stress disorder: systematic review and meta‐analysis

Lewis

Roberts

Simon

et al. 2019

Acta Psychiatr Scand

View full text Add to dashboard Cite

Internet-delivered cognitive behavioural therapy for post-traumatic stress disorder: systematic review and meta-analysis.Objective: To determine whether Internet-delivered cognitive behavioural therapy (i-CBT) is an effective treatment for those who meet diagnostic criteria for post-traumatic stress disorder (PTSD). Method: A systematic review was undertaken according to Cochrane Collaboration Guidelines. The primary outcome measures were reduction in PTSD symptoms and drop-out. Categorical outcomes were meta-analysed as risk ratios (RRs) and continuous outcomes as mean differences (MDs) or standardised mean differences (SMDs). Results: Ten studies with 720 participants were included. Evidence showed that i-CBT may be associated with a clinically important reduction in post-treatment PTSD symptoms compared with wait list (SMD À0.60, 95% confidence interval À0.97 to À0.24; N = 560); however, only three studies reported follow-up data, and there was no evidence to support the maintenance of symptom improvement at follow-up of 3-6 months. There was no evidence of a difference in PTSD symptoms between i-CBT and Internet-delivered non-CBT posttreatment. There was evidence of greater treatment effect from traumafocused i-CBT than i-CBT without a trauma focus, as well as evidence that treatment effect was increased by the provision of guidance. Conclusions: While the review found some beneficial effects of i-CBT for PTSD post-treatment, the quality of the evidence was very low because of the small number of included trials and there was insufficient evidence to support the maintenance of improvement at follow-up of 3-6 months. Further work is required to establish non-inferiority to current first-line interventions; to determine long-term efficacy; to explore mechanisms of effect; and to establish optimal levels of guidance. Summations• i-CBT may be associated with a clinically important reduction in PTSD symptoms post-treatment, but there is currently a lack of evidence to support maintenance of the effect at follow-up.• There was evidence of greater treatment effect from trauma-focused i-CBT than i-CBT without a trauma focus, as well as evidence that treatment effect was increased by the provision of guidance.• Further work is required to establish non-inferiority to current first-line interventions. Limitations• Only ten studies were eligible for inclusion, and sample sizes were often small. • Participants included in the ten studies were predominantly from the United States and Western Europe, employed and had relatively high levels of education. It is not possible to determine whether similar results would have been obtained from participants with more representative demographic characteristics.• There was a lack of independent evaluation. All but one of the programmes were evaluated by the programme developers themselves.

show abstract

Section: Discussionmentioning

confidence: 99%

Internet‐delivered cognitive behavioural therapy for post‐traumatic stress disorder: systematic review and meta‐analysis

Lewis

Roberts

Simon

et al. 2019

Acta Psychiatr Scand

View full text Add to dashboard Cite

show abstract

“…Updated systematic reviews of Internet‐based therapies are required to evaluate efficacy and acceptability in a rapidly evolving field. RCT research is currently underway exploring perspectives of patients and therapists (Nollett et␣al., 2018), and it would be beneficial also to research these perspectives in the context of routine NHS practice. Interviewees perceived that Internet‐based approaches may exclude some people due to literacy and online access issues.…”

Section: Resultsmentioning

confidence: 99%

“…Qualitative methodology was employed to gather in‐depth stakeholder views, as a sub‐study of the ongoing RAPID Trial (Nollett et␣al., 2018). RAPID is a pragmatic non‐inferiority Phase III trial with nested process evaluation comparing the efficacy of an Internet‐based GSH trauma‐focused CBT (TF‐CBT) intervention, ‘Spring’ (Lewis et␣al., 2017) with individual TF‐CBT.…”

Section: Methodsmentioning

confidence: 99%

Internet‐based psychological therapies: A qualitative study of National Health Service commissioners and managers views

et al. 2021

Self Cite

View full text Add to dashboard Cite

Objectives. To explore in-depth the views on Internet-based psychological therapies and their implementation from the perspective of National Health Service (NHS) commissioners and managers.Design. Qualitative interview study. Method.Ten NHS commissioners and managers participated in a semi-structured, coproduced interview. Each transcribed interview was double-coded and thematically analysed using The Framework Method. Results. Interviews generated three main themes. (1) Capacity issues across psychological therapy services create barriers to face-to-face therapies, and Internet-based interventions offer a solution. (2) Despite reservations, there is growing acceptance of Internet-based therapies. Different ways of connecting with patients are required, and Internet-based treatments are accessible and empowering treatment options, with guided self-help (GSH) preferred. Internet-based interventions may however exclude some individuals and be a threat to the therapeutic relationship between patient and practitioner. (3) Successful roll-out of Internet-based interventions would be facilitated by a strong empirical-or practice-based evidence, a national coordinated approach and timely training and supervision. Barriers to the roll-out include digital intervention set-up costs and delays due to NHS inflexibility.Conclusions. The study highlights factors influencing access to Internet-based therapies, important given the rapid evolution of e-therapies, and particularly timely given increasing use of remote therapies due to COVID-19 restrictions. Interviewees were open to Internet-based approaches, particularly GSH interventions, so long as they do notThis is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

show abstract

“…Participants will be people with PTSD living in South Wales. Recruitment will primarily occur through University Health Boards in South Wales using approaches that have proved successful in other RCTs run by Cardiff University’s Traumatic Stress Research Group (Lewis et al, 2017 ; Nollett et al, 2018 ).…”

Section: Methodsmentioning

confidence: 99%

The reconsolidation using rewind study (RETURN): trial protocol

Wright

Barawi

Simon

et al. 2021

European Journal of Psychotraumatology

Self Cite

View full text Add to dashboard Cite

Background: An increasing body of research highlights reconsolidation-based therapies as emerging treatments for post-traumatic stress disorder (PTSD). The Rewind Technique is a non-pharmacological reconsolidation-based therapy with promising early results, which now requires evaluation through an RCT. Objectives: This is a preliminary efficacy RCT to determine if the Rewind Technique is likely to be a good candidate to test against usual care in a future pragmatic efficacy RCT. Methods: 40 participants will be randomised to receive either the Rewind Technique immediately, or after an 8 week wait. The primary outcome will be PTSD symptom severity as measured by the Clinician-Administered PTSD Scale for DSM5 (CAPS-5) at 8 and 16 weeks post-randomisation. Secondary outcome measures include the PTSD Checklist (PCL-5), International Trauma Questionnaire (ITQ), Patient Health Questionnaire (PHQ-9), the General Anxiety Disorder-7 (GAD-7), Insomnia Severity Index, the Euro-Qol-5D (EQ5D-5 L), the prominence of re-experiencing specific symptoms (CAPS-5) and an intervention acceptability questionnaire to measure tolerability of the intervention. Conclusions: This study will be the first RCT to assess the Rewind Technique. Using a crossover methodology we hope to rigorously assess the efficacy and tolerability of Rewind using pragmatic inclusion criteria. Potential challenges include participant recruitment and retention. Trial registration: ISRCTN91345822 El estudio Reconsolidación Usando Rebobinado (RETURN): protocolo de pruebaAntecedentes: Un creciente cuerpo de investigación destaca las terapias basadas en la reconsolidación como tratamientos emergentes para el trastorno de estrés postraumático (TEPT). La Técnica de Rebobinado es una terapia no farmacológica basada en la reconsolidación con resultados tempranos prometedores, que ahora requiere evaluación a través de un ECA. Objetivos: Este es un ECA preliminar de eficacia para determinar si es probable que la técnica de rebobinado sea una candidata adecuada para probar en comparación con el cuidado habitual en un futuro ECA de eficacia pragmática. Método: 40 participantes serán asignados al azar para recibir la técnica de rebobinado inmediatamente o después de una espera de 8 semanas. El resultado primario será la gravedad de los síntomas del TEPT según lo medido por la Escala de TEPT administrada por el médico para DSM5 (CAPS-5 en su sigla en inglés) a las 8 y 16 semanas posteriores a la aleatorización. Las medidas de resultados secundarios incluyen la Lista de Verificación de TEPT (PCL-5 en su sigla en inglés), el Cuestionario Internacional de Trauma (ITQ en su sigla en inglés), el Cuestionario de Salud del Paciente (PHQ-9 en su sigla en inglés), el Trastorno de Ansiedad General-7 (GAD-7 en su sigla en inglés), el Índice de Gravedad del Insomnio, el Euro-Qol-5D (EQ5D-5L en su sigla en inglés), la prominencia de re-experimentar los síntomas específicos (CAPS-5) y un cuestionario de aceptabilidad de la intervención para medir la tolerabilidad de la intervención. Conclus...

show abstract

Pragmatic RAndomised controlled trial of a trauma-focused guided self-help Programme versus InDividual trauma-focused cognitive Behavioural therapy for post-traumatic stress disorder (RAPID): trial protocol

Cited by 13 publications

References 52 publications

Internet‐delivered cognitive behavioural therapy for post‐traumatic stress disorder: systematic review and meta‐analysis

Internet‐delivered cognitive behavioural therapy for post‐traumatic stress disorder: systematic review and meta‐analysis

Internet‐based psychological therapies: A qualitative study of National Health Service commissioners and managers views

The reconsolidation using rewind study (RETURN): trial protocol

Contact Info

Product

Resources

About