Pragmatic randomised controlled trial of guided self-help versus individual cognitive behavioural therapy with a trauma focus for post-traumatic stress disorder (RAPID)
Bisson JI, Ariti C, Cullen K, Kitchiner N, Lewis C, Roberts NP, Simon N, Smallman K, Addison K, Bell V, Brookes-Howell L, Cosgrove S, Ehlers A, Fitzsimmons D, Foscarini-Craggs P, Harris SR, Kelson M, Lovell K, McKenna M, McNamara R, Nollett C, Pickles T, Williams-Thomas R
Record ID 32018005349
Authors' objectives: Guided self-help has been shown to be effective for other mental conditions and, if effective for post-traumatic stress disorder, would offer a time-efficient and accessible treatment option, with the potential to reduce waiting times and costs. To determine if trauma-focused guided self-help is non-inferior to individual, face-to-face cognitive-behavioural therapy with a trauma focus for mild to moderate post-traumatic stress disorder to a single traumatic event. Post-traumatic stress disorder (PTSD) is a common mental health condition that may develop following exposure to traumatic events that involve threatened or actual death, serious injury or sexual violence. PTSD causes significant distress to those affected by it, often co-occurs with other physical and mental health conditions and is associated with a large economic burden. Face-to-face, trauma-focused psychological treatments (TFPT) have been found to be the most effective currently available treatments for PTSD and are recommended first line by treatment guidelines across the world. Unfortunately, the limited number of suitably trained therapists available to deliver TFPT in the National Health Service often prevents timely access to treatment and some people find accessing and fully engaging with face-to-face TFPT difficult for other reasons, including work commitments, travel and childcare. Guided self-help (GSH) provides an alternative approach to the delivery of treatment by combining the use of self-help materials with regular guidance from a trained professional and requires less therapist time than recommended face-to-face TFPT. GSH has been shown to be effective for other mental conditions and, if effective for PTSD, GSH would offer a time-efficient and accessible treatment option, with the potential to reduce waiting times and intervention costs. The main aim of the RAPID trial was to determine the likely clinical and cost-effectiveness of GSH using Spring, an internet-based programme based on cognitive behavioural therapies with a trauma focus (CBT-TF), for mild to moderate PTSD. RAPID also aimed to describe the experience of receiving GSH using Spring from the recipient’s perspective, and the delivery of GSH using Spring from the therapist’s perspective. The objectives were to determine if: GSH using Spring was at least equivalent in effectiveness and cost-effective relative to individual face-to-face CBT-TF for people with PTSD, as judged by reduced symptoms of PTSD and improved quality of life. GSH using Spring improved functioning and reduced symptoms of depression, symptoms of anxiety, alcohol use and perceived social support. Specific factors may impact effectiveness and successful roll-out of GSH for PTSD in the NHS.
Authors' results and conclusions: Non-inferiority was demonstrated at the primary end point of 16 weeks on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [mean difference 1.01 (one-sided 95% CI −∞ to 3.90, non-inferiority p = 0.012)]. Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, score improvements of over 60% in both groups were maintained at 52 weeks but the non-inferiority results were inconclusive in favour of cognitive-behavioural therapy with a trauma focus at this timepoint [mean difference 3.20 (one-sided 95% confidence interval −∞ to 6.00, non-inferiority p = 0.15)]. Guided self-help using Spring was not shown to be more cost-effective than face-to-face cognitive-behavioural therapy with a trauma focus although there was no significant difference in accruing quality-adjusted life-years, incremental quality-adjusted life-years −0.04 (95% confidence interval −0.10 to 0.01) and guided self-help using Spring was significantly cheaper to deliver [£277 (95% confidence interval £253 to £301) vs. £729 (95% CI £671 to £788)]. Guided self-help using Spring appeared to be acceptable and well tolerated by participants. No important adverse events or side effects were identified. Guided self-help using Spring for mild to moderate post-traumatic stress disorder to a single traumatic event appears to be non-inferior to individual face-to-face cognitive-behavioural therapy with a trauma focus and the results suggest it should be considered a first-line treatment for people with this condition. One hundred and ninety-six participants were randomised with 82% retention at 16 weeks and 71% at 52 weeks. There were no serious imbalances observed in the baseline data between the two groups. Non-inferiority (margin of 5 points) was demonstrated at the primary endpoint of 16 weeks on the CAPS-5 using the intention to treat principle [mean difference 1.0, 95% one-sided confidence interval (CI) (−∞, 3.9, non-inferiority p = 0.012)]. This was also the case for all secondary outcomes at this time point, except for client satisfaction that was inconclusive but in favour of CBT-TF. At 52 weeks post-randomisation, non-inferiority was shown for Multidimensional Scale for Perceived Social Support (MSPSS), Alcohol Use Disorders Test and GSES; non-inferiority was not shown for the other outcomes but the results, which were inconclusive, were in favour of CBT-TF. Further examination of the Impact of Event Scale-Revised (IES-R) longitudinal measurements indicated that while the GSH group maintained their reduction (improvement) in IES-R scores between the 16- and 52-week assessments, the CBT-TF group continued to improve at a slow rate over the same period. There were no subgroup effects that showed any evidence of difference between the interventions including gender (pre-specified), mode of data collection or assessments conducted after the introduction of the COVID-19 lockdown. Spring was cheaper to deliver than face-to-face CBT TF [£277 (95% CI £253 to £301) vs. £729 (95% CI £671 to £788)]. When total costs were included, Spring was £572 (95% CI £64.96 to £1080.14) cheaper and produced but derived fewer quality-adjusted life-years (QALYs) compared to CBT-TF, −0.04 (95% CI −0.10 to 0.01). At a willingness-to-pay threshold of £30,000 per QALY gained, the probability of GSH being cost-effective was 29.74%. The process data provided evidence of acceptability of the overall trial methodology, although key points were identified for consideration in future randomised controlled design, especially concerning burden and impact of outcome measures on participants and how they are delivered and explained. Intervention acceptability was indicated for both GSH and CBT-TF interventions, although there was a preference for face-to-face treatment. Therapeutic relationship was an important factor highlighted in the acceptability of the interventions. Flexibility identified with GSH was seen as positive and some activities within Spring were described as more helpful than others. Implications for health care GSH using Spring was found to be non-inferior to face-to-face CBT-TF at treating people with mild to moderate PTSD. Significant gains were maintained in the GSH using Spring group at 52 weeks but some ongoing improvements in the CBT-TF group appeared to result in largely inconclusive findings with respect to non-inferiority at 52 weeks. The additional benefits of GSH using Spring with respect to time, cost and convenience, and having another evidence-based treatment option could be argued as outweighing what appear to be minor differences at 52 weeks. The results of the RAPID trial should herald a step change in the approach of services to the provision of evidence-based treatment to people with mild to moderate PTSD. There is now an urgent need to make GSH using Spring available as a low-intensity treatment option for people with PTSD.
Authors' methods: Multicentre pragmatic randomised controlled non-inferiority trial with economic evaluation to determine cost-effectiveness and nested process evaluation to assess fidelity and adherence, dose and factors that influence outcome (including context, acceptability, facilitators and barriers, measured qualitatively). Participants were randomised in a 1 : 1 ratio. The primary analysis was intention to treat using multilevel analysis of covariance. Primary and secondary mental health settings across the United Kingdom’s National Health Service. One hundred and ninety-six adults with a primary diagnosis of mild to moderate post-traumatic stress disorder were randomised with 82% retention at 16 weeks and 71% at 52 weeks. Nineteen participants and ten therapists were interviewed for the process evaluation. Up to 12 face-to-face, manualised, individual cognitive-behavioural therapy with a trauma focus sessions, each lasting 60–90 minutes, or to guided self-help using Spring, an eight-step online guided self-help programme based on cognitive-behavioural therapy with a trauma focus, with up to five face-to-face meetings of up to 3 hours in total and four brief telephone calls or e-mail contacts between sessions. Primary outcome: the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, at 16 weeks post-randomisation. Secondary outcomes: included severity of post-traumatic stress disorder symptoms at 52 weeks, and functioning, symptoms of depression, symptoms of anxiety, alcohol use and perceived social support at both 16 and 52 weeks post-randomisation. Those assessing outcomes were blinded to group assignment. The results are not generalisable to people with post-traumatic stress disorder to more than one traumatic event. RAPID was a multicentre pragmatic randomised controlled non-inferiority trial with assessors masked to treatment allocation. Individual randomisation was used. Economic evaluation was undertaken to determine cost-effectiveness and nested process evaluation to assess fidelity and adherence, dose and factors that may influence outcome (including context, acceptability, and facilitators and barriers, measured qualitatively). GSH using Spring was not expected to be more effective than face-to-face CBT-TF, and therefore, a non-inferiority design was chosen. Participants were recruited from NHS Improving Access to Psychological Therapy services based in primary care in England, and NHS psychological treatment settings based in primary and secondary care in Scotland and Wales. Wide eligibility criteria were used to ensure good external validity. Participants were aged 18 or over, had mild to moderate PTSD as their primary diagnosis, had regular access to the internet and gave informed consent to take part. Exclusion criteria were inability to read and write fluently in English, previous completion of a course of TFPT for PTSD, current PTSD symptoms to more than one traumatic event, current engagement in psychological therapy, psychosis, substance dependence, active suicide risk and change in psychotropic medication in the past 4 weeks. Participants were randomised to receive up to 12 face-to-face, manualised, individual CBT-TF sessions, each lasting 60–90 minutes, or to GSH using Spring. Spring is a manualised, eight-step online GSH programme based on CBT-TF. An initial meeting of 1 hour between the therapist and the person with PTSD is followed by four subsequent fortnightly meetings of 30 minutes, with four brief telephone calls or e-mail contacts between sessions. The primary outcome was the severity of symptoms of PTSD over the previous week as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at 16 weeks post-randomisation. Secondary outcomes included severity of PTSD symptoms at 52 weeks, and functioning, symptoms of depression, symptoms of anxiety, alcohol use, and perceived social support at both 16 and 52 weeks post-randomisation. Resource use was also collected to support the health economic evaluation. Semistructured interviews were conducted with 19 participants and 10 therapists as part of the process evaluation, to gather perspectives of receiving and delivering the interventions, to examine underlying mechanisms and factors influencing future implementation.
Project Status: Completed
URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/14/192/97
Year Published: 2023
URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/YTQW8336
URL for additional information: English
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: England, United Kingdom
- Stress Disorders, Post-Traumatic
- Cognitive Behavioral Therapy
- Self Care
- Psychiatric Rehabilitation
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
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