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Trauma-Focus Matters: A Randomised Controlled Trial of Therapist-Assisted Online Psychological Therapies for Post-Traumatic Stress Disorder (STOP-PTSD)
42 Pages Posted: 22 Mar 2023
More...Abstract
Background: Psychological treatments for posttraumatic stress disorder (PTSD) are effective, but many patients are currently unable to access these treatments. Therapist-assisted internet-based treatments may help increase access, but it remains untested whether trauma-focused online treatments are superior to nontrauma-focused online treatments.
Methods: A single-blind randomised controlled trial, with an embedded process study, compared two therapist-assisted online therapies: (1) a novel internet-delivered cognitive therapy for PTSD (iCT-PTSD), which implements all procedures of a NICE-recommended first-line trauma-focused intervention for PTSD and (2) internet-delivered stress management therapy (iStress-PTSD), a comprehensive cognitive behavioural treatment programme focusing on a wide range of coping skills. Participants were mainly recruited from National Health Service (NHS) Improving Access to Psychological Therapies (IAPT) services and met DSM-5 criteria for PTSD to single or multiple events (N=217), with 24% reporting symptoms of ICD-11 complex PTSD. They were randomly allocated by a computer programme (3:3:1) to iCT-PTSD, iStress-PTSD or a 3-month waitlist with usual NHS care (WUC). Post-wait, patients who still met PTSD criteria were randomly allocated (1:1) to iCT-PTSD or iStress-PTSD. The primary outcome was the severity of PTSD symptoms at 13 weeks (end of weekly treatment phase) as measured by the PTSD Checklist for DSM-5 (PCL-5). Further assessments occurred at 6, 26 (end of booster phase), 39 and 65 weeks and included interviews by blinded independent assessors, measures of other symptoms, quality of life and patient experience. Process analyses investigated acceptability and compliance with treatment as well as candidate moderators and mediators of outcome. Registered at ISRCTN16806208.
Outcomes: iCT-PTSD was superior to iStress-PTSD in improving PTSD symptoms (d’s between 0.38 and 0.44 for PCL-5 at 13 weeks), depression, anxiety, disability, well-being, quality of life, and in satisfaction with treatment, but not sleep quality. Both treatments were superior to WUC (PCL-5, d = 1.67 and 1.29, respectively), were well accepted with drop-out rates below 10%, and high ratings credibility, working alliance and patient satisfaction. Treatment gains were maintained during follow-up. Differences in quality of life between the treatments increased during follow-up. The advantages in outcome for iCT-PTSD were greater for patients with complex PTSD or high dissociation. Mediation analyses were in line with theoretical predictions.
Interpretation: Trauma-focused iCT-PTSD is highly effective and acceptable to patients with PTSD, and superior to a comprehensive nontrauma-focused cognitive behavioural stress management therapy. This points to specific treatment effects beyond those of good general CBT. The outcomes suggest iCT-PTSD is an effective way of delivering the contents of CT-PTSD, one of the NICE-recommended first-line treatments for PTSD, while making substantial savings in therapist time.
Trial Registration: Registered at ISRCTN16806208. Trial Information: Participants were recruited between 15 January 2018 and 31 March 2020. Data collection (last follow-up) ended on 31st December 2021.
Funding: Wellcome Trust grant 200796 (AE, DMC), NIHR Oxford Health Biomedical Research Centre (Prof John Geddes, BRC-1215-2000).
Declaration of Interest: Face-to-face CT-PTSD and iCT-PTSD were developed by Anke Ehlers and David M. Clark’s team. AE, NG, JW, EWP, HM and DMC occasionally give paid workshops on CT- PTSD. iStress was developed by Gerhard Andersson’s team.
Ethical Approval: Participants gave informed consent for the assessment, and if eligible, for participation in the trial including random allocation (Ethics reference: 17/WM/0441; IRAS project ID: 224759). The Ethics Committee who issued the approval was the West Midlands - Black Country Research Ethics Committee Ethics Approval, Ref: 17/WM/0441, approval 4th January 2018 (IRAS Project ID: 224759). HRA Approval: 8th January 2018
Keywords: postttraumatic stress disorder, PTSD, trauma, cognitive therapy, cognitive-behavioural therapy, stress management, digital therapy, online therapy, internet-delivered therapy, clinical trial, randomised controlled trial, moderation, mediation
Suggested Citation: Suggested Citation