Issue link: https://read.uberflip.com/i/1503815
METHOD Study design An 8-week randomized controlled trial (RCT) with 2:1 (iCBT intervention: waiting-list control) allocation, and 12-month follow-up in the intervention- arm. This study uses a pragmatic design where the trial procedures were built around the standard service procedures used at step 2 of IAPT and the support was offered by service employees. The study setting was an NHS IAPT Trust in England (i.e., a local health service provider covering the population within a geographical area). At Step 2 IAPT offers low-intensity psychological interventions to individuals experiencing mild to moderate symptoms of depression and anxiety. The trial protocol 26 was approved by the National Health Service (NHS) England Research Ethics Committee (REC Reference: 17/NW/0311). The trial was prospectively registered: Current Controlled Trials ISRCTN91967124; Clinicaltrials.gov Identifier: NCT03188575. See "Supplementary Methods" for declarations of protocol deviations and measures reported. Participants Participants were chosen based on IAPT standard operating procedures to best represent participants who may be eligible and require iCBT as part of usual IAPT care. Participants were new IAPT referrals, included if aged between 18–80 years, screened for psychological pathology using clinical thresholds for Patient-Health Questionnaire-9 (PHQ-9 ≥ 9) 27 and/or Gen- eralised Anxiety Disorder-7 (GAD-7 ≥ 8) 28 , and suitable for iCBT (i.e. willing to engage in iCBT, internet access). Exclusion criteria included: suicidal ideation/intended (PHQ-9 question 9 score > 2 and/or expressed during clinical interview); psychotic illness; organic mental health disorder; alcohol and/or drug misuse; and currently receiving psychological treatment. Recruited participants signed informed consent via digital signature. Randomization and masking Participants were randomized at an individual level using an algorithm developed by a computer scientist (Sealed Envelope, 2016) and executed independently of the research team, employing random permuted blocks using block sizes of 9, and including stratification within a 2:1 allocation ratio between treatment and waiting list control groups. The Psychological Wellbeing Practitioners (PWP) who carried out the support and assessment of the patients could not be blinded to allocation for practical reasons. Procedures As per routine practice, clients attending the IAPT service received an assessment of their needs which determined their initial presentation (depression/anxiety), suitability for Step 2 and for iCBT, and allocation to one of the available programmes. Subsequently, eligible participants were invited to the trial and thereafter, as part of this research trial, signed informed consent via digital signature, completed the baseline research assessments and completed the M.I.N.I.7.0.2 with a PWP to determine a primary diagnosis of depression or anxiety with initial treatment assign- ment as per routine service's practice (most suitable intervention based on their symptomology). Given the higher prevalence of anxiety disorders compared to depression 29 , primary diagnosis was used for randomization to ensure a balanced sample; this data will inform future secondary analyses. Those randomized to the intervention-arm commenced their treatment with their PWP supporter. The iCBT programs were SilverCloud Health's 'Space from Depression', 'Space from Anxiety' and 'Space from Depression and Anxiety' interventions, whose efficacy has been previously supported 16 and which have been described in detail elsewhere 26 . The interventions share core CBT content with customisations for depression and specific anxiety-disorder presenta- tions (e.g., social anxiety, generalized anxiety, panic disorder, etc.). Participants were supported during their iCBT treatment by PWPs, who are psychology graduates specifically trained in the provision of low- intensity CBT interventions 5 . PWPs were located in offices across several localities in the area, which are separate to primary care premises. Assessment and triage for services typically occurs over the phone but can sometimes occur in face-to-face settings. PWPs assessed participants for suitability, assigned participants to a specific iCBT programme, monitored their progress throughout the trial and provided regular reviews. During the reviews, PWPs provided feedback to clients based on their work from week-to-week (e.g. modules completed, tools used, shared journal entries) and encouragement in order to promote meaningful engagement with the programme 30 . PWPs were instructed to provide six online reviews (15 min per participant per review) over the 8-week intervention period. Potential risk to participants was monitored in line with routine service procedures (see protocol for full description of risk management). Fidelity to the treatment was ensured through checklists and clinical supervision offered by case managers. Specifically, the checklist assessed if the content of the review offered by the supporter considered the client, the tools used and the previous levels of engagement of the client when writing the review. In total, 176 checklists were completed that represented 85 cases with an average of 2 supervisions per case. One-hundred-and-seventy (n = 170) of the checklists were marked as compliant with the content of online reviews. 6 cases were either not indicated as compliant (reason not stated) or marked as the client not attending the session. After 8 weeks, all participants were asked to complete relevant measures online and the control-arm participants began treatment. Follow-up procedures included telephone administration of the Mini International Neuropsychiatric Interview 7.0.2 (M.I.N.I.7.0.2) 31 at 3-month; the timeframe was decided in order to allow enough time for the intervention to have an Fig. 4 CEAC representing probability of cost-effectiveness of iCBT relative to waiting-list control over 8 weeks, and predicted over 6, 9, and 12 months. ITT Intention-to-treat, BA Baseline-Adjusted; QALY Quality-Adjusted Life year. D. Richards et al. 7 Scripps Research Translational Institute npj Digital Medicine (2020) 85