A pragmatic randomized waitlist-controlled effectiveness and cost-effectiveness trial of digital interventions for depression and anxiety

Abstract

Utilization of internet-delivered cognitive behavioural therapy (iCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK’s Improving Access to Psychological Therapies (IAPT), is a potential solution for addressing the treatment gap in mental health. We investigated the effectiveness and cost-effectiveness of iCBT when fully integrated within IAPT stepped-care settings. We conducted an 8-week pragmatic randomized controlled trial with a 2:1 (iCBT intervention: waiting-list) allocation, for participants referred to an IAPT Step 2 service with depression and anxiety symptoms (Trial registration: ISRCTN91967124). The primary outcomes measures were PHQ-9 (depressive symptoms) and GAD-7 (anxiety symptoms) and WSAS (functional impairment) as a secondary outcome. The cost-effectiveness analysis was based on EQ-5D-5L (preference-based health status) to elicit the quality-adjust life year (QALY) and a modified-Client Service Receipt Inventory (care resource-use). Diagnostic interviews were administered at baseline and 3 months. Three-hundred and sixty-one participants were randomized (iCBT, 241; waiting-list, 120). Intention-to-treat analyses showed significant interaction effects for the PHQ-9 (b = −2.75, 95% CI −4.00, −1.50) and GAD-7 (b = −2.79, 95% CI −4.00, −1.58) in favour of iCBT at 8-week and further improvements observed up to 12-months. Over 8-weeks the probability of cost-effectiveness was 46.6% if decision makers are willing to pay £30,000 per QALY, increasing to 91.2% when the control-arm’s outcomes and costs were extrapolated over 12-months. Results indicate that iCBT for depression and anxiety is effective and potentially cost-effective in the long-term within IAPT. Upscaling the use of iCBT as part of stepped care could help to enhance IAPT outcomes. The pragmatic trial design supports the ecological validity of the findings.

The effectiveness of Internet‐delivered treatment for generalized anxiety disorder: An updated systematic review and meta‐analysis

“…This differentiation is key, as the sole focus on the Internet as a treatment modality, irrespective of ever debated psychotherapeutic models, is what may help to fill existing gaps in the provision of treatment to those suffering from GAD (Alonso et al, 2018;Richards et al, 2020). In terms of secondary findings, beneficial large effects of psychological interventions for GAD on depressive symptoms have also been previously reported (Carl et al, 2020;Cuijpers et al, 2016) and are encouraging considering frequent comorbidity between MDD and GAD and close associations between anxiety and depressive symptoms (Jacobson & Newman, 2017;Moffitt et al, 2007).…”

“…Across 20 studies a total of 1333 participants were included—767 in treatment conditions and 566 control conditions. Sample size ranged from 13 (Bell et al, 2012) to 199 (Richards et al, 2020) with a mean sample size of 52. All participants were adults, ranging in age from 18 to 81.…”

“…While both studies found comparable large effect sizes across their primary outcomes ( g = 0.76, n = 39; g = 0.80, n = 64), crucially neither focused on the effects of Internet‐delivered interventions on GAD specifically, with the first also including non‐Internet‐delivered interventions and the latter only including Internet‐delivered interventions based on CBT. This differentiation is key, as the sole focus on the Internet as a treatment modality, irrespective of ever debated psychotherapeutic models, is what may help to fill existing gaps in the provision of treatment to those suffering from GAD (Alonso et al, 2018; Richards et al, 2020). In terms of secondary findings, beneficial large effects of psychological interventions for GAD on depressive symptoms have also been previously reported (Carl et al, 2020; Cuijpers et al, 2016) and are encouraging considering frequent comorbidity between MDD and GAD and close associations between anxiety and depressive symptoms (Jacobson & Newman, 2017; Moffitt et al, 2007).…”

Evidence on Technology-Based Psychological Interventions in Diagnosed Depression: Systematic Review

“…In contrast, traditional stepped care approaches without TBIs have been found to be effective for treating depression [ 113 ]. Thus, not surprisingly, we only identified 2 studies [ 33 , 34 ] offering TBIs (internet-based CBT) as a low-threshold intervention in the course of a stepped care approach. To assess the usefulness of specific TBIs within stepped care approaches, we need studies testing different treatment options comparatively at different levels of the stepped care approach (for instance, first step: watchful waiting vs iCBT (internet-based CBT) vs bibliotherapy; second step: F2F psychotherapy vs telephone psychotherapy).…”

Cost-effectiveness of guideline-based stepped and collaborative care versus treatment as usual for patients with depression – a cluster-randomized trial

“…Considering the cost-effectiveness, there is evidence from several studies. However, most of these studies took a rather specific focus on stepped care approaches by evaluating the inclusion of digital measures into stepped care models [ 15 – 18 ] or by investigating stepped care in populations with specific underlying diseases [ 19 – 21 ] or in combination with other interventions [ 22 , 23 ] or in specific populations [ 24 – 30 ]. There are three studies that show a certain degree of comparability to our study by evaluating stepped care exclusively for depression in a primary care sample.…”