Integrated therapist and online cognitive behavioural therapy in addition to usual care versus usual care for depression in primary care in England (INTERACT): a two-group, parallel, multicentre, randomised controlled trial

Background Online interventions can improve access to cognitive behavioural therapy (CBT). We developed, a novel approach integrating therapist delivered CBT online with independent access to, supportive materials. We evaluated its effectiveness compared with usual care for primary care, patients with depression. Methods INTERACT was a pragmatic, multi-centre, randomised controlled trial with two parallel groups, that recruited from 67 primary care practices in England. Eligible participants were: ≥18 years;, scoring ≥14 on the Beck Depression Inventory (BDI-II); and met ICD-10 depression criteria., Participants were randomised (stratified by centre and minimised on three factors) using an, automated remote randomisation service to receive integrated CBT in addition to usual GP care, (intervention), or to continue with usual GP care (UC). Patients, therapists and researchers were, not blinded to allocation. There were no restrictions on UC treatments. Integrated CBT, comprised nine therapist-led sessions, delivered online via instant messaging within the, dedicated INTERACT therapy platform. Primary outcome was depressive symptoms (BDI-II, score) at 6 months post-randomisation. Analyses were undertaken on an intention-to-treat, basis. Trial registration: ISRCTN13112900 (status: complete). Findings Between 01/28/2021 and 04/27/2023, 451 participants were eligible and randomised tothe, intervention (n=225) or UC (n=226). Mean age was 39.3 years (SD 14.9). Most were female (self-, reported gender) (n=313, 69.4%) and (self-reported ethnicity) White (n=381; 84.5%). The primary, analysis included 334 participants (74%) (171 intervention; 163 UC) (median 6.2 months [IQR:, 6.0, 6.7]). The intervention group had a BDI-II score that was, on average, 4.4 points lower (less depressed), than the UC group at 6 months (difference in means: -4.4 (95%CI: -7.0 to -1.9), p=0.001, effect, size 0.43). There were 54 adverse events (intervention: n=45; UC: n=23) and 14 serious adverse, events (intervention: n=12; UC: n=2) during the study. The most common adverse events were, self harm (n=6) and referrals for mental health (n=6). No SAEs were definitely/probably related, to the intervention. There were no participant deaths. Interpretation Integrated CBT is effective for patients with depression. This novel mode of delivery could increase the availability of CBT and access for those who find in-person appointments difficult. Research in context Evidence before this study As part of our programme grant, we searched (MEDLINE 1950-), EMBASE (1974-), PsycINFO, (1967-) and the Cochrane Central Register of Controlled Trials (CENTRAL) via the specialised, register of the Cochrane Common Mental Disorders Group (CCMDCTR) (with no language, restrictions) to 10 June 2016 for randomised controlled trials in adults with a primary diagnosis, of depression, which included a CBT intervention. The search terms included MeSH Headings, (e.g. depressive disorder, major/ or depressive disorder, treatment-resistant/ or dysthymic, disorder/); and keywords/text searches (e.g. mood disorder*, affective disorder*, depression or, depressive or dysthymi*), (*therap* or psychotherapy*), (cognitive) (*CBT or cognitive-behavi*)., No language restrictions were applied to the searches. Our systematic review and network, meta-analysis published in 2019 concluded that multimedia and hybrid CBT might be as, effective as face-to-face CBT. To our knowledge, there are no other studies, which incorporate, online CBT materials to which the patient has independent access, as an integral part of therapy, delivered online in real time to primary care patients with depression. We have previously, shown that CBT delivered in real time online by instant messaging is effective, but this modality, alone does not support the practice of CBT outside therapy sessions (‘homework’) which is a, key component of CBT. Others have ‘blended’ in-person CBT with use of an internet-based, therapy platform, but this content is not tailored to the individual and the two components are, not integrated. Internet-based CBT ‘support systems’ or mobile app(lications) that contain some, CBT materials have been developed, but these have only been evaluated in small samples of, patients recruited from psychiatric clinics. Added Value of this study This study integrates computer and mobile technology with a therapist led approach. This, approach aligns with the CBT competences framework and the idea of ‘meta-competences’, whereby the therapist adapts CBT to each patient’s needs. The therapy is delivered online in real, time within a platform which offers access to a wealth of CBT materials both during and outside, the therapy session. To our knowledge, this is the first large scale randomised trial of this, approach and demonstrates its clinical effectiveness in primary care patients with depression. Implications of all the available evidence Implementation of the INTERACT platform has the potential to increase the availability of CBT,, including for those who find it difficult or inconvenient to meet in person. Future research needs, to examine which aspects of the platform led to improvements and whether the beneficial, effects are sustained beyond 12 months.