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. Funding NIHR Programme Grants for Applied Research (RP-PG-0514–20012).
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)