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Background Online interventions can improve access to cognitive behavioural therapy (CBT). We aimed to evaluate the clinical effectiveness of a novel approach integrating therapist-delivered CBT online in reducing depressive symptoms for primary care patients in England, compared with usual care. Methods INTERACT was a two-group, parallel, pragmatic, multicentre, randomised controlled trial recruiting patients from 67 general practices in England. Eligible participants were aged 18 years or older, scored 14 or more on the Beck Depression Inventory (BDI-II), and met ICD-10 criteria for a depressive episode. Patients who were under psychiatric care or had dementia, bipolar disorder, a psychotic illness, or a recent history of alcohol or substance abuse (within the past year) were excluded. Participants were randomly assigned (1:1, stratified by centre and minimised on gender, current antidepressant use, and depression severity) using an automated remote randomisation service to receive integrated CBT in addition to usual care (intervention) or to continue with usual general practitioner care (control). Patients, therapists, and researchers were not masked to allocation. There were no restrictions on usual care treatments. Integrated CBT comprised nine therapist-led sessions, delivered online via instant messaging within the dedicated INTERACT therapy platform. All sessions were delivered one-to-one by therapists accredited as CBT practitioners and were tailored to the individual patient's needs. Participants were followed up at 3, 6, 9, and 12 months after random assignment using self-report questionnaires. The primary outcome was depressive symptoms (BDI-II score) 6 months after random assignment, analysed using linear regression on an intention-to-treat basis without imputation for missing data. Adverse events and serious adverse events were recorded if identified as part of routine follow-up questionnaires or if reported by participants. The trial was registered with the ISRCTN registry (ISRCTN13112900) and is complete. Findings Between Jan 28, 2021, and April 27, 2023, 451 participants were screened for eligibility and randomly assigned to the intervention (n=225) or usual care (n=226). Mean age was 39·3 years (SD 14·9). 313 (69%) of participants self-reported their gender as female, 135 (30%) as male, and three (1%) as other. 381 (84%) participants self-reported their ethnicity as White, 27 (6%) as Asian or British Asian, 14 (3%) as Mixed, 14 (3%) as Black or Black British, 12 (3%) as Other, and three (1%) as Chinese. The primary analysis included 334 (74%) participants, 171 in the intervention group and 163 in the usual care (control) group, and the median time between random assignment and 6-month follow-up was 6·2 months (IQR 6·0–6·7). At 6 months, the mean BDI-II score in the intervention group was 22·5 (SD 14·4) and in the control group was 27·4 (SD 14·0; adjusted difference in means –4·4 [–7·90 to –1·9]; p=0·0006; effect size 0·43). There were 54 adverse events (33 in the intervention group and 21 in the control group) and 14 serious adverse events (twelve in the intervention group and two in the control group) during the trial. The most common adverse events were self-harm (n=6) and referrals to a mental health team (n=6). No serious adverse events were definitely or probably related to the intervention. There were no participant deaths. Interpretation Integrated CBT was effective for primary care patients with depression at 6 months. This novel mode of delivery could increase the availability of CBT and improve access for individuals who find in-person appointments difficult or inconvenient. Funding National Institute for Health and Care Research.
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