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. 2023 Jun 20;24(1):421.
doi: 10.1186/s13063-023-07396-9.

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial

Debbie Tallon  1 , Laura Thomas  2 , Sally Brabyn  3 , Brian Chi Fung Ching  4 , Jane Sungmin Hahn  4 , Berry Jude  4 , Mekeda X Logan  4 , Alex Burrage  2 , Fiona Fox  2 , Simon Gilbody  5 , Paul Lanham  6 , Glyn Lewis  4 , Jinshuo Li  7 , Stephanie J MacNeill  8 , Irwin Nazareth  9 , Steve Parrott  7 , Tim J Peters  10 , Roz Shafran  11 , Katrina Turner  12 , Chris Williams  13   14 , David Kessler #  2 , Nicola Wiles #  2
Affiliations

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial

Debbie Tallon et al. Trials. .

Abstract

Background: Cognitive behavioural therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at a lower cost. However, adherence is often poor and, in the absence of therapist support, effects are modest and short-term. Delivering CBT online using instant messaging is clinically and cost-effective; however, most existing platforms are limited to instant messaging sessions, without the support of between-session "homework" activities. The INTERACT intervention integrates online CBT materials and 'high-intensity' therapist-led CBT, delivered remotely in real-time. The INTERACT trial will evaluate this novel integration in terms of clinical and cost-effectiveness, and acceptability to therapists and clients.

Methods: Pragmatic, two parallel-group multi-centre individually randomised controlled trial, with 434 patients recruited from primary care practices in Bristol, London and York. Participants with depression will be identified via General Practitioner record searches and direct referrals.

Inclusion criteria: aged ≥ 18 years; score ≥ 14 on Beck Depression Inventory (BDI-II); meeting International Classification of Diseases (ICD-10) criteria for depression.

Exclusion criteria: alcohol or substance dependency in the past year; bipolar disorder; schizophrenia; psychosis; dementia; currently under psychiatric care for depression (including those referred but not yet seen); cannot complete questionnaires unaided or requires an interpreter; currently receiving CBT/other psychotherapy; received high-intensity CBT in the past four years; participating in another intervention trial; unwilling/unable to receive CBT via computer/laptop/smartphone. Eligible participants will be randomised to integrated CBT or usual care. Integrated CBT utilises the standard Beckian intervention for depression and comprises nine live therapist-led sessions, with (up to) a further three if clinically appropriate. The first session is 60-90 min via videocall, with subsequent 50-min sessions delivered online, using instant messaging. Participants allocated integrated CBT can access integrated online CBT resources (worksheets/information sheets/videos) within and between sessions. Outcome assessments at 3-, 6-, 9- and 12-month post-randomisation. The primary outcome is the Beck Depression Inventory (BDI-II) score at 6 months (as a continuous variable). A nested qualitative study and health economic evaluation will be conducted.

Discussion: If clinically and cost-effective, this model of integrated CBT could be introduced into existing psychological services, increasing access to, and equity of, CBT provision.

Trial registration: ISRCTN, ISRCTN13112900. Registered on 11/11/2020. Currently recruiting participants. Trial registration data are presented in Table 1.

Keywords: Acceptability; Blended treatment; Cognitive behavioural therapy; Depression; Integrated cognitive behavioural therapy; Internet-based treatment; Primary care; Qualitative research; Randomised controlled trial.

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Conflict of interest statement

CW is the author of written and online CBT self-help resources and is the Director of a company which commercialises these resources. The other authors have no conflict of interests with respect to this protocol.

Figures

Fig. 1
Fig. 1
INTERACT trial flowchart
Fig. 2
Fig. 2
Schedule of enrolment, interventions and assessments. *Eligible participants only. **Intervention arm participants only. ***9 sessions of integrated CBT with (up to) a further 3 if deemed clinically necessary; access to the platform CBT resources for 12-months post-randomisation
See this image and copyright information in PMC

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