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

Debbie Tallon; Laura J Thomas; Sally Brabyn; Brian Chi Fung Ching; Jane Sungmin Hahn; Berry Jude; Mekeda X Logan; Alex Burrage; Fiona E Fox; Simon Gilbody; Paul Lanham; Glyn Lewis; Jinshuo Li; Stephanie J MacNeill; Irwin Nazareth; Steve Parrott; TJ Peters; Roz Shafran; Katrina M Turner; Chris Williams; David S Kessler; Nicola J Wiles

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, Laura J Thomas, Sally Brabyn, Brian Chi Fung Ching, Jane Sungmin Hahn, Berry Jude, Mekeda X Logan, Alex Burrage, Fiona E Fox, Simon Gilbody, Paul Lanham, Glyn Lewis, Jinshuo Li, Stephanie J MacNeill, Irwin Nazareth, Steve Parrott, TJ Peters, Roz Shafran, Katrina M Turner, Chris WilliamsDavid S Kessler, Nicola J Wiles

Research output: Contribution to journal › Article (Academic Journal) › peer-review

1 Citation (Scopus)

Abstract

Background:Cognitive Behavioural Therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at 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 minutes via videocall, with subsequent 50-minute 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-months post-randomisation. 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.

Original language	English
Article number	421
Journal	Trials
Volume	24
Issue number	1
DOIs	https://doi.org/10.1186/s13063-023-07396-9
Publication status	Published - 20 Jun 2023

Bibliographical note

Funding Information:
This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol (grant number BRC-1215–20011). The NIHR Bristol Biomedical Research Centre funded the fMRI add on study.

Funding Information:
This report is independent research funded by the National Institute for Health and Care Research (Programme Grants for Applied Research, Integrated therapist and online CBT for depression in primary care, RP-PG-0514–20012). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR, the Department of Health or the Sponsor. The funder and Sponsor have no role in the study design, data collection, data analysis, interpretation of data, or manuscript writing. Dissemination of results will include the publication of a detailed report, written by the INTERACT study team and published by the NIHR.

Funding Information:
Supplementary funding was provided by the NIHR School for Primary Care Research (SPCR—2014–10043 Award: L).”

Publisher Copyright:
© 2023, The Author(s).

Keywords

depression
randomised controlled trial
cognitive behavioural therapy
internet-based treatment
blended treatment
primary care
integrated cognitive behavioural therapy
acceptability
qualitative research

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PGfAR: Stage2 BRTC Integrated therapist and online CBT for depression in primary care ("INTERACT")
Wiles, N. J. (Principal Investigator)
1/04/16 → 31/03/22
Project: Research, Parent

Cite this

Tallon, D., Thomas, L. J., Brabyn, S., Ching, B. C. F., Hahn, J. S., Jude, B., X Logan, M., Burrage, A., Fox, F. E., Gilbody, S., Lanham, P., Lewis, G., Li, J., MacNeill, S. J., Nazareth, I., Parrott, S., Peters, TJ., Shafran, R., Turner, K. M., ... Wiles, N. J. (2023). Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial. Trials, 24(1), Article 421. https://doi.org/10.1186/s13063-023-07396-9

@article{4967805d2223438ca0f6337024a6ef45,

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

abstract = "Background:Cognitive Behavioural Therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at 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 {\textquoteleft}high-intensity{\textquoteright} 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 minutes via videocall, with subsequent 50-minute 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-months post-randomisation. 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. ",

keywords = "depression, randomised controlled trial, cognitive behavioural therapy, internet-based treatment, blended treatment, primary care, integrated cognitive behavioural therapy, acceptability, qualitative research",

author = "Debbie Tallon and Thomas, {Laura J} and Sally Brabyn and Ching, {Brian Chi Fung} and Hahn, {Jane Sungmin} and Berry Jude and {X Logan}, Mekeda and Alex Burrage and Fox, {Fiona E} and Simon Gilbody and Paul Lanham and Glyn Lewis and Jinshuo Li and MacNeill, {Stephanie J} and Irwin Nazareth and Steve Parrott and TJ Peters and Roz Shafran and Turner, {Katrina M} and Chris Williams and Kessler, {David S} and Wiles, {Nicola J}",

note = "Funding Information: This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol (grant number BRC-1215–20011). The NIHR Bristol Biomedical Research Centre funded the fMRI add on study. Funding Information: This report is independent research funded by the National Institute for Health and Care Research (Programme Grants for Applied Research, Integrated therapist and online CBT for depression in primary care, RP-PG-0514–20012). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR, the Department of Health or the Sponsor. The funder and Sponsor have no role in the study design, data collection, data analysis, interpretation of data, or manuscript writing. Dissemination of results will include the publication of a detailed report, written by the INTERACT study team and published by the NIHR. Funding Information: Supplementary funding was provided by the NIHR School for Primary Care Research (SPCR—2014–10043 Award: L).” Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

month = jun,

day = "20",

doi = "10.1186/s13063-023-07396-9",

language = "English",

volume = "24",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

}

Tallon, D , Thomas, LJ, Brabyn, S, Ching, BCF, Hahn, JS, Jude, B, X Logan, M, Burrage, A, Fox, FE, Gilbody, S, Lanham, P, Lewis, G, Li, J, MacNeill, SJ, Nazareth, I, Parrott, S, Peters, TJ, Shafran, R, Turner, KM, Williams, C, Kessler, DS & Wiles, NJ 2023, 'Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial', Trials, vol. 24, no. 1, 421. https://doi.org/10.1186/s13063-023-07396-9

TY - JOUR

T1 - Integrated therapist and online CBT for depression in primary care (INTERACT)

T2 - study protocol for a multi-centre randomised controlled trial

AU - Tallon, Debbie

AU - Thomas, Laura J

AU - Brabyn, Sally

AU - Ching, Brian Chi Fung

AU - Hahn, Jane Sungmin

AU - Jude, Berry

AU - X Logan, Mekeda

AU - Burrage, Alex

AU - Fox, Fiona E

AU - Gilbody, Simon

AU - Lanham, Paul

AU - Lewis, Glyn

AU - Li, Jinshuo

AU - MacNeill, Stephanie J

AU - Nazareth, Irwin

AU - Parrott, Steve

AU - Peters, TJ

AU - Shafran, Roz

AU - Turner, Katrina M

AU - Williams, Chris

AU - Kessler, David S

AU - Wiles, Nicola J

N1 - Funding Information: This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol (grant number BRC-1215–20011). The NIHR Bristol Biomedical Research Centre funded the fMRI add on study. Funding Information: This report is independent research funded by the National Institute for Health and Care Research (Programme Grants for Applied Research, Integrated therapist and online CBT for depression in primary care, RP-PG-0514–20012). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR, the Department of Health or the Sponsor. The funder and Sponsor have no role in the study design, data collection, data analysis, interpretation of data, or manuscript writing. Dissemination of results will include the publication of a detailed report, written by the INTERACT study team and published by the NIHR. Funding Information: Supplementary funding was provided by the NIHR School for Primary Care Research (SPCR—2014–10043 Award: L).” Publisher Copyright: © 2023, The Author(s).

PY - 2023/6/20

Y1 - 2023/6/20

N2 - Background:Cognitive Behavioural Therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at 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 minutes via videocall, with subsequent 50-minute 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-months post-randomisation. 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.

AB - Background:Cognitive Behavioural Therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at 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 minutes via videocall, with subsequent 50-minute 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-months post-randomisation. 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.

KW - depression

KW - randomised controlled trial

KW - cognitive behavioural therapy

KW - internet-based treatment

KW - blended treatment

KW - primary care

KW - integrated cognitive behavioural therapy

KW - acceptability

KW - qualitative research

U2 - 10.1186/s13063-023-07396-9

DO - 10.1186/s13063-023-07396-9

M3 - Article (Academic Journal)

C2 - 37340500

SN - 1745-6215

VL - 24

JO - Trials

JF - Trials

IS - 1

M1 - 421

ER -

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

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PGfAR: Stage2 BRTC Integrated therapist and online CBT for depression in primary care ("INTERACT")

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