Effects of a hybrid digital cognitive-behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial

Talar Rita Moukhtarian; Krishane Patel; Carla Toro; Sean Russel; Guy Daly; Lukasz Walasek; Nicole K.Y. Tang; Caroline Meyer

doi:10.1136/bmjopen-2021-058062

Effects of a hybrid digital cognitive-behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial

Talar Rita Moukhtarian, Krishane Patel, Carla Toro, Sean Russel, Guy Daly, Lukasz Walasek, Nicole K.Y. Tang, Caroline Meyer

Research output: Contribution to journal › Article › peer-review

68 Downloads (Pure)

Abstract

INTRODUCTION: This trial tests the efficacy of implementing a hybrid digital cognitive-behavioural therapy for insomnia (dCBT-I) and emotion regulation (ER) in the workplace. The study protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) 2013 recommendations. METHODS AND ANALYSIS: This is a mixed methods evaluation with a two-arm randomised waitlist control design of a 6-week dCBT-I+ER intervention through self-guided online platform and four videoconferencing therapy sessions. A process evaluation will examine the fidelity of delivery and experiences of the intervention. The primary outcomes are the Insomnia Severity Index, the Patient Health Questionnaire-9 and the Generalised Anxiety Disorder-7. The secondary outcomes are job productivity, job satisfaction, well-being, quality of life, self-reported (sleep diary data) and objective (actigraphy) sleep parameters, and usage of online intervention platform. Assessments take place at baseline (T0), week 8 post-treatment (T1) and week 12 postrandomisation (T2). We will recruit 156 workers with sleep and ER problems ranging from subclinical to clinical levels not engaged in treatment at the time of the trial. ETHICS AND DISSEMINATION: Full approval was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20-21). The current protocol version is 2.9_Dec21. Publication of results will inform the scientific, clinical and business communities through peer-reviewed articles, webinars, conferences and newsletters. TRIAL REGISTRATION NUMBER: ISRCTN13596153.

Original language	English
Article number	e058062
Number of pages	12
Journal	BMJ Open
Volume	12
Issue number	7
DOIs	https://doi.org/10.1136/bmjopen-2021-058062
Publication status	Published - 15 Jul 2022

Bibliographical note

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Funder

This research is supported by Midlands Engine (R.ESWM.3932), UK as part of the Mental Health and Productivity Pilot programme (MHPP), which is collaborating across a range of diverse partners to provide an evidence-informed, cost-effective and sustainable resource that supports good mental health at work, reduces stigma and will ultimately increase productivity. The study funders had no role in the study design, collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication.

Keywords

Anxiety disorders
Depression & mood disorders

ASJC Scopus subject areas

Medicine(all)

Access to Document

10.1136/bmjopen-2021-058062Licence: CC BY-NC

PublishedFinal published version, 1 MBLicence: CC BY-NC

Cite this

@article{51bf7582d2e3467b91e1763a068b82d7,

title = "Effects of a hybrid digital cognitive-behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial",

abstract = "INTRODUCTION: This trial tests the efficacy of implementing a hybrid digital cognitive-behavioural therapy for insomnia (dCBT-I) and emotion regulation (ER) in the workplace. The study protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) 2013 recommendations. METHODS AND ANALYSIS: This is a mixed methods evaluation with a two-arm randomised waitlist control design of a 6-week dCBT-I+ER intervention through self-guided online platform and four videoconferencing therapy sessions. A process evaluation will examine the fidelity of delivery and experiences of the intervention. The primary outcomes are the Insomnia Severity Index, the Patient Health Questionnaire-9 and the Generalised Anxiety Disorder-7. The secondary outcomes are job productivity, job satisfaction, well-being, quality of life, self-reported (sleep diary data) and objective (actigraphy) sleep parameters, and usage of online intervention platform. Assessments take place at baseline (T0), week 8 post-treatment (T1) and week 12 postrandomisation (T2). We will recruit 156 workers with sleep and ER problems ranging from subclinical to clinical levels not engaged in treatment at the time of the trial. ETHICS AND DISSEMINATION: Full approval was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20-21). The current protocol version is 2.9_Dec21. Publication of results will inform the scientific, clinical and business communities through peer-reviewed articles, webinars, conferences and newsletters. TRIAL REGISTRATION NUMBER: ISRCTN13596153.",

keywords = "Anxiety disorders, Depression & mood disorders",

author = "Moukhtarian, {Talar Rita} and Krishane Patel and Carla Toro and Sean Russel and Guy Daly and Lukasz Walasek and Tang, {Nicole K.Y.} and Caroline Meyer",

note = "{\textcopyright} Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.",

year = "2022",

month = jul,

day = "15",

doi = "10.1136/bmjopen-2021-058062",

language = "English",

volume = "12",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "7",

}

TY - JOUR

T1 - Effects of a hybrid digital cognitive-behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP)

T2 - study protocol for a randomised waitlist control trial

AU - Moukhtarian, Talar Rita

AU - Patel, Krishane

AU - Toro, Carla

AU - Russel, Sean

AU - Daly, Guy

AU - Walasek, Lukasz

AU - Tang, Nicole K.Y.

AU - Meyer, Caroline

N1 - © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

PY - 2022/7/15

Y1 - 2022/7/15

N2 - INTRODUCTION: This trial tests the efficacy of implementing a hybrid digital cognitive-behavioural therapy for insomnia (dCBT-I) and emotion regulation (ER) in the workplace. The study protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) 2013 recommendations. METHODS AND ANALYSIS: This is a mixed methods evaluation with a two-arm randomised waitlist control design of a 6-week dCBT-I+ER intervention through self-guided online platform and four videoconferencing therapy sessions. A process evaluation will examine the fidelity of delivery and experiences of the intervention. The primary outcomes are the Insomnia Severity Index, the Patient Health Questionnaire-9 and the Generalised Anxiety Disorder-7. The secondary outcomes are job productivity, job satisfaction, well-being, quality of life, self-reported (sleep diary data) and objective (actigraphy) sleep parameters, and usage of online intervention platform. Assessments take place at baseline (T0), week 8 post-treatment (T1) and week 12 postrandomisation (T2). We will recruit 156 workers with sleep and ER problems ranging from subclinical to clinical levels not engaged in treatment at the time of the trial. ETHICS AND DISSEMINATION: Full approval was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20-21). The current protocol version is 2.9_Dec21. Publication of results will inform the scientific, clinical and business communities through peer-reviewed articles, webinars, conferences and newsletters. TRIAL REGISTRATION NUMBER: ISRCTN13596153.

AB - INTRODUCTION: This trial tests the efficacy of implementing a hybrid digital cognitive-behavioural therapy for insomnia (dCBT-I) and emotion regulation (ER) in the workplace. The study protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) 2013 recommendations. METHODS AND ANALYSIS: This is a mixed methods evaluation with a two-arm randomised waitlist control design of a 6-week dCBT-I+ER intervention through self-guided online platform and four videoconferencing therapy sessions. A process evaluation will examine the fidelity of delivery and experiences of the intervention. The primary outcomes are the Insomnia Severity Index, the Patient Health Questionnaire-9 and the Generalised Anxiety Disorder-7. The secondary outcomes are job productivity, job satisfaction, well-being, quality of life, self-reported (sleep diary data) and objective (actigraphy) sleep parameters, and usage of online intervention platform. Assessments take place at baseline (T0), week 8 post-treatment (T1) and week 12 postrandomisation (T2). We will recruit 156 workers with sleep and ER problems ranging from subclinical to clinical levels not engaged in treatment at the time of the trial. ETHICS AND DISSEMINATION: Full approval was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20-21). The current protocol version is 2.9_Dec21. Publication of results will inform the scientific, clinical and business communities through peer-reviewed articles, webinars, conferences and newsletters. TRIAL REGISTRATION NUMBER: ISRCTN13596153.

KW - Anxiety disorders

KW - Depression & mood disorders

UR - http://www.scopus.com/inward/record.url?scp=85134632327&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2021-058062

DO - 10.1136/bmjopen-2021-058062

M3 - Article

C2 - 35840305

AN - SCOPUS:85134632327

SN - 2044-6055

VL - 12

JO - BMJ Open

JF - BMJ Open

IS - 7

M1 - e058062

ER -

Effects of a hybrid digital cognitive-behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial

Abstract

Bibliographical note

Funder

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this