Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: Study protocol

Rhys Bevan Jones; Sally Merry; Paul Stallard; Elizabeth Randell; Bryony Weavers; Anna Gray; Elaine Hindle; Marcela Gavigan; Samantha Clarkstone; Rhys Williams-Thomas; Vince Poile; Rebecca Playle; Jonathan I. Bisson; Rachel McNamara; Frances Rice; Sharon Anne Simpson

doi:10.1136/bmjopen-2022-070369

Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: Study protocol

Rhys Bevan Jones, Sally Merry, Paul Stallard, Elizabeth Randell, Bryony Weavers, Anna Gray, Elaine Hindle, Marcela Gavigan, Samantha Clarkstone, Rhys Williams-Thomas, Vince Poile, Rebecca Playle, Jonathan I. Bisson, Rachel McNamara, Frances Rice, Sharon Anne Simpson

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

Abstract

Introduction: A digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. This study aims to refine the programme based on user feedback, and to assess the acceptability and feasibility of the updated version and study methods.

Methods and analysis: Initially, this study will refine MoodHwb with the involvement of young people, including in a pretrial acceptability phase. This will be followed by a multicentre feasibility randomised controlled trial comparing MoodHwb plus usual care with a digital information pack plus usual care. Up to 120 young people aged 13-19 years with symptoms of depression and their parents/carers will be recruited through schools, mental health services, youth services, charities and voluntary self-referral in Wales and Scotland. The primary outcomes are the feasibility and acceptability of the MoodHwb programme (including usage, design and content) and of trial methods (including recruitment and retention rates), assessed 2 months postrandomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, well-being and depression and anxiety symptoms measured at 2 months postrandomisation.

Ethics and dissemination: The pretrial acceptability phase was approved by the Cardiff University School of Medicine Research Ethics Committee (REC) and the University of Glasgow College of Medicine, Veterinary and Life Sciences REC. The trial was approved by Wales NHS REC 3 (21/WA/0205), the Health Research Authority(HRA), Health and Care Research Wales (HCRW), university health board Research and Development (R&D) departments in Wales, and schools in Wales and Scotland. Findings will be disseminated in peer-reviewed open-access journals, at conferences and meetings, and online to academic, clinical, and educational audiences and the wider public. Trial registration number ISRCTN12437531.

Original language	English
Article number	e070369
Number of pages	10
Journal	BMJ Open
Volume	13
Issue number	6
DOIs	https://doi.org/10.1136/bmjopen-2022-070369
Publication status	Published - 5 Jun 2023

Bibliographical note

Funding Information:
This work was supported by a National Institute for Health Research (NIHR) and Health and Care Research Wales (HCRW) Post Doctoral Fellowship programme, grant number NIHR-PDF-2018, awarded to RBJ. SAS was supported by UK MRC and Scottish Chief Scientist Office core funding as part of the MRC/CSO Social and Public Health Sciences Unit ‘Complexity in Health Improvement’ programme (MC_UU_12017/14 and SPHSU14) and MC-PC_13027. SM was supported by Cure Kids, New Zealand. The work was also supported by the NCMH, WCYPMH (established with support from the Wolfson Foundation) and TRIUMPH network (ES/S004351/1).

Publisher Copyright:
© 2023 BMJ Publishing Group. All rights reserved.

Funding

This work was supported by a National Institute for Health Research (NIHR) and Health and Care Research Wales (HCRW) Post Doctoral Fellowship programme, grant number NIHR-PDF-2018, awarded to RBJ. SAS was supported by UK MRC and Scottish Chief Scientist Office core funding as part of the MRC/CSO Social and Public Health Sciences Unit ‘Complexity in Health Improvement’ programme (MC_UU_12017/14 and SPHSU14) and MC-PC_13027. SM was supported by Cure Kids, New Zealand. The work was also supported by the NCMH, WCYPMH (established with support from the Wolfson Foundation) and TRIUMPH network (ES/S004351/1).

Keywords

Child & adolescent psychiatry
Clinical trials
Depression & mood disorders
MENTAL HEALTH

ASJC Scopus subject areas

General Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1136/bmjopen-2022-070369Licence: CC BY

Cite this

Bevan Jones, R., Merry, S., Stallard, P., Randell, E., Weavers, B., Gray, A., Hindle, E., Gavigan, M., Clarkstone, S., Williams-Thomas, R., Poile, V., Playle, R., Bisson, J. I., McNamara, R., Rice, F., & Simpson, S. A. (2023). Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: Study protocol. BMJ Open, 13(6), Article e070369. https://doi.org/10.1136/bmjopen-2022-070369

Bevan Jones, R, Merry, S, Stallard, P, Randell, E, Weavers, B, Gray, A, Hindle, E, Gavigan, M, Clarkstone, S, Williams-Thomas, R, Poile, V, Playle, R, Bisson, JI, McNamara, R, Rice, F & Simpson, SA 2023, 'Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: Study protocol', BMJ Open, vol. 13, no. 6, e070369. https://doi.org/10.1136/bmjopen-2022-070369

@article{b1ee82065d7a41bb96f911ecad97cbf4,

title = "Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: Study protocol",

abstract = "Introduction: A digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. This study aims to refine the programme based on user feedback, and to assess the acceptability and feasibility of the updated version and study methods. Methods and analysis: Initially, this study will refine MoodHwb with the involvement of young people, including in a pretrial acceptability phase. This will be followed by a multicentre feasibility randomised controlled trial comparing MoodHwb plus usual care with a digital information pack plus usual care. Up to 120 young people aged 13-19 years with symptoms of depression and their parents/carers will be recruited through schools, mental health services, youth services, charities and voluntary self-referral in Wales and Scotland. The primary outcomes are the feasibility and acceptability of the MoodHwb programme (including usage, design and content) and of trial methods (including recruitment and retention rates), assessed 2 months postrandomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, well-being and depression and anxiety symptoms measured at 2 months postrandomisation. Ethics and dissemination: The pretrial acceptability phase was approved by the Cardiff University School of Medicine Research Ethics Committee (REC) and the University of Glasgow College of Medicine, Veterinary and Life Sciences REC. The trial was approved by Wales NHS REC 3 (21/WA/0205), the Health Research Authority(HRA), Health and Care Research Wales (HCRW), university health board Research and Development (R&D) departments in Wales, and schools in Wales and Scotland. Findings will be disseminated in peer-reviewed open-access journals, at conferences and meetings, and online to academic, clinical, and educational audiences and the wider public. Trial registration number ISRCTN12437531.",

keywords = "Child & adolescent psychiatry, Clinical trials, Depression & mood disorders, MENTAL HEALTH",

author = "{Bevan Jones}, Rhys and Sally Merry and Paul Stallard and Elizabeth Randell and Bryony Weavers and Anna Gray and Elaine Hindle and Marcela Gavigan and Samantha Clarkstone and Rhys Williams-Thomas and Vince Poile and Rebecca Playle and Bisson, {Jonathan I.} and Rachel McNamara and Frances Rice and Simpson, {Sharon Anne}",

note = "Funding Information: This work was supported by a National Institute for Health Research (NIHR) and Health and Care Research Wales (HCRW) Post Doctoral Fellowship programme, grant number NIHR-PDF-2018, awarded to RBJ. SAS was supported by UK MRC and Scottish Chief Scientist Office core funding as part of the MRC/CSO Social and Public Health Sciences Unit {\textquoteleft}Complexity in Health Improvement{\textquoteright} programme (MC_UU_12017/14 and SPHSU14) and MC-PC_13027. SM was supported by Cure Kids, New Zealand. The work was also supported by the NCMH, WCYPMH (established with support from the Wolfson Foundation) and TRIUMPH network (ES/S004351/1). Publisher Copyright: {\textcopyright} 2023 BMJ Publishing Group. All rights reserved.",

year = "2023",

month = jun,

day = "5",

doi = "10.1136/bmjopen-2022-070369",

language = "English",

volume = "13",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "6",

}

TY - JOUR

T1 - Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb

T2 - Study protocol

AU - Bevan Jones, Rhys

AU - Merry, Sally

AU - Stallard, Paul

AU - Randell, Elizabeth

AU - Weavers, Bryony

AU - Gray, Anna

AU - Hindle, Elaine

AU - Gavigan, Marcela

AU - Clarkstone, Samantha

AU - Williams-Thomas, Rhys

AU - Poile, Vince

AU - Playle, Rebecca

AU - Bisson, Jonathan I.

AU - McNamara, Rachel

AU - Rice, Frances

AU - Simpson, Sharon Anne

N1 - Funding Information: This work was supported by a National Institute for Health Research (NIHR) and Health and Care Research Wales (HCRW) Post Doctoral Fellowship programme, grant number NIHR-PDF-2018, awarded to RBJ. SAS was supported by UK MRC and Scottish Chief Scientist Office core funding as part of the MRC/CSO Social and Public Health Sciences Unit ‘Complexity in Health Improvement’ programme (MC_UU_12017/14 and SPHSU14) and MC-PC_13027. SM was supported by Cure Kids, New Zealand. The work was also supported by the NCMH, WCYPMH (established with support from the Wolfson Foundation) and TRIUMPH network (ES/S004351/1). Publisher Copyright: © 2023 BMJ Publishing Group. All rights reserved.

PY - 2023/6/5

Y1 - 2023/6/5

N2 - Introduction: A digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. This study aims to refine the programme based on user feedback, and to assess the acceptability and feasibility of the updated version and study methods. Methods and analysis: Initially, this study will refine MoodHwb with the involvement of young people, including in a pretrial acceptability phase. This will be followed by a multicentre feasibility randomised controlled trial comparing MoodHwb plus usual care with a digital information pack plus usual care. Up to 120 young people aged 13-19 years with symptoms of depression and their parents/carers will be recruited through schools, mental health services, youth services, charities and voluntary self-referral in Wales and Scotland. The primary outcomes are the feasibility and acceptability of the MoodHwb programme (including usage, design and content) and of trial methods (including recruitment and retention rates), assessed 2 months postrandomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, well-being and depression and anxiety symptoms measured at 2 months postrandomisation. Ethics and dissemination: The pretrial acceptability phase was approved by the Cardiff University School of Medicine Research Ethics Committee (REC) and the University of Glasgow College of Medicine, Veterinary and Life Sciences REC. The trial was approved by Wales NHS REC 3 (21/WA/0205), the Health Research Authority(HRA), Health and Care Research Wales (HCRW), university health board Research and Development (R&D) departments in Wales, and schools in Wales and Scotland. Findings will be disseminated in peer-reviewed open-access journals, at conferences and meetings, and online to academic, clinical, and educational audiences and the wider public. Trial registration number ISRCTN12437531.

AB - Introduction: A digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. This study aims to refine the programme based on user feedback, and to assess the acceptability and feasibility of the updated version and study methods. Methods and analysis: Initially, this study will refine MoodHwb with the involvement of young people, including in a pretrial acceptability phase. This will be followed by a multicentre feasibility randomised controlled trial comparing MoodHwb plus usual care with a digital information pack plus usual care. Up to 120 young people aged 13-19 years with symptoms of depression and their parents/carers will be recruited through schools, mental health services, youth services, charities and voluntary self-referral in Wales and Scotland. The primary outcomes are the feasibility and acceptability of the MoodHwb programme (including usage, design and content) and of trial methods (including recruitment and retention rates), assessed 2 months postrandomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, well-being and depression and anxiety symptoms measured at 2 months postrandomisation. Ethics and dissemination: The pretrial acceptability phase was approved by the Cardiff University School of Medicine Research Ethics Committee (REC) and the University of Glasgow College of Medicine, Veterinary and Life Sciences REC. The trial was approved by Wales NHS REC 3 (21/WA/0205), the Health Research Authority(HRA), Health and Care Research Wales (HCRW), university health board Research and Development (R&D) departments in Wales, and schools in Wales and Scotland. Findings will be disseminated in peer-reviewed open-access journals, at conferences and meetings, and online to academic, clinical, and educational audiences and the wider public. Trial registration number ISRCTN12437531.

KW - Child & adolescent psychiatry

KW - Clinical trials

KW - Depression & mood disorders

KW - MENTAL HEALTH

UR - http://www.scopus.com/inward/record.url?scp=85160972865&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2022-070369

DO - 10.1136/bmjopen-2022-070369

M3 - Article

C2 - 37277220

AN - SCOPUS:85160972865

SN - 2044-6055

VL - 13

JO - BMJ Open

JF - BMJ Open

IS - 6

M1 - e070369

ER -

Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: Study protocol

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this