A web-based intervention for carers of individuals with anorexia nervosa (We Can): Trial protocol of a randomised controlled trial investigating the effectiveness of different levels of support.
AESED, accommodation and enabling scale for eating disorders
AN, anorexia nervosa
AQoL-8D, assessment of quality of Life-8D
AUDIT, alcohol use disorders identification test
Anorexia nervosa
BDSEE, brief dyadic scale of expressed emotion
BFI-10, Big Five – 10 item version
BMI, body mass index
CASK, caregiver skills scale
CD-RISC-10, Connor–Davidson resilience scale-10
CEQ, adapted credibility/expectancy questionnaire
CSRI, client service receipt inventory
Carer support
DUDIT, drug use disorders identification test
E-treatment
ECI, experience of caregiving inventory
EDE-Q, eating disorder examination-questionnaire
EDSIS, eating disorders symptom impact scale
GAD-7, generalized anxiety disorder (GAD)-7 scale
ICare
Mental health
OAO, overcoming anorexia online
Online interventions
PHQ-9, patient health questionnaire 9-item depression scale
RCT, randomised controlled trial
RSE, rosenberg self-esteem scale
WAI-SR, adapted working alliance inventory – short revised
WHOQOL, World Health Organisation quality of life scale
We Can-Chat, We Can with moderated carer chatroom support
We Can-Forum, We Can with online forum support only
We Can-Ind, We Can with clinician email support
Journal
Internet interventions
ISSN: 2214-7829
Titre abrégé: Internet Interv
Pays: Netherlands
ID NLM: 101631612
Informations de publication
Date de publication:
Apr 2019
Apr 2019
Historique:
received:
27
12
2017
accepted:
17
02
2018
entrez:
19
2
2019
pubmed:
19
2
2019
medline:
19
2
2019
Statut:
epublish
Résumé
Anorexia nervosa (AN) is a life-threatening mental disorder that is associated with substantial caregiver burden. Carers of individuals with AN report high levels of distress and self-blame, and insufficient knowledge to help their loved ones. However, carers can have a very important role to play in aiding recovery from AN, and are often highly motivated to assist in the treatment process. This manuscript presents the protocol for a randomised controlled trial (RCT) of We Can, a web-based intervention for carers for people with AN. The study aims to investigate the effectiveness of We Can delivered with different intensities of support. The study takes the form of a multi-site, two-country, three group RCT, comparing We Can (a) with clinician messaging support (We Can-Ind), (b) with moderated carer chatroom support (We Can-Chat) and (c) with online forum only (We Can-Forum). Participants will be 303 carers of individuals with AN as well as, where possible, the individuals with AN themselves. Recruitment will be via specialist eating disorder services and carer support services in the UK and Germany. Randomisation of carers to one of the three intervention conditions in a 1:1:1 ratio will be stratified by whether or not the individual with AN has (a) agreed to participate in the study and (b) is a current inpatient. The We Can intervention will be provided to carers online over a period of 12 weeks. Participants will complete self-report questionnaires at pre-intervention (T1), mid-intervention (mediators only; 4-weeks post-randomisation), post-intervention (T2; 3-months post randomisation), and 6 months (T3) and 12 months (T4) after randomisation. The primary outcome variables are carer symptoms of depression and anxiety. Secondary outcome variables will be measured in both carers and individuals with AN. Secondary carer outcome variables will include alcohol and drug use and quality of life, caregiving behaviour, and the acceptability and use of We Can and associated supports. Secondary outcomes measured in individuals with AN will include eating disorder symptoms, and symptoms of depression and anxiety. The study will also evaluate the cost-effectiveness of the three We Can conditions, and test for mediators and moderators of the effects of We Can. The trial is registered at the International Standard Randomisation Controlled Trial Number (ISRCTN) database, registration number: ISRCTN11399850. The study will provide insight into the effectiveness of We Can and its optimal method/s of delivery.
Sections du résumé
BACKGROUND
BACKGROUND
Anorexia nervosa (AN) is a life-threatening mental disorder that is associated with substantial caregiver burden. Carers of individuals with AN report high levels of distress and self-blame, and insufficient knowledge to help their loved ones. However, carers can have a very important role to play in aiding recovery from AN, and are often highly motivated to assist in the treatment process. This manuscript presents the protocol for a randomised controlled trial (RCT) of We Can, a web-based intervention for carers for people with AN. The study aims to investigate the effectiveness of We Can delivered with different intensities of support.
METHODS
METHODS
The study takes the form of a multi-site, two-country, three group RCT, comparing We Can (a) with clinician messaging support (We Can-Ind), (b) with moderated carer chatroom support (We Can-Chat) and (c) with online forum only (We Can-Forum). Participants will be 303 carers of individuals with AN as well as, where possible, the individuals with AN themselves. Recruitment will be via specialist eating disorder services and carer support services in the UK and Germany. Randomisation of carers to one of the three intervention conditions in a 1:1:1 ratio will be stratified by whether or not the individual with AN has (a) agreed to participate in the study and (b) is a current inpatient. The We Can intervention will be provided to carers online over a period of 12 weeks. Participants will complete self-report questionnaires at pre-intervention (T1), mid-intervention (mediators only; 4-weeks post-randomisation), post-intervention (T2; 3-months post randomisation), and 6 months (T3) and 12 months (T4) after randomisation. The primary outcome variables are carer symptoms of depression and anxiety. Secondary outcome variables will be measured in both carers and individuals with AN. Secondary carer outcome variables will include alcohol and drug use and quality of life, caregiving behaviour, and the acceptability and use of We Can and associated supports. Secondary outcomes measured in individuals with AN will include eating disorder symptoms, and symptoms of depression and anxiety. The study will also evaluate the cost-effectiveness of the three We Can conditions, and test for mediators and moderators of the effects of We Can. The trial is registered at the International Standard Randomisation Controlled Trial Number (ISRCTN) database, registration number: ISRCTN11399850.
DISCUSSION
CONCLUSIONS
The study will provide insight into the effectiveness of We Can and its optimal method/s of delivery.
Identifiants
pubmed: 30775267
doi: 10.1016/j.invent.2018.02.005
pii: S2214-7829(17)30135-5
pmc: PMC6364327
doi:
Types de publication
Journal Article
Langues
eng
Pagination
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