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.
Internet Interv
; 16: 76-85, 2019 Apr.
Article
em En
| MEDLINE
| ID: mdl-30775267
ABSTRACT
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:
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 111 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 12â¯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 6â¯months (T3) and 12â¯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:
The study will provide insight into the effectiveness of We Can and its optimal method/s of delivery.
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, ConnorDavidson 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
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Guideline
/
Prognostic_studies
Idioma:
En
Revista:
Internet Interv
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Reino Unido