Adaptation and implementation of an intervention programme on Spanish carers and adolescent patients with an eating disorder
| ISRCTN | ISRCTN43554732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43554732 |
| Secondary identifying numbers | ID:2020/49555 |
- Submission date
- 23/04/2021
- Registration date
- 18/05/2021
- Last edited
- 21/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
One of the major problems with inpatient treatment of adolescent girls with an eating disorder (ED) is that the guidelines learned during their hospital stay are not easily applied or maintained in their daily lives, and this has been related to high rates of relapse and readmission. Interventions that may optimise the outcome during and following inpatient or day-patient treatment are needed, and to this end, the ECHOMANTRA programme has been developed.
The aim of this study is to evaluate the effectiveness of an adaptation of a novel intervention for eating disorder patients and their carers (ECHOMANTRA) as an add-on to treatment-as-usual.
Who can participate?
Adolescent patients diagnosed with an eating disorder receiving treatment in a specialist inpatient/day-patient eating disorder unit and their carers.
What does the study involve?
Participants will be randomly allocated to the control or experimental group. In the experimental group, the adaptation of the ECHOMANTRA programme will be implemented. This programme involves a skills-sharing intervention for patients with eating disorders and their carers to facilitate the transition from hospital/daycare center back into the community. Participants allocated to the control group will follow the treatment provided in the hospital/day center where they are treated (treatment as usual).
What are the possible benefits and risks of participating?
There will be no risk. There should be benefits in the transition of these patients from inpatient to daily life, and positive cognitive and behaviour changes and strengthened relationships with their family and social groups.
Where is the study run from?
The study has been set up by the Universities of Miguel Hernandez (Elche) in collaboration with the Eating Disorders Unit of the San Juan of Alicante Hospital, CREA, and ADANER (Spain)
When is the study starting and how long is it expected to run for?
February 2020 to November 2022
Who is funding the study?
Alicia Koplowitz Foundation (Spain)
Who is the main contact?
Dr Yolanda Quiles Marcos
y.quiles@umh.es
Contact information
Public
Behavioral Sciences and Health Department
University Miguel Hernández
Avda. de la Universidad s/n
Elche
03202
Spain
 ORCID ID |
0000-0003-0966-7058 |
|---|---|
| Phone | +34 630 10 00 21 |
| y.quiles@umh.es |
Study information
| Study design | Multicentre pilot randomized controlled blind superiority study with two parallel groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Adaptation and implementation of an intervention programme on Spanish carers and adolescent patients with an eating disorder: a randomised controlled trial |
| Study hypothesis | The aim of this study is to evaluate the efficacy of an adaptation of a novel intervention for eating disorders patients and their carers as an add-on to treatment-as-usual. Hypothesis: 1. Patients from the experimental group (Treatment As Usual + ECHOMANTRA) will show significantly greater improvements in health outcomes (body mass index, symptoms, emotional state, psychosocial adjustment, perfectionism, motivation to change), and other efficacy indicators (rate of treatment dropout and readmission) in comparison to patients from the control group. 2. The efficacy of the combined intervention (TAU+ ECHOMANTRA) will be stable in the short (6 months) and middle term (9 months). 3. Family members from the experimental group will present a better emotional state and lower symptom accommodation, expressed emotion, and symptom impact in comparison to family members from the control group. 4. Family members from the experimental group will have more ED carer skills in comparison to family members from the control group. |
| Ethics approval(s) | Approved 17/11/2020, Ethics Committee of the University Miguel Hernandez (Comité De Ética E Integridad en La Investigación, Vicerrectorado De Investigación, Universidad Miguel Hernández De Elche, Avda. de la Universidad s/n, C. P. 03202 Elche (Alicante), Spain; +34 (0)965222687; oir@umh.es), ref: 2020/49555 |
| Condition | Eating disorders |
| Intervention | Patients will be recruited from three different specialist inpatient/day-patient eating disorder units. This study will involve adolescent girls who have received an eating disorder diagnosis according to DSM-5 criteria. Patients will be asked to nominate a carer and the researcher will invite that carer to participate in the trial. After screening and consent, patients and their carers will be randomised as a dyad using a randomised computer-generated sequence. Eating disorder patients and their carers will be randomised to receive either the ECHOMANTRA intervention as an add-on to treatment-as-usual (TAU) or TAU alone. In the experimental group, the adaptation of the Echomantra programme, developed by Professor Janet Treasure and her research team (Cardi et al., 2017), will be implemented. This programme involves a skills-sharing intervention for patients with eating disorders and their carers to facilitate the transition from hospital/day care centre back into the community. The ECHOMANTRA-guided skills-sharing intervention includes materials and eight online sessions (one per week) for carers and patients. Participants assigned to the control group will follow the treatment as usual (TAU) provided in the hospital center where they are receiving their treatment. A repeated measures analysis will be conducted at 3, 6, and 9 months following randomisation. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Psychological well-being measured using Depression, Anxiety and Stress Scale (DASS-21) at baseline, 3, 6, and 9 months 2. Eating disorders symptoms measured using Eating Disorder Examination Questionnaire (EDE-Q) at baseline, 3, 6, and 9 months |
| Secondary outcome measures | 1. Body mass index measured using weight and height at baseline, 3, 6, and 9 months 2. Obsessive-compulsive symptoms measured using Obsessive-Compulsive Inventory-Revised (OCI-R) at baseline, 3, 6, and 9 months 3. Perfectionism measured using Child and Adolescent Perfectionism Scale (CAPS) at baseline, 3, 6, and 9 months 4. Motivation to change measured using a Visual analogue scale that assesses confidence and importance in changing symptoms of ED at baseline, 3, 6, and 9 months 5. Psychosocial adjustment measured using Eating Disorders Quality of Life (EDQL) at baseline, 3, 6, and 9 months 6. Number of days in hospital or day centre measured using a register at baseline, 3, 6, and 9 months |
| Overall study start date | 01/02/2020 |
| Overall study end date | 01/11/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target number of participants | 80 |
| Participant inclusion criteria | 1. Adolescent girls who have received an eating disorder diagnosis according to DSM-5 criteria (American Psychiatric Association, 2013), including diagnoses of anorexia nervosa, bulimia nervosa, and other specified or unspecified eating disorders 2. Age between 12 and 19 years 3. No psychiatric comorbidity 4. Receiving treatment for ED in a specialist inpatient/day-patient ED unit 5. A family member willing to participate in the study 6. Ability to manage an electronic device (e.g. mobile phone, computer, laptop, tablet) and the Internet in order to access the online sessions |
| Participant exclusion criteria | 1. Suffer from a severe mental or physical illness that needs priority treatment (for example psychosis, acute suicidality, substance abuse) |
| Recruitment start date | 01/02/2021 |
| Recruitment end date | 01/09/2022 |
Locations
Countries of recruitment
- Spain
Study participating centre
Avda. de la Universidad s/n
Alicante
03202
Spain
Sponsor information
Charity
C/Paseo de Eduardo dato,18
Madrid
28010
Spain
| Phone | +34 917027992 |
|---|---|
| mgarcia@fundacionaliciakoplowitz.org | |
| Website | https://www.fundacionaliciakoplowitz.org/ |
"ROR" |
https://ror.org/036jhs482 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Alicia Koplowitz Foundation
- Location
- Spain
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The study protocol will be available. The study protocol has been submitted to a journal, and is currently under review. It has not yet been published. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to participants of this research having given their consent for their data to be used only for the purposes of this research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 22/10/2021 | 21/12/2021 | Yes | No | |
| Results article | 15/05/2024 | 25/06/2024 | Yes | No |
Editorial Notes
21/12/2021: Publication reference added.
30/04/2021: Trial's existence confirmed by the Ethics Committee of the University Hospital of San Juan.
