- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01927042
Effectiveness of the ECHOs Approach for Patients With Eating Disorders and Their Carers (ECHO)
July 16, 2018 updated by: Aaron Keshen, Nova Scotia Health Authority
Effectiveness of the Expert Carers Helping Others (ECHOs) Approach for Patients With Eating Disorders and Their Carers
Family therapy is considered an empirically supported treatment approach for adolescents and adults with eating disorders.
One family based approach, Expert Carers Helping Others (ECHO) is based on evidence that suggests family environment, e.g., carer criticism, can influence an individual's eating disorder symptoms.
ECHO aims to improve carer coping, reduce expressed emotion and manage eating disorder symptoms, and has been associated with reduced carer distress, caregiver burden, and an increase in general well being.
The current pilot study seeks to evaluate a new condensed version of the ECHO intervention that is delivered entirely in a 2 ½ hour self-help DVD format (ECHOs).
Sixty patients and their carers will be recruited from the Capital Health Eating Disorders Service and randomized into either a treatment as usual group (TAU) or a TAU+ECHOs group.
Both carers and patients will be assessed along a variety of dimensions including psychiatric symptoms, family functioning, and carer and patient collaboration, at pre-intervention, four weeks later at post-intervention, and then three-months post-intervention.
ANOVAs will be used to compare the primary outcomes between the two groups over time.
This pilot study will be the first evaluation of ECHOs, which may ultimately boost the efficacy of current treatment for adults with eating disorders and reduce carer distress.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H2E2
- Capital Health District Health Authority
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with an ED (AN, BN, EDNOS) according to DSM-V criteria (American Psychiatric Association, 2013) as determined by standard clinical interview completed by team psychiatrist or clinical psychologist.
- Patients age of >17y.o.
- Carers can include parents/partners/siblings/extended family who provide unpaid help and support. Peers and roommates could also be included in circumstances within which they play a significant role in the person's life and meet the following criteria:
- Live with or have regular, current contact with the patient (at least 7 hours/week) throughout the duration of the trial (approximately 6months).
- Interact with the patient in some meaningful manner regarding their ED (e.g. provide support, eat meals together, discussions about behaviours).
- Consent from patient and at least one carer
Exclusion Criteria:
- ED comorbid with severe psychiatric or physical comorbidity: e.g. current psychotic illness (inc. bipolar disorder), severe alcohol/drug abuse, significant metabolic or gastrointestinal problems (i.e. treatment interfering) as determined by standard clinical interview completed by team psychiatrist or clinical psychologist.
- Family in a concurrent treatment trial.
- Either patient or carer has insufficient knowledge of English.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Expert Cares Helping Others plus Treatment as Usual
The experimental treatment (ECHOs plus TAU) will consist of the standard treatment consisting of group psychotherapy and skills training, nutritional counselling, and meal support, PLUS self-help unguided DVD series for carers, providing education about eating disorders and coping strategies for supporting those living with eating disorders.
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A self-help DVD that provides information for carers on eating disorders and teaches coping strategies to carers.
Other Names:
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Active Comparator: Treatment as Usual
Treatment as usual (TAU) consists of group psychotherapy and skills training, nutritional counselling, and meal support.
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Treatment as Usual at the Eating Disorder Services includes group psychotherapy and skills training, nutritional counselling, and meal support.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Carer and Patient Collaboration Scale (CPCS).
Time Frame: baseline, 4-weeks post-intervention, 3 months follow-up
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A scale to assess self efficacy in caregiving, specifically tailored to measure the skills taught in the ECHOs intervention.
This scale will assess changes from baseline to post-internvention in caregiver efficacy.
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baseline, 4-weeks post-intervention, 3 months follow-up
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Changes in Short Evaluation of Eating Disorders (SEED)
Time Frame: baseline, 4-weeks post-intervention, 3 months follow-up
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This measure will asssess changes in the severity of key anorexic and bulimic symptoms from baseline to post-treatment, and follow-up.
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baseline, 4-weeks post-intervention, 3 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression, Stress and Anxiety Scale (DASS-21)
Time Frame: baseline, 4-weeks post-intervention, 3 months follow-up
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a measure of severity of anxiety, depression and stress pre- to post-treatment
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baseline, 4-weeks post-intervention, 3 months follow-up
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The Family Questionnaire (FQ)
Time Frame: baseline, 4-weeks post-intervention, 3 months follow-up
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20-item self report measure of expressed emotion in carers.
Scores are given on a 4-point Likert scale and will measure the levels of expressed emotion from pre-intervention to post-intervention.
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baseline, 4-weeks post-intervention, 3 months follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2014
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
August 15, 2013
First Submitted That Met QC Criteria
August 21, 2013
First Posted (Estimate)
August 22, 2013
Study Record Updates
Last Update Posted (Actual)
July 17, 2018
Last Update Submitted That Met QC Criteria
July 16, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 59093005
- 59095003 (Other Identifier: Capital Health)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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