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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H2E2
        • Capital Health District Health Authority

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: ECHOs plus TAU
A self-help DVD that provides information for carers on eating disorders and teaches coping strategies to carers.
Other Names:
  • Expert Carers Helping Others plus Treatment as Usual
Active Comparator: Treatment as Usual
Treatment as usual (TAU) consists of group psychotherapy and skills training, nutritional counselling, and meal support.
Behavioral: Treatment as Usual
Treatment as Usual at the Eating Disorder Services includes group psychotherapy and skills training, nutritional counselling, and meal support.
Other Names:
  • TAU

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
baseline, 4-weeks post-intervention, 3 months follow-up
Changes in Short Evaluation of Eating Disorders (SEED)
Time Frame: baseline, 4-weeks post-intervention, 3 months follow-up
This measure will asssess changes in the severity of key anorexic and bulimic symptoms from baseline to post-treatment, and follow-up.
baseline, 4-weeks post-intervention, 3 months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression, Stress and Anxiety Scale (DASS-21)
Time Frame: baseline, 4-weeks post-intervention, 3 months follow-up
a measure of severity of anxiety, depression and stress pre- to post-treatment
baseline, 4-weeks post-intervention, 3 months follow-up
The Family Questionnaire (FQ)
Time Frame: baseline, 4-weeks post-intervention, 3 months follow-up
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.
baseline, 4-weeks post-intervention, 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nova Scotia Health Authority

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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