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Effectiveness of the ECHOs Approach for Patients With Eating Disorders and Their Carers (ECHO)

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ECHOs plus TAU
Treatment as Usual
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Eating Disorders, Carers

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Capital Health District Health Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Expert Cares Helping Others plus Treatment as Usual

Treatment as Usual

Arm Description

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.

Treatment as usual (TAU) consists of group psychotherapy and skills training, nutritional counselling, and meal support.

Outcomes

Primary Outcome Measures

Changes in Carer and Patient Collaboration Scale (CPCS).
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.
Changes in Short Evaluation of Eating Disorders (SEED)
This measure will asssess changes in the severity of key anorexic and bulimic symptoms from baseline to post-treatment, and follow-up.

Secondary Outcome Measures

Depression, Stress and Anxiety Scale (DASS-21)
a measure of severity of anxiety, depression and stress pre- to post-treatment
The Family Questionnaire (FQ)
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.

Full Information

First Posted
August 15, 2013
Last Updated
July 16, 2018
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01927042
Brief Title
Effectiveness of the ECHOs Approach for Patients With Eating Disorders and Their Carers
Acronym
ECHO
Official Title
Effectiveness of the Expert Carers Helping Others (ECHOs) Approach for Patients With Eating Disorders and Their Carers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Eating Disorders, Carers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expert Cares Helping Others plus Treatment as Usual
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as usual (TAU) consists of group psychotherapy and skills training, nutritional counselling, and meal support.
Intervention Type
Behavioral
Intervention Name(s)
ECHOs plus TAU
Other Intervention Name(s)
Expert Carers Helping Others plus Treatment as Usual
Intervention Description
A self-help DVD that provides information for carers on eating disorders and teaches coping strategies to carers.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
TAU
Intervention Description
Treatment as Usual at the Eating Disorder Services includes group psychotherapy and skills training, nutritional counselling, and meal support.
Primary Outcome Measure Information:
Title
Changes in Carer and Patient Collaboration Scale (CPCS).
Description
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.
Time Frame
baseline, 4-weeks post-intervention, 3 months follow-up
Title
Changes in Short Evaluation of Eating Disorders (SEED)
Description
This measure will asssess changes in the severity of key anorexic and bulimic symptoms from baseline to post-treatment, and follow-up.
Time Frame
baseline, 4-weeks post-intervention, 3 months follow-up
Secondary Outcome Measure Information:
Title
Depression, Stress and Anxiety Scale (DASS-21)
Description
a measure of severity of anxiety, depression and stress pre- to post-treatment
Time Frame
baseline, 4-weeks post-intervention, 3 months follow-up
Title
The Family Questionnaire (FQ)
Description
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.
Time Frame
baseline, 4-weeks post-intervention, 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Capital Health District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2E2
Country
Canada

12. IPD Sharing Statement

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Effectiveness of the ECHOs Approach for Patients With Eating Disorders and Their Carers

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