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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Aaron Keshen, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01927042
First received: August 15, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Eating Disorders
Behavioral: ECHOs plus TAU
Behavioral: Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the Expert Carers Helping Others (ECHOs) Approach for Patients With Eating Disorders and Their Carers

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Changes in Carer and Patient Collaboration Scale (CPCS). [ Time Frame: baseline, 4-weeks post-intervention, 3 months follow-up ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline, 4-weeks post-intervention, 3 months follow-up ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline, 4-weeks post-intervention, 3 months follow-up ] [ Designated as safety issue: No ]
    a measure of severity of anxiety, depression and stress pre- to post-treatment

  • The Family Questionnaire (FQ) [ Time Frame: baseline, 4-weeks post-intervention, 3 months follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: April 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: TAU

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927042

Locations
Canada, Nova Scotia
Capital Health District Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H2E2
Contact: Aaron Keshen, MD, FRCPC    473-2577    aaron.keshen@cdha.nshealth.ca   
Contact: Iryna V Ivanova, PhD    902-473-1560    iryna.ivanova@mail.utoronto.ca   
Principal Investigator: Aaron Keshen, MD, FRCPC         
Sub-Investigator: Iryna V Ivanova, PhD         
Sub-Investigator: Phil Masson, PhD         
Sub-Investigator: Joel Town, PhD         
Sub-Investigator: Yvette Scattolon, PhD         
Sub-Investigator: Cheryl Aubie, PhD         
Sponsors and Collaborators
Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: Aaron Keshen, Psychiatrist, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01927042     History of Changes
Other Study ID Numbers: 59093005, 59095003
Study First Received: August 15, 2013
Last Updated: June 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Capital District Health Authority, Canada:
Eating Disorders
Carers

Additional relevant MeSH terms:
Disease
Eating Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014