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

Sponsor
Nova Scotia Health Authority (Other)
Overall Status
Completed
CT.gov ID
NCT01927042
Collaborator
(none)
58
1
2
44
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ECHOs plus TAU
  • Behavioral: Treatment as Usual
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of the Expert Carers Helping Others (ECHOs) Approach for Patients With Eating Disorders and Their Carers
Actual Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

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.

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
  • Outcome Measures

    Primary Outcome Measures

    1. Changes in Carer and Patient Collaboration Scale (CPCS). [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.

    2. Changes in Short Evaluation of Eating Disorders (SEED) [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.

    Secondary Outcome Measures

    1. Depression, Stress and Anxiety Scale (DASS-21) [baseline, 4-weeks post-intervention, 3 months follow-up]

      a measure of severity of anxiety, depression and stress pre- to post-treatment

    2. The Family Questionnaire (FQ) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Capital Health District Health Authority Halifax Nova Scotia Canada B3H2E2

    Sponsors and Collaborators

    • Nova Scotia Health Authority

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aaron Keshen, Psychiatrist, Nova Scotia Health Authority
    ClinicalTrials.gov Identifier:
    NCT01927042
    Other Study ID Numbers:
    • 59093005
    • 59095003
    First Posted:
    Aug 22, 2013
    Last Update Posted:
    Jul 17, 2018
    Last Verified:
    Jul 1, 2018
    Keywords provided by Aaron Keshen, Psychiatrist, Nova Scotia Health Authority
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 17, 2018