NCT01927042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

3.7 years

First QC Date

August 15, 2013

Last Update Submit

July 16, 2018

Conditions

Keywords

Eating DisordersCarers

Outcome Measures

Primary Outcomes (2)

  • 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.

    baseline, 4-weeks post-intervention, 3 months follow-up

  • 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.

    baseline, 4-weeks post-intervention, 3 months follow-up

Secondary Outcomes (2)

  • Depression, Stress and Anxiety Scale (DASS-21)

    baseline, 4-weeks post-intervention, 3 months follow-up

  • The Family Questionnaire (FQ)

    baseline, 4-weeks post-intervention, 3 months follow-up

Study Arms (2)

Expert Cares Helping Others plus Treatment as Usual

EXPERIMENTAL

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

Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Treatment as Usual

Interventions

ECHOs plus TAUBEHAVIORAL

A self-help DVD that provides information for carers on eating disorders and teaches coping strategies to carers.

Also known as: Expert Carers Helping Others plus Treatment as Usual
Expert Cares Helping Others plus Treatment as Usual

Treatment as Usual at the Eating Disorder Services includes group psychotherapy and skills training, nutritional counselling, and meal support.

Also known as: TAU
Treatment as Usual

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Health District Health Authority

Halifax, Nova Scotia, B3H2E2, Canada

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist

Study Record Dates

First Submitted

August 15, 2013

First Posted

August 22, 2013

Study Start

April 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations