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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01927042
Other study ID # 59093005
Secondary ID 59095003
Status Completed
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date December 2017

Study information

Verified date July 2018
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 17 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
ECHOs plus TAU
A self-help DVD that provides information for carers on eating disorders and teaches coping strategies to carers.
Treatment as Usual
Treatment as Usual at the Eating Disorder Services includes group psychotherapy and skills training, nutritional counselling, and meal support.

Locations

Country Name City State
Canada Capital Health District Health Authority Halifax Nova Scotia

Sponsors (1)

Lead Sponsor Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Depression, Stress and Anxiety Scale (DASS-21) a measure of severity of anxiety, depression and stress pre- to post-treatment baseline, 4-weeks post-intervention, 3 months follow-up
Secondary 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. baseline, 4-weeks post-intervention, 3 months follow-up
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