- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01927042
Effectiveness of the ECHOs Approach for Patients With Eating Disorders and Their Carers (ECHO)
16 juli 2018 uppdaterad av: Aaron Keshen, Nova Scotia Health Authority
Effectiveness of the Expert Carers Helping Others (ECHOs) Approach for Patients With Eating Disorders and Their Carers
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
58
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H2E2
- Capital Health District Health Authority
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
17 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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A self-help DVD that provides information for carers on eating disorders and teaches coping strategies to carers.
Andra namn:
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Aktiv komparator: Treatment as Usual
Treatment as usual (TAU) consists of group psychotherapy and skills training, nutritional counselling, and meal support.
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Treatment as Usual at the Eating Disorder Services includes group psychotherapy and skills training, nutritional counselling, and meal support.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in Carer and Patient Collaboration Scale (CPCS).
Tidsram: baseline, 4-weeks post-intervention, 3 months follow-up
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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.
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baseline, 4-weeks post-intervention, 3 months follow-up
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Changes in Short Evaluation of Eating Disorders (SEED)
Tidsram: baseline, 4-weeks post-intervention, 3 months follow-up
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This measure will asssess changes in the severity of key anorexic and bulimic symptoms from baseline to post-treatment, and follow-up.
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baseline, 4-weeks post-intervention, 3 months follow-up
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Depression, Stress and Anxiety Scale (DASS-21)
Tidsram: baseline, 4-weeks post-intervention, 3 months follow-up
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a measure of severity of anxiety, depression and stress pre- to post-treatment
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baseline, 4-weeks post-intervention, 3 months follow-up
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The Family Questionnaire (FQ)
Tidsram: baseline, 4-weeks post-intervention, 3 months follow-up
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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.
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baseline, 4-weeks post-intervention, 3 months follow-up
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2014
Primärt slutförande (Faktisk)
1 december 2017
Avslutad studie (Faktisk)
1 december 2017
Studieregistreringsdatum
Först inskickad
15 augusti 2013
Först inskickad som uppfyllde QC-kriterierna
21 augusti 2013
Första postat (Uppskatta)
22 augusti 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juli 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2018
Senast verifierad
1 juli 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 59093005
- 59095003 (Annan identifierare: Capital Health)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .