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Improving Patient Outcome in Group Therapy for Eating Disorders (F-EAT)

This study is currently recruiting participants.
Verified November 2012 by Psychotherapeutic Center Stolpegard
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
Marianne Lau, MD, DSci., Psychotherapeutic Center Stolpegard
ClinicalTrials.gov Identifier:
NCT01693237
First received: August 28, 2012
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

The current trial aims to investigate the impact of continuous feedback on dropout and outcome in group therapy. The hypothesis is that continuous feedback to patient and therapist on treatment progress and alliance will 1) reduce the number of dropouts and 2) increase treatment outcome.


Condition Intervention Phase
Bulimia Nervosa (BN)
Binge Eating Disorder (BED)
Eating Disorder Not Otherwise Specified (EDNOS)
 Other: Group psychotherapy
Other: Group psychotherapy with feedback
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feedback Versus Non-feedback to Improve Patient Outcome in Group Psychotherapy for Eating Disorders: A Randomised Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources

Further study details as provided by Psychotherapeutic Center Stolpegard:

Primary Outcome Measures:
  • Dropout [ Time Frame: At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Eating Disorders Examination Interview [ Time Frame: At intake, end of treatment and follow-up. Participants will be followed for the duration of treatment and follow-up, an expected average of 3 years. ] [ Designated as safety issue: No ]
  • Outcome Rating Scale [ Time Frame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks. ] [ Designated as safety issue: No ]
  • Symptom Check List-90R [ Time Frame: At intake, end of treatment and follow-up. Participants will be followed for the duration of treatment and follow-up, an expected average of three years. ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: At intake, end of treatment and follow-up. Participants will be followed for the duration of treatment, an expected average of three years. ] [ Designated as safety issue: No ]
  • WHO-Five Well-being Index [ Time Frame: At intake, end of treatment and follow-up. Participants will be followed for the duration of treatment and follow-up, an expected average of three years. ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning [ Time Frame: At intake, end of treatment and follow-up. Participants will be followed for the duration of treatment, an expected average of three years. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Self-Harm Inventory [ Time Frame: At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 196
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group psychotherapy
20 sessions of systemic and narrative group psychotherapy
 Other: Group psychotherapy
20 sessions of systemic and narrative group therapy
Experimental: Group psychotherapy with feedback
20 sessions of systemic and narrative group psychotherapy with session-to-session feedback to patient and therapist.
 Other: Group psychotherapy with feedback
20 sessions of systemic and narrative group therapy

Detailed Description:

Background: In the psychotherapy of eating disorders, a dropout rate between 30% and 50% is reported internationally. The fact that up to half of the patients drop out of treatment calls for ways to improve it. Research shows that feedback to patient and therapist increases outcome and reduces the number of dropouts; however there is only two published works on the effect of feedback in eating disorders treatment. Therefore, the present trial, at the eating disorders unit at Stolpegaard Psychotherapy Centre, Gentofte, Denmark, may contribute to necessary improvements in the field.

Objective: The current trial, which will be conducted from August 2012 to August 2014, aims to investigate the impact of continuous feedback on outcome and dropout in group therapy. The hypothesis is that continuous feedback to patient and therapist on treatment progress and alliance will 1)reduce the number of dropouts 2) increase treatment outcome.

Method: The trial is set up in a randomized design with 196 patients allocated to a) treatment with feedback intervention or b) treatment as usual.

Participants: The participants are diagnosed with Bulimia Nervosa or Eating Disorder Not Otherwise Specified.

Interventions: In the experimental group, two sets of feedback measures are added to the TAU: Outcome Rating Scale (ORS) and Group Session Rating Scale (GSRS). The ORS assesses areas of life functioning known to change as a result of therapeutic intervention. The GSRS assesses key dimensions of effective therapeutic relationships.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 or older.
  • BMI 20-40
  • Meet the diagnostic criteria for Bulimia Nervosa or EDNOS according to DSM- IV.

Exclusion Criteria:

  • Severe or non-regulated physical comorbidity
  • Pregnancy
  • Unable to understand Danish
  • Previous participation in the current trial
  • Considered unable to attend treatment sessions as planned
  • Lack of informed consent
  • Acute suicidal risk
  • Psychosis
  • Severe depression
  • Abuse of alcohol, medicine and/or narcotics up to 6 months before referral.
  • Concomitant psychotherapeutic/psychiatric treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693237

Contacts
Contact: Marianne E Lau, D.Sci. +4538645311 marianne.engelbrecht.lau@regionh.dk
Contact: Annika H Davidsen, MSc. Psych. +4538645300 annika.helgadottir.davidsen@regionh.dk

Locations
Denmark
Stolpegaard Psychotherapy Centre Recruiting
Gentofte, Denmark, 2820
Contact: Marianne Lau, dr.med.     +45 68 64 53 00     marianne.engelbrecht.lau@regionh.dk    
Principal Investigator: Marianne Lau, MD            
Sub-Investigator: Annika H Davidsen, MSc. Psych.            
Sponsors and Collaborators
Marianne Lau, MD, DSci.
The Ministry of Science, Technology and Innovation, Denmark
Investigators
Principal Investigator: Marianne E. Lau, D.Sci. Stolpegaard Psychotherapy Centre
  More Information

No publications provided

Responsible Party: Marianne Lau, MD, DSci., Research Manager, Psychotherapeutic Center Stolpegard
ClinicalTrials.gov Identifier: NCT01693237     History of Changes
Other Study ID Numbers: 10-084080
Study First Received: August 28, 2012
Last Updated: November 13, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
Denmark: Danish Health and Medicines Authority

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Bulimia Nervosa
 Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013