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

February 25, 2014 updated by: Marianne Lau, MD, DSci.

Feedback Versus no Feedback to Improve Patient Outcome in Group Psychotherapy for Eating Disorders: A Randomised Clinical Trial

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) increase adherence and 2) increase treatment outcome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 three 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 adherence and outcome in group psychotherapy. The hypothesis is that continuous feedback to patient and therapist on treatment progress and alliance will 1)increase adherence 2) increase treatment outcome.

Method: The trial is set up in a randomized design with 159 patients allocated to a) treatment with feedback intervention or b) treatment as usual.

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

Interventions: In the experimental group, two sets of feedback measures are added to the standard treatment: 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.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2820
        • Stolpegaard Psychotherapy Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 or older.
  • BMI of minimum 20.
  • Meet the diagnostic criteria for Bulimia Nervosa, Binge Eating Disorder or EDNOS according to DSM- IV.

Exclusion Criteria:

  • Acute suicidal risk.
  • Psychosis.
  • Severe depression.
  • Abuse of alcohol, medicine and/or narcotics up to 3 months before referral.
  • Use of cannabis once a month is accepted at intake but must stop during treatment.
  • Concomitant psychotherapeutic/ psychiatric treatment outside Stolpegaard Psychotherapy Centre.
  • Severe or non-regulated physical co-morbidity.
  • Pregnancy.
  • Unable to understand Danish.
  • Previous participation in the current trial.
  • Considered unable to attend treatment sessions as planned.
  • Lack of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.
Treatment adherence in the intervention period defined as a rate, i.e., number of attended therapy sessions divided by the number of planned therapy sessions. If a patient ends therapy prematurely, and this is in accordance with the therapists, the number of attended sessions will be set equal to the planned number of sessions.
At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Other Outcome Measures

Outcome Measure
Time Frame
Self-Harm Inventory
Time Frame: At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks.
At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks.
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.
At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.
Symptom Check List-90R
Time Frame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.
At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.
Sheehan Disability Scale
Time Frame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.
At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.
WHO-Five Well-being Index
Time Frame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.
At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marianne Lau, MD, DSci.

Collaborators

The Ministry of Science, Technology and Innovation, Denmark

Investigators

  • Principal Investigator: Marianne E. Lau, D.Sci., Stolpegaard Psychotherapy Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

September 25, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Estimate)

February 26, 2014

Last Update Submitted That Met QC Criteria

February 25, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-084080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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