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

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ClinicalTrials.gov Identifier: NCT01693237
Recruitment Status : Unknown
Verified February 2014 by Marianne Lau, MD, DSci., Psychotherapeutic Center Stolpegard.
Recruitment status was:  Active, not recruiting
First Posted : September 26, 2012
Last Update Posted : February 26, 2014
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
Marianne Lau, MD, DSci., Psychotherapeutic Center Stolpegard

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment 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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feedback Versus no Feedback to Improve Patient Outcome in Group Psychotherapy for Eating Disorders: A Randomised Clinical Trial
Study Start Date : August 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]

Other Outcome Measures:
  1. Self-Harm Inventory [ Time Frame: At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693237


Locations
Denmark
Stolpegaard Psychotherapy Centre
Gentofte, Denmark, 2820
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
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Additional Information:
University of Copenhagen, Department of Psychology  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marianne Lau, MD, DSci., Research Manager, Psychotherapeutic Center Stolpegard
ClinicalTrials.gov Identifier: NCT01693237     History of Changes
Other Study ID Numbers: 10-084080
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014

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