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

This study is ongoing, but not recruiting participants.
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: February 25, 2014
Last verified: February 2014
  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) increase adherence 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 no Feedback to Improve Patient Outcome in Group Psychotherapy for Eating Disorders: A Randomised Clinical Trial

Resource links provided by NLM:


Further study details as provided by Psychotherapeutic Center Stolpegard:

Primary Outcome Measures:
  • Adherence [ 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 ]
    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:
  • 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 ]

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 ]
  • 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 start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 159
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 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 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.

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided by Psychotherapeutic Center Stolpegard

Additional 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
Study First Received: August 28, 2012
Last Updated: February 25, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
Denmark: Danish Health and Medicines Authority

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

ClinicalTrials.gov processed this record on September 30, 2014