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

Primary Purpose

Bulimia Nervosa (BN), Binge Eating Disorder (BED), Eating Disorder Not Otherwise Specified (EDNOS)

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Group psychotherapy
Group psychotherapy with feedback
Sponsored by
Marianne Lau, MD, DSci.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa (BN)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stolpegaard Psychotherapy Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group psychotherapy

Group psychotherapy with feedback

Arm Description

20 sessions of systemic and narrative group psychotherapy

20 sessions of systemic and narrative group psychotherapy with session-to-session feedback to patient and therapist.

Outcomes

Primary Outcome Measures

Adherence
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

Full Information

First Posted
August 28, 2012
Last Updated
February 25, 2014
Sponsor
Marianne Lau, MD, DSci.
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01693237
Brief Title
Improving Patient Outcome in Group Therapy for Eating Disorders
Acronym
F-EAT
Official Title
Feedback Versus no Feedback to Improve Patient Outcome in Group Psychotherapy for Eating Disorders: A Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marianne Lau, MD, DSci.
Collaborators
The Ministry of Science, Technology and Innovation, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa (BN), Binge Eating Disorder (BED), Eating Disorder Not Otherwise Specified (EDNOS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group psychotherapy
Arm Type
Active Comparator
Arm Description
20 sessions of systemic and narrative group psychotherapy
Arm Title
Group psychotherapy with feedback
Arm Type
Experimental
Arm Description
20 sessions of systemic and narrative group psychotherapy with session-to-session feedback to patient and therapist.
Intervention Type
Other
Intervention Name(s)
Group psychotherapy
Intervention Description
20 sessions of systemic and narrative group therapy
Intervention Type
Other
Intervention Name(s)
Group psychotherapy with feedback
Intervention Description
20 sessions of systemic and narrative group therapy
Primary Outcome Measure Information:
Title
Adherence
Description
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.
Time Frame
At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Self-Harm Inventory
Time Frame
At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks.
Title
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.
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne E. Lau, D.Sci.
Organizational Affiliation
Stolpegaard Psychotherapy Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stolpegaard Psychotherapy Centre
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28333513
Citation
Davidsen AH, Poulsen S, Lindschou J, Winkel P, Trondarson MF, Waaddegaard M, Lau M. Feedback in group psychotherapy for eating disorders: A randomized clinical trial. J Consult Clin Psychol. 2017 May;85(5):484-494. doi: 10.1037/ccp0000173. Epub 2017 Mar 23.
Results Reference
derived
PubMed Identifier
24754974
Citation
Davidsen AH, Poulsen S, Waaddegaard M, Lindschou J, Lau M. Feedback versus no feedback in improving patient outcome in group psychotherapy for eating disorders (F-EAT): protocol for a randomized clinical trial. Trials. 2014 Apr 23;15:138. doi: 10.1186/1745-6215-15-138.
Results Reference
derived

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Improving Patient Outcome in Group Therapy for Eating Disorders

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