Improving Patient Outcome in Group Therapy for Eating Disorders

Binge Eating Disorder (BED) Clinical Trial

— F-EAT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01693237
• Other study ID #: 10-084080
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: August 28, 2012
• Last updated: February 25, 2014
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2014
• Source: Psychotherapeutic Center Stolpegard
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeDenmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 159
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge Eating Disorder (BED)
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Bulimia Nervosa (BN)
• Disease
• Eating Disorder Not Otherwise Specified (EDNOS)
• Eating Disorders

Intervention

Other:
• Group psychotherapy
20 sessions of systemic and narrative group therapy
• Group psychotherapy with feedback
20 sessions of systemic and narrative group therapy

Locations

Country	Name	City	State
Denmark	Stolpegaard Psychotherapy Centre	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
Marianne Lau, MD, DSci.	The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Harm Inventory		At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks.	Yes
Other	Outcome Rating Scale		At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.	No
Other	Symptom Check List-90R		At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.	No
Other	Sheehan Disability Scale		At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.	No
Other	WHO-Five Well-being Index		At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.	No
Primary	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.	At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.	No
Secondary	Eating Disorders Examination Interview		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.	No

External Links

•   University of Copenhagen, Department of Psychology