Overview

This trial is active, not recruiting.

Conditions bulimia nervosa (bn), binge eating disorder (bed), eating disorder not otherwise specified (ednos)
Treatments group psychotherapy, group psychotherapy with feedback
Phase phase 2/phase 3
Sponsor Marianne Lau, MD, DSci.
Collaborator The Ministry of Science, Technology and Innovation, Denmark
Start date August 2012
End date August 2014
Trial size 159 participants
Trial identifier NCT01693237, 10-084080

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
20 sessions of systemic and narrative group psychotherapy
group psychotherapy
20 sessions of systemic and narrative group therapy
(Experimental)
20 sessions of systemic and narrative group psychotherapy with session-to-session feedback to patient and therapist.
group psychotherapy with feedback
20 sessions of systemic and narrative group therapy

Primary Outcomes

Measure
Adherence
time frame: At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Feedback Versus no Feedback to Improve Patient Outcome in Group Psychotherapy for Eating Disorders: A Randomised Clinical Trial
Principal investigator Marianne E. Lau, D.Sci.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Psychotherapeutic Center Stolpegard.