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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Group psychotherapy
20 sessions of systemic and narrative group psychotherapy
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Other: Group psychotherapy
20 sessions of systemic and narrative group therapy
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Experimental: Group psychotherapy with feedback
20 sessions of systemic and narrative group psychotherapy with session-to-session feedback to patient and therapist.
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Other: Group psychotherapy with feedback
20 sessions of systemic and narrative group therapy
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- 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.
- 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. ]
- Self-Harm Inventory [ Time Frame: At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Denmark | |
Stolpegaard Psychotherapy Centre | |
Gentofte, Denmark, 2820 |
Principal Investigator: | Marianne E. Lau, D.Sci. | Stolpegaard Psychotherapy Centre |
Additional Information:
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 |