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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	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

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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 Outcome Measures:

1. Self-Harm Inventory [ Time Frame: At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks. ]
2. 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. ]
3. 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. ]
4. 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. ]
5. 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. ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Additional Information:

University of Copenhagen, Department of Psychology 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Davidsen AH, Poulsen S, Lindschou J, Winkel P, Tróndarson 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.

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.

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
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