Improving Patient Outcome in Group Therapy for Eating Disorders

NCT ID: NCT01693237

Last Updated: 2014-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group psychotherapy

20 sessions of systemic and narrative group psychotherapy

Group Type ACTIVE_COMPARATOR

Group psychotherapy

Intervention Type OTHER

20 sessions of systemic and narrative group therapy

Group psychotherapy with feedback

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

Group Type EXPERIMENTAL

Group psychotherapy with feedback

Intervention Type OTHER

20 sessions of systemic and narrative group therapy

Interventions

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Group psychotherapy

20 sessions of systemic and narrative group therapy

Intervention Type OTHER

Group psychotherapy with feedback

20 sessions of systemic and narrative group therapy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Ministry of Science, Technology and Innovation, Denmark

OTHER_GOV

Sponsor Role collaborator

Marianne Lau, MD, DSci.

OTHER_GOV

Sponsor Role lead

Responsible Party

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Marianne Lau, MD, DSci.

Research Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marianne E. Lau, D.Sci.

Role: PRINCIPAL_INVESTIGATOR

Stolpegaard Psychotherapy Centre

Locations

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Stolpegaard Psychotherapy Centre

Gentofte Municipality, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 28333513 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24754974 (View on PubMed)

Related Links

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Other Identifiers

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10-084080

Identifier Type: -

Identifier Source: org_study_id

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