Clinical trial NCT01693237: Improving Patient Outcome in Group Therapy for Eating Disorders
Official title: Feedback Versus no Feedback to Improve Patient Outcome in Group Psychotherapy for Eating Disorders: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Bulimia Nervosa (BN)
Binge Eating Disorder (BED)
Eating Disorder Not Otherwise Specified (EDNOS)
Lead sponsor: Psychotherapeutic Center Stolpegard
Sponsor class: OTHER_GOV
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
First posted: 2012-09-26
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Adherence
timeFrame: 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
timeFrame: 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 outcomes:
measure: Self-Harm Inventory
timeFrame: At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks.
measure: Outcome Rating Scale
timeFrame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.
measure: Symptom Check List-90R
timeFrame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.
measure: Sheehan Disability Scale
timeFrame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.
measure: WHO-Five Well-being Index
timeFrame: At start of treatment and during treatment. Participants will be followed for the duration of treatment, an expected average of three years.
Locations:
city: Gentofte
country: Denmark
facility: Stolpegaard Psychotherapy Centre
Study officials:
affiliation: Stolpegaard Psychotherapy Centre
name: Marianne E. Lau, D.Sci.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.