Improving Patient Outcome in Group Therapy for Eating Disorders (F-EAT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2014 by Psychotherapeutic Center Stolpegard.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Marianne Lau, MD, DSci.
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
Marianne Lau, MD, DSci., Psychotherapeutic Center Stolpegard
ClinicalTrials.gov Identifier:
NCT01693237
First received: August 28, 2012
Last updated: February 25, 2014
Last verified: February 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by Psychotherapeutic Center Stolpegard:
Primary Outcome Measures:
- Adherence [ Time Frame: At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks. ] [ Designated as safety issue: No ]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:
- 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. ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Self-Harm Inventory [ Time Frame: At end of treatment? Participants will be followed for the duration of treatment, an expected average of 20 weeks. ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 159 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693237
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693237
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
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 |
| Study First Received: | August 28, 2012 |
| Last Updated: | February 25, 2014 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Ethics Committee Denmark: Danish Health and Medicines Authority |
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 |
ClinicalTrials.gov processed this record on September 27, 2016