Bulimia Nervosa (BN)Phase 2/3F-EATNCT01693237
Improving Patient Outcome in Group Therapy for Eating Disorders
A Phase 2/3 study testing Group psychotherapy and Group psychotherapy with feedback in people with Bulimia Nervosa (BN) and Binge Eating Disorder (BED), run by Marianne Lau, MD, DSci. at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bulimia Nervosa (BN), Binge Eating Disorder (BED), Eating Disorder Not Otherwise Specified (EDNOS)
- What is being tested?
- Group psychotherapy and Group psychotherapy with feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Dec 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or older.
- BMI of minimum 20.
- Meet the diagnostic criteria for Bulimia Nervosa, Binge Eating Disorder or EDNOS according to DSM- IV.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feedback Versus no Feedback to Improve Patient Outcome in Group Psychotherapy for Eating Disorders: A Randomised Clinical Trial
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.
Read the 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.
- Conditions
- Bulimia Nervosa (BN), Binge Eating Disorder (BED), Eating Disorder Not Otherwise Specified (EDNOS)
- Being tested
- Group psychotherapy, Group psychotherapy with feedback
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group psychotherapyOther
20 sessions of systemic and narrative group therapy
Group psychotherapy with feedbackOther
20 sessions of systemic and narrative group therapy
| Study group | Role | What they receive |
|---|---|---|
| Group psychotherapy | Active comparator | 20 sessions of systemic and narrative group psychotherapy Receives: Other: Group psychotherapy |
| Group psychotherapy with feedback | Experimental | 20 sessions of systemic and narrative group psychotherapy with session-to-session feedback to patient and therapist. Receives: Other: Group psychotherapy with feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
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.
Measured: At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.
Secondary outcomes (1)
Eating Disorders Examination Interview
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bulimia Nervosa (BN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marianne Lau, MD, DSci.
- Sponsor type
- Other government
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Responsible party
- Sponsor-investigator, Marianne Lau, MD, DSci., Psychotherapeutic Center Stolpegard
- Investigators
- Marianne E. Lau, D.Sci., Principal investigator, Stolpegaard Psychotherapy Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693237
- Sponsor's protocol ID
- 10-084080
- Acronym
- F-EAT
- Status last verified
- Feb 2014
- First submitted
- 28 Aug 2012
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28333513Davidsen 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.
PubMed 24754974
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedback Versus no Feedback to Improve Patient Outcome in Group Psychotherapy for Eating Disorders: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01693237
- Acronym / sponsor ID
- F-EAT / 10-084080
- Conditions
- Bulimia Nervosa (BN), Binge Eating Disorder (BED), Eating Disorder Not Otherwise Specified (EDNOS)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Marianne Lau, MD, DSci.Other government
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group psychotherapy | Active comparator | Other: Group psychotherapy20 sessions of systemic and narrative group psychotherapy |
| Group psychotherapy with feedback | Experimental | Other: Group psychotherapy with feedback20 sessions of systemic and narrative group psychotherapy with session-to-session feedback to patient and therapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 or older.
- BMI of minimum 20.
- Meet the diagnostic criteria for Bulimia Nervosa, Binge Eating Disorder or EDNOS according to DSM- IV.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group psychotherapy20 sessions of systemic and narrative group therapy | Other | Group psychotherapy |
| Group psychotherapy with feedback20 sessions of systemic and narrative group therapy | Other | Group psychotherapy with feedback |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
- Derived from this study: PubMed 28333513Davidsen 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.
- Derived from this study: PubMed 24754974Davidsen 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.
- Stolpegaard Psychotherapy CentreLink provided by the sponsor.
Related trials for Bulimia Nervosa (BN)
RecruitingPhase 1
MDMA Assisted Therapy for BN
Bulimia Nervosa
Active, not recruitingObservational study
AN/BN Risk Factors Study
Eating Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne E. Lau, D.Sci. principal investigator
Stolpegaard Psychotherapy Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Group psychotherapy and Group psychotherapy with feedback in people with Bulimia Nervosa (BN) and Binge Eating Disorder (BED), run by Marianne Lau, MD, DSci. at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01693237, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2014.