Plain English Summary
Background and study aims?
The purpose of the study is to compare two different psychological treatments for the eating disorder Bulimia Nervosa. The aim is to find out which of the two treatments are most helpful to persons with Bulimia Nervosa. In Denmark, eating disorders have traditionally been treated with psychotherapy. More recently, another treatment method known as cognitive behavior therapy has become increasingly used in the treatment of eating disorders. Cognitive behavior therapy is a focused, symptom-oriented treatment method lasting 20 weeks with sessions twice a week for the first three weeks and bi-weekly for the last three weeks. Several studies have demonstrated that cognitive behavior therapy has a beneficial impact on Bulimia Nervosa. Psychotherapy, which comprises weekly sessions over two years, is oriented toward more fundamental aspects of the personality and focuses less directly on the bulimic symptoms. This is considered a promising treatment, however, it has not been researched thoroughly with regard to Bulimia Nervosa. Thus, it is not possible to tell in advance, which of the two methods are the most efficient.
Who can participate?
All in all, 70 persons will participate. To participate you must be diagnosed with Bulimia Nervosa. Furthermore, participants must be available for the whole two-year treatment period. Although it is possible to participate in the study while in psychopharmacological treatment, the study does not apply for persons with serious psychiatric disorders such as for instance severe depression.
What does the study involve?
In addition to participation in the psychotherapeutic treatment, the study involves a number of assessment interviews before beginning treatment as well as 6 and 24 months after beginning treatment. Additionally, participants will be asked to fill out a number of questionnaires every six months for the first three and a half years after beginning treatment and again five years after beginning treatment.
What are the possible benefits and risks of participating?
The benefits of the study are a reduction or end to bulimic symptoms. There are no known negative side effects related to the treatments.
Where is the study run from?
All assessment interviews will be undertaken at the University Clinic, Department of Psychology, University of Copenhagen. Some of the psychotherapeutic treatments will take place at the University Clinic whereas others will take place with psychologists and psychiatrists in private practice in central Copenhagen.
When is the study starting and how long is it expected to run for?
The study begins in November 2004 and will continue to recruit participants until May 2008. Accordingly, we expect the final data of the study to be collected in May 2013.
Who is funding the study?
Danish Research Council for the Humanities and the Egmont Foundation
Who is the main contact?
Heidi Riiber
bulimi@psy.ku.dk
http://psychology.ku.dk/research/bulimia/
Trial website
Contact information
Type
Scientific
Primary contact
Prof Stig Poulsen
ORCID ID
Contact details
Department of Psychology
University of Copenhagen
Øster Farimagsgade 2A
Copenhagen K
DK-1353
Denmark
+45 (0)35 32 48 00
stig.poulsen@psy.ku.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9901684/25-01-0011 (Danish Council for Independent Research, 41470 (Egmont Foundation), 07018005 (Ivan Nielsen Foundation)
Study information
Scientific title
Cognitive behaviour therapy versus psychoanalytic psychotherapy for bulimia nervosa: a randomised, observer blinded clinical trial
Acronym
Study hypothesis
1. After 20 weeks of therapy in an intent-to-treat analysis the percentage of both recovered and remitted patients will be the same after cognitive behavior therapy (CBT) as after psychoanalytic psychotherapy (PPT).
2. At the end of each treatment (20 weeks after the start of CBT / 2 years after the start of PPT) the percentage of both recovered and remitted patients will be the same after CBT as after PPT.
3. Two years after the start of the treatment in an intent-to-treat analysis the per-centage of both recovered and remitted patients will be the same after CBT as after PPT
4. At follow-up 2½, 3½, and 5 years after the start of the treatment in an intent-to-treat analysis the percentage of both recovered and remitted patients will be the same after CBT as after PPT
Ethics approval
Research Ethics Committee, Capital Region of Denmark, 21/03/2004
Study design
Single-centre randomised parallel-group clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bulimia Nervosa (DSM-IV-TR)
Intervention
1. Psychoanalytic psychotherapy, weekly sessions for two years (approximately 90 sessions)
2. Cognitive behavior therapy, 21 sessions over approximately 20 weeks
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Recovery from bulimia nervosa, defined as no binge eating or purging during the previous 28 days assessed with the Eating Disorder Examination (Fairburn & Cooper, 1993)
2. Remission of the bulimic symptoms, defined as binge eating and purging less than twice per week over the last 28 days (i.e. below the DSM-IV frequency threshold) assessed with the Eating Disorder Examination (Fairburn & Cooper, 1993)
Secondary outcome measures
Symptom measures
1. Symptom Checklist-92 (SCL-92) (Derogatis, 1983; Derogatis & Lazarus, 1994)
2. Beck Depression Inventory (BDI) (Beck et al., 1961)
3. State-Trait Anxiety Inventory (STAI) (Spielberger, 1983)
4. Target complaints (TC) (Battle et al., 1966; Mintz & Kiesler, 1982)
Personality measures
1. Defense Style Questionnaire-40 (DSQ-40) (Bond et al., 1983)
2. Inventory of Interpersonal Problems (IIP) (Horowitz et al., 1988)
3. Inventory of Personality Organization (IPO) (Lenzenweger et al., 2001)
4. Adult Attachment Interview (AAI) (George et al., 1985; Main & Goldwyn, 1998)
5. Reflective-Functioning Scales (Fonagy et al., 1998)
Overall trial start date
08/11/2004
Overall trial end date
31/05/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age > 17 years
2. Patient fulfilling the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for bulimia nervosa
3. The patient has signed written informed consent before randomisation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Participant exclusion criteria
1. Concurrent ICD-10 diagnosis within the categories F00-31 (organic disorders, substance-related disorders, disorders of the schizophrenic spectrum, manic and bipolar disturbances), F32.1, 32.2, 32.3, 33.1, 33.2 and 33.3 (moderate and severe depression)
2. Concurrent ICD-10 diagnosis within the categories F40-49 (anxiety disorders, dissociative disorders, somatoform disorders), if the disorder is judged to be a major obstacle to the psychotherapeutic treatment of bulimia
3. Alcohol dependency or abuse of psychoactive substances
4. Concurrent somatic illness which will be a major obstacle to the psychothera-peutic treatment
5. Pregnancy or plans interfering with the treatment such as longer travels
6. Inability to speak and/or understand Danish
Recruitment start date
08/11/2004
Recruitment end date
31/05/2008
Locations
Countries of recruitment
Denmark
Trial participating centre
University of Copenhagen
Copenhagen K
DK-1353
Denmark
Sponsor information
Organisation
Danish Council for Independent Research (Denmark)
Sponsor details
Humanities
40 Bredgade
Copenhagen K
DK-1260
Denmark
-
dasti@dasti.dk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Danish Council for Independent Research, Humanities (Denmark) ref: 9901684/25-01-0011
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Egmont Foundation (Denmark) ref: 41470
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ivan Nielsen Foundation (Denmark) ref: 07018005
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary