Eating DisorderNCT00184301
A Comparison Study of Treatments Given to Patients With Concurrent Eating Disorder and Personality Disorder.
A study testing inpatient treatment and outpatient treatment in people with Eating Disorder and Anorexia Nervosa, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of this study is to determine whether in-patient treatment is better then intensive out-patient group treatment for patients with concurrent eating disorder and personality disorder. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Eating Disorder, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- inpatient treatment and outpatient treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2005to Oct 2013
- Phase
- Interventional
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Anorexia nervosa, bulimia nervosa, personality disorder.
Who cannot join
- male, schizophrenia.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim.
Trondheim
About this study
Official title: Treatment of Patients With Concurrent Eating Disorder and Personality Disorder: A Controlled Randomized Comparison Study, of Treatments Given to In-patients and Out-patients.
The aim of this study is to determine whether in-patient treatment is better then intensive out-patient group treatment for patients with concurrent eating disorder and personality disorder.
Read the detailed description
The main aim of the study is to compare the effects of in-patient treatment with a group based intensive out-patient treatment. It is a randomized controlled comparison study including patients with concurrent eating disorder and personality disorder. 18 patients will receive an in-patient treatment lasting one year. 18 patients will receive intensive out-patient treatment consisting of two-weekly group sessions, lasting one year. Personality disorder, eating behavior, symptoms, and function will be followed for two years.
- Being tested
- inpatient treatment, outpatient treatment
- Keywords
- Eating disorders, Anorexia nervosa, Bulimia nervosa, Personality disorders, In-patient treatment, out-patient treatment, group therapy
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inpatient treatmentBehavioural
inpatient treatment during 1 year
outpatient treatmentBehavioural
intensive outpatient treatment consisting of two-weekly group sessions during 1 year
| Study group | Role | What they receive |
|---|---|---|
| inpatient treatment | Experimental | inpatient treatment during 1 year Receives: Behavioral: inpatient treatment |
| outpatient treatment | Active comparator | intensive outpatient treatment consisting of two-weekly group sessions during 1 year Receives: Behavioral: outpatient treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on personality, interpersonal, eating disorder and symptom scales
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian Foundation for Health and Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Are Holen, PhD MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184301
- Sponsor's protocol ID
- 064.03
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2005
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Concurrent Eating Disorder and Personality Disorder: A Controlled Randomized Comparison Study, of Treatments Given to In-patients and Out-patients.
- ClinicalTrials.gov ID
- NCT00184301
- Acronym / sponsor ID
- 064.03
- Keywords
- Eating disorders, Anorexia nervosa, Bulimia nervosa, Personality disorders, In-patient treatment, out-patient treatment, group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian Foundation for Health and Rehabilitation
- Study start
- Sep 2005 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 Sep 2005 (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 aim of this study is to determine whether in-patient treatment is better then intensive out-patient group treatment for patients with concurrent eating disorder and personality disorder.
Detailed description
The main aim of the study is to compare the effects of in-patient treatment with a group based intensive out-patient treatment. It is a randomized controlled comparison study including patients with concurrent eating disorder and personality disorder. 18 patients will receive an in-patient treatment lasting one year. 18 patients will receive intensive out-patient treatment consisting of two-weekly group sessions, lasting one year. Personality disorder, eating behavior, symptoms, and function will be followed for two years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inpatient treatment | Experimental | Behavioral: inpatient treatmentinpatient treatment during 1 year |
| outpatient treatment | Active comparator | Behavioral: outpatient treatmentintensive outpatient treatment consisting of two-weekly group sessions during 1 year |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Anorexia nervosa, bulimia nervosa, personality disorder.
Key exclusion criteria (1 listed)
- male, schizophrenia.
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 |
|---|---|---|
| inpatient treatmentinpatient treatment during 1 year | Behavioural | inpatient treatment |
| outpatient treatmentintensive outpatient treatment consisting of two-weekly group sessions during 1 year | Behavioural | outpatient treatment |
Primary outcome
Score on personality, interpersonal, eating disorder and symptom scales
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Are Holen, PhD MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inpatient treatment and outpatient treatment in people with Eating Disorder and Anorexia Nervosa, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Mar 2017. 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 Norway. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score on personality, interpersonal, eating disorder and symptom scales (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2017.