Anorexia NervosaNCT02745067
Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa
A study testing enhanced cognitive behavioral therapy in people with Anorexia Nervosa, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The primary objective of this study is to gain knowledge about the effectiveness of enhanced cognitive behavioral therapy (CBT-E) for anorexia nervosa (AN). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- enhanced cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2016to Jan 2022
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients aged >16 years
- suffering from AN, as diagnosed based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) and confirmed with a clinical examination.
- either at least one unsuccessful treatment attempt in a secondary health-care service unit or severe AN that is evaluated as not manageable in a secondary health-care service unit.
Who cannot join
- deemed unsafe to manage on an outpatient basis
- psychiatric comorbidity that precludes a focused eating-disorder treatment, such as psychosis or drug abuse.
- not available to participate during the requested treatment period
- for the analysis of the gut microbiota: patients suffering from inflammatory bowel disease, acute or chronic diarrhea or other bowel disease, treatment with antibiotics during the previous 3 months before stool sampling, or laxative abuse;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa: a Prospective Multidisciplinary Study
The primary objective of this study is to gain knowledge about the effectiveness of enhanced cognitive behavioral therapy (CBT-E) for anorexia nervosa (AN).
Read the detailed description
The study will assess the potency of outpatient CBT-E in a sample of patients suffering from AN who are admitted to the Section for Eating Disorders at the Department for Psychosomatic Medicine, Haukeland University Hospital in Bergen, Norway.
Secondary objectives are to (1) prospectively identify baseline predictors of treatment outcome and dropout, (2) determine variables related to the treatment process and patient engagement as predictors of the outcome and/or treatment dropout, and (3) in a multidisciplinary approach, focus on selected pathophysiological mechanisms including changes in the gut microbiota as well as immunological measures in patients with severe AN in different stages of the disease, and determine to what extent they are related to treatment outcome.
- Conditions
- Anorexia Nervosa
- Being tested
- enhanced cognitive behavioral therapy
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced cognitive behavioral therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Enhanced cognitive behavioral therapy | Other | Enhanced cognitive behavioral therapy (CBT-E) for eating disorders Receives: Behavioral: enhanced cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination Questionnaire (EDE-Q), score
Measured: 1 year
BMI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2021
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ute Kessler, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745067
- Sponsor's protocol ID
- 2015/2328
- Status last verified
- Mar 2022
- First submitted
- 13 Apr 2016
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kessler U, Kleppe MM, Rekkedal GA, Ro O, Danielsen Y. Experiences when implementing enhanced cognitive behavioral therapy as a standard treatment for anorexia nervosa in outpatients at a public specialized eating-disorder treatment unit. J Eat Disord. 2022 Feb 5;10(1):15. doi: 10.1186/s40337-022-00536-7.
PubMed 35123583Kleppe MM, Kessler U, Rekkedal GA, Skjakodegard HF, Danielsen YS. Differences in sleep patterns between patients with anorexia nervosa and healthy controls: a cross-sectional study. J Eat Disord. 2023 May 16;11(1):76. doi: 10.1186/s40337-023-00799-8.
PubMed 37194104Kleppe MM, Bronstad I, Lied GA, Danielsen Y, Rekkedal GA, Kessler U. Intestinal barrier integrity in anorexia nervosa (a pilot study). Int J Eat Disord. 2022 May;55(5):703-708. doi: 10.1002/eat.23678. Epub 2022 Jan 17.
PubMed 35040160Kessler U, Rekkedal GA, Ro O, Berentsen B, Steinsvik EK, Lied GA, Danielsen Y. Association between gastrointestinal complaints and psychopathology in patients with anorexia nervosa. Int J Eat Disord. 2020 May;53(5):532-536. doi: 10.1002/eat.23243. Epub 2020 Feb 10.
PubMed 32040232Danielsen YS, Ardal Rekkedal G, Frostad S, Kessler U. Effectiveness of enhanced cognitive behavioral therapy (CBT-E) in the treatment of anorexia nervosa: a prospective multidisciplinary study. BMC Psychiatry. 2016 Oct 5;16(1):342. doi: 10.1186/s12888-016-1056-6.
PubMed 27716162
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa: a Prospective Multidisciplinary Study
- ClinicalTrials.gov ID
- NCT02745067
- Acronym / sponsor ID
- 2015/2328
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 20 Apr 2016 (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 primary objective of this study is to gain knowledge about the effectiveness of enhanced cognitive behavioral therapy (CBT-E) for anorexia nervosa (AN).
Detailed description
The study will assess the potency of outpatient CBT-E in a sample of patients suffering from AN who are admitted to the Section for Eating Disorders at the Department for Psychosomatic Medicine, Haukeland University Hospital in Bergen, Norway.
Secondary objectives are to (1) prospectively identify baseline predictors of treatment outcome and dropout, (2) determine variables related to the treatment process and patient engagement as predictors of the outcome and/or treatment dropout, and (3) in a multidisciplinary approach, focus on selected pathophysiological mechanisms including changes in the gut microbiota as well as immunological measures in patients with severe AN in different stages of the disease, and determine to what extent they are related to treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced cognitive behavioral therapy | Other | Behavioral: enhanced cognitive behavioral therapyEnhanced cognitive behavioral therapy (CBT-E) for eating disorders |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged >16 years
- suffering from AN, as diagnosed based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) and confirmed with a clinical examination.
- either at least one unsuccessful treatment attempt in a secondary health-care service unit or severe AN that is evaluated as not manageable in a secondary health-care service unit.
Key exclusion criteria (4 listed)
- deemed unsafe to manage on an outpatient basis
- psychiatric comorbidity that precludes a focused eating-disorder treatment, such as psychosis or drug abuse.
- not available to participate during the requested treatment period
- for the analysis of the gut microbiota: patients suffering from inflammatory bowel disease, acute or chronic diarrhea or other bowel disease, treatment with antibiotics during the previous 3 months before stool sampling, or laxative abuse;
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 |
|---|---|---|
| enhanced cognitive behavioral therapy | Behavioural | Enhanced cognitive behavioral therapy |
Primary outcome
Eating Disorder Examination Questionnaire (EDE-Q), score
Time frame: 1 year
BMI
Time frame: 1 year
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 26 Mar 2025.
- Results publication: PubMed 35123583Kessler U, Kleppe MM, Rekkedal GA, Ro O, Danielsen Y. Experiences when implementing enhanced cognitive behavioral therapy as a standard treatment for anorexia nervosa in outpatients at a public specialized eating-disorder treatment unit. J Eat Disord. 2022 Feb 5;10(1):15. doi: 10.1186/s40337-022-00536-7.
- Derived from this study: PubMed 37194104Kleppe MM, Kessler U, Rekkedal GA, Skjakodegard HF, Danielsen YS. Differences in sleep patterns between patients with anorexia nervosa and healthy controls: a cross-sectional study. J Eat Disord. 2023 May 16;11(1):76. doi: 10.1186/s40337-023-00799-8.
- Derived from this study: PubMed 35040160Kleppe MM, Bronstad I, Lied GA, Danielsen Y, Rekkedal GA, Kessler U. Intestinal barrier integrity in anorexia nervosa (a pilot study). Int J Eat Disord. 2022 May;55(5):703-708. doi: 10.1002/eat.23678. Epub 2022 Jan 17.
- Derived from this study: PubMed 32040232Kessler U, Rekkedal GA, Ro O, Berentsen B, Steinsvik EK, Lied GA, Danielsen Y. Association between gastrointestinal complaints and psychopathology in patients with anorexia nervosa. Int J Eat Disord. 2020 May;53(5):532-536. doi: 10.1002/eat.23243. Epub 2020 Feb 10.
- Derived from this study: PubMed 27716162Danielsen YS, Ardal Rekkedal G, Frostad S, Kessler U. Effectiveness of enhanced cognitive behavioral therapy (CBT-E) in the treatment of anorexia nervosa: a prospective multidisciplinary study. BMC Psychiatry. 2016 Oct 5;16(1):342. doi: 10.1186/s12888-016-1056-6.
- Individual participant dataSharing planned: Undecided
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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.
Ute Kessler, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced cognitive behavioral therapy in people with Anorexia Nervosa, run by Haukeland University Hospital 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 3 inclusion and 4 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 26 Mar 2025. 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?
Eating Disorder Examination Questionnaire (EDE-Q), score (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT02745067, which also lists 5 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 Mar 2025.