NCT02745067

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2022

Enrollment Period

5.3 years

First QC Date

April 13, 2016

Last Update Submit

March 21, 2025

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (2)

  • Eating Disorder Examination Questionnaire (EDE-Q), score

    1 year

  • BMI

    1 year

Study Arms (1)

Enhanced cognitive behavioral therapy

OTHER

Enhanced cognitive behavioral therapy (CBT-E) for eating disorders

Behavioral: enhanced cognitive behavioral therapy

Interventions

enhanced cognitive behavioral therapyBEHAVIORAL
Enhanced cognitive behavioral therapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (5)

  • 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.

    PMID: 35123583RESULT

  • Kleppe 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.

    PMID: 37194104DERIVED

  • Kleppe 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.

    PMID: 35040160DERIVED

  • Kessler 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.

    PMID: 32040232DERIVED

  • Danielsen 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.

    PMID: 27716162DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Ute Kessler, PhD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 20, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

March 26, 2025

Record last verified: 2022-03

Locations

NO(1)