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Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

enhanced cognitive behavioral therapy

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;

Sites / Locations

Haukeland University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Enhanced cognitive behavioral therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Eating Disorder Examination Questionnaire (EDE-Q), score

BMI

Secondary Outcome Measures

Full Information

NCT ID

NCT02745067

First Posted

April 13, 2016

Last Updated

April 19, 2022

Sponsor

Haukeland University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02745067

Brief Title

Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa

Official Title

Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa: a Prospective Multidisciplinary Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

December 2021 (Actual)

Study Completion Date

January 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Haukeland University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia Nervosa

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enhanced cognitive behavioral therapy

Arm Type

Other

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

enhanced cognitive behavioral therapy

Primary Outcome Measure Information:

Title

Eating Disorder Examination Questionnaire (EDE-Q), score

Time Frame

1 year

Title

BMI

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ute Kessler, PhD

Organizational Affiliation

Haukeland University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Haukeland University Hospital

City

Bergen

ZIP/Postal Code

5021

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35123583

Citation

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.

Results Reference

derived

PubMed Identifier

35040160

Citation

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.

Results Reference

derived

PubMed Identifier

32040232

Citation

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.

Results Reference

derived

PubMed Identifier

27716162

Citation

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.

Results Reference

derived

Learn more about this trial

Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa

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