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Trial record 5 of 806 for:    cognitive behavioral | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT02745067
First received: April 13, 2016
Last updated: September 23, 2016
Last verified: September 2016
  Purpose
The primary objective of this study is to gain knowledge about the effectiveness of enhanced cognitive behavioral therapy (CBT-E) for anorexia nervosa (AN).

Condition Intervention
Anorexia Nervosa Behavioral: enhanced cognitive behavioral therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa: a Prospective Multidisciplinary Study

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Eating Disorder Examination Questionnaire (EDE-Q), score [ Time Frame: 1 year ]
  • BMI [ Time Frame: 1 year ]

Estimated Enrollment: 100
Study Start Date: September 2016
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Enhanced cognitive behavioral therapy
Enhanced cognitive behavioral therapy (CBT-E) for eating disorders
Behavioral: enhanced cognitive behavioral therapy

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.

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02745067

Contacts
Contact: Guro Rekkedal, PhD Guro.ardal.rekkedal@helse-bergen.no
Contact: Yngvild Danielsen, PhD yngvild.danielsen@uib.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Ute Kessler, PhD Haukeland University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02745067     History of Changes
Other Study ID Numbers: 2015/2328
Study First Received: April 13, 2016
Last Updated: September 23, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2017