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Clinical Trial Summary

The goal of this clinical trial is to study the effect of Radically Open Dialectical Behaviour Therapy (RO-DBT) in patients with anorexia nervosa (AN) in an extended baseline experimental case series study design over 30 weeks. The main questions the trial aims to answer are: 1. Does RO-DBT reduce eating disorder psychopathology in AN as measured by the Eating Disorder Examination Questionnaire (EDE-Q)? 2. Does RO-DBT reduce maladaptive overcontrol and neuroticism in AN as measured by change in the total score of the Five-Factor Obsessive Compulsive Inventory (FFOCI-SF), and the neuroticism domain in the NEO Five-Factor Inventory-3 (NEOFFI-3), respectively? 3. Does RO-DBT reduce emotional dysregulation in AN as measured by change in the Expressive Supression subscore of Emotion Regulation Questionnaire (ERQ)? 4. Does RO-DBT increase body weight as measured by change in Body Mass Index (BMI)?


Clinical Trial Description

Anorexia nervosa (AN) demonstrate high chronicity rates and high mortality rates. The prevalence of AN is relatively high with no effective treatment available and often long treatment durations and high dropout rates. Emotional dysregulation (EDR), neuroticism and maladaptive overcontrol (MO) are essential in the psychopathology of AN and directly involved in the high mortality and chronicity of the disorder. Radically Open Dialectical Behaviour Therapy (RO-DBT) addresses MO and has been found effective in pilot studies in AN. Given this, and the urgent need for effective treatments for AN, this project aims to study the effect of RO-DBT in reducing ED symptoms, MO, neuroticism, and EDR in patients with AN. This will be done using an extended baseline experimental case series study design over 30 weeks with 31 patients older than 16 years of age with typical or atypical AN. All outcomes will be assessed using validated psychometric instruments, and RO-DBT will be performed by trained psychotherapists. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06244576
Study type Interventional
Source Umeå University
Contact
Status Active, not recruiting
Phase N/A
Start date September 15, 2023
Completion date December 30, 2024

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