Clinical Trials Logo

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

See also
  Status Clinical Trial Phase
Recruiting NCT05531604 - Appetitive Conditioning in Anorexia Nervosa
Enrolling by invitation NCT04174703 - Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing N/A
Active, not recruiting NCT04883554 - Impact of an Olfactory Sensory Therapeutic Group for Adolescent Patients With Restrictive Anorexia Nervosa , Pilot Study N/A
Recruiting NCT04213820 - TMS and Body Image Treatment for Anorexia Nervosa N/A
Completed NCT03414112 - The Impact of Oxytocin on the Neurobiology of Anorexia Nervosa Early Phase 1
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Recruiting NCT05803707 - Home-based Adapted Physical Activity in Anorexia Nervosa: a Feasibility Pilot Study N/A
Recruiting NCT05682417 - Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa N/A
Not yet recruiting NCT06380257 - Anorexia Nervosa and Brain in Adolescence
Not yet recruiting NCT04804800 - Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa N/A
Not yet recruiting NCT03600610 - Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa N/A
Completed NCT02745067 - Effectiveness of Enhanced Cognitive Behavioral Therapy (CBT-E) in the Treatment of Anorexia Nervosa N/A
Completed NCT02382055 - Changing Habits in Anorexia Nervosa: Novel Treatment Development N/A
Terminated NCT02240797 - Kappa Opioid Receptor Imaging in Anorexia N/A
Completed NCT03075371 - Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa N/A
Completed NCT03144986 - Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa N/A
Unknown status NCT01761942 - Fatty Acids Omega -3 Diet Supplementation Efficiency and Safety Evaluation in Anorexia Nervosa Phase 2
Completed NCT02551445 - A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders. N/A
Completed NCT01579682 - Adaptive Family Treatment for Adolescent Anorexia Nervosa N/A
Completed NCT00946816 - The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity N/A