Anorexia Nervosa Clinical Trial
— EMAROOfficial title:
Emotional Dysregulation and Maladaptive Overcontrol in Anorexia Nervosa and the Effect of Radically Open Dialectical Behaviour Therapy
Verified date | February 2024 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)?
Status | Active, not recruiting |
Enrollment | 31 |
Est. completion date | December 30, 2024 |
Est. primary completion date | May 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility | Inclusion Criteria: - Diagnosis of anorexia nervosa (typical or atypical or in partial remission, i.e. may have a BMI above ~18.5 but meets criteria B and/or C according to the Diagnostic and Statistical Manual; DSM-5) - Signed written informed consent form - Age 16-65 - Sufficient knowledge of Swedish Exclusion Criteria: - Substance dependence - Not willing to accept randomization - Undergoing simultaneous psychotherapy via another healthcare provider - Intellectual disability - Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the investigators and after any consults if indicated, participation in the study is not in the best interest of the patient. |
Country | Name | City | State |
---|---|---|---|
Sweden | Sundsvalls sjukhus, Lasarettsvagen 21 | Sundsvall | Vasternorrland |
Lead Sponsor | Collaborator |
---|---|
Umeå University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Eating Disorder Examination Questionnaire (EDE-Q) | A 36-item self-report questionnaire designed to measure eating disorder symptoms. The range of scores is 0-132. Higher scores mean more eating disorder symptoms | 30 weeks | |
Secondary | The NEO Personality Five-Factor Inventory-3 (NEO-FFI-3): neuroticism subscale | A 12-item self-report subscale questionnaire designed to measure the personality trait neuroticism. The range of scores is 12-144. Higher scores mean higher neuroticism. | 30 weeks | |
Secondary | The Five Factor Obsessive Compulsive Inventory - Short Form (FFOCI-SF) | A 48-item self-report questionnaire designed to measure obsessive-compulsive personality traits. The range of scores is 48-240. Higher scores mean more obsessive-compulsive personality traits. | 30 weeks | |
Secondary | The Emotion Regulation Questionnaire (ERQ) | A 10-item self-report questionnaire designed to measure adaptive and maladaptive strategies for emotion regulation. The adaptive subscale contains 6 questions and range between 6-42. Higher scores on this subscale mean more adaptive regulation strategies. The maladaptive subscale contains 4 questions and range between 4-28. Higher scores on this subscale mean more maladaptive regulation strategies. | 30 weeks | |
Secondary | Body mass index (BMI) | A statistical index using a peron's weight and height to provide an estimate of body fat in people. A BMI of <18.5 indicates medically underweight. A BMI of 18.5 - 25 indicates normal weight. A BMI of >25 indicates overweight. | 30 weeks |
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