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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06244576
Other study ID # 278846
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 15, 2023
Est. completion date December 30, 2024

Study information

Verified date February 2024
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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)?


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Behavioral:
Radically Open Dialectical Behaviour Therapy (RO-DBT)
RO-DBT is a transdiagnostic intervention specifically designed to treat a spectrum of disorders characterized by excessive overcontrol such as anorexia nervosa, autism spectrum disorder, refractory depression, cluster c personality disorders, and mood disorders.

Locations

Country Name City State
Sweden Sundsvalls sjukhus, Lasarettsvagen 21 Sundsvall Vasternorrland

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

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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