Emotional Dysregulation, Maladaptive Overcontrol in Anorexia - Effect of Radically Open Dialectical Behaviour Therapy

Anorexia Nervosa Clinical Trial

— EMARO  

Official title:

Emotional Dysregulation and Maladaptive Overcontrol in Anorexia Nervosa and the Effect of Radically Open Dialectical Behaviour Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06244576
• Other study ID #: 278846
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia in Adolescence
• Anorexia Nervosa
• Anorexia Nervosa, Atypical

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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