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

February 2, 2024 updated by: Umeå University

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

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)?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Estimated)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Vasternorrland
      • Sundsvall, Vasternorrland, Sweden, 856 43
        • Sundsvalls sjukhus, Lasarettsvagen 21

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radically Open Dialectical Behaviour Therapy (RO-DBT)
RO-DBT consists of a 1 hour weekly individual session and a 2,5 hour weekly group skill training during 39 weeks in accordance with the published treatment manual and session guides for RO-DBT. For skills training, the 31 patients will be divided into four equal groups in terms on number.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Eating Disorder Examination Questionnaire (EDE-Q)
Time Frame: 30 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The NEO Personality Five-Factor Inventory-3 (NEO-FFI-3): neuroticism subscale
Time Frame: 30 weeks
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
The Five Factor Obsessive Compulsive Inventory - Short Form (FFOCI-SF)
Time Frame: 30 weeks
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
The Emotion Regulation Questionnaire (ERQ)
Time Frame: 30 weeks
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
Body mass index (BMI)
Time Frame: 30 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Magnus Sjögren, PhD, Umea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 278846

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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