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

December 5, 2024 updated by: Umeå University

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

This clinical trial employs a two-fold approach, utilizing a single-arm feasibility design within a larger multiple baseline experimental case series study framework over 32 weeks. The study aims to investigate both the feasibility and efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in patients with anorexia nervosa (AN). Feasibility will be assessed through treatment retention, data collection engagement, patient satisfaction, and the occurrence of adverse events. Efficacy outcomes will focus on RO-DBT's impact on ED psychopathology, obsessive-compulsive personality traits, EDR, and BMI.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Anorexia nervosa (AN) is characterized by high chronicity and mortality rates. Despite its relatively high prevalence, effective treatments remain elusive, often resulting in extended treatment durations and high dropout rates. Emotional dysregulation (EDR) and obsessive-compulsive personality traits are central to the psychopathology of AN, directly contributing to the disorder's severity and persistence. Radically Open Dialectical Behaviour Therapy (RO-DBT) targets the psychopathology mentioned above and has shown promise in pilot studies with AN patients.

Given the urgent need for effective AN treatments and the potential of RO-DBT, this study aims to investigate both the feasibility and efficacy of this therapy in a clinical setting. The study will employ a single-arm feasibility design within a multiple baseline experimental case series framework over 32 weeks, involving 31 patients aged 16 years and older diagnosed with typical or atypical AN. All assessments will utilize validated psychometric instruments, and trained psychotherapists will administer RO-DBT.

Feasibility will be assessed through:

  • Treatment retention
  • Data collection engagement
  • Patient satisfaction with treatment
  • Occurrence of adverse events.

The primary efficacy outcome this trial aims to investigate is:

* Does RO-DBT reduce eating disorder psychopathology in AN as measured by the Eating Disorder Examination Questionnaire (EDE-Q)?

The secondary efficacy outcomes this trial aims to investigate are:

  • Does RO-DBT reduce emotional dysregulation in AN as measured by change in the Expressive Suppression subscore of Emotion Regulation Questionnaire (ERQ)?
  • Does RO-DBT reduce obsessive-compulsive personality traits in AN as measured by change in the total score of the Five-Factor Obsessive Compulsive Inventory (FFOCI-SF)
  • Does RO-DBT increase body weight as measured by change in Body Mass Index (BMI)?

We hypothesize that RO-DBT will be a feasible treatment option for individuals with AN. Furthermore, we anticipate observing reductions in ED psychopathology and expressive suppression, alongside an increase in BMI, between pre- and post-treatment assessments.

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 or atypical nervosa (i.e., in partial remission with a BMI above ~18.5 but meets criteria B and/or C) according to the Diagnostic and Statistical Manual fifth edition (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 32 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 trans diagnostic 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: 32 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
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Five Factor Obsessive Compulsive Inventory - Short Form (FFOCI-SF)
Time Frame: 32 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.
32 weeks
The Emotion Regulation Questionnaire (ERQ)
Time Frame: 32 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.
32 weeks
Body mass index (BMI)
Time Frame: 32 weeks
A statistical index using a person'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.
32 weeks
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 32 weeks
An 8-item self-report questionnaire to measure patient satisfaction with treatment
32 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, Umeå 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, 2025

Study Completion (Estimated)

December 30, 2025

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 (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 278846

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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