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

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What is being tested

Radically Open Dialectical Behaviour Therapy (RO-DBT)

Behavioral
Who is being recruted

Anorexia Nervosa

+ Feeding and Eating Disorders

+ Mental Disorders

From 16 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2023
See protocol details

Summary

Principal SponsorUmeå University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 15, 2023

Actual date on which the first participant was enrolled.

This study focuses on exploring a new therapy method called Radically Open Dialectical Behaviour Therapy (RO-DBT) for treating anorexia nervosa (AN). Anorexia nervosa is a serious eating disorder that often involves emotional dysregulation and overly controlling behaviors, making it difficult to treat. RO-DBT aims to address these specific issues, and previous small-scale studies have shown promising results for patients with AN. The study is important because finding more effective treatments for AN could help many people who currently struggle with long treatment times and high dropout rates, ultimately improving their quality of life and potentially saving lives. The study involves 31 participants aged 16 and older who have been diagnosed with anorexia nervosa. Over 32 weeks, these participants will receive RO-DBT from trained psychotherapists. The study will measure the success of the therapy by checking if participants can stick with it, how engaged they are with data collection, and their satisfaction with the treatment. Researchers will also look at any side effects. They will measure outcomes using questionnaires that assess eating disorder behaviors, emotional regulation, and personality traits. Additionally, they will track changes in body weight through Body Mass Index (BMI). The study hopes to show that RO-DBT can effectively reduce symptoms of anorexia nervosa and improve emotional regulation and body weight.

Official TitleEmotional Dysregulation and Maladaptive Overcontrol in Anorexia Nervosa and the Effect of Radically Open Dialectical Behaviour Therapy
Principal SponsorUmeå University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anorexia NervosaFeeding and Eating DisordersMental Disorders

Criteria

4 inclusion criteria required to participate
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

5 exclusion criteria prevent from participating
Substance dependence

Not willing to accept randomization

Undergoing simultaneous psychotherapy via another healthcare provider

Intellectual disability

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sundsvalls sjukhus, Lasarettsvagen 21

Sundsvall, SwedenOpen Sundsvalls sjukhus, Lasarettsvagen 21 in Google Maps
SuspendedOne Study Center