Emotional Dysregulation, Maladaptive Overcontrol in Anorexia - Effect of Radically Open Dialectical Behaviour Therapy
NCT ID: NCT06244576
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
31 participants
INTERVENTIONAL
2023-09-15
2025-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent form
* Age 16-65
* Sufficient knowledge of Swedish
Exclusion Criteria
* 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.
16 Years
65 Years
ALL
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Principal Investigators
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Magnus Sjögren, PhD
Role: PRINCIPAL_INVESTIGATOR
Umea University
Locations
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Sundsvalls sjukhus, Lasarettsvagen 21
Sundsvall, Västernorrland County, Sweden
Countries
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Related Links
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Related link
Related link
Related link
Other Identifiers
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278846
Identifier Type: -
Identifier Source: org_study_id