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

NCT06244576 | Active Not Recruiting

• 1 other identifier: 278846
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anorexia Nervosa; Anorexia in Adolescence; Anorexia Nervosa, Atypical

Keywords

Anorexia nervosa; Intervention; Multiple baseline case-series experimental design study; Primary outcome: EDE-Q total score; RO DBT; Feasibility

Outcome Measures

Primary Outcomes (1)

• 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

  32 weeks

Secondary Outcomes (4)

• The Five Factor Obsessive Compulsive Inventory - Short Form (FFOCI-SF)

  32 weeks

• The Emotion Regulation Questionnaire (ERQ)

  32 weeks

• Body mass index (BMI)

  32 weeks

• Client Satisfaction Questionnaire (CSQ-8)

  32 weeks

Study Arms (1)

Radically Open Dialectical Behaviour Therapy (RO-DBT)

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.

Behavioral: Radically Open Dialectical Behaviour Therapy (RO-DBT)

Interventions

Radically Open Dialectical Behaviour Therapy (RO-DBT) BEHAVIORAL

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.

Radically Open Dialectical Behaviour Therapy (RO-DBT)

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Sundsvalls sjukhus, Lasarettsvagen 21

Sundsvall, Västernorrland County, 856 43, Sweden

Location

Related Links

• Related link
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MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Magnus Sjögren, PhD

  Umea University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 6, 2024
• Study Start: September 15, 2023
• Primary Completion: May 15, 2025
• Study Completion: December 30, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)