NCT05913557

Radical Openness for Adolescents Pilot

Targeting the Transdiagnostic Mechanism of Performance Monitoring and Overcontrol in Adolescence: Adaptation and Feasibility

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 13 Years – 21 Years
• Healthy volunteers: Accepted

Summary

Heightened performance monitoring and overcontrol (HPM/OC) is characterized by inflexibility, a need for control, perfectionism, anxious apprehension and high error monitoring. HPM/OC is a cross-diagnostic (transdiagnostic) characteristic occurring across multiple forms of psychiatric illness that emerge in adolescence, including anorexia nervosa (AN), obsessive compulsive disorder (OCD) and social anxiety disorder. This study characterizes behavioral and neural HPM/OC in healthy adolescents and adolescents with disorders characterized by HPM/OC, including AN and related eating disorders and anxiety, depressive and obsessive compulsive disorders. We then examine feasibility of a novel treatment for HPM/OC in adolescents, examining recruitment feasibility, exploration of the mechanism of HPM/OC and examining whether treatment is able to target neural and behavioral HPM/OC.

Detailed description

Eligible patient (n=30) and healthy (n=30) adolescents and young adults will attend a baseline session where they will undergo an ERP neural assessment and fill out questionnaires. 8 patient participants interested in participating in a 4 month free RO DBT therapy trial will participate in weekly individual and skills class sessions. At the end of this 4 months, they will complete a second follow-up session where they will undergo an event related potential (ERP) neural assessment and fill out questionnaires. 8 of the remaining 30 patient participants who do not want to complete the free therapy trial will have the option to return for a second follow-up session where they will undergo an ERP neural assessment and fill out questionnaires while undergoing treatment as usual (outside of therapy trial).

Conditions

• Anorexia Nervosa
• Obsessive-Compulsive Disorder
• Social Phobia
• Depression, Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Radically Open Dialectical Behavior Therapy (RO DBT)	Radically Open Dialectical Behavior therapy (RO DBT) is a type of cognitive behavioral therapy developed by Dr. Thomas Lynch for disorders of emotional overcontrol. RO DBT is a treatment indicated for patients across multiple psychiatric disorders, including diagnoses of chronic depression, treatment resistant anxiety disorders, anorexia nervosa, autism spectrum disorders, and avoidant, paranoid, and obsessive-compulsive personality disorders.

Timeline

• Start date: 2020-08-11
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2023-06-22
• Last updated: 2023-06-22

Locations

1 site across 1 country: United States