Radical Openness for Adolescents Pilot

Early Phase 1CompletedNCT05913557

Washington University School of Medicine61 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

Radically Open Dialectical Behavior Therapy (RO DBT)BEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Adolescents with HPM/OC: Female adolescents and young adults with AN and related eating disordered pathology and other disorders of HPM/OC. Inclusion criteria include ages 13-21, female gender, and must be characterized by elevated dimensional HPM/OC. Inclusion criteria also require a psychiatric disorder and/or impairment related to HPM/OC, including a diagnosis of AN, related eating disordered pathology related to AN that is characterized by HPM/OC (Eating disorder not otherwise specified; EDNOS; with high HPM/OC),and/or a diagnosis of a related disorder characterized by HPM/OC, namely obsessive compulsive disorder (OCD) or social anxiety disorder. Importantly, not only psychiatric illness, but psychiatric illness characterized by HPM/OC is required. Participants will not be excluded due to medication status. Other inclusion include: for adolescents younger than 17, the consent and participation of a legal caregiver. Other inclusion include if participating in therapy beyond baseline session: living in the St. Louis region (to attend sessions) and willingness to have RO DBT-A as only psychosocial treatment engaged in (medication treatment may continue). Healthy adolescents: Female adolescents and young adults age 13-21 matched to patient sample on age and gender (all females). Inclusion criteria: no diagnosis of disorders of HPM/OC, including AN and related eating disordered pathology, OCD, or social anxiety disorder, ability to complete the EEG and baseline session, and scores below the clinical cut-off on a questionnaire, the Youth Self Report (YSR). Exclusion Criteria: Adolescents with HPM/OC: Exclusion criteria include: male gender, outside age range, significant developmental or cognitive delays, seizure or other major neurological disorder, severe head injury, inability to understand, speak and read English sufficiently (both adolescent and caregiver if under age 18). Healthy adolescents: Exclusion criteria: male gender, outside age range, significant developmental or cognitive delays, seizure or other major neurological disorder, severe head injury, inability to understand, speak and read English sufficiently (both adolescent and caregiver if under age 18), or disorder of AN, OCD, Social Anxiety Disorder.

Outcomes

Primary Outcomes

Changes in error-related negativity (ERN) amplitudes

ERN data is obtained during electroencephalogram (EEG) sessions during which participants engage in several behavioral tasks. These tasks include Flankers (participant must quickly press an arrow key that corresponds to the center arrowhead depicted on the screen)