Clinical trial NCT05913557: Radical Openness for Adolescents Pilot
Official title: Targeting the Transdiagnostic Mechanism of Performance Monitoring and Overcontrol in Adolescence: Adaptation and Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Anorexia Nervosa
Obsessive-Compulsive Disorder
Social Phobia
Depression, Anxiety
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 61
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were either in a healthy group that did not receive treatment but did complete a baseline assessment or in one of two clinical groups. The first clinical group completed a baseline assessment, received 4 months of Radically Open Dialectical Behavior Therapy (RO DBT) treatment, then completed a follow-up assessment. The non-treatment clinical received no treatment (but could complete any other ongoing treatment as usual (TAU) treatment) and completed a baseline assessment and a subset also completed a follow-up assessment.
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in error-related negativity (ERN) amplitudes
timeFrame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
measure: Changes in scores on Overcontrol Youth Checklist (OCYC)
timeFrame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
measure: Changes in scores on Adolescent Over- and Under-control Trait Measure (OUT'M)
timeFrame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
measure: Changes in Behavioral Reward Responding using the Temporal Experience of Pleasure Scale (TEPS), including the anticipatory and consummatory subscales
timeFrame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
measure: Changes in Reward Positivity (RewP) amplitudes
timeFrame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
Secondary outcomes:
measure: Changes in disruptive eating symptomology using Eating Disorder Examination-Questionnaire (EDE-Q)
timeFrame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
measure: Changes in anxious symptomology using Screen for Child Anxiety Related Disorders (SCARED)
timeFrame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
measure: Changes in functional impairment using Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQLES-Q)
timeFrame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
measure: Changes in social impairment using Social Connectedness Scale (SCS)
timeFrame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
measure: Changes in depressive symptomology using Child Depression Inventory (CDI)
timeFrame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References: