Radical Openness for Adolescents Pilot

NCT05913557 | Completed Early Phase 1

• 1 other identifier: 201912169
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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)

  Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])

• Changes in scores on Overcontrol Youth Checklist (OCYC)

  The OCYC is a validated self-report checklist that assesses levels of hyper-performance monitoring and overcontrol. The youth is asked to respond yes/no to a variety of personality-based questions. A total score is generated, as well as a frustration/rigidity score and a social concern/perfectionism score.

  Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])

• Changes in scores on Adolescent Over- and Under-control Trait Measure (OUT'M)

  The OUT'M is a validated self-report checklist that assesses levels of overcontrol as well as undercontrol. Youths are asked to rate themselves on a variety of personality traits using a scale from 0-6. Overcontrol and undercontrol scores are generated.

  Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])

• Changes in Behavioral Reward Responding using the Temporal Experience of Pleasure Scale (TEPS), including the anticipatory and consummatory subscales

  The TEPS is an 18-item measure, rated from one ("very false for me") to six ("very true for me"; α = 0.89). Examples of items include "I look forward to a lot of things in my life" (anticipatory) and "I enjoy taking a deep breath of fresh air when I walk outside" (consummatory).

  Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])

• Changes in Reward Positivity (RewP) amplitudes

  RewP data is obtained during electroencephalogram (EEG) sessions during which participants engage in a behavioral task of opening a door and receiving a small amount of money to win if they open the correct door, or lose a small amount of money if they do not open the 'correct' door. The RewP is measured by examining neural response to winning money subtracting out the neural response to losing money.

  Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])

Secondary Outcomes (5)

• Changes in disruptive eating symptomology using Eating Disorder Examination-Questionnaire (EDE-Q)

  Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])

• Changes in anxious symptomology using Screen for Child Anxiety Related Disorders (SCARED)

  Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])

• Changes in functional impairment using Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQLES-Q)

  Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])

• Changes in social impairment using Social Connectedness Scale (SCS)

  Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])

• Changes in depressive symptomology using Child Depression Inventory (CDI)

  Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])

Study Arms (3)

Treatment Group

EXPERIMENTAL

Participants completed a baseline assessment, received 4 months of RO DBT therapy, then completed a follow-up assessment.

Behavioral: Radically Open Dialectical Behavior Therapy (RO DBT)

No Treatment Group

NO INTERVENTION

Participants completed baseline assessment but did not receive treatment. A small subset also completed a follow-up assessment.

Healthy Controls

NO INTERVENTION

Participants completed baseline assessment but did not receive treatment.

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.

Treatment Group

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Obsessive-Compulsive Disorder; Phobia, Social; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Phobic Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants self-selected to receive the therapy or not receive the therapy. Researchers and providers were also made aware of treatment group as they would then set up assessments and first treatment session.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: August 11, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (1)