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Radical Openness for Adolescents Pilot (ROA)

Primary Purpose

Anorexia Nervosa, Obsessive-Compulsive Disorder, Social Phobia

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Radically Open Dialectical Behavior Therapy (RO DBT)

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

13 Years - 21 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

No Treatment Group

Healthy Controls

Arm Description

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

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

Participants completed baseline assessment but did not receive treatment.

Outcomes

Primary Outcome Measures

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)

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.

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.

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).

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.

Secondary Outcome Measures

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

The EDE-Q is a self-report measure of eating disorder pathology for the last 28 days. It is a 36-item, 7-point scale (Fairburn & Beglin, 1994). The resulting global score (α = 0.83), and four subscales, are comprised of item averages which, when over 4, indicate clinically significant eating pathology.

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

The SCARED is a 41-item scale (α = 0.90) rated from zero ("Not True or Hardly Ever True") to two ("Very True or Often True"). Summed total scores (α = 0.90) over 25 indicate clinically significant anxiety.

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

The PQLES-Q is a 15-item scale, with items rated from one ("Very Poor") to six ("Very Good") where the first 14 items are summed for a total score and the last item is a self-reported global measure (α = 0.93). Higher scores indicate higher satisfaction and enjoyment.

Changes in social impairment using Social Connectedness Scale (SCS)

The SCS is an 8-item measure, rated from one ("Agree") to six ("Disagree") and summed, with higher scores indicating more social connectedness (α = 0.91). An example item from the SCS is "I feel so distant from people".

Changes in depressive symptomology using Child Depression Inventory (CDI)

The CDI is a 27-item scale rated from 0 to 2 and summed to create a total score. The suicidality question was omitted, yielding 26 questions. The T-score of the total score was used (α = 0.92).

Full Information

NCT ID

NCT05913557

First Posted

June 12, 2023

Last Updated

June 12, 2023

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05913557

Brief Title

Radical Openness for Adolescents Pilot

Acronym

ROA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 11, 2020 (Actual)

Primary Completion Date

February 28, 2022 (Actual)

Study Completion Date

February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Masking Description

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.

Allocation

Non-Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

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

Arm Title

No Treatment Group

Arm Type

No Intervention

Arm Description

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

Arm Title

Healthy Controls

Arm Type

No Intervention

Arm Description

Participants completed baseline assessment but did not receive treatment.

Intervention Type

Behavioral

Intervention Name(s)

Radically Open Dialectical Behavior Therapy (RO DBT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in error-related negativity (ERN) amplitudes

Description

Time Frame