Anorexia NervosaEarly Phase 1ROANCT05913557
Radical Openness for Adolescents Pilot
A Early Phase 1 study testing Radically Open Dialectical Behavior Therapy (RO DBT) in people with Anorexia Nervosa and Obsessive-Compulsive Disorder, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Obsessive-Compulsive Disorder, Social Phobia
- What is being tested?
- Radically Open Dialectical Behavior Therapy (RO DBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2020to 28 Feb 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Targeting the Transdiagnostic Mechanism of Performance Monitoring and Overcontrol in Adolescence: Adaptation and Feasibility
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.
Read the 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).
- Being tested
- Radically Open Dialectical Behavior Therapy (RO DBT)
- Medical subject headings
- Anorexia Nervosa, Obsessive-Compulsive Disorder, Phobia, Social, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radically Open Dialectical Behavior Therapy (RO DBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants completed a baseline assessment, received 4 months of RO DBT therapy, then completed a follow-up assessment. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
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".
Measured: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
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).
Measured: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start11 Aug 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913557
- Sponsor's protocol ID
- 201912169
- Acronym
- ROA
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Transdiagnostic Mechanism of Performance Monitoring and Overcontrol in Adolescence: Adaptation and Feasibility
- ClinicalTrials.gov ID
- NCT05913557
- Acronym / sponsor ID
- ROA / 201912169
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Radically Open Dialectical Behavior Therapy (RO DBT)Participants completed a baseline assessment, received 4 months of RO DBT therapy, then completed a follow-up assessment. |
| 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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Treatment Group |
Primary outcome
Changes in error-related negativity (ERN) amplitudes
Time frame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
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)
Time frame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
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)
Time frame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
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
Time frame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
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
Time frame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
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.
5 secondary outcomes
Changes in disruptive eating symptomology using Eating Disorder Examination-Questionnaire (EDE-Q)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
Changes in social impairment using Social Connectedness Scale (SCS)
Time frame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
Changes in depressive symptomology using Child Depression Inventory (CDI)
Time frame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Radically Open Dialectical Behavior Therapy (RO DBT) in people with Anorexia Nervosa and Obsessive-Compulsive Disorder, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in error-related negativity (ERN) amplitudes (time frame: Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up])). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.