Targeting the Transdiagnostic Mechanism of Performance Monitoring and Overcontrol in Adolescence: Adaptation and Feasibility
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Changes in scores on Adolescent Over- and Under-control Trait Measure (OUT'M)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Changes in scores on Adolescent Over- and Under-control Trait Measure (OUT'M)
时间窗: 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
时间窗: 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 scores on Overcontrol Youth Checklist (OCYC)
时间窗: 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 Reward Positivity (RewP) amplitudes
时间窗: 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.
Changes in error-related negativity (ERN) amplitudes
时间窗: 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)
次要结局
- Changes in depressive symptomology using Child Depression Inventory (CDI)(Baseline (all groups), 4 months (treatment group, no treatment group [subset completing follow-up]))
- 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 social impairment using Social Connectedness Scale (SCS)(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]))