Targeting Attentional and Cognitive Control to Enhance the Transdiagnostic Treatment of Repetitive Negative Thinking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Transdiagnostic Repetitive Negative Thinking (Measured by the Perseverative Thinking Questionnaire [PTQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
研究概览
简要总结
The investigators are conducting this study to learn more about the cognitive and attentional processes among individuals with three types of repetitive negative thinking (RNT): mental rituals (as seen in obsessive compulsive disorder, OCD), worries (as seen in generalized anxiety disorder, GAD), and ruminations (as seen in major depressive disorder, MDD). Specifically, the investigators are studying whether psychological treatment can help people with RNT who have trouble stopping unwanted thoughts and shifting their attention.
详细描述
The current study will examine whether enhancing attention regulation skills in a transdiagnostic intervention for repetitive negative thinking (RNT) will significantly improve the target of attentional/cognitive control. Phase 1 is an open pilot trial in which participants will be assigned to eight 60 minute sessions (over 8 weeks) of Emotion Regulation Therapy-Attention Regulation (AR-ERT). In Phase 2, participants will be randomly assigned (like the flip of a coin) to receive eight 60 minute sessions (over 8 weeks) of either: AR-ERT or Supportive Psychotherapy (SPT). The investigators will use a multi-method approach to measure attentional/cognitive control: (a) behavioral (i.e., eye tracking fixations and reaction time), (b) electrophysiological (i.e., event related potentials), and (c) self-report (i.e., perceived ability to shift and focus attention). They also will examine early signs of treatment efficacy of AR-ERT and SPT and target validation (i.e., whether changes in attentional/cognitive control correlate with changes in RNT and associated symptoms). Participants will receive assessments of these target and outcome measures at baseline (week 0), mid-treatment (week 4), post-treatment (week 8), and 3-month follow-up (week 20 - Phase 2 only). While most of these procedures are conducted virtually (e.g., therapy sessions), some (e.g., eye tracking and electrophysiological assessments) will be performed in-person. Findings could help identify a cross-cutting target that can be engaged to optimize treatment response for individuals with elevated RNT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent evaluators will remain blind to treatment condition throughout the study for all participants. Participants and study therapists will be aware which treatment they have been assigned to.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18-60 years old
- •Right-handed
- •Living in Massachusetts
- •Repetitive Negative Thinking (RNT) in the form of mental rituals, worries, and/or depressive ruminations is the primary reason for seeking treatment
- •RNT significant enough to warrant intervention
- •Fluent in English, willing to provide informed consent, and willing to comply with the study protocol
- •Access to a device with an internet connection, camera, and microphone (e.g., computer, smart phone, tablet)
- •Comfortable and capable of using a computer and completing reaction-time tasks
排除标准
- •History of head injury or neurologic disease, mental retardation, or borderline intellectual functioning that would interfere with ability to participate in the study.
- •Impaired (or uncorrected) vision, medical illness, or medical treatment that would interfere with participation.
- •Active suicidal or homicidal ideation or any features requiring a higher level of care.
- •Lifetime psychotic disorder or bipolar disorder
- •Substance or alcohol use disorder that would interfere with treatment.
- •Current Attention Deficit Hyperactivity Disorder (ADHD) that would interfere with attentional tasks.
- •Unstable dose of psychotropic medications or recent discontinuation of psychotropic medication.
- •Current psychotherapy or plans to initiate such treatment during the study.
- •Previous course of treatment with cognitive behavioral therapy and/or mindfulness/meditation for obsessive compulsive disorder (OCD), generalized anxiety disorder (GAD), or depression.
研究组 & 干预措施
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
干预措施: Emotion Regulation Therapy - Attention Regulation (AR-ERT) (Behavioral)
Phase 2: Supportive Psychotherapy (SPT)
Individuals with repetitive negative thinking receiving Supportive Psychotherapy.
干预措施: Supportive Psychotherapy (SPT) (Behavioral)
Phase 1: Pilot Testing Phase
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
干预措施: Emotion Regulation Therapy - Attention Regulation (AR-ERT) (Behavioral)
结局指标
主要结局
Transdiagnostic Repetitive Negative Thinking (Measured by the Perseverative Thinking Questionnaire [PTQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
时间窗: Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
15-item self-report measure of transdiagnostic repetitive negative thinking that includes items about thoughts as repetitive, intrusive, unproductive, and capturing mental capacity (e.g., "I think about many problems without solving any of them"). Total scores range from 0-60, with higher scores indicating more repetitive negative thinking (i.e., worse outcomes).
次要结局
- Worry (Measured by the Penn State Worry Questionnaire [PSWQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial(Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up))
- Rumination (Measured by the Rumination Response Scale [RRS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial(Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up))
- Mental Rituals (Measured by the Rumination on Obsessions and Compulsions Scale [ROCS] - Mental Neutralizing Subscale) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial(Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up))
- OCD Symptom Severity (Measured by the Yale-Brown Obsessive-Compulsive Scale [Y-BOCS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial(Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up))
- Generalized Anxiety Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale [SIGH-A]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial(Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up))
- Depression Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Depression Rating Scale [SIGH-D]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial(Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up))
- Functional Impairment (Measured by the Work and Social Adjustment Scale [WSAS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial(Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up))
研究者
Ryan Jane Jacoby
Clinical Psychologist, Center for OCD and Related Disorders
Massachusetts General Hospital