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临床试验/NCT07478393
NCT07478393招募中不适用

Readiness and Progress in Emotion Regulation Therapy

Teachers College, Columbia University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年10月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Weekly Assessment of Change in Attentional Control

研究概览

简要总结

This study is an open trial designed to examine individual changes that occur before, during, and after 6 modules of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism.

详细描述

The main questions this study aims to answer are to:

  1. Examine temporal patterns of ERT-specific treatment mechanisms (attention regulation, metacognitive regulation, motivation regulation, and valued living), relationships between these mechanisms and negative self-referential processing (NSRP; i.e., rumination, worry, and self-criticism) severity over time, and changes in these mechanisms in response to specific intervention strategies/modules.
  2. Investigate the effect of concordance and/or discordance between therapists and clients regarding skill acquisition, treatment goals, and case conceptualizations on treatment mechanisms as well as measures of treatment outcome and satisfaction.
  3. Demonstrate the preliminary efficacy of a 6-module, time-variable version of ERT in reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination, self-criticism), changing ERT-specific treatment mechanisms (e.g., attention regulation), and improving quality of life and overall functioning.

Participants will:

  1. Fill out an online pre-screening questionnaire and complete a structured clinical interview via Zoom Healthcare
  2. Be enrolled as a patient at the Dean Hope Center for Educational and Psychological Services (DHCEPS), located at Teachers College
  3. Attend between 12-22 once-weekly telehealth ERT sessions
  4. Complete between 18-28 weekly questionnaires online via Qualtrics (two before starting treatment, 12-22 during each week of treatment, and 4 after ending treatment).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18 and 65
  • Fluent in English (and therefore able to provide consent)
  • Currently living in New York State
  • Access to at least one device with internet and video-conferencing capabilities
  • High self-reported worry, rumination, and/or self-criticism
  • Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for at least one, current psychological disorder

排除标准

  • Active suicidal ideation or intent
  • Substance dependence disorder, schizophrenia, bipolar-I disorder, or a primary DSM-5 diagnosis of borderline or narcissistic personality disorder
  • Currently in therapy or receiving any type of psychosocial treatment
  • Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months
  • Current students at Teachers College, Columbia University

研究组 & 干预措施

Treatment

Experimental

All participants will receive a 6-module, time-variable version of Emotion Regulation Therapy delivered weekly via synchronous telehealth using videoconferencing software and an asynchronous Internet-based online platform to supplement the content covered in each session.

干预措施: Emotion Regulation Therapy via Telehealth (Behavioral)

结局指标

主要结局

Weekly Assessment of Change in Attentional Control

时间窗: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)

The Attentional Control Scale (ACS) is a 21-item measure used to measure difficulties with concentration associated with problems regulating emotions. The focusing and shifting subscales of the ACS align with the two attention emotion regulation (ER) skills taught in ERT.

Weekly Assessment of Change in Decentering

时间窗: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)

The decentering subscale of the Experiences Questionnaire (EQ-D) is an 11-item subscale assessing one's ability to distance themselves from their emotional experience, which is one metacognitive ER skill taught during ERT. Higher scores on this subscale indicate better ability to distancing oneself from one's emotional experience.

Weekly Assessment of Change in Reappraisal

时间窗: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)

The reappraisal subscale of the Emotion Regulation Questionnaire (ERQ) is a 6-item measure of the ability to regulate emotions, using the strategy of reappraisal. Higher scores on this subscale indicate a better ability to regulate emotions using the strategy of reappraisal.

Weekly Assessment of Change in Valued Living/Action

时间窗: Baseline, 1st Treatment Session, Follow-Up (4 weeks)

The Valuing Questionnaire (VQ) is a 10-item measure of the degree to which patients live by their values in daily life. It uses a 7-point Likert scale (0-6) to assess progress and obstructions to valued living. Higher scores on this measure indicate more valued living.

Weekly Assessment of Change in Clarity of Approach-Avoidance Motivation

时间窗: Baseline, 1st Treatment Session, Follow-Up (4 weeks)

The Mental Representation of Approach Avoidance Questionnaire (MRAAQ) is a 42-item self-report assessment designed to capture the mental representation of approach-avoidance motivation.

Weekly Assessment of Change in Rumination

时间窗: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)

The Rumination-Reflection Questionnaire (RRQ) is a 12-item measure that assesses past-focused rumination with specificity regarding the types of rumination that people may experience. Higher scores on this measure indicate greater rumination.

Weekly Assessment of Change in Worry

时间窗: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)

The Penn State Worry Questionnaire - Past Week (PSWQ-PW) is an adapted version of the original PSWQ, contains 15 items (rated on a 0-6 scale), and assesses the extent to which worry has been excessive, uncontrollable, and pervasive in the past week. Higher scores on this measure indicate greater worry in the past week.

Weekly Assessment of Change in Self-Criticism

时间窗: Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)

The self-judgment subscale of the Self-Compassion Scale (SCS) contains 5-items and assesses the tendency to self-criticize. Higher scores on this measure indicate greater self-criticism.

次要结局

  • Weekly Assessment of Change in Depression Severity(Baseline, 1st Treatment Session, Follow-Up (4 weeks))
  • Weekly Assessment of Change in Anxiety Severity(Baseline, 1st Treatment Session, Follow-Up (4 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas Mennin

Professor of Clinical Psychology, Director of Clinical Training

Teachers College, Columbia University

研究点 (1)

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