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临床试验/NCT06570603
NCT06570603招募中不适用

Targeting Components of Distress Tolerance

University of Arkansas, Fayetteville1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年10月3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
240
试验地点
1
主要终点
Binge Eating Disorder Scale

研究概览

简要总结

The goal of this clinical trial is to learn which aspects of distress intolerance (i.e., difficulties withstanding upsetting emotional states) are the most important for improving effective emotion regulation and associated mental health symptoms.

The main questions it aims to answer are:

How are willingness to feel upset and self-efficacy for withstanding distress associated with different emotion regulation strategies used in daily life?

Does targeting willingness to feel upset and/or self-efficacy for withstanding distress help people use more effective emotion regulation strategies in daily life when they feel upset?

Are improvements in emotion regulation strategies in daily life associated with fewer symptoms of mental health problems over time?

Participants will:

Answer questions about their moods, willingness to feel upset, self-efficacy for withstanding distress and emotion regulation strategies for three weeks using a cell phone app

Undergo a willingness, self-efficacy, combined or psychoeducational control intervention in the lab

Be prompted to use the intervention skill via the cell phone app during the second week, after the intervention

Complete weekly reports of mental health symptoms

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 (Participant)

入排标准

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

入选标准

  • •Fluent in English
  • •Uses Android or iPhone smartphone
  • •Depression Anxiety and Stress Scale (DASS-21) scores of 42 and higher
  • •Distress Intolerance Index (DII) scores of 3 or higher

排除标准

  • •Work or School that does not allow consistent access to phone (or is unsafe)
  • •No internet access for completing follow-up surveys

研究组 & 干预措施

Combined Willingness and Self-Efficacy

Experimental

Single session intervention focused on increasing both willingness and self-efficacy. Will include brief psychoeducation about emotion, then a combination of using values and self-compassion to increase both allowing and self-efficacy.

干预措施: Self-Efficacy (Behavioral)

Combined Willingness and Self-Efficacy

Experimental

Single session intervention focused on increasing both willingness and self-efficacy. Will include brief psychoeducation about emotion, then a combination of using values and self-compassion to increase both allowing and self-efficacy.

干预措施: Willingness (Behavioral)

Combined Willingness and Self-Efficacy

Experimental

Single session intervention focused on increasing both willingness and self-efficacy. Will include brief psychoeducation about emotion, then a combination of using values and self-compassion to increase both allowing and self-efficacy.

干预措施: Psychoeducation (Behavioral)

Psychoeducational Control

Placebo Comparator

Participants will receive psychoeducation only

干预措施: Psychoeducation (Behavioral)

Self-Efficacy (Only)

Experimental

Single session intervention focusing on increasing self-efficacy to manage distress. Will include brief psychoeducation about emotion, then a focus on agency and self-criticism, using stressors the participant provided from the previous week, with an aim to teach self-compassion skills that will improve self-efficacy.

干预措施: Self-Efficacy (Behavioral)

Self-Efficacy (Only)

Experimental

Single session intervention focusing on increasing self-efficacy to manage distress. Will include brief psychoeducation about emotion, then a focus on agency and self-criticism, using stressors the participant provided from the previous week, with an aim to teach self-compassion skills that will improve self-efficacy.

干预措施: Psychoeducation (Behavioral)

Willingness (Only)

Experimental

Single session intervention focused on increasing willingness to allow distress. Will include brief psychoeducation about emotion, then a discussion of values and how allowing and experiencing emotions nourishes values, experiencing discomfort enhances growth. Will use stressors from the prior week as examples.

干预措施: Willingness (Behavioral)

Willingness (Only)

Experimental

Single session intervention focused on increasing willingness to allow distress. Will include brief psychoeducation about emotion, then a discussion of values and how allowing and experiencing emotions nourishes values, experiencing discomfort enhances growth. Will use stressors from the prior week as examples.

干预措施: Psychoeducation (Behavioral)

结局指标

主要结局

Binge Eating Disorder Scale

时间窗: Baseline, weekly for three weeks and then after one month followup

binge eating symptoms

Engagement behaviors

时间窗: Assessed 5x/day via ecological momentary assessment

Emotion regulation strategies reflective of engagement; these are new items developed for this study and are not from an established scale. All items will be rated from 0 (not at all) to 6 (extremely). There will be 7 items assessing labeling ("I'm using emotion words to describe how I feel right now"), processing ("I'm reflecting on or writing about my feelings"), sharing ("I'm sharing how I feel with another person"), physical feeling ("I'm intentionally feeling my feelings in my body"), curiously considering ("I'm curiously considering how my feelings came about"), defusion ("I'm observing my feelings without getting 'stuck' in them"), and importance ("I'm trying to think about how this current situation maps on to what matters.")

GAD-7

时间窗: Baseline, weekly for three weeks and then after one month followup

Symptoms of anxiety

PHQ-9

时间窗: Baseline, weekly for three weeks and then after one month followup

symptoms of depression

Disengagement behaviors

时间窗: Assessed 5x/day via ecological momentary assessment

Emotion regulation strategies reflective of disengagement, some of which were modified from a momentary experiential avoidance measure (Hershenberg et al., 2017). All items will be rated from 0 (not at all) to 6 (extremely).Items will assess distraction ("Trying to distract myself from my feelings'), thought suppression ("Trying to push unwanted thoughts out of my mind."), discounting ("I'm telling myself I shouldn't be feeling the way I'm feeling"), expressive suppression ("I'm trying to control my feelings by not expressing them"), procrastination ("I'm intentionally putting of an unpleasant task until later"), denial ("I'm trying to 'turn off' the feelings that I don't want to feel"), and reduce importance ("Trying to think about the current situation as unimportant to me.")

AUDIT

时间窗: Baseline, weekly for three weeks and then after one month followup

Alcohol misuse

DSM Cross-Cutting Symptom Measure

时间窗: Baseline, weekly for three weeks and then after one month followup

symptoms of psychopathology

次要结局

  • Satisfaction with Life Scale (SWLS)(Baseline, weekly for three weeks and then after one month followup)
  • State Loss of Interest and Pleasure Scale(Baseline, weekly for three weeks and then after one month followup)
  • Self-Compassion Scale - Short(Baseline, weekly for three weeks and then after one month followup)
  • Rumination and Reflection Questionnaire(Baseline, weekly for three weeks and then after one month followup)

研究者

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

Jennifer C Veilleux

Associate Professor

University of Arkansas, Fayetteville

研究点 (1)

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