Living Well: A Digital ACT Intervention
Living Well: A Digital Acceptance and Commitment Therapy-Informed Intervention
研究概览
详细说明
Depression and anxiety disorders are among the most prevalent psychological difficulties and contribute to negative economic, social, and health outcomes. As they are frequently comorbid and share underlying mechanisms of dysfunction, many scholars have conceptualized these as a unified category of emotional disorders. Addressing processes contributing to dysfunction among individuals who are at risk for developing emotional disorders has the potential to prevent significant negative impact.
Acceptance and Commitment Therapy (ACT) has received empirical support in the treatment of depression and anxiety in a number of examinations. ACT aims to shape acceptance of challenging thoughts and feelings and engagement with areas of life one finds meaningful and important. The converse of acceptance, experiential avoidance, or the unwillingness to experience unpleasant thoughts and emotions even when doing so is maladaptive, has been predictive of symptoms of depression and anxiety. Reducing experiential avoidance and shaping alternative responses, such as acceptance and behavior consistent with one's values, termed committed action, is a promising strategy for targeting risk for emotional disorders.
Traditional means of delivering interventions fail to reach a substantial proportion of those who struggle with psychological difficulties. Barriers such as distance, time, and cost contribute to these challenges. Digital mental health interventions offer a means to overcome treatment barriers and increase access. These approaches can be delivered in individual's homes at the time of their choosing. Additionally, digital interventions can be delivered to many people at the same time, reducing cost. Support for the impact of ACT-informed digital interventions on symptoms of depression and anxiety has been obtained, suggesting that this framework is promising for reducing risk.
The goal of the current study is to compare the impact of a digital ACT-informed intervention on psychological symptoms and processes of change among individuals at risk for depression and anxiety. The following hypotheses will be evaluated:
- Individuals in the treatment condition will experience a decrease in symptoms of depression and anxiety compared to those in the control group
- Individuals in the treatment condition will experience a decrease in experiential avoidance and increase in values consistent behavior compared to those in the control group
- The digital intervention will generally be rated positively
- The relationship between cognitive fusion and treatment response will be explored
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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Tyler、Texas、美国、75701
- UT Tyler
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Undergraduate students aged 18 or older
- Mildly to moderately elevated symptoms of depression or anxiety as reflected by DASS-21 Depression (5-10) or Anxiety scores (4-7).
Exclusion Criteria:
- Participants under the age of 18
- Severe or extremely severe scores on DASS-21 Depression (11 or greater) or Anxiety (8 or greater).
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Living Well Intervention Group
Participants in the Living Well treatment group will receive a brief digital intervention informed by Acceptance and Commitment Therapy.
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Living Well is a single session digital intervention that aims to decrease experiential avoidance and increase engagement in values-consistent behavior.
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无干预：Control Group
Participants in the control group will not receive any intervention.
These individuals will have the option to access the intervention at the conclusion of their study participation.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Depression Anxiety Stress Scales-21 Depression Scale repeated measure of change
大体时间：pre-intervention, two week post intervention, and four week post intervention
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Depression Anxiety Stress Scales-21 (DASS-21) is a 21 item self report questionnaire assessing symptoms of depression, anxiety, and stress.
The DASS-21 seven item Depression Scale will be used to assess symptoms of depression and with higher scores indicating greater depressive symptoms.
Scores on the DASS-21 Depression Scale range from 0 to 21.
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pre-intervention, two week post intervention, and four week post intervention
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Depression Anxiety Stress Scales-21 Anxiety Scale repeated measure of change
大体时间：pre-intervention, two week post intervention, and four week post intervention
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Depression Anxiety Stress Scales-21 (DASS-21) is a 21 item self report questionnaire assessing symptoms of depression, anxiety, and stress.
The DASS-21 seven item Anxiety Scale will be used to assess symptoms of anxiety with higher scores indicating greater anxiety symptoms.
Scores on the DASS-21 Anxiety Scale range from 0 to 21.
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pre-intervention, two week post intervention, and four week post intervention
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Brief Experiential Avoidance Questionnaire repeated measure of change
大体时间：pre-intervention, two week post intervention, and four week post intervention
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Brief Experiential Avoidance Questionnaire (BEAQ) is a 15 item self report measure assessing experiential avoidance.
Higher scores on the BEAQ indicate greater experiential avoidance.
Scores on the BEAQ can range from 15 to 90.
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pre-intervention, two week post intervention, and four week post intervention
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Valuing Questionnaire-Progress Scale repeated measure of change
大体时间：pre-intervention, two week post intervention, and four week post intervention
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Valuing Questionnaire-Progress Scale (VQ-P) is a five item scale assessing the extent to which one made progress towards one's values that is a part of the ten item Valuing Questionnaire.
Higher scores on the VQ-P indicate greater progress towards one's values and VQ-P scores can range from 0 to 30.
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pre-intervention, two week post intervention, and four week post intervention
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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COVID-19 Impact Indicators repeated measure of change
大体时间：Measured at baseline, 2 weeks post baseline, and 4 weeks post baseline
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Participants will provide information on how they have been impacted by the COVID-19 pandemic.
They will respond to the question "How has the COVID-19 outbreak affected you in the past two weeks (you can select multiple options)" selecting from among 10 possible options: Diagnosed with COVID-19, worked remotely or from home more than you usually do, worked more hours than usual, worked reduced hours, was not able to work, had difficulty arranging for childcare, incurred increased costs for childcare expenses, income or pay has been reduced, not paid at all, had serious financial problems.
Participants may choose between 0 and 10 possible COVID-19 impacts.
These do not belong to a standardized questionnaire, but have been used by other researchers to describe the impact of COVID-19.
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Measured at baseline, 2 weeks post baseline, and 4 weeks post baseline
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Cognitive Fusion Questionnaire
大体时间：Measured at baseline
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The Cognitive Fusion Questionnaire is a self report measure of cognitive fusion consisting of seven items.
Higher scores indicate greater cognitive fusion and scores can range from 7 to 49.
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Measured at baseline
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Treatment Experience/Perceived Need Questions
大体时间：Measured at baseline
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Participants will respond to three questions about past experience with mental health treatment and perceived future need with yes/no responses. These questions do not belong to a standardized questionnaire, but have been used by other researchers to describe participant experience. In the past 12 months, did you receive therapy from a professional counselor or therapist to help you with emotional or mental health problems such as feeling sad, blue, anxious, or nervous? In the past 12 months, did a healthcare professional prescribe medications to help you with emotional or mental health problems such as feeling sad, blue, anxious, or nervous? In the past 12 months, did you think you needed help for emotional or mental health problems such as feeling sad, blue, anxious, or nervous? |
Measured at baseline
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合作者和调查者
调查人员
- 首席研究员：Olga Berkout, PhD、University of Texas at Tyler
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Living Well的临床试验
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Fundació EurecatSilicium Laboratories S.L.; San Antonio Technologies S.L.; Catholic University of Murcia (UCAM); Zaidin Experimental Station, Spanish Council for Scientific Research (CSIC) Agency完全的
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Laura E SimonsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)完全的
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Geisinger ClinicPatient-Centered Outcomes Research Institute; Penn State University; University of Nebraska; Iowa...主动，不招人
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Universiti Teknologi MaraUniversity of Malaya; Universiti Sains Malaysia完全的
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University of PittsburghNational Institute of Mental Health (NIMH)招聘中