Effectiveness of Interpretation of Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,748
- 试验地点
- 2
- 主要终点
- Change in Recognition Ratings (Positive Interpretation Bias)
研究概览
简要总结
The project aims to compare effectiveness and target engagement of CBM-I delivered via computer vs. mobile phone, and test if adding minimal human contact for participants at risk of dropout improves retention and outcomes.
详细描述
Approximately 25-30% of the U.S. population will experience anxiety pathology severe enough to qualify for an anxiety disorder diagnosis during their lifetime. Critically, the majority will not receive treatment, creating a serious need to consider alternative approaches to delivering mental health services that can meet needs on a larger scale. Cognitive Bias Modification (CBM) interventions for anxiety hold considerable promise as a way to meet these needs. These programs alter biased ways of thinking, such as selective assignment of threat interpretations, which are known to cause and maintain anxiety. CBM for interpretation bias (CBM-I) has established efficacy when administered via computer in the laboratory, and there is clear evidence for target engagement (i.e., change in interpretations, the identified mechanism). Now, effectiveness needs to be tested in the community, using sufficiently large samples to evaluate key moderators of its effects, including delivery method (computer vs. mobile phone) and the addition of minimal human contact (for those at risk of attrition). Addressing attrition is critical given high rates of drop out for web-based interventions. Via the PI's MindTrails web site (established with the lab's prior NIMH R34MH106770 award), the lab already has the infrastructure to deliver CBM to the public and recruit large anxious samples. Moreover, the PI and Co-I have established infrastructure to do mobile sensing of mood and CBM-I delivery via mobile phones. Thus, the project can respond to NIMH's request for "Effectiveness trials that can contribute to advancing the personalization of mental health care." The current proposal aims to compare effectiveness and target engagement of CBM-I delivered via computer vs. mobile phone, and test if adding minimal human contact for participants at risk of dropout improves retention and outcomes. Study 1 will provide a pilot feasibility and user experience test of the CBM-I program on mobile phones. Study 2 will examine the lab's current online, computer-based CBM-I data to help determine empirical indicators of attrition. Study 3 will provide the primary test of moderators of effectiveness. Namely, in Study 3, high anxious participants will be randomized to one of 2 conditions: 1) CBM-I training delivered by computer or mobile phone (at existing MindTrails site); 2) Alternate intervention group-Psychoeducation only. CBM-I and Psychoeducation conditions include 5 weekly training sessions. Based on theoretically- and empirically-derived predictors of attrition, participants identified as high-risk for dropout in condition 1 will then be randomly assigned to add minimal human contact (using a modified TeleCoach protocol) or no change. Using this adaptive intervention, known as Sequential, Multiple Assignment, Randomized Trial (SMART), the project can test both the effects of CBM-I delivery method and the added value of human contact to improve retention for participants at high-risk for dropping out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Participants will be aware whether they are completing the intervention by phone or computer, and will know if they are receiving coaching or not.
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
- •Age 18 and over
- •Moderate to extremely severe anxiety range (i.e., 10 or higher) on the Depression, Anxiety, Stress Scales - Short Form: Anxiety Subscale
- •Regular access to the Internet via Smartphone or computer
排除标准
- 未提供
结局指标
主要结局
Change in Recognition Ratings (Positive Interpretation Bias)
时间窗: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the positive, threat-related ratings index positive interpretation bias. Higher scores represent a more positive interpretation bias.
Change in Recognition Ratings (Negative Interpretation Bias)
时间窗: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the negative, threat-related ratings index negative interpretation bias. Higher scores represent a more negative interpretation bias.
Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias)
时间窗: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the threat-unrelated ratings as an index of benign interpretation bias. Higher scores represent a more benign interpretation bias.
Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias)
时间窗: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the negative, threat-related ratings as an index of negative interpretation bias. Higher scores represent a more negative interpretation bias.
Change in Overall Anxiety Severity and Impairment Scale
时间窗: Baseline, and after sessions 1,2, 3, 4, 5 (sessions will be spaced ~1 week apart) & at 2-month follow-up (~2 months after session 5). Session 1 occurs ~0-7 days after baseline. Measure will be completed immediately following that day's training session.
This 5-item measure of anxiety symptom severity and impairment has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 4 (5-point scale). Total scale range = 0-20, with a higher score indicating more severe anxiety. Average item scores are reported below.
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
时间窗: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
This 7-item measure of anxiety symptoms has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 3 (4-point scale). Total DASS-21 anxiety subscale range = 0-21 (multiplied by 2 for DASS-42 = 0-42), with a higher score indicating more severe anxiety symptoms. Average item scores are reported below.
次要结局
- Change in Depression Comorbid Symptoms(Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.)
- Change in Alcohol Use Comorbid Symptoms(Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.)
- Change in Wellness Measures - Optimism(Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.)
- Change in Wellness Measures - Growth Mindset(Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.)
- Change in Wellness Measures - Self-efficacy(Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.)
- Change in Wellness Measures - Life Satisfaction(Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.)
- Change in Mechanisms Underlying Bias Change - Cognitive Flexibility(Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.)
- Change in Mechanisms Underlying Bias Change - Experiential Avoidance(Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.)
- Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal(Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.)
- Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty(Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.)
- Change in Anxiety and Identity Circles(Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.)
研究者
Bethany A. Teachman, Ph.D.
Professor
University of Virginia