A Megastudy of Single-Session Interventions to Challenge Depression in American Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,505
- 试验地点
- 1
- 主要终点
- Change in Patient Health Questionnaire-9 at week 4 (PHQ-9; Kroenke et al., 2001)
研究概览
简要总结
This project aims to learn if new kinds of digital single-session interventions (SSIs) for depression could be effective for American adults. Many existing SSIs are delivered in a simple text-based format. However, it might be that different kinds of SSIs (in terms of both content and style) also have potential for scalable impact. Specifically, this study will investigate the effectiveness of 11 innovative SSIs by comparing them to a passive control and to an existing SSI with established efficacy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least 18 years old
- •Able to read and write fluently in English
- •Have enough access to the internet to complete two sessions over four weeks
- •Score at least 10 on the PHQ-9 screen (suggesting moderate depression; Kroenke et al., 2001)
- •Pass the bot check during the screening survey
- •All participants who are randomized to an experimental condition (and therefore completed all baseline measures) will be included in analyses, except for participants who indicate at the end of either the baseline or week 4 session that they did not participate in the study seriously. Researchers will only keep data from the first survey session a participant begins.
排除标准
- 未提供
研究组 & 干预措施
Passive control (All About Trout)
The passive control condition aims to hold one's attention for 8-10 minutes without influencing depressive symptoms or mood (a three-minute video, multiple-choice questions, two-minute reading passage, three-minute writing exercise, all about trout).
干预措施: All about Trout (Behavioral)
Behavioral Activation (Action Brings Change Project)
A behavioral activation SSI where users learn about negative thought spirals, share advice with an imagined peer, and create an "action plan" of helpful activities to engage in in the future.
干预措施: Behavioral Activation (Action Brings Change Project 10-Minute Version) (Behavioral)
SSI 1: Mindful Acceptance
A clinical psychologist explains a few ways to use mindful acceptance to deal with difficult thoughts and feelings.
干预措施: Mindful Acceptance (Behavioral)
SSI 2: Moral Elevation
Users learn about moral elevation, then watch a touching video where a man does good deeds for people in his community. Finally, they plan a positive action they can take to help others in their own life.
干预措施: Moral Elevation (Behavioral)
SSI 3: Mindful Attention Skills
A series of videos teach mindfulness skills: how to release thoughts and re-evaluate.
干预措施: Mindful Attention Skills (Behavioral)
SSI 4: 5 Habits to Beat Depression
A clinical psychologist and science communicator describes his top 5 one-minute habits to beat depression.
干预措施: 5 Habits to Beat Depression (Behavioral)
SSI 5: Interactive Cognitive Reappraisal
An interactive SSI where participants learn how to reframe negative thoughts.
干预措施: Interactive Cognitive Reappraisal (Behavioral)
SSI 6: Expressive Writing (AI-supported)
Participants describe a persistent negative thought they struggle with and a large language model system helps them to consider a story in which someone learns to overcome that thought.
干预措施: Expressive Writing (AI-supported) (Behavioral)
SSI 7: Inner Child Healing Walk
An interactive journey to reconnect and heal one's inner child through breathing exercises, positive affirmations, and supportive animal companions.
干预措施: Inner Child Healing Walk (Behavioral)
SSI 8: Savoring Strategies
An SSI introducing savoring strategies to improve mood.
干预措施: Savoring Strategies (Behavioral)
SSI 9: Personalized Intervention Recommender
Identifies the kinds of depression one struggles most with and offers a personalized recommendation for future depression support options.
干预措施: Personalized Intervention Recommender (Behavioral)
SSI 10: Dialectical Behavioral Therapy Skills
Presents videos from dialectical behavioral therapy on various ways to control negative emotions.
干预措施: Dialectical Behavioral Therapy Skills (Behavioral)
SSI 11: Reframing Negative Thoughts
An audio-only program in which users are guided to reflect on how they might challenge negative automatic thoughts and beliefs they struggle with.
干预措施: Reframing Negative Thoughts (Behavioral)
结局指标
主要结局
Change in Patient Health Questionnaire-9 at week 4 (PHQ-9; Kroenke et al., 2001)
时间窗: Baseline to week 4
The Patient Health Questionnaire-9 is a validated and self-administered measure to assess depression symptom severity in the general population. Participants are asked to rate how often they are bothered by 9 items (e.g., Poor appetite or overeating) on a scale of 0 (Not at all) to 3 (Nearly every day). Total score can range from 0 to 27, with higher scores indicating higher symptom severity.
次要结局
- Change in Readiness for Change at immediate post-intervention(Baseline to immediate post-intervention)
- Change in Beck Hopelessness Scale at immediate post-intervention (BHS-4; Perczel Forintos et al., 2013)(Baseline to immediate post-intervention)
- Change in Beck Hopelessness Scale at week 4 (BHS-4; Perczel Forintos et al., 2013)(Baseline to week 4)
- Change in Pathways Subscale of the State Hope Scale at immediate post-intervention (Snyder et al., 1996)(Baseline to immediate post-intervention)
- Change in Pathways Subscale of the State Hope Scale at week 4 (Snyder et al., 1996)(Baseline to week 4)
- Change in Readiness for Change at week 4(Baseline to week 4)
- Change in Depression Expectancies for Change at immediate post-intervention (Eddington et al., 2014)(Baseline to immediate post-intervention)
- Change in Depression Expectancies for Change at week 4 (Eddington et al., 2014)(Baseline to week 4)
- Change in Frequency of Actions and Thoughts Scale at immediate post-intervention (FATS; Terides et al., 2016).(Baseline to immediate post-intervention)
- Change in Frequency of Actions and Thoughts Scale at week 4 (FATS; Terides et al., 2016).(Baseline to week 4)
- Credibility and Expectancy Questionnaire at immediate post-intervention (CEQ; Devilly & Borkovec; 2000)(immediate post-intervention)
- Insight Experience at immediate post-intervention(immediate post-intervention)
- Insight Experience at week four(week 4)
- Star rating at immediate post-intervention(immediate post-intervention)
- Star rating at week 4(week 4)
研究者
Jessica Schleider
Professor
Northwestern University