An Online Wellness Intervention: Investigating the Efficacy of the Common Elements Toolbox
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 829
- 试验地点
- 2
- 主要终点
- 2-week change in the Generalized Anxiety Disorder 7 scale (GAD7)
研究概览
简要总结
In this study, the investigators will test the effectiveness of a digital, single-session mental health intervention. There will be two conditions: the COMET intervention and the control group. The program, COMET (Common Elements Toolbox), will include a variety of modules which will focus on cognitive restructuring, gratitude, behavioral activation, and self-compassion. A similar intervention has previously been tested with Indian adolescents and adapted for US graduate students.
详细描述
Participants who follow the study link in Prolific will immediately be taken to the Informed Consent Statement (ICS), which will include a description of the study, risks and benefits, payment, and confidentiality. After reading the ICS, participants will confirm their consent by clicking "I consent to participate in this study." They will then be taken to the welcome page for the study and confirm that they will provide their best answers. Once participants have confirmed their consent, they will be taken to the rest of the survey.
All participants will fill out a series of questionnaires including: the Generalized Anxiety Disorder 7-item (GAD-7), Patient Health Questionnaire 8-item (PHQ-8), WHO-5 Wellbeing Index (WHO-5), 3 questions from the Insomnia Severity Index (ISI), Emotion Regulation Questionnaire (ERQ), Ten-Item Personality Inventory (TIPI), Adverse Childhood Experiences Scale (ACES), Work and Social Adjustment Scale (WSAS), 4 mechanisms questions, 3 items from the Secondary Control Scale (SCS), Module preferences and the System Usability Scale (SUS). After completing these questionnaires participants will be randomized to either the COMET intervention condition (who receive the intervention immediately) or the control condition (who will receive the intervention after 8 weeks). they will be randomized to one of two conditions: COMET (will receive the COMET intervention immediately) or a waitlist control (will receive the COMET intervention in 8 weeks). This randomization will be completed via the Qualtrics randomizer function - which randomly and evenly assigns participants to the two conditions.
Participants who are assigned to the COMET condition will then be taken to the intervention introduction. They will then receive the following modules: cognitive restructuring (labeled "flexible thinking"), behavioral activation (labeled "positive activities"), gratitude, and self-compassion. In the flexible thinking module, participants will learn to identify and reframe negative beliefs. They will first read about a hypothetical character who is adjusting to changes in their routine. Then, using the character's story as an example, they will try to identify negative beliefs that the character may be experiencing and ways the character could reframe the belief. Then, they will apply this technique to a situation in their own life. In the positive activities module, participants will identify and reflect on activities that are important to them. They will list activities they find enjoyable and meaningful. Then, they will reflect on why these activities matter to them and schedule in time to perform these activities in the weeks ahead. In the gratitude module, participants will be asked to reflect and write about 3 things they are grateful about. They will then be asked to think and write about things they notice around them that they enjoy and are grateful for. In the self-compassion module, participants will be asked to write a self-compassion letter to themselves, expressing compassion towards themselves just as they would towards a friend or family member. They will also be requested to create a few sentences that they would like to hear when feeling self-critical.
After completing the COMET intervention, participants will complete the post-intervention questions. A mental wellbeing resource list will be provided at the end of the session.
Participants who are assigned to the control condition will complete a separate series of questionnaires: hypothetical questions about emotional experiences using questions from the GAD-7 (Hypothetical Questions - GAD-7) and hypothetical questions about emotional experiences using questions from the PHQ-9 (Hypothetical Questions - PHQ-9).
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A positive response (i.e., "yes") to the question: "Do you have or have you had a diagnosed, ongoing mental health/illness/condition?"
排除标准
- 未提供
结局指标
主要结局
2-week change in the Generalized Anxiety Disorder 7 scale (GAD7)
时间窗: 2 weeks
Changes in GAD7 from baseline to Week 2. The GAD7 is a measure of anxiety and the measure is scored on a scale of 0 - 21 where higher scores indicate higher anxiety (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
8-week change in the Generalized Anxiety Disorder 7 scale (GAD7) 8-week change in the Generalized Anxiety Disorder 7 scale (GAD7)
时间窗: 8 weeks
Changes in GAD7 from baseline to Week 2. The GAD7 is a measure of anxiety and the measure is scored on a scale of 0 - 21 where higher scores indicate higher anxiety (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
8-week change in the Patient Health Questionnaire
时间窗: 8 weeks
Changes in PHQ8 from baseline to Week 8. The PHQ8 is a measure of depression and the measure is scored on a scale of 0 - 24 where higher scores indicate higher depression (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
2-week change in the Patient Health Questionnaire
时间窗: 2 weeks
Changes in PHQ8 from baseline to Week 2. The PHQ8 is a measure of depression and the measure is scored on a scale of 0 - 24 where higher scores indicate higher depression (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.
次要结局
- 8-week change in the World Health Organization Well-being Index 5 (WHO5)(8 weeks)
- 8-week change in the Work and Social Adjustment Scale (WSAS)(8 weeks)
- 8-week change in Emotion Regulation Scale (ERQ) - Reappraisal subscale(8 weeks)
- 8-week change in the Emotion Regulation Scale (ERQ) - Suppression subscale(8 weeks)
研究者
Lorenzo Lorenzo-Luaces
Assistant Professor Pyschological and Brain Sciences
Indiana University
