Testing a Mindfulness-Based Intervention With a Multi-Modal Adaptive Supplement for Stress-Related Problems in College Students
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Program-specific intervention knowledge evaluations
研究概览
简要总结
The investigators hope to add to the feasible, acceptable, and effective interventions that offer reductions in depression, anxiety, and stress for students at U.S. colleges and universities, the majority of whom experience mental health problems but the minority of whom who receive adequate mental health support. By studying the extent to which a multi-modal supplement boosts effects for a mindfulness-based intervention (and comparing both to an active health education control program) to reduce depression, anxiety, and stress, the proposed research seeks to rigorously investigate complementary and integrative health interventions and their roles in improving health.
详细描述
There have been dramatic and concerning increases in rates of psychological distress in students enrolled in US colleges and universities over the last decade. The majority of college students in the last year experienced mental health problems, and if left untreated, symptoms of these problems have serious individual and public health consequences, both in the short- and long-term. However the vast majority of students do not receive professional mental health support because traditional treatments are perceived as ineffective and inconvenient. Additionally, many on campus resources cannot meet the demand of students needing support. As a result, it is critical to identify acceptable and effective interventions to address what is being called a "campus mental health crisis." Mindfulness-based interventions (MBIs) are very well-liked by college students, most of whom are late adolescents; in addition they are effective at increasing mindfulness and emotion regulation as well as reducing stress and depression. However, MBI effects have typically been small-to-moderate. Outside of the mindfulness literature, technological supplements to group-based programs like MBIs have been found to be effective at increasing intervention efficacy. The investigative team developed the first multi-modal adaptive supplement to an MBI (5K01AT009592), Learning To BREATHE PLUS ( L2B PLUS), which supplements an evidence-based group MBI with multiple methods of support for practicing mindfulness in daily life. The investigators program of research provides evidence at a single site that L2P PLUS is feasible and highly acceptable to adolescents, results in sustained levels of engagement across the group program period, and appears to be more effective than the standard Learning To BREATHE group program (L2B) at increasing daily mindfulness practice and consistency of mindfulness during stress as well as reducing psychological distress. In turn, L2B appears more effective in reducing stress-related behavior compared to an active, didactic health education control (HealthEd). Building directly on the investigators' prior work the proposed R01 study is a multisite, pilot randomized controlled trial implemented at four sites in order to prepare for a future multi-site efficacy trial testing the effects of L2B PLUS relative to the standard L2B program and HealthEd on depression, anxiety, and stress. Specific aims of the current proposal are to: 1) evaluate multi-site fidelity of training and implementation of 6-week L2B PLUS, 6 week L2B and 6-week HealthEd to college students experiencing stress, 2) test multi-site feasibility and acceptability of recruitment, retention, and protocol adherence for randomized control trial (RCT) involving L2B PLUS, L2B, and HealthEd, and 3) modify training/implementation and protocol for a future, fully powered multi-site efficacy trial. Completion of these aims will prepare us for an adequately-powered, multi-site efficacy trial, and ultimately inform a complementary and integrative approach to supporting college students experiencing problems with stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18-25 years
- •enrolled in a college or university
- •experiencing elevated stress
- •plan to be available in-person in the semester following the study
- •own a smart phone.
排除标准
- •have several depressive symptoms
- •have suicidal ideation.
研究组 & 干预措施
HealthEd
干预措施: HealthEd (Behavioral)
Learning to BREATHE (L2B)
干预措施: Learning to BREATHE (Behavioral)
Learning to BREATHE Plus (L2B PLUS)
干预措施: Learning to BREATHE Plus (Behavioral)
结局指标
主要结局
Program-specific intervention knowledge evaluations
时间窗: 2 months before baseline
Post-training L2B, L2B PLUS, and HealthEd knowledge assessments (0-25) will be completed by facilitators with higher scores indicating higher intervention knowledge
Number of eligible participants recruited with elevated stress as assessed by the Perceived Stress Scale
时间窗: Within a 12-month period
Study goal of 120 participants total across 4 sites who have elevated stress (\>14) on the Perceived Stress Scale (0-40) where higher scores indicate higher stress
Program-specific facilitator adherence ratings of mock intervention group sessions
时间窗: 2 months before baseline
Facilitator adherence to each intervention manual (0-100) for L2B, L2B PLUS, and HealthEd, during mock sessions after intervention facilitation training where higher scores mean higher adherence
Acceptability ratings of intervention by participants
时间窗: Within one-month of intervention end
Acceptability ratings (1-5) with higher scores meaning higher acceptability
Qualitative assessment of acceptability of interventions
时间窗: Within one-month of intervention end
Focus within group programs will qualitatively assess the acceptability of interventions
Percent of participants retained at post-test
时间窗: Post intervention, 6 weeks after baseline
Percent retention at six-month follow-up
时间窗: 32 weeks after baseline
Program-specific facilitator competence ratings of mock intervention group sessions
时间窗: 2 months before baseline
Facilitator competence of each intervention manual (0-100) for L2B, L2B PLUS, and HealthEd, during mock sessions after intervention facilitation training where higher scores mean higher competence
Percentage of eligible students who enroll
时间窗: Within a 12-month period
Percentage of enrolled participants who attend 5/6 intervention sessions
时间窗: During 6-week interventions
Adherence to standardized data collection protocol measured via standardized checklists
时间窗: At baseline, 6 weeks after, and 32 weeks after
Percentage of data collection protocol adhered to by assessors (0-100) with higher scores indicating better adherence
Qualitative assessment of acceptability of interventions
时间窗: Within one-month of intervention end
Focus within group programs will qualitatively assess the acceptability of interventions
Percent of participants retained at post-test
时间窗: Post intervention, 6 weeks after baseline
Percent retention at six-month follow-up
时间窗: 32 weeks after baseline
Adherence to standardized data collection protocol measured via standardized checklists
时间窗: At baseline, 6 weeks after, and 32 weeks after
Percentage of data collection protocol adhered to by assessors (0-100) with higher scores indicating better adherence
Acceptability ratings of intervention by participants
时间窗: Within one-month of intervention end
Acceptability ratings (1-5) with higher scores meaning higher acceptability
Program-specific intervention knowledge evaluations
时间窗: 2 months before baseline
Post-training L2B, L2B PLUS, and HealthEd knowledge assessments (0-25) will be completed by facilitators with higher scores indicating higher intervention knowledge
Number of eligible participants recruited with elevated stress as assessed by the Perceived Stress Scale
时间窗: Within a 12-month period
Study goal of 120 participants total across 4 sites who have elevated stress (\>14) on the Perceived Stress Scale (0-40) where higher scores indicate higher stress
Program-specific facilitator adherence ratings of mock intervention group sessions
时间窗: 2 months before baseline
Facilitator adherence to each intervention manual (0-100) for L2B, L2B PLUS, and HealthEd, during mock sessions after intervention facilitation training where higher scores mean higher adherence
Program-specific facilitator competence ratings of mock intervention group sessions
时间窗: 2 months before baseline
Facilitator competence of each intervention manual (0-100) for L2B, L2B PLUS, and HealthEd, during mock sessions after intervention facilitation training where higher scores mean higher competence
Percentage of eligible students who enroll
时间窗: Within a 12-month period
Percentage of enrolled participants who attend 5/6 intervention sessions
时间窗: During 6-week interventions
次要结局
- Depressive Symptoms(At baseline, 6 weeks after, and 32 weeks after)
- Clinical Depression(At baseline, 6 weeks after, and 32 weeks after)
- Mindful Attention(At baseline, 6 weeks after, and 32 weeks after)
- Anxiety(At baseline, 6 weeks after, and 32 weeks after)
- Perceived Stress(At baseline, 6 weeks after, and 32 weeks after)
- Social Support(At baseline, 6 weeks after, and 32 weeks after)
- Self Compassion(At baseline, 6 weeks after, and 32 weeks after)
- Application of Mindfulness(At baseline, 6 weeks after, and 32 weeks after)
- Previous Experience with Mindfulness(At baseline, 6 weeks after, and 32 weeks after)
- Meaning in Life(At baseline, 6 weeks after, and 32 weeks after)
- Previous Experience with Meditation(At baseline, 6 weeks after, and 32 weeks after)
- Cortisol stress reactivity(3 visits; baseline, after 6-week intervention, and at 6-month followup)
- Blood pressure reactivity(3 visits; baseline, after 6-week intervention, and at 6-month followup)
- Daily mindful attention(During the 6-week group program)
- Heart rate reactivity(3 visits; baseline, after 6-week intervention, and at 6-month followup)
- Daily self-compassion(During the 6-week group program)
- Daily home practice of intervention material(During the 6-week group program)
- Daily negative events(During the 6-week group program)
- Daily psychological distress(During the 6-week group program)
- Depressive Symptoms(At baseline, 6 weeks after, and 32 weeks after)
- Clinical Depression(At baseline, 6 weeks after, and 32 weeks after)
- Anxiety(At baseline, 6 weeks after, and 32 weeks after)
- Perceived Stress(At baseline, 6 weeks after, and 32 weeks after)
- Social Support(At baseline, 6 weeks after, and 32 weeks after)
- Meaning in Life(At baseline, 6 weeks after, and 32 weeks after)
- Mindful Attention(At baseline, 6 weeks after, and 32 weeks after)
- Self Compassion(At baseline, 6 weeks after, and 32 weeks after)
- Application of Mindfulness(At baseline, 6 weeks after, and 32 weeks after)
- Previous Experience with Mindfulness(At baseline, 6 weeks after, and 32 weeks after)
- Previous Experience with Meditation(At baseline, 6 weeks after, and 32 weeks after)
- Cortisol stress reactivity(3 visits; baseline, after 6-week intervention, and at 6-month followup)
- Blood pressure reactivity(3 visits; baseline, after 6-week intervention, and at 6-month followup)
- Heart rate reactivity(3 visits; baseline, after 6-week intervention, and at 6-month followup)
- Daily mindful attention(During the 6-week group program)
- Daily self-compassion(During the 6-week group program)
- Daily home practice of intervention material(During the 6-week group program)
- Daily negative events(During the 6-week group program)
- Daily psychological distress(During the 6-week group program)
研究者
Rachel Graham
Professor of Human Development & Family Studies and Colorado School of Public Health
Colorado State University