Mindfulness-Based Intervention With a Supplement for Stress-Related Problems in College Students Across Multiple Sites (4SITE)

Colorado State University (CSU)

Status: Enrolling

Conditions: Mindfulness Based Stress Reduction; Mental Health; Stress

Treatments: Behavioral: Learning to BREATHE Plus; Behavioral: Learning to BREATHE; Behavioral: HealthEd

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07098845

1R01AT012652 (U.S. NIH Grant/Contract)

5036

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• have several depressive symptoms
• have suicidal ideation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Learning to BREATHE (L2B)

Active Comparator group

Treatment:

Behavioral: Learning to BREATHE

Learning to BREATHE Plus (L2B PLUS)

Experimental group

Treatment:

Behavioral: Learning to BREATHE Plus

HealthEd

Active Comparator group

Treatment:

Behavioral: HealthEd