Anxiety, Stress
Conditions
Keywords
Mindfulness-Based Cognitive Therapy
Brief summary
To understand the potential effectiveness of a 4 week Mindfulness-Based Cognitive Therapy intervention delivered using a smartphone application for reducing anxiety and stress within college students.
Detailed description
The objective of this project is to understand the potential effectiveness of a 4 week Mindfulness-Based Cognitive Therapy intervention delivered using a smartphone application for reducing anxiety and stress within college students. Although in-person mindfulness-based cognitive therapy approaches have been found effective for reducing anxiety and stress; given the pervasiveness of anxiety and stress in this population, there is a need to provide alternative and accessible interventions to improve students' mental health. One such approach may be by leveraging existing tools such Sanvello - a free mindfulness-based cognitive therapy smartphone application - which could more easily be deployed across a broader population. Accordingly, using a cluster-randomized controlled design, this intervention will assess the extent to which 4-weeks of using the Sanvello application was effective for reducing anxiety and stress within college students.
Interventions
BEHAVIORALMindfulness Practice
Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks.
Sponsors
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cluster randomized allocation to Mindfulness-Based Cognitive Therapy intervention or positive control intervention.
Eligibility
Sex/Gender
ALL
Age
17 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
* Enrolled in course
Exclusion criteria
* Complete inattendance in course during the pretest and study period. * Opted out of data being available for research use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory | Change from baseline, 4 weeks. | Trait scale of the Spielberger State-Trait Inventory as an index of trait anxiety. The possible trait scores range from 20 to 80, with higher scores indicating greater levels of anxiety. |
| Perceived Stress Scale | Change from baseline, 4 weeks. | The Perceived Stress Scale-4 as an index of perceived chronic stress levels. The possible scores range from 0 to 16, with higher scores indicating higher perceived chronic stress levels. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew B Pontifex, PhD
Michigan State University
Participant flow
Recruitment details
Potential participants were enrolled in a single predominately first year-level college course in health-sciences at Michigan State University.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 19.4 Years STANDARD_DEVIATION 1.6 |
| Education | 13.4 Years STANDARD_DEVIATION 0.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 282 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 116 Participants |
| Sex: Female, Male Female | 95 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 139 | 0 / 150 |
| other Total, other adverse events | 0 / 139 | 0 / 150 |
| serious Total, serious adverse events | 0 / 139 | 0 / 150 |
Outcome results
None listed