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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Control | Active Comparator | The control experimental group received training on the utilization of mindfulness-based stress reduction breathing techniques. Participants were instructed to set a timer for 5 minutes in order to engage in mindfulness breathing. Comprehensive instructions were provided during the initial laboratory time, elucidating the method by which participants were to direct their attention towards their breath. Moreover, participants were encouraged to cultivate a non-judgmental attitude when confronted with potential distractions and to subsequently redirect their focus back to their breathing. Participants were advised to integrate this technique into their daily lives as a means to alleviate anxiety and stress. |
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| Mindfulness-Based Cognitive Therapy intervention | Experimental | The active experimental group received a mindfulness based cognitive therapy through the Sanvello smartphone application. Participants were encouraged to practice mindfulness daily through the application program "Braving Anxiety," which consisted of 35 modules. The anxiety management program consists of 1) Watch, 2) Read, 3) Listen, 4) Plan, 5) Listen - Mindfulness practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Practice | Behavioral | Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory | 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. | Change from baseline, 4 weeks. |
| Perceived Stress Scale | 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. | Change from baseline, 4 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew B Pontifex, PhD | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Kinesiology | East Lansing | Michigan | 48824 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39525940 | Derived | Ellison OK, Bullard LE, Lee GK, Vazou S, Pfeiffer KA, Baez SE, Pontifex MB. Examining efficacy and potential mechanisms of mindfulness-based cognitive therapy for anxiety and stress reduction among college students in a cluster-randomized controlled trial. Int J Clin Health Psychol. 2024 Oct-Dec;24(4):100514. doi: 10.1016/j.ijchp.2024.100514. Epub 2024 Oct 29. |
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Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.
Data will be available following primary publication of the results.
By request and completion of an institutional data-safety and sharing agreement.
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Potential participants were enrolled in a single predominately first year-level college course in health-sciences at Michigan State University.
| ID | Title | Description |
|---|---|---|
| FG000 | Positive Control | The control experimental group received training on the utilization of mindfulness-based stress reduction breathing techniques. Participants were instructed to set a timer for 5 minutes in order to engage in mindfulness breathing. Comprehensive instructions were provided during the initial laboratory time, elucidating the method by which participants were to direct their attention towards their breath. Moreover, participants were encouraged to cultivate a non-judgmental attitude when confronted with potential distractions and to subsequently redirect their focus back to their breathing. Participants were advised to integrate this technique into their daily lives as a means to alleviate anxiety and stress. |
| FG001 | Mindfulness-Based Cognitive Therapy Intervention | The active experimental group received a mindfulness based cognitive therapy through the Sanvello smartphone application. Participants were encouraged to practice mindfulness daily through the application program "Braving Anxiety," which consisted of 35 modules. The anxiety management program consists of 1) Watch, 2) Read, 3) Listen, 4) Plan, 5) Listen - Mindfulness practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants were included in analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Control | The control experimental group received training on the utilization of mindfulness-based stress reduction breathing techniques. Participants were instructed to set a timer for 5 minutes in order to engage in mindfulness breathing. Comprehensive instructions were provided during the initial laboratory time, elucidating the method by which participants were to direct their attention towards their breath. Moreover, participants were encouraged to cultivate a non-judgmental attitude when confronted with potential distractions and to subsequently redirect their focus back to their breathing. Participants were advised to integrate this technique into their daily lives as a means to alleviate anxiety and stress. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Years since birth |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | State-Trait Anxiety Inventory | 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. | All randomized participants were included in analysis. | Posted | Mean | Standard Error | Scale Rating | Change from baseline, 4 weeks. |
|
From enrollment until end of follow-up, up to 4 weeks
Assessed via participant reporting using ClinicalTrials.gov definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Positive Control | The control experimental group received training on the utilization of mindfulness-based stress reduction breathing techniques. Participants were instructed to set a timer for 5 minutes in order to engage in mindfulness breathing. Comprehensive instructions were provided during the initial laboratory time, elucidating the method by which participants were to direct their attention towards their breath. Moreover, participants were encouraged to cultivate a non-judgmental attitude when confronted with potential distractions and to subsequently redirect their focus back to their breathing. Participants were advised to integrate this technique into their daily lives as a means to alleviate anxiety and stress. |
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Although the intervention was not a priori designed as a crisis interventional approach, it was implemented only a month after a mass-shooting event occurred on campus. Thus as Foa et al. (2005, doi: 10.1037/0022-006X.73.5.953), observed that cognitive restructuring had limited effects on individuals with post-traumatic stress disorder (PTSD) and their perceived levels of chronic stress; it is important to acknowledge and consider the limitations this might introduce.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew B. Pontifex | Michigan State University | (517) 355-4730 | pontifex@msu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2023 | Jul 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Cluster randomized allocation to Mindfulness-Based Cognitive Therapy intervention or positive control intervention.
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| BG001 | Mindfulness-Based Cognitive Therapy Intervention | The active experimental group received a mindfulness based cognitive therapy through the Sanvello smartphone application. Participants were encouraged to practice mindfulness daily through the application program "Braving Anxiety," which consisted of 35 modules. The anxiety management program consists of 1) Watch, 2) Read, 3) Listen, 4) Plan, 5) Listen - Mindfulness practice. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Self reported sex at birth | All participants were included in analysis. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Self reported race | All participants were included in analysis. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Self reported ethnicity | All participants were included in analysis. | Count of Participants | Participants |
|
| Education | Self reported years of education. | All participants were included in analysis. | Mean | Standard Deviation | Years |
|
| OG001 | Mindfulness-Based Cognitive Therapy Intervention | The active experimental group received a mindfulness based cognitive therapy through the Sanvello smartphone application. Participants were encouraged to practice mindfulness daily through the application program "Braving Anxiety," which consisted of 35 modules. The anxiety management program consists of 1) Watch, 2) Read, 3) Listen, 4) Plan, 5) Listen - Mindfulness practice. |
|
|
| Primary | Perceived Stress Scale | 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. | All randomized participants were included in analysis. | Posted | Mean | Standard Error | Scale Rating | Change from baseline, 4 weeks. |
|
|
|
| 0 |
| 139 |
| 0 |
| 139 |
| 0 |
| 139 |
| EG001 | Mindfulness-Based Cognitive Therapy Intervention | The active experimental group received a mindfulness based cognitive therapy through the Sanvello smartphone application. Participants were encouraged to practice mindfulness daily through the application program "Braving Anxiety," which consisted of 35 modules. The anxiety management program consists of 1) Watch, 2) Read, 3) Listen, 4) Plan, 5) Listen - Mindfulness practice. | 0 | 150 | 0 | 150 | 0 | 150 |
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