AnxietyNCT06019299
Cluster-randomized Controlled Trial of Mindfulness-Based Cognitive Therapy Effects on Anxiety and Stress
A study testing Mindfulness Practice in people with Anxiety and Stress, run by Michigan State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 42 yearsHealthy volunteers can take part
- What is being tested?
- Mindfulness Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2023to 26 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 42 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled in course
Who cannot join
- Complete inattendance in course during the pretest and study period.
- Opted out of data being available for research use
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology
East Lansing, Michigan, 48824
About this study
Official title: Cluster-randomized Controlled Trial Examining the Effectiveness of Mindfulness-Based Cognitive Therapy for Anxiety and Stress Reduction Within College Students
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.
Read the 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.
- Being tested
- Mindfulness Practice
- Keywords
- Mindfulness-Based Cognitive Therapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness PracticeBehavioural
Participants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness Practice |
| 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. Receives: Behavioral: Mindfulness Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline, 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start21 Mar 2023
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized allocation to Mindfulness-Based Cognitive Therapy intervention or positive control intervention.
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew B. Pontifex, Ph.D., Michigan State University
- Investigators
- Matthew B Pontifex, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019299
- Sponsor's protocol ID
- STUDY00008121
- Status last verified
- May 2026
- First submitted
- 18 Jul 2023
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39525940
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster-randomized Controlled Trial Examining the Effectiveness of Mindfulness-Based Cognitive Therapy for Anxiety and Stress Reduction Within College Students
- ClinicalTrials.gov ID
- NCT06019299
- Acronym / sponsor ID
- STUDY00008121
- Keywords
- Mindfulness-Based Cognitive Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized allocation to Mindfulness-Based Cognitive Therapy intervention or positive control intervention.
| Arm | Type | Receives |
|---|---|---|
| Positive Control | Active comparator | Behavioral: Mindfulness PracticeThe 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. |
| Mindfulness-Based Cognitive Therapy intervention | Experimental | Behavioral: Mindfulness PracticeThe 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. |
Who may qualify
- Ages
- 17 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Enrolled in course
Key exclusion criteria (2 listed)
- Complete inattendance in course during the pretest and study period.
- Opted out of data being available for research use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness PracticeParticipants were instructed to practice mindfulness daily using their instructed approaches for a period of 4 weeks. | Behavioural | Mindfulness-Based Cognitive Therapy intervention, Positive Control |
Primary outcome
State-Trait Anxiety Inventory
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39525940Ellison 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew B Pontifex, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Practice in people with Anxiety and Stress, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (time frame: Change from baseline, 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.