StressNCT03704779
Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress
A study testing Multimodal mindfulness activity program in people with Stress, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this pilot study is to develop and assess a multimodal mindfulness activity program for physical and occupational therapy students intended to teach management of stressors impacting educational performance. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Multimodal mindfulness activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 11 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be student volunteers in the Columbia University Physical and Occupational Therapy Programs.
- Students must be in their first or second year, second semester in order to compare GPA pre- and post-intervention.
Who cannot join
- Students who are practiced meditators or who have prior experience with mindfulness training will be excluded from study participation, as such previous experience could bias intervention results.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to develop and assess a multimodal mindfulness activity program for physical and occupational therapy students intended to teach management of stressors impacting educational performance. This study will use a two group, randomized controlled design in which approximately 25 students will be randomized to an intervention group and 25 to a control group. Intervention will be implemented in an 8-week period with pre- and post-study measures administered at 1-week prior to and 1-week following intervention.
Read the detailed description
College students have reported increasing stress levels in the last 5 years with 1 in 6 students experiencing anxiety levels that adversely impact school function. This study's intervention uses a variety of media and both online and in-person delivery strategies. For example, students will have the opportunity to participate in yoga, Tai Chi, guided imagery meditation, creative arts, journaling, and pet therapy. Students will additionally have the opportunity to participate in activities delivered through online media and accessible at all times throughout the study. Approximately 50 occupational and physical therapy students will be recruited to participate in this study. Half will be selected by chance to participate in the 8-week program; the remaining half will be selected by chance to participate in a non-intervention group in which they do not receive the program but are still assessed at pre- and post-program to measure perceived stress levels. It is anticipated that study results will provide information to educational institutions to help students better manage stress levels.
- Conditions
- Stress
- Being tested
- Multimodal mindfulness activity program
- Keywords
- Mindfulness, Student
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal mindfulness activity programBehavioural
This program will provide the opportunity for participants to engage in in-person and online activities. The in-person activities will be held from 12:00 pm to 12:45 pm in the Georgian Physical Therapy Lab (and offered twice per week). The online activities will be available at all times during the study at convenience. There are one 40-minute in-person and four 10-minute online mindfulness activities per week (combined time of 1 hour and 20 minutes per week).
In-person activities will consist of mindfulness activities including guided imagery meditation, yoga, Tai Chi, progressive muscle relaxation, creating a Zen garden, aromatherapy, journaling, self-massage, and pet therapy. Online materials will additionally include guided and unguided meditations.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Mindfulness Activity Program | Experimental | Students assigned to the intervention will receive 8 weeks of the mindfulness activity intervention. Receives: Behavioral: Multimodal mindfulness activity program |
| Control Group | No intervention | Students assigned to the control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
The Perceived Stress Scale (PSS) is a 10-item, 5-point, self-report Likert scale (0 = no stress, 5 = high stress) that requires 5 minutes to complete. The scale yields a total score ranging from 0 (no stress) to 50 (highest stress) with scores 25+ indicating a possible stress disorder. The PSS measures stress level in the last month and was intended for use by community-dwelling adults.
Measured: 10 minutes
Secondary outcomes (4)
Student Stress Management Questionnaire
The Student Stress Management Questionnaire (SSMQ) is a 12-item, 5-point Likert scale (0 = no stress, 5 = high stress) that requires 5 minutes to complete. The scale yields a total score ranging from 0 (no stress) to 60 (highest stress) with scores 40+ indicating a possible stress disorder. The SSMQ measures stress level in the last month and was intended for use by college students.
Measured: 10 minutes
Daily Log
The daily log is a 6-item questionnaire that allows students to record the number and length of mindfulness activities in which they participated that day. Students also report their level of stress before and after participation using a 5-point Likert scale (0 = no stress, 5 = high stress). Scores of 15+ indicate higher stress levels.
Measured: 10 minutes
Grade Point Average (GPA)
GPA will be calculated for the semester prior to and directly after study participation.
Measured: 5 minutes
Number of Student Wellness Center Visits
The number of Student Wellness Center visits prior to and directly after study participation will be collected.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Feb 2019
- Primary completion11 Apr 2019
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Intervention will be implemented over 8 consecutive weeks and will consist of experiential mindfulness activities that can be accessed in-person and online. In-person mindfulness activities will be available twice per week and last approximately 40 minutes in length. Mindfulness meditation videos posted online will be available 24/7 and last 10-45 minutes. Students will be asked to participate in one 40-minute in-person and four 10-minute online mindfulness activities per week (total of 1 hour and 20 minutes per week). Week 1. Progressive muscle relaxation, mindfulness meditation, guided imagery. Week 2. Mindfulness: Zen garden, painting, craftwork. Week 3. Active Meditation: yoga, Tai Chi. Week 4. Aromatherapy. Week 5. Addiction Information and Management Strategies. Week 6. Positive Psychology Strategies: cognitive reframing techniques. Week 7. Self-Compassion Strategies: walking meditation, nutritious snacks, self-massage. Week 8. Pet Therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Gutman, Columbia University
- Investigators
- Sharon A Gutman, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704779
- Sponsor's protocol ID
- AAAS0303
- Status last verified
- Apr 2019
- First submitted
- 10 Oct 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multimodal Mindfulness Program to Alleviate Graduate Student Stress
- ClinicalTrials.gov ID
- NCT03704779
- Acronym / sponsor ID
- AAAS0303
- Conditions
- Stress
- Keywords
- Mindfulness, Student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to develop and assess a multimodal mindfulness activity program for physical and occupational therapy students intended to teach management of stressors impacting educational performance. This study will use a two group, randomized controlled design in which approximately 25 students will be randomized to an intervention group and 25 to a control group. Intervention will be implemented in an 8-week period with pre- and post-study measures administered at 1-week prior to and 1-week following intervention.
Detailed description
College students have reported increasing stress levels in the last 5 years with 1 in 6 students experiencing anxiety levels that adversely impact school function. This study's intervention uses a variety of media and both online and in-person delivery strategies. For example, students will have the opportunity to participate in yoga, Tai Chi, guided imagery meditation, creative arts, journaling, and pet therapy. Students will additionally have the opportunity to participate in activities delivered through online media and accessible at all times throughout the study. Approximately 50 occupational and physical therapy students will be recruited to participate in this study. Half will be selected by chance to participate in the 8-week program; the remaining half will be selected by chance to participate in a non-intervention group in which they do not receive the program but are still assessed at pre- and post-program to measure perceived stress levels. It is anticipated that study results will provide information to educational institutions to help students better manage stress levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention will be implemented over 8 consecutive weeks and will consist of experiential mindfulness activities that can be accessed in-person and online. In-person mindfulness activities will be available twice per week and last approximately 40 minutes in length. Mindfulness meditation videos posted online will be available 24/7 and last 10-45 minutes. Students will be asked to participate in one 40-minute in-person and four 10-minute online mindfulness activities per week (total of 1 hour and 20 minutes per week). Week 1. Progressive muscle relaxation, mindfulness meditation, guided imagery. Week 2. Mindfulness: Zen garden, painting, craftwork. Week 3. Active Meditation: yoga, Tai Chi. Week 4. Aromatherapy. Week 5. Addiction Information and Management Strategies. Week 6. Positive Psychology Strategies: cognitive reframing techniques. Week 7. Self-Compassion Strategies: walking meditation, nutritious snacks, self-massage. Week 8. Pet Therapy.
| Arm | Type | Receives |
|---|---|---|
| Multimodal Mindfulness Activity Program | Experimental | Behavioral: Multimodal mindfulness activity programStudents assigned to the intervention will receive 8 weeks of the mindfulness activity intervention. |
| Control Group | No intervention | –Students assigned to the control group will not receive any intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants will be student volunteers in the Columbia University Physical and Occupational Therapy Programs.
- Students must be in their first or second year, second semester in order to compare GPA pre- and post-intervention.
Key exclusion criteria (1 listed)
- Students who are practiced meditators or who have prior experience with mindfulness training will be excluded from study participation, as such previous experience could bias intervention results.
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 |
|---|---|---|
| Multimodal mindfulness activity programThis program will provide the opportunity for participants to engage in in-person and online activities. The in-person activities will be held from 12:00 pm to 12:45 pm in the Georgian Physical Therapy Lab (and offered twice per week). The online activities will be available at all times during the study at convenience. There are one 40-minute in-person and four 10-minute online mindfulness activities per week (combined time of 1 hour and 20 minutes per week). In-person activities will consist of mindfulness activities including guided imagery meditation, yoga, Tai Chi, progressive muscle relaxation, creating a Zen garden, aromatherapy, journaling, self-massage, and pet therapy. Online materials will additionally include guided and unguided meditations. | Behavioural | Multimodal Mindfulness Activity Program |
Primary outcome
Perceived Stress Scale
Time frame: 10 minutes
The Perceived Stress Scale (PSS) is a 10-item, 5-point, self-report Likert scale (0 = no stress, 5 = high stress) that requires 5 minutes to complete. The scale yields a total score ranging from 0 (no stress) to 50 (highest stress) with scores 25+ indicating a possible stress disorder. The PSS measures stress level in the last month and was intended for use by community-dwelling adults.
4 secondary outcomes
Student Stress Management Questionnaire
Time frame: 10 minutes
Daily Log
Time frame: 10 minutes
Grade Point Average (GPA)
Time frame: 5 minutes
Number of Student Wellness Center Visits
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Sharon A Gutman, PhD principal investigator
Columbia 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 Multimodal mindfulness activity program in people with Stress, run by Columbia 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 2 inclusion and 1 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 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived Stress Scale (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2019.