WorryNCT05180513
Mellowing Mind: Comparing Two Technology Based Mindfulness Interventions for Stress Impacted by COVID-19 in Underserved Communities
A study testing Teleconference Mindfulness Intervention and Smartphone App Mindfulness Intervention in people with Worry and Stress, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to examine the comparative effectiveness of two technology-based Mindfulness Based Stress Reduction (MBSR) programs (one via video/teleconference and one via a smartphone app) for reducing worry, anxiety and/or related mental health effects of stress in members of identified underserved… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Teleconference Mindfulness Intervention and Smartphone App Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 30 Jun 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Significant worry as per the Penn State Worry Questionnaire-Abbreviated [PSWQ-A]
- Fluent in English
- Reside in one of the local city zip codes, identified as underserved, and primarily African American, communities
Who cannot join
- Severe depression as per Patient Health Questionnaire [PHQ-9]
- Active suicidal intent as per PHQ-9 question 9
- Diagnosis of psychosis, or bipolar disorder, or moderate or severe substance use disorder in the past month as per self report
- Cognitive impairment as per (modified) Short Portable Mental Status Questionnaire [SPMSQ]
- Currently receiving psychotherapy or behavioral counseling, including MBSR
- Change in psychotropic medications within the last month as per self report
- Unable to communicate in a way that would allow for participation in screenings or sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York, University at Buffalo
Buffalo, New York, 14214
About this study
Official title: Comparing Two Ways to Mitigate the Impact of the COVID-19 Pandemic on Mental Health Among Adults From Underserved and Racial Minority Communities
The purpose of this study is to examine the comparative effectiveness of two technology-based Mindfulness Based Stress Reduction (MBSR) programs (one via video/teleconference and one via a smartphone app) for reducing worry, anxiety and/or related mental health effects of stress in members of identified underserved communities, which were highly impacted by the COVID-19 pandemic.
Read the detailed description
The purpose of this randomized controlled study is to examine the comparative effectiveness of two technology-based Mindfulness Based Stress Reduction (MBSR) programs (one via video/teleconference and one via a smartphone app) for reducing worry, anxiety, and/or related mental health effects of stress in members of identified underserved communities, which were highly impacted by the COVID-19 pandemic. Participants will be randomly assigned to a teleconference MBSR program, a MBSR smartphone app program, or a waitlist control group. Each intervention includes participation in a 9-week (8 sessions plus an introduction) mindfulness intervention that consists of instruction and daily practice. Questionnaires and semi-structured interviews will be administered at mid-intervention, post-intervention, and one-month and three-month follow-up points. It is hypothesized that participants in the two intervention groups will show measurable and sustained improvement in the primary outcome, worry, as well as in the secondary outcomes, anxiety and related mental health effects. It is further hypothesized that the smartphone app mindfulness intervention will show similar effectiveness to the teleconference mindfulness intervention.
- Being tested
- Teleconference Mindfulness Intervention, Smartphone App Mindfulness Intervention
- Keywords
- Mindfulness Based Stress Reduction, Community Based Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teleconference Mindfulness InterventionBehavioural
The teleconference intervention is administered by a trained interventionist via Zoom and is based on a manual adapted from a traditional MBSR version. Practices and activities include meditations, mindful breathing exercises and movements, discussions, and reflections, which participants learn at weekly sessions and practice on their own throughout the week. To adapt the traditional MBSR program for the target community population, intervention materials were reviewed for feedback from community stakeholders, and modified according to their feedback.
Smartphone App Mindfulness InterventionBehavioural
The smartphone app intervention is administered through the app. The smartphone app aligns with the traditional MBSR format, but training and practice is done individually and independently by members of this group. To adapt the traditional MBSR program for the target community population, the app was tested by community stakeholders and modified according to their feedback.
| Study group | Role | What they receive |
|---|---|---|
| Teleconference Mindfulness Intervention Group | Other | MBSR training program that has been adapted for use via Zoom teleconferencing and for cultural relevancy Receives: Behavioral: Teleconference Mindfulness Intervention |
| Smartphone App Mindfulness Intervention Group | Other | MBSR training program that has been adapted for use via smartphone app and for cultural relevancy Receives: Behavioral: Smartphone App Mindfulness Intervention |
| Waitlist Control Group | No intervention | No intervention; control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Worry from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
A total score on the Penn State Worry Questionnaire [PSWQ], a scaled measure with total scores ranging from 16 to 80, in which higher scores indicate greater severity of worry
Measured: 21 Weeks: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Secondary outcomes (9)
Changes in Anxiety from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
A total score on the Generalized Anxiety Disorder Scale [GAD-7], a scaled measure with total scores ranging from 0 to 21, in which higher scores indicate more severe anxiety
Measured: 21 Weeks: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Perceived Stress from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
A total score on the Perceived Stress Scale [PSS], a scaled measure with total scores ranging from 0 to 40, in which higher scores indicate higher levels of perceived stress
Measured: 21 Weeks: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Depression from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
A total score on the Patient Health Questionnaire [PHQ-9], a scaled measure for assessing minimal to severe depression, with total scores ranging from 0 to 27, in which higher scores indicate more severe depression
Measured: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Sleep Quality from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
A global score on the Pittsburgh Sleep Quality Index [PSQI], which contains seven scaled components for sleep quality, with global scores ranging from 0 to 21, in which lower global scores indicate better overall quality of sleep.
Measured: 21 weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Loneliness from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
A total score on the UCLA Loneliness Scale, a scaled measure with total scores ranging from 0 to 60, in which higher total scores indicate higher levels of loneliness
Measured: 21 Weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Social Disconnectedness from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
A total score on the Social Disconnectedness Scale, a scaled measure with total scores ranging from 0 to 43, in which higher scores indicate higher social disconnectedness
Measured: 21 Weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Mindfulness from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
A global score on the Five Facet Mindfulness Questionnaire [FFMQ], which contains five scaled components for attributes of mindfulness and with total scores ranging from 39 to 195, in which higher global scores indicate greater overall mindfulness
Measured: 21 weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Quality of life, satisfaction with
A total score on the Quality of Life Scale [QOLS], a scaled measure with total scores ranging from16 to 112, in which higher total scores indicate greater satisfaction with or quality of life
Measured: 21 Weeks Change from Baseline score to score at mid-intervention, end of intervention, and follow-up scores at one month and three months past end of intervention
Changes in Psychological Well-being from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
A total score on the Flourishing Scale [FS], a scaled measure with with total scores ranging from 8 to 56, in which higher total scores indicate greater flourishing or psychological well-being
Measured: 21 Weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start14 May 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WorryStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Yu-Ping Chang, State University of New York at Buffalo
- Investigators
- Yu-Ping Chang, PhD, Principal investigator, SUNY at Buffalo School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180513
- Sponsor's protocol ID
- COVID-2020C2-1115
- Status last verified
- Sep 2024
- First submitted
- 19 May 2021
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Ways to Mitigate the Impact of the COVID-19 Pandemic on Mental Health Among Adults From Underserved and Racial Minority Communities
- ClinicalTrials.gov ID
- NCT05180513
- Acronym / sponsor ID
- COVID-2020C2-1115
- Keywords
- Mindfulness Based Stress Reduction, Community Based Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 14 May 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Jan 2022 (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 study is to examine the comparative effectiveness of two technology-based Mindfulness Based Stress Reduction (MBSR) programs (one via video/teleconference and one via a smartphone app) for reducing worry, anxiety and/or related mental health effects of stress in members of identified underserved communities, which were highly impacted by the COVID-19 pandemic.
Detailed description
The purpose of this randomized controlled study is to examine the comparative effectiveness of two technology-based Mindfulness Based Stress Reduction (MBSR) programs (one via video/teleconference and one via a smartphone app) for reducing worry, anxiety, and/or related mental health effects of stress in members of identified underserved communities, which were highly impacted by the COVID-19 pandemic. Participants will be randomly assigned to a teleconference MBSR program, a MBSR smartphone app program, or a waitlist control group. Each intervention includes participation in a 9-week (8 sessions plus an introduction) mindfulness intervention that consists of instruction and daily practice. Questionnaires and semi-structured interviews will be administered at mid-intervention, post-intervention, and one-month and three-month follow-up points. It is hypothesized that participants in the two intervention groups will show measurable and sustained improvement in the primary outcome, worry, as well as in the secondary outcomes, anxiety and related mental health effects. It is further hypothesized that the smartphone app mindfulness intervention will show similar effectiveness to the teleconference mindfulness intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Teleconference Mindfulness Intervention Group | Other | Behavioral: Teleconference Mindfulness InterventionMBSR training program that has been adapted for use via Zoom teleconferencing and for cultural relevancy |
| Smartphone App Mindfulness Intervention Group | Other | Behavioral: Smartphone App Mindfulness InterventionMBSR training program that has been adapted for use via smartphone app and for cultural relevancy |
| Waitlist Control Group | No intervention | –No intervention; control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- Significant worry as per the Penn State Worry Questionnaire-Abbreviated [PSWQ-A]
- Fluent in English
- Reside in one of the local city zip codes, identified as underserved, and primarily African American, communities
Key exclusion criteria (7 listed)
- Severe depression as per Patient Health Questionnaire [PHQ-9]
- Active suicidal intent as per PHQ-9 question 9
- Diagnosis of psychosis, or bipolar disorder, or moderate or severe substance use disorder in the past month as per self report
- Cognitive impairment as per (modified) Short Portable Mental Status Questionnaire [SPMSQ]
- Currently receiving psychotherapy or behavioral counseling, including MBSR
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 |
|---|---|---|
| Teleconference Mindfulness InterventionThe teleconference intervention is administered by a trained interventionist via Zoom and is based on a manual adapted from a traditional MBSR version. Practices and activities include meditations, mindful breathing exercises and movements, discussions, and reflections, which participants learn at weekly sessions and practice on their own throughout the week. To adapt the traditional MBSR program for the target community population, intervention materials were reviewed for feedback from community stakeholders, and modified according to their feedback. | Behavioural | Teleconference Mindfulness Intervention Group |
| Smartphone App Mindfulness InterventionThe smartphone app intervention is administered through the app. The smartphone app aligns with the traditional MBSR format, but training and practice is done individually and independently by members of this group. To adapt the traditional MBSR program for the target community population, the app was tested by community stakeholders and modified according to their feedback. | Behavioural | Smartphone App Mindfulness Intervention Group |
Primary outcome
Changes in Worry from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
Time frame: 21 Weeks: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
A total score on the Penn State Worry Questionnaire [PSWQ], a scaled measure with total scores ranging from 16 to 80, in which higher scores indicate greater severity of worry
9 secondary outcomes
Changes in Anxiety from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
Time frame: 21 Weeks: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Perceived Stress from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
Time frame: 21 Weeks: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Depression from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
Time frame: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Sleep Quality from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
Time frame: 21 weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Loneliness from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
Time frame: 21 Weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Social Disconnectedness from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
Time frame: 21 Weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Changes in Mindfulness from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
Time frame: 21 weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
Quality of life, satisfaction with
Time frame: 21 Weeks Change from Baseline score to score at mid-intervention, end of intervention, and follow-up scores at one month and three months past end of intervention
Changes in Psychological Well-being from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention
Time frame: 21 Weeks Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention
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 20 Sep 2024.
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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.
Yu-Ping Chang, PhD principal investigator
SUNY at Buffalo School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconference Mindfulness Intervention and Smartphone App Mindfulness Intervention in people with Worry and Stress, run by State University of New York at Buffalo 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 4 inclusion and 7 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 20 Sep 2024. 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?
Changes in Worry from baseline to mid-intervention at five weeks, post-intervention at nine weeks, and follow-ups to assess sustainability at one and three months following end of intervention (time frame: 21 Weeks: Change from Baseline score to score at mid-intervention, post-intervention, and follow-up scores at one month and three months past end of intervention). 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 20 Sep 2024.