StressNCT04702477
Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients
A study testing Mindfulness Based Stress Reduction in people with Stress and Diabetes, run by Clemson University at 1 site in United States.
Trial summary
Examining a number of health outcomes in those with diabetes and prediabetes before and after a group-based mindfulness intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Diabetes, Pre-Diabetes
- What is being tested?
- Mindfulness Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 31 Jan 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- English speaking
- Having a diagnosis of diabetes or prediabetes
- Participation in a previous group-based clinical care model-JUMP (as in "JUMPing into Diabetes Control")
Who cannot join
- Under 18 years old
- Non-English Speaking
- not having a diagnosis of diabetes or prediabetes
- No participation in JUMP model
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Innovative Approach With Group Counseling and Mindfulness Training Among Prediabetes Patients
Examining a number of health outcomes in those with diabetes and prediabetes before and after a group-based mindfulness intervention.
Read the detailed description
This is a pilot study to examine the feasibility of integrating a mindfulness-based stress reduction (MBSR) intervention in addition to an existing group-based, peer supported clinical care model (JUMP) among patients with pre-diabetes or diabetes using a mixed-method design.
- Conditions
- Stress, Diabetes, Pre-Diabetes, Health Behavior, Quality of Life
- Being tested
- Mindfulness Based Stress Reduction
- Keywords
- Stress, Mindfulness, Diabetes, Pre-Diabetes
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress ReductionBehavioural
Mindfulness Based Stress Reduction (MBSR) is a well-documented approach to reduce participants' stress level [19], with the existing group-based peer support, self-empowerment, and lifestyle counseling intervention. MBSR is a type of meditation therapy with the goal of actively cultivating conscious attention and awareness to enhance health benefits. This included 10 hours of intervention with groups of 3-5 people.
| Study group | Role | What they receive |
|---|---|---|
| Only Arm | Experimental | This is a single-arm, paired-sample pilot intervention study among participants with pre-diabetes or diabetes. Goal to integrate a MBSR intervention into a group-based, lifestyle intervention among patients with prediabetes or diabetes in the primary care setting Receives: Behavioral: Mindfulness Based Stress Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Attendance
How many hours of intervention sessions an individual attended
Measured: 8-weeks while completing the intervention
Secondary outcomes (10)
Perceived Stress Scale
Change in perceived stress measured by 4 Items to assess perceived stress where higher levels indicating higher levels of stress with a range of 4 to 20.
Measured: Up to 3 months before intervention, immediately following intervention, one month after intervention
Depression
Change in depression scores from the Center for Epidemiologic Studies Depression Scale (CES-D), where higher scores indicate higher levels of depression with a range of 0 to 80.
Measured: Up to 3 months before intervention, immediately following intervention, one month after intervention
Anxiety
Change in anxiety assessed using the Generalized anxiety disorder 7-item scale (GAD-7).
Measured: Up to 3 months before intervention, immediately following intervention, one month after intervention
Medication Adherence
Change in medication adherence assessed using the 8-item Morisky Medication Adherence Scale. A higher score indicates higher adherence with a range of 0 to 8.
Measured: Up to 3 months before intervention, immediately following intervention, one month after intervention
Perceived Health Status
Change in perceived health status assessed using a question asking participants to rate their health status on a 5-points rating scale where lower ratings indicate higher levels of perceived health status and higher ratings indicate lower levels of perceived health status.
Measured: Up to 3 months before intervention, immediately following intervention, one month after intervention
Sleep Quality
Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) ranges from 7 to 28, with higher scores indicating worse sleep quality.
Measured: Up to 3 months before intervention, immediately following intervention, one month after intervention
Physical Activity
Change in physical activity assessed using the Rapid Assessment of Physical Activity Scale (RAPA).
Measured: Up to 3 months before intervention, immediately following intervention, one month after intervention
Mindfulness
Change in Mindfulness assessed using a 15-item Five-Facet Mindfulness Questionnaire (FFMQ).
Measured: Up to 3 months before intervention, immediately following intervention, one month after intervention
HbA1C levels
HbA1C blood levels
Measured: Up to 3 months before intervention, immediately following intervention, one month after intervention
Program satisfaction and barriers for attending sessions
Open ended questions to address engagement in the intervention, perceived usefulness of the MBSR, recommendations for intervention modification, what participants enjoyed most/least about the intervention, and reasons for missing intervention sessions. This is a qualitative measure, not numeric values were assigned. Based on Zgierska A, Rabago D, Zuelsdorff M, Coe C, Miller M, Fleming M. Mindfulness meditation for alcohol relapse prevention: a feasibility pilot study. J Addict Med. 2008 Sep;2(3):165-73. doi: 10.1097/ADM.0b013e31816f8546.
Measured: Immediately following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Aug 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, paired-sample pilot intervention study.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clemson University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Prisma Health-Upstate
- Responsible party
- Principal investigator, Heidi Zinzow, Clemson University
- Investigators
- Lu Shi, PhD, Principal investigator, Clemson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702477
- Sponsor's protocol ID
- Pro00076863
- Status last verified
- Dec 2020
- First submitted
- 23 Nov 2020
- Last updated
- 11 Jan 2021
- 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 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Approach With Group Counseling and Mindfulness Training Among Prediabetes Patients
- ClinicalTrials.gov ID
- NCT04702477
- Acronym / sponsor ID
- Pro00076863
- Conditions
- Stress, Diabetes, Pre-Diabetes, Health Behavior, Quality of Life
- Keywords
- Stress, Mindfulness, Diabetes, Pre-Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Clemson UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Prisma Health-Upstate
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 11 Jan 2021 (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.
Examining a number of health outcomes in those with diabetes and prediabetes before and after a group-based mindfulness intervention.
Detailed description
This is a pilot study to examine the feasibility of integrating a mindfulness-based stress reduction (MBSR) intervention in addition to an existing group-based, peer supported clinical care model (JUMP) among patients with pre-diabetes or diabetes using a mixed-method design.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, paired-sample pilot intervention study.
| Arm | Type | Receives |
|---|---|---|
| Only Arm | Experimental | Behavioral: Mindfulness Based Stress ReductionThis is a single-arm, paired-sample pilot intervention study among participants with pre-diabetes or diabetes. Goal to integrate a MBSR intervention into a group-based, lifestyle intervention among patients with prediabetes or diabetes in the primary care setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- English speaking
- Having a diagnosis of diabetes or prediabetes
- Participation in a previous group-based clinical care model-JUMP (as in "JUMPing into Diabetes Control")
Key exclusion criteria (4 listed)
- Under 18 years old
- Non-English Speaking
- not having a diagnosis of diabetes or prediabetes
- No participation in JUMP model
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 Based Stress ReductionMindfulness Based Stress Reduction (MBSR) is a well-documented approach to reduce participants' stress level [19], with the existing group-based peer support, self-empowerment, and lifestyle counseling intervention. MBSR is a type of meditation therapy with the goal of actively cultivating conscious attention and awareness to enhance health benefits. This included 10 hours of intervention with groups of 3-5 people. | Behavioural | Only Arm |
Primary outcome
Intervention Attendance
Time frame: 8-weeks while completing the intervention
How many hours of intervention sessions an individual attended
10 secondary outcomes
Perceived Stress Scale
Time frame: Up to 3 months before intervention, immediately following intervention, one month after intervention
Depression
Time frame: Up to 3 months before intervention, immediately following intervention, one month after intervention
Anxiety
Time frame: Up to 3 months before intervention, immediately following intervention, one month after intervention
Medication Adherence
Time frame: Up to 3 months before intervention, immediately following intervention, one month after intervention
Perceived Health Status
Time frame: Up to 3 months before intervention, immediately following intervention, one month after intervention
Sleep Quality
Time frame: Up to 3 months before intervention, immediately following intervention, one month after intervention
Physical Activity
Time frame: Up to 3 months before intervention, immediately following intervention, one month after intervention
Mindfulness
Time frame: Up to 3 months before intervention, immediately following intervention, one month after intervention
HbA1C levels
Time frame: Up to 3 months before intervention, immediately following intervention, one month after intervention
Program satisfaction and barriers for attending sessions
Time frame: Immediately following 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 11 Jan 2021.
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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.
Lu Shi, PhD principal investigator
Clemson 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 Based Stress Reduction in people with Stress and Diabetes, run by Clemson 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 4 inclusion and 4 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 11 Jan 2021. 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?
Intervention Attendance (time frame: 8-weeks while completing the 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 11 Jan 2021.