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Emotional DistressNCT01805245

Mindfulness: a Novel Approach for the Management of Diabetes-related Distress

A study testing Mindfulness Based Stress Reduction in people with Emotional Distress and Type 2 Diabetes, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the impact of stress reduction on physiological and psychological variables in adults with Type 2 diabetes (T2DM) who have moderate to severe levels of diabetes-related emotional distress. Subjects will be randomized to one of two interventions. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Emotional Distress, Type 2 Diabetes, Stress
What is being tested?
Mindfulness Based Stress Reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteUnited States
Study dates
Jan 2012to Dec 2015
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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 30 years
  • Male or female
  • Duration of diabetes 1-15 years from time of initial diagnosis
  • Diagnosis of T2DM made/confirmed by physician
  • Completed diabetes education in the past
  • Most recent HgA1c >7%; measurement must be within the past 6 months either in physicians office or at the Thriving with Diabetes Boot Camp Class
Show all 11Show fewer
  • Treatment for diabetes must include any or all of the following modalities:
  • diet, exercise, oral medications, insulin or other injectable diabetic medication
  • Score > 30 on the Problem Area in Diabetes (PAID) Questionnaire
  • Able to use a glucometer for self-monitoring of blood glucose values
  • Most recent clinic blood pressure less than 180/95

Who cannot join

  • History of ketoacidosis
  • Age at diagnosis of T2DM < 30 years
  • Score >15 on the PHQ-9
  • Previous training in relaxation or meditation techniques
  • Current practice of yoga, tai chi or any other mind-body movement for > 60 minutes per week
  • Current use of a psychoactive drug for less than 3 months or not yet on a stable dose
Show all 19Show fewer
  • Inability to participate fully or behave appropriately in the group treatment setting, as observed by baseline acknowledgement of substance abuse, psychotic episode(s), psychiatric hospitalization or history of self- harm within the past 2 years, or current suicidal or homicidal ideation
  • Inability to complete standardized instruments because of a cognitive deficit or language barrier
  • Current use or use within the past 3 months of oral glucocorticoids, excluding intraocular, topical or inhaled preparations
  • History of inflammatory diseases including rheumatoid arthritis and inflammatory bowel disease
  • Use of immune modulating agents
  • Night shift work or other type of schedule in which sleep wake cycle is disrupted
  • Women who consume > 7 alcoholic drinks per week and men who consume > 14 drinks per week
  • Current use or history of daily tobacco use within the past 1 year
  • End stage renal failure on dialysis
  • Pregnancy or post partum <3 months
  • Subjects with known secondary causes of hypertension including renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronemia
  • Non-dominant arm circumference > 46cm
  • Unwilling to accept randomization

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

The purpose of this study is to evaluate the impact of stress reduction on physiological and psychological variables in adults with Type 2 diabetes (T2DM) who have moderate to severe levels of diabetes-related emotional distress. Subjects will be randomized to one of two interventions. We will evaluate the impact of the interventions on glucose metabolism, blood pressure, diabetes-related distress and quality of life. Additionally, we will investigate the role of neuroendocrine dysfunction, systemic inflammation and diabetes self-care practices as mediators in the relationship between increased stress, adverse glucose metabolism and elevated blood pressure in those subjects with T2DM.

Being tested
Mindfulness Based Stress Reduction
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based Stress ReductionBehavioural

    Standard 8-week MBSR program; classes meet for 2.5 hours once weekly The health education control group meets at the same time and for the same amount of time

Study groups in NCT01805245
Study groupRoleWhat they receive
Mindfulness Based Stress ReductionExperimentalNot described
Receives: Behavioral: Mindfulness Based Stress Reduction
Health Education ControlActive comparatorNot described
Receives: Behavioral: Mindfulness Based Stress Reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HgA1c

    We will assess change in glycemic control using the A1c. It will be measured at baseline, immediately following the 8 week intervention and at 24 weeks from baseline.

    Measured: 0,8,24 weeks

  2. Diabetes Distress

    The Problem Areas in Diabetes will be used to assess the change in diabetes emotional distress at baseline, immediately following the 8 week intervention and at 24 weeks from baseline

    Measured: 0,8,24 weeks

Secondary outcomes (23)

  1. SF36 Physical Health Score

    This measure is a patient reported outcome assessing general quality of life and will be assessed using the standardized SF36 tool.

    Measured: 0, 8,24 weeks

  2. SF36 Mental Health Score

    This measure is a patient reported outcome assessing general quality of life and will be assessed using the standardized SF36 tool.

    Measured: 0,8,24 weeks

  3. Mean 24 hour ambulatory systolic blood pressure

    Mean systolic blood pressure over 24 hours.

    Measured: 0,8,24 weeks

  4. Mean 24 hour diastolic ambulatory blood pressure

    Mean diastolic blood pressure over 24 hours

    Measured: 0,8,24 weeks

  5. HOMA-IR

    For those participants that are not using insulin, we will assess the degree of insulin resistance using the HOMA-IR, which is derived from the fasting insulin and fasting glucose.

    Measured: 0,8,24 weeks

  6. Depression

    Using the Beck Depression Inventory we will assess symptoms of depression using this standardized patient reported outcome.

    Measured: 0,8,24 weeks

  7. State Anxiety

    Using the State and Trait Anxiety Assessment we will measure "state" anxiety.

    Measured: 0,8,24 weeks

  8. Trait Anxiety

    Using the State and Trait Anxiety Survey we will assess "trait" anxiety.

    Measured: 0,8,24 weeks

  9. Social Support

    Using the Duke Social Support and Stress Scale we will assess the degree of social support participants report in their lives.

    Measured: 0,8,24 weeks

  10. Coping Style

    Using the Coping Orientation to Problems Experienced Scale, we will evaluate the various coping styles and how they may change over time.

    Measured: 0,8,24 weeks

  11. General Stress

    Using the Perceived Stress Scale we will assess general life stressors.

    Measured: 0,8,24 weeks

  12. Cortisol 24 hour area under the curve

    Calculating the area under the curve for 24 hours we will assess cortisol secretion as a physiological assessment of stress

    Measured: 0,8,24 weeks

  13. Cortisol Awakening Response

    We will measure the cortisol awakening response using measures of cortisol prior to arising and 30 minutes after waking up.

    Measured: 0,8,24 weeks

  14. IL-6

    IL-6 is an assessment of systemic inflammation and will be measured in serum.

    Measured: 0,8, 24 weeks

  15. Summary of Diabetes Self-Care Activities

    This patient reported measure assesses the frequency which participants engage in self-care activities that are critical for DM self-management.

    Measured: 0,8,24 weeks

  16. Average 24 hour glucose by continuous glucose monitor (cgm)

    Average cgm glucose over 24 hours

    Measured: 0,8,24 weeks

  17. Average night time glucose

    Average night time glucose from 10pm-6am using continuous glucose monitoring values

    Measured: 0,8,24 weeks

  18. Average day time glucose

    Average day time glucose from 6am-10pm using continuous glucose monitoring values

    Measured: 0,8,24 weeks

  19. Block Food Frequency Questionnaire

    Standardized assessment of dietary patterns

    Measured: Week 0

  20. Mean Day Systolic Ambulatory Blood Pressure

    The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm

    Measured: 0,8,24 weeks

  21. Mean Day Diastolic Ambulatory Blood Pressure

    The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm

    Measured: 0,8,24 weeks

  22. Mean Night Systolic Ambulatory Blood Pressure

    The average systolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am.

    Measured: 0,8,24 weeks

  23. Mean Night Diastolic Ambulatory Blood Pressure

    The average diastolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am.

    Measured: 0,8,24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2013 (estimated)
  2. Study startJan 2012
  3. Primary completionNov 2014
  4. Study completionDec 2015

Resources

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
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01805245
Sponsor's protocol ID
11-0333
Status last verified
Apr 2017
First submitted
15 Jun 2012
Last updated
19 Apr 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Stress Reduction in people with Emotional Distress and Type 2 Diabetes, run by University of North Carolina, Chapel Hill 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 11 inclusion and 19 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 19 Apr 2017. 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?

HgA1c (time frame: 0,8,24 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 NCT01805245.

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 19 Apr 2017.

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