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Completed

NCT Number: NCT01805245

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

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

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

Primary outcomes

  1. HgA1c

    Time frame: 0,8,24 weeks

    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.

  2. Diabetes Distress

    Time frame: 0,8,24 weeks

    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

Secondary outcomes

  1. SF36 Physical Health Score

    Time frame: 0, 8,24 weeks

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

  2. SF36 Mental Health Score

    Time frame: 0,8,24 weeks

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

  3. Mean 24 hour ambulatory systolic blood pressure

    Time frame: 0,8,24 weeks

    Mean systolic blood pressure over 24 hours.

  4. Mean 24 hour diastolic ambulatory blood pressure

    Time frame: 0,8,24 weeks

    Mean diastolic blood pressure over 24 hours

  5. HOMA-IR

    Time frame: 0,8,24 weeks

    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.

  6. Depression

    Time frame: 0,8,24 weeks

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

  7. State Anxiety

    Time frame: 0,8,24 weeks

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

  8. Trait Anxiety

    Time frame: 0,8,24 weeks

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

  9. Social Support

    Time frame: 0,8,24 weeks

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

  10. Coping Style

    Time frame: 0,8,24 weeks

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

  11. General Stress

    Time frame: 0,8,24 weeks

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

  12. Cortisol 24 hour area under the curve

    Time frame: 0,8,24 weeks

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

  13. Cortisol Awakening Response

    Time frame: 0,8,24 weeks

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

  14. IL-6

    Time frame: 0,8, 24 weeks

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

  15. Summary of Diabetes Self-Care Activities

    Time frame: 0,8,24 weeks

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

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

    Time frame: 0,8,24 weeks

    Average cgm glucose over 24 hours

  17. Average night time glucose

    Time frame: 0,8,24 weeks

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

  18. Average day time glucose

    Time frame: 0,8,24 weeks

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

  19. Block Food Frequency Questionnaire

    Time frame: Week 0

    Standardized assessment of dietary patterns

  20. Mean Day Systolic Ambulatory Blood Pressure

    Time frame: 0,8,24 weeks

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

  21. Mean Day Diastolic Ambulatory Blood Pressure

    Time frame: 0,8,24 weeks

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

  22. Mean Night Systolic Ambulatory Blood Pressure

    Time frame: 0,8,24 weeks

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

  23. Mean Night Diastolic Ambulatory Blood Pressure

    Time frame: 0,8,24 weeks

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

Other outcomes

  1. Mindfulness

    Time frame: 0,8,24 weeks

    To assess mindfulness we will utilize the Five Facet Mindfulness Questionnaire.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 6, 2013
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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