MedPath

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

Not Applicable
Completed
Conditions
Emotional Distress
Type 2 Diabetes
Stress
Interventions
Behavioral: Mindfulness Based Stress Reduction
Registration Number
NCT01805245
Lead Sponsor
University of North Carolina, Chapel Hill
Brief 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. 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
78
Inclusion Criteria
  1. Age > 30 years

  2. Male or female

  3. Duration of diabetes 1-15 years from time of initial diagnosis

  4. Diagnosis of T2DM made/confirmed by physician

  5. Completed diabetes education in the past

  6. 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

  7. Treatment for diabetes must include any or all of the following modalities:

    diet, exercise, oral medications, insulin or other injectable diabetic medication

  8. Score > 30 on the Problem Area in Diabetes (PAID) Questionnaire

  9. Able to use a glucometer for self-monitoring of blood glucose values

  10. Most recent clinic blood pressure less than 180/95

Read More
Exclusion Criteria
  1. History of ketoacidosis
  2. Age at diagnosis of T2DM < 30 years
  3. Score >15 on the PHQ-9
  4. Previous training in relaxation or meditation techniques
  5. Current practice of yoga, tai chi or any other mind-body movement for > 60 minutes per week
  6. Current use of a psychoactive drug for less than 3 months or not yet on a stable dose
  7. 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
  8. Inability to complete standardized instruments because of a cognitive deficit or language barrier
  9. Current use or use within the past 3 months of oral glucocorticoids, excluding intraocular, topical or inhaled preparations
  10. History of inflammatory diseases including rheumatoid arthritis and inflammatory bowel disease
  11. Use of immune modulating agents
  12. Night shift work or other type of schedule in which sleep wake cycle is disrupted
  13. Women who consume > 7 alcoholic drinks per week and men who consume > 14 drinks per week
  14. Current use or history of daily tobacco use within the past 1 year
  15. End stage renal failure on dialysis
  16. Pregnancy or post partum <3 months
  17. Subjects with known secondary causes of hypertension including renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronemia
  18. Non-dominant arm circumference > 46cm
  19. Unwilling to accept randomization
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mindfulness Based Stress ReductionMindfulness Based Stress Reduction-
Health Education ControlMindfulness Based Stress Reduction-
Primary Outcome Measures
NameTimeMethod
Diabetes Distress0,8,24 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

HgA1c0,8,24 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.

Secondary Outcome Measures
NameTimeMethod
Average day time glucose0,8,24 weeks

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

SF36 Mental Health Score0,8,24 weeks

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

SF36 Physical Health Score0, 8,24 weeks

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

Depression0,8,24 weeks

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

Trait Anxiety0,8,24 weeks

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

Coping Style0,8,24 weeks

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

IL-60,8, 24 weeks

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

Average 24 hour glucose by continuous glucose monitor (cgm)0,8,24 weeks

Average cgm glucose over 24 hours

Mean Day Diastolic Ambulatory Blood Pressure0,8,24 weeks

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

Cortisol Awakening Response0,8,24 weeks

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

General Stress0,8,24 weeks

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

Block Food Frequency QuestionnaireWeek 0

Standardized assessment of dietary patterns

Mean Night Systolic Ambulatory Blood Pressure0,8,24 weeks

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

Mean 24 hour ambulatory systolic blood pressure0,8,24 weeks

Mean systolic blood pressure over 24 hours.

Mean 24 hour diastolic ambulatory blood pressure0,8,24 weeks

Mean diastolic blood pressure over 24 hours

HOMA-IR0,8,24 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.

State Anxiety0,8,24 weeks

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

Cortisol 24 hour area under the curve0,8,24 weeks

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

Summary of Diabetes Self-Care Activities0,8,24 weeks

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

Social Support0,8,24 weeks

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

Average night time glucose0,8,24 weeks

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

Mean Day Systolic Ambulatory Blood Pressure0,8,24 weeks

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

Mean Night Diastolic Ambulatory Blood Pressure0,8,24 weeks

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

Trial Locations

Locations (1)

University of North Carolina

🇺🇸

Chapel Hill, North Carolina, United States

© Copyright 2025. All Rights Reserved by MedPath