Overview

This trial is active, not recruiting.

Conditions emotional distress, type 2 diabetes, stress
Treatment mindfulness based stress reduction
Phase phase 2/phase 3
Sponsor University of North Carolina, Chapel Hill
Start date January 2012
End date November 2014
Trial size 90 participants
Trial identifier NCT01805245, 11-0333

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
mindfulness based stress reduction
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
(Active Comparator)
mindfulness based stress reduction
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

Measure
HgA1c
time frame: 0,8,24 weeks
Diabetes Distress
time frame: 0,8,24 weeks

Secondary Outcomes

Measure
SF36 Physical Health Score
time frame: 0, 8,24 weeks
SF36 Mental Health Score
time frame: 0,8,24 weeks
Mean 24 hour ambulatory systolic blood pressure
time frame: 0,8,24 weeks
Mean 24 hour diastolic ambulatory blood pressure
time frame: 0,8,24 weeks
HOMA-IR
time frame: 0,8,24 weeks
Depression
time frame: 0,8,24 weeks
State Anxiety
time frame: 0,8,24 weeks
Trait Anxiety
time frame: 0,8,24 weeks
Social Support
time frame: 0,8,24 weeks
Coping Style
time frame: 0,8,24 weeks
General Stress
time frame: 0,8,24 weeks
Cortisol 24 hour area under the curve
time frame: 0,8,24 weeks
Cortisol Awakening Response
time frame: 0,8,24 weeks
IL-6
time frame: 0,8, 24 weeks
Summary of Diabetes Self-Care Activities
time frame: 0,8,24 weeks
Average 24 hour glucose by continuous glucose monitor (cgm)
time frame: 0,8,24 weeks
Average night time glucose
time frame: 0,8,24 weeks
Average day time glucose
time frame: 0,8,24 weeks
Block Food Frequency Questionnaire
time frame: Week 0
Mean Day Systolic Ambulatory Blood Pressure
time frame: 0,8,24 weeks
Mean Day Diastolic Ambulatory Blood Pressure
time frame: 0,8,24 weeks
Mean Night Systolic Ambulatory Blood Pressure
time frame: 0,8,24 weeks
Mean Night Diastolic Ambulatory Blood Pressure
time frame: 0,8,24 weeks

Eligibility Criteria

Male or female participants at least 30 years old.

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 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

Additional Information

Official title Mindfulness: a Novel Approach for the Management of Diabetes-related Distress
Principal investigator Laura A Young, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.