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

NCT ID: NCT01805245

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Emotional Distress; Type 2 Diabetes; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mindfulness Based Stress Reduction

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction

Intervention Type: 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

Health Education Control

Group Type: ACTIVE_COMPARATOR

Mindfulness Based Stress Reduction

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura A Young, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

11-0333

Identifier Type: -

Identifier Source: org_study_id