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

NCT01805245 | Completed DMC

• 1 other identifier: 11-0333
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  0,8,24 weeks

• 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

  0,8,24 weeks

Secondary Outcomes (23)

• SF36 Physical Health Score

  0, 8,24 weeks

• SF36 Mental Health Score

  0,8,24 weeks

• Mean 24 hour ambulatory systolic blood pressure

  0,8,24 weeks

• Mean 24 hour diastolic ambulatory blood pressure

  0,8,24 weeks

• HOMA-IR

  0,8,24 weeks

Other Outcomes (1)

• Mindfulness

  0,8,24 weeks

Study Arms (2)

Mindfulness Based Stress Reduction

EXPERIMENTAL

Behavioral: Mindfulness Based Stress Reduction

Health Education Control

ACTIVE COMPARATOR

Behavioral: Mindfulness Based Stress Reduction

Interventions

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

Health Education Control; Mindfulness Based Stress Reduction

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Laura A Young, MD, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: March 6, 2013
• Study Start: January 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2015
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

US (1)