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Mindfulness: a Novel Approach for the Management of Diabetes-related Distress 78 Gerandomiseerd Innovatief

Afgerond
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De klinische studie NCT01805245 was een interventioneel studie bij Emotionele nood, Type 2 diabetes, Stress en is nu afgerond. Er werd gestreefd naar inclusie van 78 deelnemers vanaf 1 januari 2012. De studie werd geleid door de Universiteit van North Carolina te Chapel Hill en was gepland te worden voltooid op 1 december 2015. Laatste update op ClinicalTrials.gov: 19 april 2017.
Beknopte samenvatting
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...Toon meer
Officiële titel

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

Aandoeningen
Emotionele noodType 2 diabetesStress
Andere studie-ID's
  • 11-0333
NCT-ID
NCT01805245
Startdatum (Werkelijk)
2012-01
Laatste update geplaatst
2017-04-19
Verwachte einddatum
2015-12
Inschrijving (Geschat)
78
Studietype
Interventioneel
FASE
N.v.t.
Status
Afgerond
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Enkelblind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelMindfulness Based Stress Reduction
Mindfulness-gebaseerde stressreductie
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
Actieve comparatorHealth Education Control
Mindfulness-gebaseerde stressreductie
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
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
SF36 Physical Health Score
This measure is a patient reported outcome assessing general quality of life and will be assessed using the standardized SF36 tool.
0, 8,24 weeks
SF36 Mental Health Score
This measure is a patient reported outcome assessing general quality of life and will be assessed using the standardized SF36 tool.
0,8,24 weeks
Mean 24 hour ambulatory systolic blood pressure
Mean systolic blood pressure over 24 hours.
0,8,24 weeks
Mean 24 hour diastolic ambulatory blood pressure
Mean diastolic blood pressure over 24 hours
0,8,24 weeks
HOMA-IR
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.
0,8,24 weeks
Depression
Using the Beck Depression Inventory we will assess symptoms of depression using this standardized patient reported outcome.
0,8,24 weeks
State Anxiety
Using the State and Trait Anxiety Assessment we will measure "state" anxiety.
0,8,24 weeks
Trait Anxiety
Using the State and Trait Anxiety Survey we will assess "trait" anxiety.
0,8,24 weeks
Social Support
Using the Duke Social Support and Stress Scale we will assess the degree of social support participants report in their lives.
0,8,24 weeks
Coping Style
Using the Coping Orientation to Problems Experienced Scale, we will evaluate the various coping styles and how they may change over time.
0,8,24 weeks
General Stress
Using the Perceived Stress Scale we will assess general life stressors.
0,8,24 weeks
Cortisol 24 hour area under the curve
Calculating the area under the curve for 24 hours we will assess cortisol secretion as a physiological assessment of stress
0,8,24 weeks
Cortisol Awakening Response
We will measure the cortisol awakening response using measures of cortisol prior to arising and 30 minutes after waking up.
0,8,24 weeks
IL-6
IL-6 is an assessment of systemic inflammation and will be measured in serum.
0,8, 24 weeks
Summary of Diabetes Self-Care Activities
This patient reported measure assesses the frequency which participants engage in self-care activities that are critical for DM self-management.
0,8,24 weeks
Average 24 hour glucose by continuous glucose monitor (cgm)
Average cgm glucose over 24 hours
0,8,24 weeks
Average night time glucose
Average night time glucose from 10pm-6am using continuous glucose monitoring values
0,8,24 weeks
Average day time glucose
Average day time glucose from 6am-10pm using continuous glucose monitoring values
0,8,24 weeks
Block Food Frequency Questionnaire
Standardized assessment of dietary patterns
Week 0
Mean Day Systolic Ambulatory Blood Pressure
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm
0,8,24 weeks
Mean Day Diastolic Ambulatory Blood Pressure
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 6 am and 10 pm
0,8,24 weeks
Mean Night Systolic Ambulatory Blood Pressure
The average systolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am.
0,8,24 weeks
Mean Night Diastolic Ambulatory Blood Pressure
The average diastolic blood pressure measured by ambulatory blood pressure monitoring between 10 pm and 6 am.
0,8,24 weeks
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
30 Years
Geslachten die in aanmerking komen voor de studie
Allen

  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

  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
University of North Carolina, Chapel Hill logoUniversiteit van North Carolina te Chapel Hill241 actieve klinische studies om te verkennen
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North Carolina

University of North Carolina, Chapel Hill, North Carolina, 27599, United States