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Decreasing Stress in Diabetes: A Randomized Controlled Trial (DE-STRESS)

The purpose of this study is to find out how two different stress reduction programs affect blood sugar levels in people with diabetes. Participants will attend fourteen study sessions online via videoconferencing (Zoom) where they will take part in one or more of the following activities: breathing exercises, meditation, stretching exercises or health education activities. Participants will attend four study visits online via zoom conference call or in-person at Hershey Medical Center. They will remotely attend stress management classes and respond to online surveys. If study visits are done in-person at Hershey Medical Center, participants will provide lab samples, and undergo brief physical exams. It will take participants about six months to complete this study. Compensation up to $300 is provided to eligible participants.

Attend 14 sessions/visits remotely via zoom: 8 of these visits are stress management classes, 4 of them are booster sessions, one of these visits is orientation and one of these visits is a retreat. There are 5 clinical visits with coordinators, and these are currently completed remotely via zoom. These include a screening visit, a baseline visit, a 4 week-follow up phone call, a 2 month visit, and a 6 month visit. Participants are also sent daily stress questions after baseline visit is complete. Participants have the option to provide activity data via activity monitor, and also record food intake on a web-based NIH site.

$300

Nazia Raja-Khan
John Graybeal - at jgraybeal@pennstatehealth.psu.edu
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04016415
STUDY00010532
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Inclusion Criteria:
Age 18 years or older
Type 2 diabetes diagnosed for one year or more
Have a hemoglobin A1C of 7.5% or greater
Have a device with internet connection, camera and microphone for participation in online stress reduction classes
Able to attend 14 online stress reduction classes

Exclusion Criteria:
Current suicidality, history of significant psychopathology such as bipolar disorder or psychosis
History of an inpatient admission for psychiatric disorder within the past two years
Active alcohol or drug abuse
Inability to read, write or speak English
Current enrollment in a stress reduction program, or in any other investigative study
Mental & Behavioral Health, Diabetes & Hormones
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See this study on ClinicalTrials.gov
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Location Contacts
Hershey, PA ,