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The SongDance Study: Stress, Ongoing Self- Monitoring and Diabetes, Nerve Stimulation and Cognitive Empowerment

NCT03576430 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2019-07-15

No results posted yet for this study

Summary

Type 2 diabetes (DM2) I may be associated with low level of Quality of Life (QOL), depression, persistent stress and autonomic nervous system dysfunction (ANSD). A new biological measure measuring the Pressure Pain Sensitivity (PPS) of the chest bone has been found to be a marker for persistent stress and ANS function, and linked to depression, QOL, chronic inflammation and HbA1c. An intervention which uses the PPS measure as a biological feedback marker for stress reduces the level of persistent stress (PPS) and depression, reduces blood pressure, serum lipids, restores ANSD and increases quality of life.

Objectives: primary: if a simple individualized self-care based intervention, using the PPS of the chest bone as a biofeedback marker for stress, reduces PPS and with concomitant reduction in HbA1c. Secondly, if changes in PPS and HbA1c correlate, if the level of depression and number of clinical stress symptoms are reduced, and QOL and personal empowerment increased. Thirdly, if use of glucose-lowering medication, blood pressure, heart rate, work of the heart, autonomic nervous system dysfunction measured by PPS and cardiovascular response to tilt table test and heart rate variability, serum lipids and low-grade inflammation are reduced. As a separate part of the study, the implementation aspects of the PPS guided intervention are studied.

Design:RCT,single-blinded, 1:1 randomization, in which diabetic treatment as usual (TAU) is compared to TAU plus a self-care based intervention program based on daily PPS measurements at home over a 6 months period and daily 2 times nervestimulation as mandatory. The study will be open to the patient and the treating professionals but blinded towards the evaluating researchers. The implementation part of the study will be conducted according to WHO guidelines.

Patients: 160 patients with DM2 from primary health care. Effect variables: Primary: HbA1c. Secondary : PPS, depression, QOL, personal empowerment, and the correlation between changes in PPS and HbA1c.

Treatment: All patients receive diabetes care as usual. The active group receives in addition the self-care based, non-pharmacological PPS guided intervention program, which focuses on daily PPS measurement for cognitive reflection and cutaneous sensory nerve stimulation for reduction of PPS with the aim to reduce the elevated PPS.

Conditions

  • Diabetes Mellitus, Type 2, Stress

Interventions

DEVICE

active stress handling

biofeed back stress handling

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • jens faber, professor · Herlev Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2019-12-31
Completion
2020-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576430 on ClinicalTrials.gov