NCT03576430: SongDance

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

Status unknown NA Last updated 15 July 2019

What this trial tests

NA trial testing active stress handling in Diabetes Mellitus, Type 2, Stress in 160 participants. Status unknown.

Timeline

31 May 2018

Primary endpoint
31 December 2019

28 February 2020

Quick facts

Lead sponsor	Herlev Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	160
Start date	31 May 2018
Primary completion	31 December 2019
Estimated completion	28 February 2020
Sites	1 location across Denmark

Drugs / interventions tested

• active stress handling

Conditions studied

• Diabetes Mellitus, Type 2, Stress — all drugs for Diabetes Mellitus, Type 2, Stress →

Sponsor

Herlev Hospital

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2, Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reduction of Pressure Pain Sensitivity as Novel Non-pharmacological Therapeutic Approach to Type 2 Diabetes: A Randomized Trial.
   Faber J, Eldrup E, Selmer C, Pichat C, et al · · 2021 · cited 7× · PMID 33776633 · DOI 10.3389/fnins.2021.613858