This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
tDCS together with audio providing mindfulness instruction and music
Placebo electrical sitmulation and audio-guided mindfulness instruction
Soterix Medical, Inc.
Woodbridge, New Jersey, United States
RECRUITINGHamilton Depression Rating Scale (HDRS)
Change in HDRS score from Baseline
Time frame: Week 4 and Week 7
Blinding Integrity
Participants will be asked to guess whether they received active or sham treatment, providing a third option of "don't know"
Time frame: Week 7
Response and Remission rates defined by HDRS
Response rate, defined as a reduction in the HDRS score by 50% or more, and the remission rate, defined as an HDRS score ≤7.
Time frame: Week4, Week 7, Week 10, and Week 13
Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR)
Safety outcome will be tested using the QIDS-SR through a web portal
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF
Participants will enter responses to the Q-LES-Q-SF questionnaire through the web interface
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13
Clinical Global Impression severity (CGI-S) and improvement (CGI-I) subscales
Participants will enter responses to the CGI-S and CGI-I questionnaires through the web interface
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13
Sheehan Disability Scale (SDS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will be scored on the SDS at Baseline and at the end of the acute and maintenance phases.
Time frame: Baseline, Week 7, and Week 13
Montgomery-Asburg Depression Rating Scale (MADRS)
Trained clinical MADRS scores will be obtained at the end of the Acute phase and Maintenance phase.
Time frame: Baseline, Week 7 and Week 13