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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS and Mindfulness | Experimental | Application of electrical stimulation to the brain non-invasively combined with mindfulness |
|
| Sham tDCS and Mindfulness | Sham Comparator | Sham electrical stimulation and mindfulness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation (tDCS) and mindfulness instruction | Device | tDCS together with audio providing mindfulness instruction and music |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HDRS) | Change in HDRS score from Baseline | 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" | Week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week4, Week 7, Week 10, and Week 13 |
| Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Questionnaire | Participants will report any side effects experienced, their severity (mild, moderate, severe), pain scores based on the Wong-Baker pain scale, and temporal relationship with the tDCS session (before, during, after) | 5 times per week for 7 weeks |
| Current Mood Score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Thomas Researcher | Contact | 18889908327 | 104 | trials@soterixmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soterix Medical, Inc. | Recruiting | Woodbridge | New Jersey | 07095 | United States |
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| Label | URL |
|---|---|
| Sponsor's webpage with information about the study | View source |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham tDCS and Mindfulness | Device | Placebo electrical sitmulation and audio-guided mindfulness instruction |
|
Safety outcome will be tested using the QIDS-SR through a web portal |
| 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 | 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 | 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) | Participants will be scored on the SDS at Baseline and at the end of the acute and maintenance phases. | 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. | Baseline, Week 7 and Week 13 |
Participants will enter a daily mood score on a scale of 0-10 (0= feeling normal and not depressed at all and 10= feeling as depressed as they possibly could be) on the web interface |
| 5 times per week for 7 weeks |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |