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| ID | Type | Description | Link |
|---|---|---|---|
| 2010A050442 | Other Identifier | Harvard Medical School |
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| Name | Class |
|---|---|
| Mclean Hospital | OTHER |
| North Suffolk Mental Health Association | OTHER |
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The purpose of this study is to see if using Transcranial LED Therapy (TLT) using the PhotoMedex's Omnilux NEw-U LED helps improve symptoms of major depressive disorder (MDD). TLT works by briefly delivering near-infrared (non-visible) radiations to the forehead. The radiations penetrate the brain and stimulate the cells & metabolism.
Our goals are
TLT has previously been evaluated in two large studies of people who have had a stroke. To date, TLT has been administered to over 550 people who have had a stroke. TLT has also been used in 10 people with MDD who were taking part in a research study. During this study, TLT was shown to relieve MDD symptoms without causing too many side effects.
The -Infrared Radiation (NIR) device is also marketed for wrinkles treatment, however it is experimental for the use in depression. An experimental device means that it is one that has not been approved by the U.S. Food and Drug Administration (FDA).
During this study, the investigators hope to better find out if NIR TLT is helpful for treating depression. The investigators will do this by comparing the effects of TLT ("active treatment") NIR device to a sham treatment (which is an inactive or "pretend" treatment) device. The sham ("pretend") device looks exactly like the NIR device but will not use a near-infrared radiation during the study visits. There are two sets of identical devices that will be used in this study, producing active and sham treatment, respectively. The devices work exactly the same when you are receiving active treatment and sham treatment, except that the devices will produce therapeutic transcranial LED energy during the active treatment sessions but it will not produce this LED energy during the sham treatment sessions.
The investigators hope to enroll about 30 subjects in this study at the Massachusetts General Hospital Depression Clinical and Research Program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TLT Treatment Group 1 | Experimental | The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks |
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| TLT Treatment Group 2 | Sham Comparator | The sham group will receive 2 treatments of the sham device per week for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near-infrared radiation via Transcranial LED Therapy | Device | The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads. The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale (HAM-D 17) Score | We anticipate that TLT will decrease HAM-D17 scores in study subjects significantly more than Sham treatment. We expect that we will be also able to estimate the effect size of the antidepressant action of TLT. Analyses were done for all evaluable subjects (participants who met the a priori cut-off of a minimum of 4 t-PBM sessions for inclusion in the study analyses) and treatment completers (participants followed for the entire 8-week study period and who received a clinical assessment immediately after). HAM-D17 questions are rated on a scale of 0-4 or 0-2 (total score: 0-50) with higher scores indicating more severe pathology. Scores typically fall into the following ranges: not depressed = 0-7; mildly depressed = 8-13; moderately depressed = 14-18; severely depressed = 19-22; very severely depressed = 23 and over. For the pilot study, we analyzed subjects from Baseline to Week 8. A last observation carried forward (LOCF) was performed to account for one week 8n missing value. | Visit 1 (Baseline) and Visit 17 (Week 9); Pilot Phase: Visit 1 (Baseline) and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Systematic Assessment for Treatment Emergent Events-systematic Inquiry (SAFTEE-SI) | To assess the safety and tolerability of TLT in depressed subjects: We predict that TLT will be safe and well-tolerated, as assessed by the SAFTEE-SI. We anticipate no significant differences between TLT and Sham in side-effects.The SAFTEE is a commonly used instrument developed by the NIMH and adapted into a self-report instrument. The version we used is the same used by the NIMH-sponsored CO-MED trial. It examines all possible treatment-emergent side effects and adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior. The SAFTEE analyses are ongoing and will be reported in a second paper (they are not included in the primary outcomes paper). The single value analyzed is the total number of distinct treatment-emergent side-effects (a side effect is defined as any item on the SAFTEE for which severity increased by two or more levels from baseline to any visit) that occurred for each subject. Range: 0 to 165; higher values represent worse outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Cassano, MD, PhD | Massachusetts General Hospital, Harvard Medical School, and North Suffolk Mental Health Association | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital- Depression Clinical and Research Program | Boston | Massachusetts | 02114 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26356811 | Derived | Cassano P, Cusin C, Mischoulon D, Hamblin MR, De Taboada L, Pisoni A, Chang T, Yeung A, Ionescu DF, Petrie SR, Nierenberg AA, Fava M, Iosifescu DV. Near-Infrared Transcranial Radiation for Major Depressive Disorder: Proof of Concept Study. Psychiatry J. 2015;2015:352979. doi: 10.1155/2015/352979. Epub 2015 Aug 19. |
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10 subjects from the pilot phase and 9 subjects from phase 2 screen failed (HAM-D scores below or above threshold, active substance abuse, exclusionary comorbid medical disorder, did not pass drug screen, just started psychotherapy). 6 participants dropped out after screen (time constraints, moving, LTFU). 1 subject had primary diagnosis of PTSD.
Participants were recruited in 2012 for the pilot phase of the study. Participants were recruited from February 2014 through June 2015 via Craigslist advertisements and the general research phone line for the Depression Clinical and Research Program at Massachusetts General Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | TLT Treatment Group 1 (Active TLT Treatment) | The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads. The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject. |
| FG001 | TLT Treatment Group 2 (Placebo) | The sham group will receive 2 treatments of the sham device per week for 8 weeks Sham device: The sham device does not emit near-infrared radiation. |
| FG002 | Pilot Study Treatment Group 1 | The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks. (see protocol change 10/28/2014) |
| FG003 | Pilot Study Treatment Group 2 | The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks. (see protocol change 10/28/2014) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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TLT: 3 randomized participants completed less than 4 treatments so they were not included in analyses. 9 participants screen failed. 5 participants decided not to participate after the screen (time commitment, no longer interested, etc). 1 participant was discontinued by the investigator pre-treatment - discovered that primary diagnosis was PTSD.
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| ID | Title | Description |
|---|---|---|
| BG000 | TLT Treatment Group 1 | The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads. The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hamilton Depression Rating Scale (HAM-D 17) Score | We anticipate that TLT will decrease HAM-D17 scores in study subjects significantly more than Sham treatment. We expect that we will be also able to estimate the effect size of the antidepressant action of TLT. Analyses were done for all evaluable subjects (participants who met the a priori cut-off of a minimum of 4 t-PBM sessions for inclusion in the study analyses) and treatment completers (participants followed for the entire 8-week study period and who received a clinical assessment immediately after). HAM-D17 questions are rated on a scale of 0-4 or 0-2 (total score: 0-50) with higher scores indicating more severe pathology. Scores typically fall into the following ranges: not depressed = 0-7; mildly depressed = 8-13; moderately depressed = 14-18; severely depressed = 19-22; very severely depressed = 23 and over. For the pilot study, we analyzed subjects from Baseline to Week 8. A last observation carried forward (LOCF) was performed to account for one week 8n missing value. | 3 randomized subjects excluded from TLT analyses because they received <4 t-PBM treatments. 2 study completers from Group 1(last visit out of window,started new treatment ),1 subject from Group 2(started therapy)excluded as completers in analyses. Pilot Study Treatment Group 2 excluded because there was no data(drop out, post screen ineligibility). | Posted | Mean | Standard Deviation | units on a scale | Visit 1 (Baseline) and Visit 17 (Week 9); Pilot Phase: Visit 1 (Baseline) and Week 8 |
Adverse events were collected for the duration of the study. Study clinicians inquired about any adverse events once a week for all 8 weeks of treatment. Clinicians also asked about adverse events at Visit 17 (follow up visit after the 8 week treatment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TLT Treatment Group 1 | The TLT group will receive 2 near-infrared radiation via Transcranial LED Therapy (TLT) treatments per week for 8 weeks Near-infrared radiation via Transcranial LED Therapy: The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads. The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastro-intestinal sickness | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paolo Cassano | Massachusetts General Hospital | 617-643-9622 | pcassano@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Sham device | Device | The sham device does not emit near-infrared radiation. |
|
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| Assessed at odd-numbered Visits 1-17. The single value to be analyzed is the number of distinct side effects that occurred at least once during these assessment visits for each subject. |
| Number of Participants With Adverse Events | To assess the safety and tolerability of the TLT in depressed subjects: We predict that the TLT will be safe and well-tolerated by depressed patients, as assessed by the following rating scales: ADVERSE EVENTS FORM. We anticipate no significant differences in between TLT and Sham treatment as concerns side-effects. Due to the small sample size and the variability of reported adverse events, we decided that descriptive reporting (i.e. reporting each subject's adverse events individually) was more appropriate than analysis. All adverse events were reported in the adverse events section. In the outcome measure data table below we report the number of participants in each group who experienced an adverse event. | Visits 1, 3, 5, 7, 9, 11, 13, 15, and 17 |
| Chelsea Counseling Center- North Suffolk Mental Health Association |
| Chelsea |
| Massachusetts |
| 02150 |
| United States |
| participant did not have time |
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| Lack of Efficacy |
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| BG001 | TLT Treatment Group 2 | The sham group will receive 2 treatments of the sham device per week for 8 weeks Sham device: The sham device does not emit near-infrared radiation. |
| BG002 | Screen Fail/Not Randomized | 9 participants screen failed (3 had HAM-D scores that were below the threshold for study inclusion, 2 had bipolar disorder, 1 had active substance abuse, 1 had an exclusionary comorbid medical disorder, 1 did not pass drug screen, 1 was not depressed) . 5 participants decided not to participate after the screen (1 due to time commitment, 2 were no longer interested, 1 was moving away, and 1 was lost to follow up). 1 was discontinued by investigator pre randomization at Visit 1 because it was discovered at Visit 1 that the patient's primary diagnosis was PTSD (MDD was secondary). Additionally, the patient's trauma symptoms significantly interfered with their ability to complete the study tasks. |
| BG003 | Pilot Study Treatment Group 1 | The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks. (see protocol change 10/28/2014) |
| BG004 | Pilot Study Treatment Group 2 | The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks. (see protocol change 10/28/2014) |
| BG005 | Pilot Study Screen Fail/Not Randomized | 10 participants screen failed (5 had HAM-D scores that were above threshold for study inclusion criteria, 1 had too many failed trials in the current depressive episode, 1 had active substance abuse, 2 did not meet criteria for Major Depressive Disorder at the time of the screening visit, 1 had just started psychotherapy at the time of the screen). 1 participant dropped out pre-randomization due to time constraints. (see protocol change 10/28/2014) |
| BG006 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Systematic Assessment for Treatment Emergent Events-systematic Inquiry (SAFTEE-SI) | To assess the safety and tolerability of TLT in depressed subjects: We predict that TLT will be safe and well-tolerated, as assessed by the SAFTEE-SI. We anticipate no significant differences between TLT and Sham in side-effects.The SAFTEE is a commonly used instrument developed by the NIMH and adapted into a self-report instrument. The version we used is the same used by the NIMH-sponsored CO-MED trial. It examines all possible treatment-emergent side effects and adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior. The SAFTEE analyses are ongoing and will be reported in a second paper (they are not included in the primary outcomes paper). The single value analyzed is the total number of distinct treatment-emergent side-effects (a side effect is defined as any item on the SAFTEE for which severity increased by two or more levels from baseline to any visit) that occurred for each subject. Range: 0 to 165; higher values represent worse outcomes. | 3 subjects excluded from TLT because they received <4 t-PBM treatments.1 excluded from Group 1 due to unreliable reporting.1 Group 1 and 1 Group 2 excluded due to no final visit score.1 excluded from Pilot Study Treatment Group 1 due to no final visit score.Pilot Study Treatment Group 2 excluded due to no data(drop out, post screen ineligibility). | Posted | Mean | Standard Deviation | units on a scale | Assessed at odd-numbered Visits 1-17. The single value to be analyzed is the number of distinct side effects that occurred at least once during these assessment visits for each subject. |
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| Secondary | Number of Participants With Adverse Events | To assess the safety and tolerability of the TLT in depressed subjects: We predict that the TLT will be safe and well-tolerated by depressed patients, as assessed by the following rating scales: ADVERSE EVENTS FORM. We anticipate no significant differences in between TLT and Sham treatment as concerns side-effects. Due to the small sample size and the variability of reported adverse events, we decided that descriptive reporting (i.e. reporting each subject's adverse events individually) was more appropriate than analysis. All adverse events were reported in the adverse events section. In the outcome measure data table below we report the number of participants in each group who experienced an adverse event. | 3 randomized subjects excluded from TLT analyses because they received <4 t-PBM treatments. | Posted | Count of Participants | Participants | Visits 1, 3, 5, 7, 9, 11, 13, 15, and 17 |
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| Post-Hoc | Change in Quick Inventory of Depressive Symptomatology-Self Rated Scale (QIDS-SR) Score | This is a brief (16-item) self-report inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation or agitation. QIDS scores range from 0-27. Severity of depression can be judged based on the total score: 1-5 = No depression, 6-10 = Mild depression, 11-15 = Moderate depression. 16-20 = Severe depression, 21-27 = Very severe depression. Analyses were done for all evaluable subjects (participants who met the a priori cut-off of a minimum of four t-PBM sessions for inclusion in the study analyses) and treatment completers (participants who were followed for the entire 8-week study period and who received a clinical assessment immediately after). Pilot Study Group 2 excluded because no analyses were completed for this group (see participant flow) | Excluded: 3 randomized subjects who had <4 t-PBM treatments; 1 from Group 1 (unreliable reporting); 2 from Group 1 (started new treatment),1 from Group 2 (started therapy). 1 from Pilot study group 1 (no final visit). Pilot Study Group 2 excluded because there was no data (2 subjects dropped out, 1 subject ineligible--see Participant Flow). | Posted | Mean | Standard Deviation | units on a scale | Visit 1 (Baseline) and Visit 17 (Week 9) |
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| 0 |
| 10 |
| 7 |
| 10 |
| EG001 | TLT Treatment Group 2 | The sham group will receive 2 treatments of the sham device per week for 8 weeks Sham device: The sham device does not emit near-infrared radiation. | 0 | 11 | 2 | 11 |
| EG002 | Pilot Study Treatment Group 1 | The TLT group will receive 2 TLT treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 sham treatments per week for 3 weeks. (see protocol change 10/28/2014) | 0 | 4 | 1 | 4 |
| EG003 | Pilot Study Treatment Group 2 | The sham group will receive 2 sham treatments per week for 3 weeks followed by a cross-over phase (where no treatment is given), followed by 2 TLT treatments per week for 3 weeks. (see protocol change 10/28/2014) | 0 | 3 | 1 | 3 |
| restless sleep | General disorders | Systematic Assessment |
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| headaches | General disorders | Systematic Assessment |
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| taste illusion | General disorders | Systematic Assessment |
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| abdominal bloating | Gastrointestinal disorders | Systematic Assessment |
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| gout | General disorders | Systematic Assessment |
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| self-harm | Psychiatric disorders | Systematic Assessment |
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| insomnia | General disorders | Systematic Assessment |
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| Irritability | General disorders | Systematic Assessment |
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| visual illusions (vivid colors) | General disorders | Systematic Assessment |
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| decreased memory; word finding difficulties | General disorders | Systematic Assessment |
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| left torso pain | General disorders | Systematic Assessment |
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| belching | General disorders | Systematic Assessment |
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| pressure/pain on back of head during 4T Scan | General disorders | Systematic Assessment |
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| dizziness/tingling sensation in head | General disorders | Systematic Assessment |
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| D001519 |
| Behavior |
| t-test, 1 sided |
One-tailed t-test to measure the change in QIDS score for treatment completers. |
| 0.01 |
a priori threshold for statistical significance: p≤0.05 |
| Superiority or Other |
| This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study. | t-test, 2 sided | Two-tailed t-test measuring change in QIDS score for treatment completers. | 0.02 | a priori threshold for statistical significance: p≤0.05 | Superiority or Other |