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| Name | Class |
|---|---|
| San Diego Veterans Healthcare System | FED |
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The primary goal of this clinical trial is to evaluate whether Personalized Augmented Cognitive Training (PACT) plus intermittent theta burst stimulation (iTBS) is effective for treating depression in Service Members, Veterans, and civilians who have sustained a mild TBI. Participants will receive PACT plus 20 sessions of iTBS or sham iTBS over 4 weeks. Assessments will occur at baseline, 2 weeks, 4 weeks, and 8 weeks. Researchers will compare the PACT+iTBS group to the PACT+sham iTBS group to see if PACT+iTBS is associated with more depression improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACT+iTBS | Experimental | Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks) |
|
| PACT+sham iTBS | Sham Comparator | Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTBS | Device | iTBS over the left dorsolateral prefrontal cortex |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression | change over 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 | change over 8 weeks | |
| Neurobehavioral Symptom Inventory | change over 8 weeks | |
| PTSD Checklist for DSM-5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Schy | Contact | 858-642-3848 | mschy@health.ucsd.edu | |
| Janae Wyckoff | Contact | 858-642-3848 | jwyckoff@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Twamley, PhD | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD | Recruiting | La Jolla | California | 92093 | United States |
IPD will be available via FITBIR.
Following study completion; deidentified data available indefinitely.
Via FITBIR request.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
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| sham iTBS |
| Device |
sham iTBS over the left dorsolateral prefrontal cortex |
|
| Personalized, Augmented Cognitive Training (PACT) | Behavioral | 6 sessions of PACT |
|
| change over 8 weeks |
| Headache Impact Test | change over 8 weeks |
| Pittsburgh Sleep Quality Index | change over 8 weeks |
| WHO Disability Assessment Schedule | change over 8 weeks |
| Glasgow Outcome Scale - Extended | change over 8 weeks |
| PROMIS Cognitive Function Abilities Short Form | change over 8 weeks |
| Patient Global Impression of Change | This measure asks the participant to rate their status since the start of the study from 1 (very much improved) to 7 (very much worse) | rating at 8 weeks |
| Traumatic Brain Injury Quality of Life | The Traumatic Brain Injury Quality of Life The Traumatic Brain Injury Quality of Life measurement system (TBI-QOL) is a TBI-specific extension of the NIH PROMIS and Neuro-QoL measures that includes 20 items measuring physical, emotional, social, and cognitive domains | change over 8 weeks |
| D-KEFS Trail Making Test | change over 8 weeks |
| D-KEFS Color Word Interference Test | change over 8 weeks |
| WMS-IV Digit Span | change over 8 weeks |
| WAIS-IV Processing Speed | change over 8 weeks |
| Hopkins Verbal Learning Test - Revised | change over 8 weeks |
| UCSD Performance-Based Skills Assessment-Brief | The UCSD Performance-Based Skills Assessment-Brief is a performance-based measure that uses role play scenarios to assess capacity for financial and communication tasks. | change over 8 weeks |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |