UCSD
La Jolla, California, 92093, United States
Location status: Recruiting
Location contact
Janae Wyckoff
CONTACT
Michelle Schy
CONTACT
NCT Number: NCT05682677
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
La Jolla, California, 92093, United States
Location status: Recruiting
Janae Wyckoff
CONTACT
Michelle Schy
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
iTBS over the left dorsolateral prefrontal cortex
sham iTBS over the left dorsolateral prefrontal cortex
6 sessions of PACT
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: rating at 8 weeks
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)
Time frame: change over 8 weeks
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
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: change over 8 weeks
Time frame: change over 8 weeks
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.
Contact information is provided by the study sponsor or research team.
Janae Wyckoff
CONTACT
Michelle Schy
CONTACT
University of California, San Diego
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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