Test Date: / 1 / 2 / 3 / 4 / 5
Timing / Up to 1 week prior to ECT start / Between treatments 6 and 7 / Within 3 days of last ECT / 1 Mos. Post / 3 Mos. Post
Procedures / Consent
Data Collection / Demographics
TBI Hx
Scales: Clinician or Rater Administered / SCID
MADRS / MADRS / MADRS / MADRS / MADRS
CAPS / CAPS / CAPS / CAPS / CAPS
MOCA / MOCA / MOCA / MOCA / MOCA
Other Cog? / Other Cog? / Other Cog? / Other Cog? / Other Cog?
Scales: Self-Report / QIDS / QIDS / QIDS / QIDS / QIDS
PCL-C / PCL-C / PCL-C / PCL-C / PCL-C
Text of the IRB-approved Protocol:
Potential participants (n=50) will be recruited from the population of veterans preparing to undergo electroconvulsive therapy (ECT) as part of their regular clinical treatment for major depression. Standardized instruments will be used to establishpsychiatric diagnoses (SCID) and to evaluate depression severity (using the QIDS and MADRS). TBI history will be assessed using the Modified VA/DoD TBI Severity Classification System. Cognitive functioning will be evaluated using standardized neuropsychological tests with comprehensive normative data. Due to high rates of comorbidity, the presence and severity of PTSD symptoms will also be evaluated using the SCID and PCL-M. Serial evaluations of depression severity, PTSD severity and cognitive functioning will be obtained at the following time-points: baseline (prior to ECT), after ECT treatment #6, at the end of the course of ECT, one month after the last ECT treatment and 3 months after the last ECT treatment.
Of note, this study is observational in nature. All decisions about treatment (e.g., medications prescribed, specific ECT protocols utilized, treatment duration, etc.) will not be influenced by this research protocol.
For data analysis following completion of the study, subjects will be sorted into two groups; specifically, those with and without a history of traumatic brain injury. The primary outcome measures will be (1) change in MADRS score before and after ECT treatment and (2) neuropsychological test variables (attention, learning and memory, executive functions) converted to z-scores based upon normative data made available in the testing manuals or programs. Secondary outcome measures include (1) change in QIDS scores and (2) change in PTSD ratings. All other pertinent demographic and clinical variables (including age, gender, medications, symptom severity, and psychiatric comorbidity) will be recorded for use as possible covariates for post-hoc analyses. Between-group comparisons for continuous measures will utilize ANOVA.
Although there are no comparable studies at this time, a review of the literature indicates that recent clinical, correlational studies of depression treatments and cognition have sample sizes of 20 – 25 in each group, and were sufficient to detect a medium effect size (r = .30 - .40; alpha of p< .05) using normative-based, standardized neuropsychological test scores. Therefore, a total sample size of 50 subjects will be obtained.