Maximizing the utility of a single site randomized controlled psychotherapy trial.
There is increasing interest in including measures of biological mechanisms as mediators and moderators of treatment outcome in randomized controlled trials (RCT's) of psychotherapy efficacy. However, examining biological mechanisms is often expensive and budget caps of most major funding agencies have remained stable in recent years. The goal of this manuscript is to describe how a psychotherapy efficacy trial is using a model of collaborative, affiliated grants to maximize resources and the potential knowledge to be gained from a single site RCT. Principal results and conclusions: The trial is an ongoing RCT comparing two psychotherapies for the treatment of concurrent posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) with a sample of treatment seeking veterans. Through collaboration with a team of investigators with independently-funded but affiliated grants, measures of select sleep, neurobiological, and genetic biomarkers were integrated into this single site RCT. This model has allowed us to pose research questions regarding the role of biological mechanisms, maximize the utility of recruitment, and be efficient in maximizing knowledge to be gained in a way that would not be possible solely on the funding of a single site RCT. Challenges of this model include high participant burden in regard to assessment and complicated coordinating procedures among studies. Strategies to address these challenges are described.
VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States; National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States. Electronic address: snorman@ucsd.edu.
Sonya B
SB
Norman
VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States. Electronic address: moira.haller@va.gov.
Moira
M
Haller
VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States. Electronic address: aspadoni@ucsd.edu.
Andrea D
AD
Spadoni
VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States; Monash University, School of Psychological Sciences, Wellington Road, Clayton, VIC 3800, Australia. Electronic address: sean.drummond@monash.edu.
Sean P A
SP
Drummond
VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States. Electronic address: vrisbrough@ucsd.edu.
Victoria
V
Risbrough
National Center for PTSD, 215 North Main Street, White River Junction, VT 05009, United States; Geisel School of Medicine at Dartmouth, Department of Psychiatry, Dartmouth-Hitchcock Medical Center, 1 Medical Center Drive, Lebanon, NH 03756, United States. Electronic address: Jessica.l.hamblen@dartmouth.edu.
Jessica L
JL
Hamblen
VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States; University of California, San Diego, Department of Psychiatry, 9500 Gilman Drive, San Diego, CA 92093, United States. Electronic address: rstrim@ucsd.edu.
Ryan S
RS
Trim
VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, United States. Electronic address: erika.blanes@va.gov.
Erika X
EX
Blanes
D000223:Adaptation, Psychological; D000437:Alcoholism / Q000150:complications / Q000378:metabolism / Q000628:therapy*; D015415:Biomarkers; D002394:Catechol O-Methyltransferase / Q000235:genetics; D015928:Cognitive Behavioral Therapy / Q000379:methods; D020022:Genetic Predisposition to Disease; D006801:Humans; D007171:Implosive Therapy / Q000379:methods; D011613:Psychotherapy / Q000379:methods*; D012890:Sleep; D013313:Stress Disorders, Post-Traumatic / Q000150:complications / Q000378:metabolism / Q000628:therapy*; D014728:Veterans
D015415:Biomarkers; C588010:COMT protein, human; D002394:Catechol O-Methyltransferase
Biomarkers; Posttraumatic stress disorders; Randomized controlled trial; Trial methods