title: Maximizing Effectiveness Trials in PTSD and SUD Through Secondary Analysis: Benefits and Limitations Using the National Institute on Drug Abuse Clinical Trials Network "Women and Trauma" Study as a Case Example.
abstract: Recent federal legislation and a renewed focus on integrative care models underscore the need for economical, effective, and science-based behavioral health care treatment. As such, maximizing the impact and reach of treatment research is of great concern. Behavioral health issues, including the frequent co-occurrence of substance use disorders (SUD) and posttraumatic stress disorder (PTSD), are often complex, with a myriad of factors contributing to the success of interventions. Although treatment guides for comorbid SUD/PTSD exist, most patients continue to suffer symptoms following the prescribed treatment course. Further, the study of efficacious treatments has been hampered by methodological challenges (e.g., overreliance on "superiority" designs (i.e., designs structured to test whether or not one treatment statistically surpasses another in terms of effect sizes) and short term interventions). Secondary analyses of randomized controlled clinical trials offer potential benefits to enhance understanding of findings and increase the personalization of treatment. This paper offers a description of the limits of randomized controlled trials as related to SUD/PTSD populations, highlights the benefits and potential pitfalls of secondary analytic techniques, and uses a case example of one of the largest effectiveness trials of behavioral treatment for co-occurring SUD/PTSD conducted within the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) and producing 19 publications. The paper concludes with implications of this secondary analytic approach to improve addiction researchers' ability to identify best practices for community-based treatment of these disorders. Innovative methods are needed to maximize the benefits of clinical studies and better support SUD/PTSD treatment options for both specialty and non-specialty healthcare settings. Moving forward, planning for and description of secondary analyses in randomized trials should be given equal consideration and care to the primary outcome analysis.
authors.affiliation: Gordon F. Derner Institute of Advanced Psychological Studies, Adelphi University; Department of Psychiatry, Columbia University College of Physicians and Surgeons, and New York State Psychiatric Institute. Electronic address: dhien@adelphi.edu.
authors.forename: Denise A
authors.initials: DA
authors.lastname: Hien
authors.affiliation: Department of Psychiatry, Columbia University College of Physicians and Surgeons, and New York State Psychiatric Institute.
authors.forename: Aimee N C
authors.initials: AN
authors.lastname: Campbell
authors.affiliation: Department of Psychology, The City College of New York, The City University of New York.
authors.forename: Lesia M
authors.initials: LM
authors.lastname: Ruglass
authors.affiliation: Division of Social Policy, Health, and Economics Research, RTI International, Research Triangle Park, NC.
authors.forename: Lissette
authors.initials: L
authors.lastname: Saavedra
authors.affiliation: Biostatistics, The EMMES Corporation, Rockville, MD.
authors.forename: Abigail G
authors.initials: AG
authors.lastname: Mathews
authors.affiliation: The Wright Institute, Berkeley, CA.
authors.forename: Grace
authors.initials: G
authors.lastname: Kiriakos
authors.affiliation: Division of Social Policy, Health, and Economics Research, RTI International, Research Triangle Park, NC.
authors.forename: Antonio
authors.initials: A
authors.lastname: Morgan-Lopez
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods / Q000706:statistics & numerical data*; D017831:Diagnosis, Dual (Psychiatry); D005260:Female; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards / Q000706:statistics & numerical data*; D054577:National Institute on Drug Abuse (U.S.); D017063:Outcome Assessment, Health Care / Q000592:standards / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000592:standards / Q000706:statistics & numerical data*; D013313:Stress Disorders, Post-Traumatic / Q000628:therapy*; D019966:Substance-Related Disorders / Q000628:therapy*; D014481:United States; D016387:Women's Health
keywords: Clinical trials; Co-occurring disorders; PTSD; Statistical methods