Sureyya S. Dikmen, PhD Clinical Trials of Behavioral Interventions

Sureyya S. Dikmen, PhD
Professor of Rehabilitation Medicine
Adjunct Professor of Neurological Surgery, and Psychiatry and Behavioral Science
University of Washington
Seattle, WA USA
Clinical Trials of Behavioral Interventions in Neurologic Patients: Developing Evidence
While much is known about impairments and disabilities in cognition, emotional health and functional
limitations associated with diseases and insults to the brain, much less is known about how successful
cognitive behavioral interventions are in these populations. In addition, such interventions are outside the
reach of many patients due to cost, distance from health care providers, and transportation
difficulties. Tele-health has proven effective in providing medical care but its success in delivering
psychological interventions has not been well studied. In this symposium we present four randomized
clinical trials primarily delivered by phone. Ehde will present the results of a trial involving treatment of
chronic pain in subjects with MS and spinal cord injuries. The other three trials involved subjects with
traumatic brain injuries. Fann will present the results of a trial for depression. Two of the other trials
involved patients with moderate to severe traumatic brain injury, treated post acutely and targeting a
broad range of difficulties. Dikmen will present the results of the single site and Bell that of the multisite
trial.
The results of these studies highlight a number of considerations for future studies of cognitive-behavioral
interventions. Our discussants Charles Bombardier (Psychologist) and Nancy Temkin (Biostatistician)
will address the role of non-specific effects and therapeutic relationships in controlled trials, intertherapist and inter-site variability, and study design issues including choice of comparison treatments and
of subjects as well as outcome measures and data analysis approaches. With the current emphasis on
evidence-based medicine, we need to learn how to better evaluate treatments that could potentially
improve the lives of so many people who have survived traumas and diseases of the brain and are living
with their sequelae.
At the conclusion of this presentation, attendees will be able to: (1) discuss the complexities of testing the
effectiveness of behavioral interventions; (2) describe the factors that may mask or mimic treatment
effects (3) understand how to better design and evaluate behavioral interventions