This application requests renewal of a randomized controlled trial (R01NR007755) whose aim was to evaluate the short and long-term efficacy of a brief psychosocial/behavioral intervention (with adjunctive antidepressant) for the treatment of post-stroke depression (PSD) in survivors of ischemic stroke. We have demonstrated that a pleasant event/problem-solving brief psychosocial-behavioral therapy delivered by psychosocial nurse practitioners is highly effective in treating major depression and promoting remission in ischemic stroke survivors for up to two years and that carrying one or more 5-HTTLPR s-alleles, a serotonin transporter gene polymorphism, was associated not only with a greater risk of PSD, but also with the greatest reduction in depressive symptoms for the psychosocial intervention. In this renewal we seek to replicate this finding in a larger sample. We also want refine the protocol, and potentially make it more cost effective, by conducting a randomized comparative effectiveness trial of in-person versus telephone delivery of the intervention, comparing with usual care control. Finally, we seek to expand our sample to include hemorrhagic stroke survivors as well as those with ischemic stroke. 225 people within 3 months of ischemic or hemorrhagic stroke and who are clinically depressed will be randomized into a pleasant events/problem-solving brief psychotherapy in person (n=75) or by telephone (n=75) or into a usual care control group (N=75). Consistent with standard of care in the community, all participants will be prescribed an antidepressant by their primary caregiver. The primary outcome is remission (Hamilton Rating Scale for Depression score <10), with treatment response (50% or greater reduction in HDRS) a secondary endpoint. We will explore the contribution of age, gender, stroke type and genetic variation to treatment response and remission. The ability to identify a relatively simple way, i.e. by genotyping, those who will benefit most from brief psychosocial-behavioral therapy will be a major breakthrough in personalized treatment of depression in chronic illness. In addition, the comparison of two modes of delivering this brief psychosocial-behavioral therapy treatment will provide additional information about cost-effective means to integrate this intervention in everyday practice.

Public Health Relevance

Post-stroke depression (PSD) adversely affects the recovery and function of stroke survivors. We have shown that a brief psychosocial/problem-solving treatment is very helpful in reducing such depression. This research will compare the outcomes of in-person versus telephone delivery of this treatment and whether there are genetic markers that may predict which people respond best to this interpersonal treatment. The information gained from this research may prove useful to healthcare providers who are determining the best and most cost-effective treatment for patients with PSD.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR007755-10
Application #
8525459
Study Section
Nursing Science: Adults and Older Adults Study Section (NSAA)
Program Officer
Matocha, Martha F
Project Start
2001-07-01
Project End
2014-07-31
Budget Start
2013-08-15
Budget End
2014-07-31
Support Year
10
Fiscal Year
2013
Total Cost
$409,620
Indirect Cost
$142,983
Name
University of Washington
Department
Other Health Professions
Type
Schools of Nursing
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
Kohen, Ruth; Cain, Kevin C; Buzaitis, Ann et al. (2011) Response to psychosocial treatment in poststroke depression is associated with serotonin transporter polymorphisms. Stroke 42:2068-70
Choi-Kwon, Smi; Mitchell, Pamela H; Veith, Richard et al. (2009) Comparing perceived burden for Korean and American informal caregivers of stroke survivors. Rehabil Nurs 34:141-50
Mitchell, Pamela H; Veith, Richard C; Becker, Kyra J et al. (2009) Brief psychosocial-behavioral intervention with antidepressant reduces poststroke depression significantly more than usual care with antidepressant: living well with stroke: randomized, controlled trial. Stroke 40:3073-8
Kohen, Ruth; Cain, Kevin C; Mitchell, Pamela H et al. (2008) Association of serotonin transporter gene polymorphisms with poststroke depression. Arch Gen Psychiatry 65:1296-302
Mitchell, Pamela H; Teri, Linda; Veith, Richard et al. (2008) Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression. J Stroke Cerebrovasc Dis 17:109-15