This resubmission for a second competitive renewal project in our program of research to develop and test treatments for late-life generalized anxiety disorder (GAD) is consistent with PA 07-163, which supports research to reduce the burden of mental illness in older adults and increase efficiency and accessibility of treatment. The original study (MH53932, 01 - 05) demonstrated the efficacy of cognitive behavior therapy (CBT), relative to a minimal contact control condition (MCC), in an academic clinical trial (Stanley et al., 2003a). The ongoing renewal project (R01 MH53932, 06 - 09) extends this research to primary care. Preliminary analyses suggest greater improvement in worry and anxiety severity in CBT than UC, with improved outcomes at 6-months relative to 3-months. Attrition in CBT is low. Effect sizes are moderate and comparable to results from prior collaborative care studies. In the proposed second renewal project (years 10 - 14), we will further promote the generalizability to contemporary real-world settings by examining the effectiveness of using Anxiety Clinic Specialists (ACS) and non-expert Counselors to deliver the intervention, relative to usual care (UC). Several enhancements to our intervention support its sustainable implementation in routine clinical practice: (1) Increased collaboration with primary care through the use of electronic medical records (EMR) to identify patients and communicate with providers; (2) CBT modifications that involve modular treatment, integration of telephone-based service delivery, incorporation of patient preference, briefer sessions and simplified procedures, more attention to coexistent depression and motivation/life values, and extended duration of care using telephone-based booster sessions; and (3) Implementation in two diverse medical settings (insurance-based primary care, Veterans Affairs Medical Center) to enhance generality of findings. A total of 222 medical patients, age 60 and over, with GAD will be recruited through primary care clinics at the new study sites. Patients will be assigned randomly to CBT-ACS (expert), CBT-Counselor (non-expert), or Usual Care. Treatment will last 6 months. Pilot data support our ability to train non-experts and recruit a more diverse and severe patient sample. Outcomes are generally equivalent to or greater than the ongoing trial. Patients who complete 6 months of CBT will enter a follow-up phase, with evaluations at 9, 12, and 18 months. Patients who exit UC after 6 months will be offered CBT.
Specific Aims will compare outcomes in CBT-ACS, CBT-Counselor, and UC over 6 months. Primary outcomes address severity of worry, anxiety, and GAD. Secondary outcomes assess coexistent symptoms (depression, sleep, pain, alcohol use), functional status, and satisfaction. Long-term maintenance of gains will be examined over the subsequent 12 months in the two CBT groups. Exploratory Aims will examine resource use/cost and potential moderators and mediators of outcome. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
2R01MH053932-10A1
Application #
7368376
Study Section
Interventions Committee for Disorders Related to Schizophrenia, Late Life, or Personality (ITSP)
Program Officer
Niederehe, George T
Project Start
1996-09-01
Project End
2013-04-30
Budget Start
2008-05-01
Budget End
2009-04-30
Support Year
10
Fiscal Year
2008
Total Cost
$634,845
Indirect Cost
Name
Baylor College of Medicine
Department
Psychiatry
Type
Schools of Medicine
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030
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Kraus-Schuman, Cynthia; Wilson, Nancy L; Amspoker, Amber B et al. (2015) Enabling lay providers to conduct CBT for older adults: key steps for expanding treatment capacity. Transl Behav Med 5:247-53
Shrestha, Srijana; Stanley, Melinda A; Wilson, Nancy L et al. (2015) Predictors of change in quality of life in older adults with generalized anxiety disorder. Int Psychogeriatr 27:1207-15
Barrera, Terri L; Cully, Jeffrey A; Amspoker, Amber B et al. (2015) Cognitive-behavioral therapy for late-life anxiety: Similarities and differences between Veteran and community participants. J Anxiety Disord 33:72-80
Cummings, Jeremy P; Carson, Cody S; Shrestha, Srijana et al. (2015) Santa Clara Strength of Religious Faith Questionnaire: psychometric analysis in older adults. Aging Ment Health 19:86-97
Nadorff, Michael R; Porter, Ben; Rhoades, Howard M et al. (2014) Bad dream frequency in older adults with generalized anxiety disorder: prevalence, correlates, and effect of cognitive behavioral treatment for anxiety. Behav Sleep Med 12:28-40
Ivan, M Cristina; Amspoker, Amber B; Nadorff, Michael R et al. (2014) Alcohol use, anxiety, and insomnia in older adults with generalized anxiety disorder. Am J Geriatr Psychiatry 22:875-83
Hundt, Natalie E; Amspoker, Amber B; Kraus-Schuman, Cynthia et al. (2014) Predictors of CBT outcome in older adults with GAD. J Anxiety Disord 28:845-50
Stanley, Melinda A; Wilson, Nancy L; Amspoker, Amber B et al. (2014) Lay providers can deliver effective cognitive behavior therapy for older adults with generalized anxiety disorder: a randomized trial. Depress Anxiety 31:391-401
Calleo, Jessica S; Bush, Amber L; Cully, Jeffrey A et al. (2013) Treating late-life generalized anxiety disorder in primary care: an effectiveness pilot study. J Nerv Ment Dis 201:414-20

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