Prior research (with predominantly younger samples) established that patients with severe mental illnesses such as schizophrenia are at risk for impaired decision making capacity, yet even within diagnostic categories substantial variability exists among patients in the levels of such capacity. While there has been little research on decision making capacity (and it enhancement) in older psychiatric patients, older patients may have a more complex array of factors to consider in evaluating the risk-benefit ratio of participating in a particular research protocol, yet may also have a partially diminished capacity to understand, appreciate and reason about these factors. Also, while informed consent is ideally viewed as a ongoing process throughout a patient-participant's enrollment in a study, there has been little research on the degree to which decision making capacity may fluctuate over time. The proposed study is designed to help fill these gaps. Subjects will include 152 patients age 50 years or older with schizophrenia (n=76) or mood disorders with psychotic features (n=76) who are considering participation in a randomized longitudinal comparison of three atypical antipsychotic medications. All subjects will be evaluated at baseline with standardized measures of decision making capacity, severity of psychiatric symptoms, insight/awareness of illness, and specific cognitive-abilities. To examine the ability of patients' to profit from multiple learning trials, decision making capacity will be assessed three times in succession at each visit. Between each of the these three within session decision-making capacity assessments, any information that patients had difficulty with on the preceding trial will be represented. The decision making capacity measure will be re- administered one-week later to establish test-retest reliability, and all of assessments will be repeated at 3-month, 1-year, and 2-year followup evaluations (except that the cognitive battery will be a shorter version of the baseline battery, targeting those cognitive abilities which might be expected to change). We hypothesize that patients' levels of capacity within four specific dimensions of decision making (understanding, appreciation, reasoning, and evidence of a choice) will be differentially associated with specific cognitive skills, psychiatric symptoms, and levels of insight. We also expect that patients' decision making capacity will be significantly improve within sessions by multiple presentations of the material. We further hypothesize that fluctuations in capacity from baseline to the 3-month, 1-year, and 2-year followups will be accompanied by parallel changes in insight deficits and severity of psychiatric symptoms.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH064722-04
Application #
6826834
Study Section
Special Emphasis Panel (ZRG1-SNEM-4 (04))
Program Officer
Muehrer, Peter R
Project Start
2001-12-01
Project End
2006-11-30
Budget Start
2004-12-01
Budget End
2005-11-30
Support Year
4
Fiscal Year
2005
Total Cost
$311,447
Indirect Cost
Name
Veterans Medical Research Fdn/San Diego
Department
Type
DUNS #
933863508
City
San Diego
State
CA
Country
United States
Zip Code
92161
Harmell, Alexandrea L; Mausbach, Brent T; Moore, Raeanne C et al. (2014) Longitudinal study of sustained attention in outpatients with bipolar disorder. J Int Neuropsychol Soc 20:230-7
Depp, Colin A; Harmell, Alexandrea L; Savla, Gauri N et al. (2014) A prospective study of the trajectories of clinical insight, affective symptoms, and cognitive ability in bipolar disorder. J Affect Disord 152-154:250-5
Palmer, Barton W; Savla, Gauri N; Roesch, Scott C et al. (2013) Changes in capacity to consent over time in patients involved in psychiatric research. Br J Psychiatry 202:454-8
Thompson, Wesley K; Savla, Gauri N; Vahia, Ipsit V et al. (2013) Characterizing trajectories of cognitive functioning in older adults with schizophrenia: does method matter? Schizophr Res 143:90-6
Burton, Cynthia Z; Twamley, Elizabeth W; Lee, Lana C et al. (2012) Undetected cognitive impairment and decision-making capacity in patients receiving hospice care. Am J Geriatr Psychiatry 20:306-16
Thorp, Steven R; Sones, Heather M; Glorioso, Danielle et al. (2012) Older patients with schizophrenia: does military veteran status matter? Am J Geriatr Psychiatry 20:248-56
Depp, C A; Savla, G N; de Dios, L A Vergel et al. (2012) Affective symptoms and intra-individual variability in the short-term course of cognitive functioning in bipolar disorder. Psychol Med 42:1409-16
Palmer, Barton W; Lanouette, Nicole M; Jeste, Dilip V (2012) Effectiveness of multimedia aids to enhance comprehension of research consent information: a systematic review. IRB 34:1-15
Harmell, Alexandrea L; Palmer, Barton W; Jeste, Dilip V (2012) Preliminary study of a web-based tool for enhancing the informed consent process in schizophrenia research. Schizophr Res 141:247-50
Savla, Gauri N; Twamley, Elizabeth W; Delis, Dean C et al. (2012) Dimensions of executive functioning in schizophrenia and their relationship with processing speed. Schizophr Bull 38:760-8

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