Impact of TimeSlips Creative Expression Program on Behavioral Symptoms and Psychotropic Medication Use in Persons with Dementia in Long-term Care: A Cluster-randomized Pilot Study Winona S. Houser, B.A., Daniel R. George, Ph.D., M.Sc., Vernon M. Chinchilli, Ph.D.
Objectives: To evaluate whether involvement in TimeSlips, a creative storytelling program, reduced mood and behavioral symptoms as well as psychotropic medication use in persons with dementia. Methods: A cluster-randomized pilot study compared two discrete dementia care units in one nursing home. The control cohort (N ¼ 10) received standard-of-care activity programming, and the intervention cohort (N ¼ 10) received standard-of-care plus two one-hour TimeSlips sessions per week for six weeks. Data on mood and behavioral symptoms and psychotropic drug prescriptions were collected, and within-group and between-group comparisons were performed. Results: Between-group comparisons did not reveal statistically significant differences in mood and behavioral symptoms. No differences in psychotropic drug prescriptions were found. Conclusions: Larger trials of longer duration are needed to determine whether involvement in TimeSlips reduces mood and behavioral symptoms that compromise quality of life for persons with dementia. (Am J Geriatr Psychiatry 2014; 22:337e340) Key Words: Dementia, behavioral symptoms, TimeSlips, creative expression programs, non-pharmacological
N
europsychiatric symptoms such as apathy, depression, or agitation are frequent complications in dementia, with more than 80% of persons with dementia (PWD) exhibiting such symptoms.1 Few pharmacological options exist for treatment, but atypical antipsychotics are frequently used off-label for these indications.2 Systematic review of drug treatments for neuropsychiatric symptoms in dementia, however, has shown small but statistically significant
evidence of efficacy only for the atypical antipsychotics aripiprazole, risperidone, and olanzapine.3 In 2005, the U.S. Food and Drug Administration issued a warning against the use of atypical antipsychotics for dementia, on the basis of increased risk of mortality. Increasing scrutiny of antipsychotic usage has created greater urgency around the development of effective nonpharmacological interventions. These are currently recommended as the first line of treatment
Received May 10, 2012; revised December 3, 2012; accepted December 10, 2012. From the Departments of Humanities (DG) and Public Health Sciences (VC), Penn State College of Medicine (WH), Hershey, PA. Send correspondence and reprint requests to Winona S. Houser, B.A., Department of Humanities, H134, Penn State College of Medicine, Milton S. Hershey Medical Center, 500 University Dr., Hershey, PA 17033. e-mail:
[email protected] Ó 2014 American Association for Geriatric Psychiatry http://dx.doi.org/10.1016/j.jagp.2012.12.005
Am J Geriatr Psychiatry 22:4, April 2014
337
TimeSlips Creative Expression Program for management of neuropsychiatric symptoms in dementia,4 and have been shown to reduce symptoms such as apathy and anxiety in PWD.5,6 Cognitive stimulation programs have demonstrated efficacy in treating neuropsychiatric symptoms and improving quality of life for PWD,7 and one modality is creative expression (CE) programs, which engage PWD in supportive environments to produce something new that is of value to self and others.8 This study examined a particular CE program called TimeSlips, a group storytelling initiative developed in the 1990s and now used across the world.9 Unlike traditional reminiscence therapies that evoke biographical details to capture a sense of who a PWD was in the past, TimeSlips elicits a performance of self in the present. The activity involves facilitators encouraging PWD to exercise their imaginations—even in the face of memory loss and disorientation—thereby underscoring the inherent dignity of PWD by creating a valued social role. A small evidence base suggests that participation in TimeSlips benefits PWD as well as their professional caregivers. Researchers have found that PWD who engaged in a 6-week session of TimeSlips experienced greater positive effect than those receiving a control intervention.10 Facilities that have integrated TimeSlips into their care services over a 10-week period report more frequent stafferesident interactions and social engagement, while nurturing more positive staff views of residents than in control facilities.8 A recent study found that participation in TimeSlips improved attitudes of medical students towards PWD.11 No existing studies, however, have quantitatively evaluated TimeSlips to examine whether the intervention is associated with reduced mood and behavioral symptoms in PWD in long-term care. Furthermore, although nonpharmacological interventions are recommended as first-line tools for managing behavioral symptoms, no studies have examined whether involvement in a CE program might effect reduced use of psychotropic medications. This study sought to address these gaps in the literature.
METHODS
Pennsylvania. LH is home to over 700 residents in independent, personal care, and skilled nursing settings, including 103 residents receiving skilled nursing care. The site operates two discrete skilled-nursing dementia special care units, each with 13 residents. Study Sample All 26 residents of LH’s skilled nursing special care units met inclusion criteria (residence in the special care unit, age older than 60 years, and physiciandocumented diagnosis of dementia) for the study, and written informed consent from a legally authorized representative was obtained for 20 participants, 10 in each unit. Because a group-based behavioral intervention was being tested, cluster randomization was chosen to minimize contamination of the treatment’s effectiveness. A randomization program generated selection of the intervention cohort. In the intervention group, there were ten women and no men, and the mean age was 85.5 years (range: 73e93). In the control group there were five women and five men, and the mean age was 84.4 years (range: 68e98). Data Collection A combination therapy design compared the control cohort, which received LH’s standard-of-care activity programming, with the intervention cohort, which participated in standard-of-care as well as two, one-hour-long TimeSlips sessions per week for 6 weeks. Participants’ psychotropic drug prescriptions and dosages were retrieved from LH’s electronic medication record, and mood and behavior data were retrieved from CareTracker, LH’s directcare data collection tool, which gathers input from caregivers three times daily for each resident. Prescription and mood and behavioral symptom patterns were compared within and between cohorts over eight months—the first four months with no intervention and the last four months including the 6-week TimeSlips intervention. This timespan was allotted to better track mood and behavioral symptom patterning and to allow for lag time in physician visits and prescription modifications.
Study Site
Ethical Approval
The study was conducted at Landis Homes (LH), a continuing-care retirement community in southeastern
Approval for all aspects of the study was obtained from the Penn State Hershey Institutional Review
338
Am J Geriatr Psychiatry 22:4, April 2014
Houser et al. Board and Human Subjects Protection Office and the LH Ethics Committee. Written consent from a legally authorized representative was required for all participants. Intervention TimeSlips encourages PWD to draw on creativity and imagination rather than memory or fact. A staged picture is distributed (e.g., an elephant sitting next to a girl on a park bench), and facilitators encourage input from all participants as a collective narrative is formed. Responses are recorded verbatim and woven into a story that is read back to the group. The process offers an avenue for community interaction, creativity, and self-worth and often engenders laughter. The Principal Investigator (WH) facilitated each one-hour TimeSlips session twice per week for 6 weeks during June and July 2011.
scores. Secondary outcomes are the scores from the 11 components of the overall mood and overall behavior scores described above. The difference in the number of occurrences between the treatment period and the pre-treatment period was calculated for each participant within each of the two groups (intervention, control). The Wilcoxon rank-sum test was calculated using a t-approximation test statistic with 18 degrees of freedom to compare the intervention and control groups with respect to these differences. Corresponding to the Wilcoxon test, the Hodges-Lehman estimate of the median and its 95% confidence interval was calculated.12 A significance level of 0.025 was invoked (Bonferroni correction) to account for the joint analysis of the two primary outcomes. A multiplicity adjustment was not imposed for the analysis of the secondary outcomes. All analyses were performed in SAS Version 9.3, and the same statistical approach was applied to both behavioral and psychotropic prescription data.
Statistical Analysis The two primary outcomes are 1) the overall mood score, based on the sum of verbal, sleep, appearance, and loss-of-interest scores, and 2) the overall behavior score, based on the sum of wandering, verbally abusive, physically abusive, sexually inappropriate, resistance to care, delusions, and hallucinations
RESULTS The differences for the 20 participants, as well as the Hodges-Lehman estimates and confidence intervals, appear in Table 1. The confidence intervals for some outcome variables could not be estimated
TABLE 1. Treatment Minus Baseline Scores for the Control and Intervention Groups, and the Results of a Nonparametric Analysis Measurement Mood Behavior Mood: Verbal Mood: Sleep Mood: Appearance Mood: Loss of Interest Behavior: Wandering Behavior: Verbally Abusive Behavior: Physically Abusive Behavior: Sexually Inappropriate Behavior: Resists Care Behavior: Delusions Behavior: Hallucinations
Treatment e Baseline Scores Control
Treatment e Baseline Scores Intervention
12, 5, 5, 3, 2, 2, 0, 7, 17, 27 14, 13, 2, 1, 0, 0, 2, 3, 5, 15 10, 0, 0, 0, 0, 0, 0, 2, 4, 31 3, 1, 1, 1, 0, 0, 0, 0, 4, 10 9, 8, 2, 2, 2, 2, 2, 0, 4, 7 0, 0, 0, 0, 0, 0, 0, 1, 1, 1 2, 1, 0, 0, 0, 0, 0, 0, 0, 4 1, 0, 0, 0, 0, 0, 0, 0, 1, 1
18, 6, 2, 2, 2, 0, 0, 5, 23, 55 15, 8, 7, 1, 1, 0, 0, 2, 2, 4 9, 8, 0, 0, 0, 0, 0, 0, 4, 20 2, 2, 2, 1, 0, 0, 0, 1, 6, 16 8, 3, 2, 1, 0, 0, 0, 4, 5, 35 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 11, 0, 0, 0, 0, 0, 0, 0, 0, 2 1, 0, 0, 0, 0, 0, 0, 0, 8, 2
6, 3, 1, 1, 0, 0, 0, 0, 0, 0
1, 1, 0, 0, 0, 0, 0, 0, 0, 0
0.0 (1.0, 0.0)
0.29
5, 1, 0, 0, 0, 0, 0, 0, 0, 1
2, 1, 0, 0, 0, 0, 0, 0, 1, 2
0.0 (1.0, 0.0)
0.69
5, 2, 2, 1, 0, 0, 0, 1, 1, 2 1, 0, 0, 0, 0, 0, 0, 0, 3, 12 2, 1, 0, 0, 0, 0, 0, 0, 0, 4
4, 4, 1, 0, 0, 0, 0, 0, 1, 1 7, 3, 0, 0, 0, 0, 0, 0, 1, 1 0, 0, 0, 0, 0, 0, 0, 0, 0, 1
0.0 (1.0, 2.0) 0.0 (0.0, 3.0) 0.0 (—, —)
0.97 0.57 0.40
Hodges-Lehman Estimate 1.0 1.0 0.0 0.0 2.0 0.0 0.0 0.0
(10.0, 12.0) (4.0, 8.0) (0.0, 4.0) (2.0, 2.0) (7.0, 2.0) (—, —) (—, —) (—, —)
Wilcoxon p-value 0.74 0.57 0.61 0.99 0.28 0.09 0.81 0.77
Notes: The Wilcoxon rank-sum test was calculated using a t-approximation test statistic with 18 degrees of freedom to compare the intervention and control groups. Corresponding to the Wilcoxon test, the Hodges-Lehman estimate of the median, and its 95% confidence interval, was calculated. A significance level of 0.025 was invoked (Bonferroni correction) to account for the joint analysis of the two primary outcomes.
Am J Geriatr Psychiatry 22:4, April 2014
339
TimeSlips Creative Expression Program because of non-response and/or lack of variability in the response. When comparing intervention with control groups with respect to the two primary outcomes of mood and behavior, there were no statistically significant results. The Hodges-Lehman estimate (a negative sign favors the intervention, and a positive sign favors the control) for the mood score was 1.0, with a 95% confidence interval of (10.0, 12.0). The Hodges-Lehman estimate for the behavior score was 1.0, with a 95% confidence interval of (4.0, 8.0). Out of the secondary outcomes, only the appearance score displayed a non-zero Hodges-Lehman estimate, which was 2.0 with a 95% confidence interval of (7.0, 2.0). With regard to the psychotropic drug data, although there was some flux in dosages and number of prescriptions, no statistically significant differences were noted within or between groups.
CONCLUSIONS Further research with a larger sample and longer intervention period is needed to determine if involvement in TimeSlips provides a statistically significant reduction in mood and behavior
symptoms, as well as psychotropic medication use, in PWD. As the incidence of dementia rises precipitously worldwide, and as pharmacological approaches continue to provide only modest help (and, in the case of anti-psychotics, increased risk of mortality), high-quality long-term care will become urgently demanded by modern healthcare systems. As an easily replicable, low-resource, and highefficacy program, TimeSlips may be a promising nonpharmacological CE intervention. This study had several limitations, key among which was a small study sample with a gender imbalance. Direct care providers who input the behavioral data used in this study were not formally aware that this data would be used for the study; they were not blind to the study, however, as it involved a behavioral intervention. The intervention was also examined over a relatively short study interval. Future research involving larger, more diverse, multicenter samples is needed to determine whether involvement in TimeSlips can reduce mood and behavior symptoms in PWD, as well as to explore whether nonpharmacological interventions for behavioral symptoms can reduce drug usage, which carries significant risk in this population. This determination could contribute to improved, lower-cost long-term care.
References 1. Lyketsos CG, Lopez O, Jones B, et al: Prevalence of neuropsychiatric symptoms in dementia and mild cognitive impairment: results from the cardiovascular health study. JAMA 2002; 288: 1475e1483 2. Ventimiglia J, Kalali AH, Vahia IV, et al: An analysis of the intended use of atypical antipsychotics in dementia. Psychiatry (Edgmont) 2010; 7:14e17 3. Maher A, Maglione M, Bagley S, et al: Efficacy and comparative effectiveness of atypical antipsychotic medications for off-label uses in adults: a systematic review and meta-analysis. JAMA 2011; 306:1359e1369 4. Sink KM, Holden KF, Yaffe K: Pharmacological treatment of neuropsychiatric symptoms of dementia: a review of the evidence. JAMA 2005; 293:596e608 5. Brodaty H, Burns K: Nonpharmacological management of apathy in dementia: a systematic review. Am J Geriatr Psychiatry 2012; 20:549e564 6. Stanley M, Calleo J, Bush A, et al: The Peaceful Mind program: a pilot test of a cognitive-behavioral therapy-based intervention
340
7.
8.
9. 10.
11.
12.
for anxious patients with dementia. Am J Geriatr Psychiatry 2012 Apr 30 [Epub ahead of print] Olazarán J, Reisberg B, Clare L, et al: Nonpharmacological therapies in Alzheimer’s disease: a systematic review of efficacy. Dement Geriatr Cogn Disord 2010; 30:161e178 Fritsch T, Kwak J, Grant S, et al: Impact of TimeSlips, a creative expression intervention program, on nursing home residents with dementia and their caregivers. Gerontologist 2009; 49:117e127 Basting AD: Forget Memory: Creating Better Lives for People with Dementia. Baltimore, MD, Johns Hopkins University Press, 2009 Phillips LJ, Reid-Arndt SA, Pak Y: Effects of a creative expression intervention on emotions, communication, and quality of life in persons with dementia. Nurs Res 2010; 59:417e425 George DR, Stuckey H, Dillon CJ, et al: Impact of participation in TimeSlips, a creative group-based storytelling program, on medical student attitudes towards persons with dementia: a qualitative study. Gerontologist 2011; 51:699e703 Hollander M, Wolfe DA: Nonparametric Statistical Methods. Second Edition. New York, NY, John Wiley & Sons, 1999
Am J Geriatr Psychiatry 22:4, April 2014