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Department of Veterans Affairs Health Services Research & Development Service
Evidence-based Synthesis Program
A Systematic Evidence Review of Non-pharmacological Interventions for Behavioral Symptoms of Dementia March 2011
Prepared for:
Department of Veterans Affairs Veterans Health Administration Health Services Research & Development Service Washington, DC 20420
Prepared by:
Evidence-based Synthesis Program (ESP) Center Portland VA Medical Center Portland, OR Devan Kansagara, MD, MCR, Director
Investigators:
Principal Investigator: Maya E. O’Neil, PhD Co-Investigators: Michele Freeman, MPH Vivian Christensen, PhD Robin Telerant, MD Ashlee Addleman, MPH Devan Kansagara, MD, MCR
Non-pharmacological Interventions for Behavioral Symptoms of Dementia
Evidence-based Synthesis Program
PREFACE Health Services Research & Development Service’s (HSR&D’s) Evidence-based Synthesis Program (ESP) was established to provide timely and accurate syntheses of targeted healthcare topics of particular importance to Veterans Affairs (VA) managers and policymakers, as they work to improve the health and healthcare of Veterans. The ESP disseminates these reports throughout VA. HSR&D provides funding for four ESP Centers and each Center has an active VA affiliation. The ESP Centers generate evidence syntheses on important clinical practice topics, and these reports help: • develop clinical policies informed by evidence, • guide the implementation of effective services to improve patient outcomes and to support VA clinical practice guidelines and performance measures, and • set the direction for future research to address gaps in clinical knowledge. In 2009, the ESP Coordinating Center was created to expand the capacity of HSR&D Central Office and the four ESP sites by developing and maintaining program processes. In addition, the Center established a Steering Committee comprised of HSR&D field-based investigators, VA Patient Care Services, Office of Quality and Performance, and Veterans Integrated Service Networks (VISN) Clinical Management Officers. The Steering Committee provides program oversight, guides strategic planning, coordinates dissemination activities, and develops collaborations with VA leadership to identify new ESP topics of importance to Veterans and the VA healthcare system. Comments on this evidence report are welcome and can be sent to Nicole Floyd, ESP Coordinating Center Program Manager, at [email protected]. Recommended citation: O’Neil M, Freeman M, Christensen V, Telerant A, Addleman A, and Kansagara D. Non-pharmacological Interventions for Behavioral Symptoms of Dementia: A Systematic Review of the Evidence. VA-ESP Project #05-225; 2011
This report is based on research conducted by the Evidence-based Synthesis Program (ESP) Center located at the Portland VA Medical Center, Portland, OR funded by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Health Services Research and Development. The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of the Department of Veterans Affairs or the United States government. Therefore, no statement in this article should be construed as an official position of the Department of Veterans Affairs. No investigators have any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in the report. i
Non-pharmacological Interventions for Behavioral Symptoms of Dementia
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TABLE OF CONTENTS EXECUTIVE SUMMARY Background..................................................................................................................................................... 1 Methods.......................................................................................................................................................... 1 Results............................................................................................................................................................ 1
INTRODUCTION Background..................................................................................................................................................... 6
METHODS Topic Development......................................................................................................................................... 7 Search Strategy............................................................................................................................................... 7 Study Selection and Quality Assessment....................................................................................................... 8 Data Synthesis................................................................................................................................................ 8 Peer Review.................................................................................................................................................... 9
RESULTS Literature Search.......................................................................................................................................... 10 Key Question #1. How do non-pharmacological treatments of behavioral symptoms compare in effectiveness with each other, with pharmacological approaches, and with no treatment?......................... 12 Cognitive/Emotion-oriented Interventions......................................................................................... 12 Reminiscence Therapy.............................................................................................................. 12 Simulated Presence Therapy..................................................................................................... 12 Validation Therapy.................................................................................................................... 13 Sensory Stimulation Interventions...................................................................................................... 14 Acupuncture.............................................................................................................................. 14 Aromatherapy............................................................................................................................ 14 Light Therapy......................................................... ...................................................................15 Massage/Touch Therapy............................................................................................................ 15 Music Therapy........................................................................................................................... 16 Snoezelen Multisensory Stimulation......................................................................................... 17 Transcutaneous Electrical Nerve Stimulation......... ..................................................................18 Behavior Management Techniques..................................................................................................... 19 Other Psychosocial Interventions....................................................................................................... 24 Animal-assisted Therapy........................................................................................................... 24 Exercise..................................................................................................................................... 27 Various Interventions Targeting a Specific Behavioral Symptom...................................................... 29 Wandering................................................................................................................................. 29 Agitation.................................................................................................................................... 30 Inappropriate Sexual Behavior.................................................................................................. 31 Comparative Effectiveness among Non-pharmacological Interventions and between Pharmacological and Non-pharmacological Approaches................................................................... 31 ii
Non-pharmacological Interventions for Behavioral Symptoms of Dementia
Evidence-based Synthesis Program
Key Question #2. How do non-pharmacological treatments of behavioral symptoms compare in safety with each other, with pharmacological approaches, and with no treatment?............................................... 32 Cognitive/Emotion-oriented Interventions......................................................................................... 32 Sensory Stimulation Interventions...................................................................................................... 32 Behavior Management Techniques..................................................................................................... 32 Other Psychosocial Interventions....................................................................................................... 33 Animal-assisted Therapy........................................................................................................... 33 Exercise..................................................................................................................................... 33 Various Interventions Targeting a Specific Behavioral Symptom...................................................... 33 Comparative Safety among Non-pharmacological Interventions and between Pharmacological and Non-pharmacological Approaches............................................................................................... 33 Key Question #3. How do non-pharmacological treatments of behavioral symptoms compare in cost with each other, with pharmacological approaches, and with no treatment?............................................... 33 Animal-assisted Therapy.................................................................................................................... 34 Tagging/Tracking Devices for Wandering.......................................................................................... 34
DISCUSSION....................................................................................................................................................... 35 Future Research Recommendations............................................................................................................. 37
CONCLUSIONS................................................................................................................................................. 38 REFERENCES.................................................................................................................................................... 42 TABLES AND FIGURES Figure 1. Literature flow for systematic reviews ....................................................................................... 11 Figure 2. Literature flow for primary studies of animal-assisted therapy ................................................. 11 Table 1. Primary studies on behavior management techniques................................................................ 20 Table 2. Studies of animal-assisted therapy............. .................................................................................25 Table 3. Summary of findings................................................................................................................... 39
APPENDIX A. Search Strategy for Non-pharmacological Treatment of Dementia, Reviews..................................................................................................... 48 APPENDIX B. Search Strategy for Primary Studies on Animal-assisted Therapy for Dementia. .................................................................................................. 51 APPENDIX C. Inclusion/Exclusion Criteria for Systematic Reviews of Non-pharmacological Interventions...................................................................... 52 APPENDIX D. Quality Rating Criteria for Systematic Reviews............................................ 53 APPENDIX E. Inclusion/Exclusion Criteria for Pet/Animal-assisted Therapy............... 54 APPENDIX F. Abbreviations..................................................................................................................... 55 APPENDIX G. Reviewer Comments and Responses. ........................................................................ 57 iii
Non-pharmacological Interventions for Behavioral Symptoms of Dementia
Evidence-based Synthesis Program
EVIDENCE REPORT INTRODUCTION BACKGROUND In 2004, the Office of the Assistant Deputy Under Secretary for Health for Policy and Planning estimated that the total number of Veterans with dementia would be as high as 563,758 in FY 2010.1 The behavioral symptoms that are associated with dementia, such as agitation/aggression, wandering, and sleep disturbances, are associated with increased caregiver burden, decreased quality of life for the patient, and increased healthcare costs.2, 3 It is estimated that behavioral symptoms occur in as many as 90 percent of people with Alzheimer’s disease (AD).4 Moreover, it is the behavioral symptoms that are most often cited by caregivers as the reason for the placement of individuals with dementia into residential care.5 Psychotropic medications are commonly used to reduce the frequency and severity of the behavioral symptoms of dementia. There is little evidence, however, that such interventions are effective,3, 6 and their potential side effects are frequent and often hazardous.5, 6 It has been reported that the use of atypical and typical antipsychotic medication is associated with the increased risk of death.6, 7 Because of the limited benefits and the potential harms associated with psychotropic medications, non-pharmacological interventions for the behavioral symptoms associated with dementia may be an attractive alternative to pharmacological treatment. The purpose of this report is to review systematically the evidence on non-pharmacological treatments for behavioral symptoms of dementia. RETURN TO CONTENTS
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METHODS TOPIC DEVELOPMENT The review was requested by the VHA Dementia Steering Committee (DSC) and commissioned by the Department of Veterans Affairs’ Evidence-based Synthesis Program. The DSC served as the technical expert panel for guiding topic development and reviewing drafts of the report. The objective of this report is to review the evidence that addresses the following questions: Key Question #1. How do non-pharmacological treatments of behavioral symptoms compare in effectiveness with each other, with pharmacological approaches, and with no treatment? Key Question #2. How do non-pharmacological treatments of behavioral symptoms compare in safety with each other, with pharmacological approaches, and with no treatment? Key Question #3. How do non-pharmacological treatments of behavioral symptoms compare in cost with each other, with pharmacological approaches, and with no treatment? Population: Adults with mild, moderate, or severe dementia. Behavioral symptoms: Apathy, agitation, disruptive vocalizations, aggression, disturbed sleep, wandering, impulsivity, disinhibition, depression, inappropriate sexual behavior, chronic/ intermittent hallucinations and delusions. Interventions: Non-pharmacological treatments include cognitive/emotion-oriented interventions (e.g., reminiscence therapy, simulated presence therapy, and validation therapy), sensory stimulation interventions (e.g., acupuncture, aromatherapy, light therapy, massage/touch therapy, music therapy, Snoezelen multisensory stimulation, and Transcutaneous Electrical Nerve Stimulation (TENS)), behavior management techniques, other psychosocial interventions (e.g., animal-assisted therapy and exercise), and various interventions targeting a specific behavioral symptom (e.g., wandering, agitation, and inappropriate sexual behavior). Comparators: Routine care; medical (e.g., ECT)/pharmacological treatment (e.g., typical and atypical antipsychotics, benzodiazepines and their pharmacological relatives, cholinesterase inhibitors, mood stabilizers, anti-depressants, N-Methyl-D-aspartic acid receptor antagonists); other non-pharmacological treatment; or no treatment. Outcomes: Use of psychotropic drugs; cognition; mood, behavioral symptoms; social function, or physical function; hospitalizations, institutionalizations, or healthcare visits including ER visits; accidents, such as accidental falls or automobile crashes; mortality; health-related quality of life; and satisfaction with healthcare. Setting: All outpatient care settings including home-based care and ambulatory care, and extended-care facility settings. Treatments for acute psychotic episodes are excluded.
Search Strategy We conducted searches for systematic reviews of non-pharmacological interventions for dementia in MEDLINE (PubMed), the Cochrane Database of Systematic Reviews, the Cochrane 7 RETURN TO CONTENTS
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Evidence-based Synthesis Program
Database of Reviews of Effects (OVID), and PsycInfo from database inception through September 2009 (Appendix A). We obtained additional articles from reference lists of pertinent studies. Additional articles were obtained through reviewer feedback following review of the initial draft of this report. All citations were imported into an electronic database (EndNote X2). Because the initial search identified no systematic reviews on animal-assisted therapy, we proceeded to conduct a search for primary studies (Appendix B).
Study Selection and Quality Assessment We included good quality systematic reviews of non-pharmacological interventions in individuals with dementia, but excluded interventions that targeted primarily caregiver outcomes as we had conducted a separate review of this topic.8 Two reviewers assessed the titles and abstracts identified by the literature search for relevance to the key questions. Potentially relevant full-text articles were retrieved for further review. Each article was reviewed using the eligibility criteria for systematic reviews shown in Appendix C. The quality rating of systematic reviews (see criteria, Appendix D) is based on the comprehensiveness and reproducibility of the search strategy, the use of standard methods to appraise the validity of included studies, and the absence of apparent bias in drawing conclusions. Because technological interventions such as GPS tracking devices are recent innovations and not widely studied, we allowed inclusion of fair quality reviews of these technologies. We conducted a search for primary studies of the effects of animal-assisted therapy on behavioral symptoms (inclusion criteria Appendix E), as no systematic reviews were available. We did not limit by study design, other than excluding case series and case reports, and rather than report a summary quality score, we noted limitations of individual studies.
Data synthesis We organized the literature into the following categories: • Cognitive/emotion-oriented interventions ◦◦ Reminiscence therapy ◦◦ Simulated presence therapy ◦◦ Validation therapy • Sensory stimulation interventions ◦◦ Acupuncture ◦◦ Aromatherapy ◦◦ Light therapy ◦◦ Massage/touch ◦◦ Music therapy ◦◦ Snoezelen multisensory stimulation ◦◦ TENS • Behavior management techniques (BMT) • Other psychosocial interventions ◦◦ Animal-assisted therapy ◦◦ Exercise 8 RETURN TO CONTENTS
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• Various interventions targeting a specific behavioral symptom ◦◦ Wandering ◦◦ Agitation We compiled a qualitative synthesis of the evidence on specific forms of therapy, and on various therapies targeting wandering and wandering behaviors. Given the breadth and complexity of studies on behavior management techniques, as well as stakeholder interest, we examined randomized controlled trials (RCTs) with sample size > 30 that were identified in previous systematic reviews, and additional studies of behavior management techniques that were referred to us by peer reviewers. Additionally, based on reviewer feedback, we included one primary study on agitation which was not captured in the review due to its recency. We assessed the overall quality of evidence for outcomes using a method developed by the GRADE Working Group.9 The GRADE method considers the consistency, coherence, and applicability of a body of evidence, as well as the internal validity of individual studies to classify the grade of evidence across outcomes. The grade of evidence is rated as high, moderate, low, or very low, based on the confidence in the estimate of effect and the likelihood that future research would have an important impact on the certainty, magnitude, or direction of the estimate. A list of abbreviations and their definitions is provided in Appendix F.
Peer review A draft version of this report was sent to the technical advisory panel and additional peer reviewers. Their comments and our responses are included in Appendix G.
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RESULTS LITERATURE SEARCH The search for systematic reviews yielded 556 citations, of which 114 were retained. An additional six articles were suggested by reviewers following initial draft review, resulting in a total of 120 articles for full-text review (Figure 1). Of these, we included 28 systematic reviews that met our quality criteria (Appendix D) and three primary studies not cited in previous systematic reviews. We additionally included a systematic review that did not fully meet our quality criteria, but contributed relevant information about recently developed technology-based interventions. The search for primary studies of animal-assisted therapies yielded 380 abstracts, of which 65 were retrieved for full-text review (Figure 2). Nine studies provided data that addressed the key questions in this review. RETURN TO CONTENTS
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Non-pharmacological Interventions for Behavioral Symptoms of Dementia
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Figure 2. Literature flow for primary studies of animal-assisted therapy
Figure 1. Literature flow for systematic reviews Abstracts imported from PubMed, Cochrane Database of Systematic Reviews, Cochrane Database of Reviews of Effects, and PsycInfo (from database inception through Sept. 2009) N = 556
Abstracts imported from PubMed, PsycINFO, and CINAHL (from database inception through December 2009) N = 380
Systematic reviews of non-pharmacological interventions for behavioral symptoms of dementia: N = 28 Primary studies from peer review: N = 3
Full-text articles retrieved N = 64
Cognitive/emotion-oriented interventions • Reminiscence therapy: 4 • Simulated presence: 2 • Validation therapy: 4
Prospective studies included N=9
Sensory stimulation interventions • Acupuncture: 1 • Aromatherapy: 2 • Light therapy: 2 • Massage/touch: 2 • Snoezelen multisensory stimulation: 4 • TENS: 1
Non-randomized controlled trial/ quasiexperimental design N=3
Behavior management techniques • 3 systematic reviews • 2 primary studies
Withinparticipants repeatedmeasures design N=6
Excluded N = 55
• Narratives, case studies, observational studies, surveys, uncontrolled studies: 29 • Population not in scope: 2 • Care setting not in scope: 5 • Study did not address behavioral symptoms: 1 • Did not evaluate effects of pet therapy: 6 • Publication inaccessible or non-English language: 5 • Used for contextual purposes only: 7
Other psychosocial interventions • Animal-assisted therapy: 0 • Exercise: 3 Various interventions for a specific behavioral symptom • Wandering: 5 • Agitation: 1 review, 1 primary study
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Evidence-based Synthesis Program
Key Question #1. How do non-pharmacological treatments of behavioral symptoms compare in effectiveness with each other, with pharmacological approaches, and with no treatment? The review of evidence addressing Key Question #1 is organized into the following categories: • • • • •
Cognitive/emotion-oriented interventions Sensory stimulation interventions Behavior management techniques Other psychosocial interventions Various interventions targeting a specific behavioral symptom
The organization of evidence on specific interventions within each category follows the order shown in Figure 1. Cognitive/Emotion-oriented Interventions Reminiscence Therapy Summary: With the exception of one small trial (N=17) that showed a benefit on mood, this limited body of evidence of small trials does not support the use of reminiscence therapy for the treatment of behavioral symptoms of dementia. Details: Reminiscence therapy involves the discussion of past activities, events and experiences with another person or group of people. Reminiscence therapy uses materials such as old newspapers, photographs, household and other familiar items from the past to stimulate memories and enable people to share and value their experiences.10, 11 General reminiscence in a group context aims to enhance interaction, whereas life review usually involves individual sessions in which the person is guided chronologically through life experiences and encouraged to evaluate them. Studies have suggested that reminiscence work assists in reducing depression in older people, and both of these approaches might plausibly have an impact on mood and wellbeing.10 We found one systematic review that focused on reminiscence therapy as a treatment for dementia.10 Four RCTs that included a combined total of 144 subjects were included in the findings of this review. Three of the RCTs assessed behavioral symptoms and found no effect of reminiscence therapy on these symptoms. One RCT (N=17) compared the effects of 12 individual weekly sessions of reminiscence therapy with no treatment, and found statistically significant improvements in depression at six weeks in the treatment group, but found no differences in other behavioral symptoms between groups.10 A systematic review examining a variety of interventions included three small RCTs (combined N=38) of reminiscence therapy, and found no clear benefit.11 Other reviews that examined reminiscence therapy in addition to other interventions similarly found no effects of reminiscence therapy on behavioral symptoms.4, 12 Simulated Presence Therapy (SPT) Summary: The findings of the included studies are mixed, and well-conducted studies are lacking. This body of research did not find consistent evidence that SPT reduces behavioral 12 RETURN TO CONTENTS
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symptoms of dementia. In addition, there is some indication that SPT may worsen behavioral symptoms of dementia in some individuals. Details: Simulated presence therapy (SPT) involves the use of audiotapes made by family members containing scripted “telephone conversations” about cherished memories from earlier life, in an effort to tap remote memory, improve behavioral symptoms, and enhance quality of life among persons with dementia.3, 13 Our search identified one systematic review that focused on SPT for the treatment of behavioral symptoms of dementia.3 A meta-analysis found a statistically significant effect of SPT on disruptive, agitated, or depressed behaviors from pre- to post-intervention, but this analysis was based on three small quasi-experimental studies (ranging from six to nine subjects in each) and one small RCT (N=30). Furthermore, there was significant statistical heterogeneity between studies and substantial variation in the research designs used, the measures used to assess challenging behavior, and the administration of SPT. The review identified three additional studies that could not be combined in the meta-analysis; of these, two studies found that SPT was effective in reducing challenging behaviors, and the third found no overall benefit and that the response to SPT may differ among individuals. Furthermore, three studies identified in the review reported that SPT actually increased agitation or disruptive behaviors in some participants. The authors of the review noted the importance of assessing participants’ suitability for emotion-oriented approaches and monitoring their responses closely.3 A review of multiple interventions included one non-randomized controlled study of SPT vs. recorded readings from a newspaper and found no statistically significant differences in monitored behaviors.12 Validation Therapy Summary: The findings are mixed, and the evidence is insufficient to draw conclusions about the efficacy of the treatment of validation therapy for dementia. Details: Validation therapy is based on the general principle of validation, the acceptance of the reality and personal truth of another’s experience, and incorporates a range of specific techniques.14 Validation therapy is intended to give the individual an opportunity to resolve unfinished conflicts by encouraging and validating expression of feelings.11 One systematic review focused on validation therapy for the treatment of dementia.14 The review included three RCTs with a combined total of 146 subjects. Comparison groups in the studies included usual care, social contact (activities such as music, art, literature, dance, and games), and reality orientation. One study compared the effects of validation therapy, reality orientation, and usual care on behavioral symptoms among 31 nursing home residents. Participants in the treatment group received 30-minute validation sessions, five days a week, for six weeks. At the end of the treatment period, the study found a significant difference in Behavior Assessment Tool (BAT) scores in favor of validation therapy compared to usual care, but there were no significant differences between validation therapy and reality orientation therapy. The second study compared usual care to validation therapy (30-minute sessions, four days per week for 52 weeks) given to 27 residents of a large VA Medical Center (VAMC). The study found no significant differences in behavior after nine months of therapy. In a study of 88 patients from four nursing 13 RETURN TO CONTENTS
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homes, a beneficial effect on depression was observed at 12 months in favor of validation therapy compared with social contact, but there was no difference compared to usual care. Three additional systematic reviews that examined validation therapy in addition to other forms of therapy found no statistically significant findings in favor of validation therapy for reducing behavioral symptoms of dementia.4, 11, 12 Sensory Stimulation Interventions Acupuncture Summary: There are currently no good quality trials evaluating acupuncture for the treatment of behavioral symptoms associated with dementia. Details: Acupuncture is an ancient Chinese method which has been used for both the prevention and treatment of diseases for over 3,000 years.15 One systematic review evaluated acupuncture in patients with vascular dementia.15 The review found 17 RCTs, but found them all to be ineligible for the following reasons: 1) the control group received some form of Western medicine in six studies; 2) there was inadequate randomization in four studies; 3) acupuncture was used in conjunction with another therapy and the effects of acupuncture could not be evaluated separately in six studies; and 4) insufficient information was available for one study. Because none of the identified RCTs met inclusion criteria for this review, the effectiveness and safety of acupuncture could not be analyzed. The authors of the review emphasized the need for randomized placebo-controlled trials of acupuncture.15 Aromatherapy Summary: There is limited evidence that aromatherapy may be an effective treatment for the behavioral symptom of agitation. Details: Aromatherapy consists of the use of fragrant oils from plants. Aromatherapy has been used in attempts to reduce behavioral symptoms, to promote sleep, and to stimulate motivational behavior in people with dementia.16 Much of the literature on aromatherapy comes from qualitative research and small scale non-randomized trials.16 One systematic review focused solely on aromatherapy, but only one RCT met its inclusion criteria.16 This clustered RCT included 72 participants with severe dementia in eight nursing homes. The four-week study examined the effects of topical Melissa oil, and sunflower oil was used at control nursing homes. Though the study found a significant decrease in measures of agitation and neuropsychiatric symptoms, there was no significant decrease in aggression, and important differences among participants such as medication use were not accounted for. A study cited in another systematic review13 similarly found that aromatherapy was associated with decreased agitation among dementia patients. In this study of 15 individuals, two percent lavender oil or water vapor was sprayed in a communal area of a dementia ward for two hours a day, on alternating days for 10 sessions. Agitation was assessed during the last hour of each session using the Pittsburgh Agitation Scale, by an observer who wore a nose clip in an effort to be blinded to the intervention. Median behavior scores were 20 percent lower while exposed to lavender compared to water vapor, and the difference was statistically significant (p= 0.016).13 14 RETURN TO CONTENTS
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Light Therapy Summary: There is insufficient evidence to draw any conclusions about the effectiveness of bright light therapy in managing sleep, behavior, or mood disturbances associated with dementia. Details: Rest-activity and sleep-wake cycles are controlled by the endogenous circadian rhythm generated by the suprachiasmatic nuclei (SCN) of the hypothalamus. Degenerative changes in the SCN appear to be a biological basis of circadian disturbances in people with dementia. In addition to the internal regulatory loss, elderly people (especially those with dementia) experience a reduction in sensory input because they are visually less sensitive to light and have less exposure to bright environmental light. Evidence suggests that circadian disturbances may be reversed by stimulation of the SCN by light.17 One Cochrane review examined RCTs of the effects of light therapy on sleep, behavior, and mood disturbances among patients with dementia in long-term care facilities.17 Only two studies met methodological and design criteria for inclusion in the review. One small RCT compared dawn-dusk simulation (maximum 400 lux) to dim red light (