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 well-being.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 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 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}

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

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 (<5 lux) for three weeks among 13 nursing home residents. There were no significant differences in any outcome: nocturnal sleep duration, night-time activity, sleep latency (defined as the amount of time between reclining in bed and the onset of sleep), agitation (Neuropsychiatric Inventory; NPI), and depression (Geriatric Depression Scale; GDS) measured at the end of light therapy and three weeks post-treatment.

Another RCT randomly assigned 92 nursing home residents with severe Alzheimer's disease to receive morning bright light, evening bright light, or morning dim red light for 10 days. The study found no differences between groups in sleep duration or agitation at the end of therapy and at five days post-treatment.

An older systematic review included four studies of bright light therapy, three of which reported beneficial effects on agitation and nocturnal restlessness during bright light treatment (1500 – 2500 lux).⁵ The studies were limited by small sample size (N ≤ 24), and three of the studies had samples of 10 subjects or fewer.

Massage and Touch Therapy

Summary: Though the true effect of massage and touch on behavioral symptoms is uncertain, this very small body of evidence preliminarily suggests that hand massage and touch may be a viable treatment option, especially given the ease of implementation and minimal training involved.

Details: Massage and touch are among the interventions used in dementia care with the aim of reducing depression, anxiety, aggression and other related psychological and behavioral manifestations.¹⁸ Expressive touch such as patting or holding a client's hand involves emotional intent, for example, to calm a patient or to show concern, as opposed to instrumental/task-associated touch within nursing care.¹⁹

A 2005 review focused on RCTs of massage and touch therapies for dementia.¹⁸ Eligibility criteria required that studies used a RCT design, employed blinding of outcome assessors, and measured changes in agitated behavior. Of 34 references identified by the search, only two small RCTs met these criteria. One RCT of 42 institutionalized patients with organic brain syndrome compared verbal encouragement with touch to verbal encouragement alone during meals, and found that touch therapy was associated with a significant increase in mean calorie and protein intake. The second RCT assessed the effect of hand massage vs. calming music, and simultaneous hand massage and calming music vs. no intervention. Sixty-eight participants were randomly assigned to one of four groups. Interventions consisted of a single 10-minute treatment. Researchers found a greater decrease in agitated behavior (CMAI score) compared with baseline during treatment, immediately after treatment, and one hour after treatment among the groups receiving hand massage compared to the group receiving no treatment. Findings were similar for hand massage, calming music, or both.

Another systematic review that examined touch interventions among other treatments for dementia identified a small RCT that found that an expressive touch intervention that involved 5.5 minutes a day of touching, including 2.5 minutes a day of gentle massage and 3 minutes a day of intermittent touching with someone talking, over a 10-day period decreased disturbed behavior from baseline immediately and for 5 days after the intervention.¹¹

Music Therapy

Summary: Music interventions have potential for reducing agitation in persons with dementia in the short-term. Well-conducted studies are lacking, and trials with adequate sample size and rigorous methodology are needed. Some interventions such as listening to recorded music during mealtimes are simple and low-cost, and they may be feasible in VA settings. The feasibility and cost-effectiveness of more resource-intensive interventions, such as individual patient interactions with a professional music therapist, need to be evaluated.

Details: People with dementia may retain the ability to sing old songs,^{20, 21} and musical abilities appear to be preserved in individuals with dementia who were musicians²² despite aphasia and memory loss. Information presented in a song context appears to enhance retention and recall of information, and structured music activities can promote interaction and communication. Music therapy can, therefore, potentially enhance cognitive skills as well as social/emotional skills, and may also serve as an alternative to medication for managing behavioral symptoms of AD.²³ There is a wide range of music interventions for older people with dementia, including listening to different types of music, instrument playing, or group exercise while listening to music. The range of music interventions includes activities administered by a professional music therapist, as well as the presentation of recorded music by a variety of caregivers, to patients privately or in a group setting.

The literature search for music and music therapy interventions for behavioral symptoms identified 18 reviews that included a total of 104 primary studies. Among these reviews, we selected four systematic reviews^{11, 24, 26} based on quality, recency, and relevance. The most rigorous systematic review was a Cochrane review²⁴ that conducted a literature search through September 2005, and included three RCTs.^27-29 Three other systematic reviews included a wider range of study designs not limited to RCTs.^{11, 25, 26}

The Cochrane review²⁴ determined that trials were poor in quality, citing inadequate reporting of methods of randomization and blinding, as well as inappropriate methods of data analysis in two of the studies.^{27, 28} Reviewers concluded that no study presented any quantitative results in sufficient detail to justify the original investigators' conclusions that music listening was more effective than control on behavioral symptoms.²⁴ In one study, when bathing was accompanied by listening to preferred music (as compared with no music), residents demonstrated significantly less aggressive behaviors.²⁷ Gerdner (2000) reports that agitation was significantly less frequent during and after music therapy when each patient listened to his or her preferred music compared with standard classical music.²⁸ Groene (1993) reported that the amount of time a wandering subject remained seated or in close proximity to the session area was longer for music sessions than for reading sessions.²⁹

Systematic reviews that included a wider range of study designs consistently concluded that music therapy decreases agitation in the short-term, although there was no evidence of long-term effects. One systematic review examined 20 studies published through 2000,²⁶ and another included 24 music interventions (including 14 of the same studies) published through 2003.¹¹ A systematic review of eight studies that specifically examined the use of preferred or individualized music found reductions in agitated behaviors that were statistically significant in all but one study.²⁵

Methodological limitations in the music intervention studies include lack of randomization, observational methods and sampling techniques, problems with internal validity, and confounding due to the possible effects of the music intervention on staff. Some studies employed momentary time sampling techniques, where the observer records whether or not the behavior is occurring at the end of a pre-specified time period. This sampling method may tend to overestimate continuous behaviors and underestimate discrete episodes of behavior. Internal validity was questionable in two studies in which some participants were transferred to "geri-chairs" that prevent the patient from leaving the chair due to a fixed tray across the chair arms. A reduction in agitation behaviors in these studies was attributed to the effects of music, despite the fact that the use of these chairs would directly affect pacing behaviors.²⁶ In another study, the effects of the music intervention on staff behavior was an unexpected confounder.³⁰ This study compared the use of taped music to no music during mealtimes, and it measured the amount of food eaten by participants. The participants' consumption of food increased during the music conditions, but the staff served more food during the music conditions as well. The effect of music on increasing food intake could not be clearly separated from the fact that the patients had received more food on their plates.

Snoezelen Multisensory Stimulation Therapy

Summary: There is no consistent evidence demonstrating a durable effect of multisensory stimulation (MSS) therapy on behavioral symptoms of dementia. Preliminary findings of short-term benefits and the reported pleasantness of the treatment of MSS, however, suggest that future research may be warranted.

Details: MSS, otherwise known as Snoezelen therapy, is based on the premise that neuropsychiatric symptoms may result from periods of sensory deprivation.^{11, 31} MSS uses multiple stimuli during a treatment session aimed at stimulating the primary senses of sight, hearing, touch, taste and smell. MSS combines the use of such treatments as lights, tactile surfaces, music, and aroma.³¹ Interventions generally occur in specially designed rooms with a variety of sensory based materials. A typical MSS room provides taped music, aroma, bubble tubes, fiber optic sprays and moving shapes projected across walls.¹² MSS has become a popular intervention for behavioral symptoms in persons with dementia, but the application of MSS varies in form, procedures, and in frequency of treatment.³¹

One systematic review included two RCTs in which MSS was used for a total of 246 individuals with dementia aged 60 and older.³¹ The first study compared eight 30-minute MSS sessions to activity sessions that were based on individual subjects' preferences and abilities, but with no obvious sensory inputs. No significant effects on mood were found either immediately after intervention or at one-month post-follow-up. The second study compared a 24-hour exposure to MSS with usual care. Although patients appeared to find MSS enjoyable, the study found no long-term significant effects on behavior or mood.

Other systematic reviews^{11, 12, 32} identified four additional RCTs and reported mixed results. One study administered MSS in specially designed rooms in 30- to 60-minute sessions and found that during the four-week treatment period, disruptive behavior outside the treatment setting briefly improved but did not last once the treatment had stopped. Two studies conducted MSS sessions for 30 to 60 minutes for three consecutive days and found that subjects were less apathetic when remaining in a multisensory stimulation room compared with remaining in the living room or receiving activity therapy. Lastly, one small (N=20) repeated-measures study set in a day-care center and mental health nursing home exposed patients to three 40-minute sessions of either MSS or reminiscence therapy and found no significant differences in behavior symptoms during or after treatment.

Transcutaneous Electrical Nerve Stimulation (TENS)

Summary: Although some short-lived improvements in neuropsychological symptoms of dementia have been observed with TENS, definite conclusions on the possible benefits of this intervention cannot be made.

Details: TENS is a simple, non-invasive analgesic technique that is most often used for pain control and occasionally for neurological and psychiatric conditions such as drug/alcohol dependency, headaches, and depression.^{33, 34} TENS is the application of an electrical current through electrodes attached to the skin. Short, pulsed electrical currents are generated by a portable pulse generator and delivered across the intact surface of the skin through conditioning pads called electrodes.³³ By carefully adjusting the intensity and duration of the pulses, a mild tingling sensation without pain or muscle contraction, or a stronger sensation involving muscle contraction, can be produced.³⁴ Few known side effects exist and there are no known drug interactions.³³ Although TENS is not routinely used for treatment of dementia, several studies in the Netherlands and one study in Japan suggest that TENS applied to the back or head may improve cognition, behavior, and sleep disorders in patients with Alzheimer's disease or multi-infarct dementia.³⁴

We identified one systematic review of the effectiveness of TENS in the treatment of dementia.³⁴ The review reported that TENS produced a statistically significant improvement directly after treatment in delayed recall of eight words in one trial, face recognition in two trials and motivation in one trial, but there were no significant effects of TENS treatment on sleep disorders or behavior disorders evaluated immediately after treatment or at six-week post-treatment. Of nine RCTs identified, only three of the studies provided sufficient data to be combined in a pooled analysis, for a combined total of 63 subjects. Two of these studies were conducted in the Netherlands, and one was conducted in Japan. In one study, TENS was provided for 30 minutes per day, five days per week for six weeks; in another study, TENS was applied for six hours per day; in the Japanese study, TENS was applied for 20 minutes daily for two weeks. In each study, a placebo treatment was delivered using electrodes that were disconnected from the device. The only adverse effects mentioned were from the Japanese study in which one patient to whom cranial electrical stimulation was applied complained of a dull pain in the head with active treatment. None of the other studies mentioned adverse effects, although it is unclear if adverse events were monitored. The authors of the review stated the following conclusions:

"Although a number of studies suggest that TENS may produce short lived improvements in some neuropsychological or behavioural aspects of dementia, the limited presentation and availability of data from these studies does not allow definite conclusions on the possible benefits of this intervention. Since most of the currently published studies are well designed, although the numbers of subjects in each study is small, analysis of the complete original data from these and/or future studies may allow more definitive conclusions to be drawn."³⁴

Animal-assisted Therapy (AAT)

Summary: Though some benefit of AAT on behavioral symptoms is suggested by the authors of these studies, this is a very limited body of evidence. Most studies were not experimental, did not have adequate control groups, had small sample sizes, and lacked methodological rigor. There were no RCTs. Moreover, no study performed a rigorous evaluation of feasibility, safety, cost, and staff training required to implement pet therapy in long-term care facilities.

Details: In 2006, the British National Institute for Health and Clinical Excellence (NICE) published guidelines for supporting people with dementia and their caretakers in health and social care.⁴ The guidelines promoted the use of pet therapy as a non-verbal treatment for patients with verbal impairment, and also advocated pet therapy for patients requiring individualized treatment plans based on preferences, skills, and abilities.⁴

Our initial search for systematic reviews identified no previously published reviews of AAT for dementia. We conducted a search for primary studies and identified nine relevant studies that used quasi-experimental or repeated-measure within-participant designs (Table 2). The largest study included 62 subjects, and four of the studies enrolled 15 or fewer subjects. There were no RCTs.

Table 2

Studies of animal-assisted therapy.

These studies examined a broad range of AATs. One small study (n=9) examined the effects of two 10-minute interactive sessions, one with a robotic cat and one with a plush toy cat, and found that agitation decreased significantly among its participants when they held a plush toy cat.⁴⁷ Another small study (n=6) compared 10-minute sessions with a live cat versus a toy cat, and found that live cats increased meaningful communication, which suggests that patients with dementia may benefit from external stimuli to encourage dialogue.⁴⁸ A third study (n=20) compared the effects of pet therapy with traditional recreation therapy in treating passivity and reported that AAT participants were significantly more engaged and motivated to interact with their environment. Mood and patient satisfaction also significantly improved in the AAT group.⁴⁹ The presence of a resident dog among 22 nursing home residents was associated with decreased scores on all subscales of the Nursing Home Behavior Problem Scale during the day shift of the study but not during the evening hours.⁵⁰ The presence of a fish aquarium was associated with increased nutritional intake among individuals with Alzheimer's disease as well as reduced wandering in some individuals.⁵¹

Exercise

Summary: This body of literature shows inconsistent results of exercise interventions on behavioral symptoms and functional status. Variations in intensity of exercise intervention, severity of dementia at baseline and outcome measures make it difficult to draw a firm conclusion. Many of the included studies were small and did not use rigorous methodology. The most consistent evidence showed that exercise did increase sleep duration and decrease nighttime awakenings. While the impact of improved sleep on distal health outcomes remains uncertain, there may be an additional benefit to caregivers who are disproportionally affected by dysfunctional sleep.

Details: We identified three systematic reviews on the effects of physical activity programs for dementia.^56-58

A Cochrane review aimed to determine whether physical activity programs maintained or improved cognition, function, behavior, depression and/or mortality when compared to usual care in persons with dementia.⁵⁶ The review included randomized controlled trials of older adults with a dementia diagnosis who were allocated to either physical activity or usual care groups. Trials in which the exercise intervention was paired with another intervention were excluded.

The search identified four studies that met methodological quality criteria. The patients in the four included studies all carried a diagnosis of dementia and resided in the community or in long-term care facilities. The interventions varied broadly in intensity, frequency and duration. Three of these trials evaluated the effects of exercise on behavior, using validated scales to measure activities such as wandering, active aggression, and restlessness.^59-61 The fourth trial evaluated function but not behavior.⁶² The authors were only able to combine data from two studies in a meta-analysis and found no effect of exercise on behavioral outcomes.

The Cochrane review was the most restrictive in its inclusion criteria among the reviews on exercise, and found insufficient evidence for drawing conclusions about the efficacy of exercise on behavioral and functional outcomes. The reviewers noted methodological shortcomings in the published literature and also noted other possible explanations for the lack of significant findings, including small sample size, quality of the intervention, poor adherence to the interventions, and differences in population characteristics.⁵⁶

Another systematic review by Eggermont et al. (2006) took a broader approach by including non-randomized controlled trials; studies in which participants had varying degrees of cognitive impairment; studies in which exercise was the primary intervention (but could be combined with another intervention); and studies in which outcomes assessed included behavior, mood, sleep, or functional ability.⁵⁷ After a comprehensive search of studies published between 1974 and 2005, the review found 27 studies that met their inclusion and exclusion criteria, for a total participant sample size of 1,160. Out of 27 studies evaluated, their review included only six RCTs that had clearly defined outcome measures, clearly defined inclusion and exclusion criteria, adequate allocation concealment, and accounting for drop outs. The other included studies were lacking at least one of these criteria. The authors then grouped all included studies by outcome measures and evaluated the effects of exercise on behavior in terms of affect, sleep, and activities of daily living.

Seventeen of the 27 studies discuss the effect of exercise on affective behavior. Five were randomized controlled trials (RCTs), and the other 12 were poorer quality RCTs or observational studies. Two of the RCTs found exercise improved affective behaviors such as depression and agitation.^{63, 64} The other three RCTs evaluating affective behavior showed neutral results.^65-67 Eggermont et al. (2006) explained this inconsistency by noting that the two positive studies used walking as part of the intervention, while the others used mostly seated strengthening exercises.

Six of the 27 studies examined the effect of exercise on sleep. Three of these were good quality RCTs which evaluated an intensive exercise intervention and used wrist sleep monitors to measure sleep.^{63, 64, 67} All had positive results with increased nighttime sleep, decreased daytime sleep, and decreased awakenings. In fact, all studies showed a positive effect on sleep except for one prospective cohort trial which had neutral results. In this study, participants had minimal sleep disturbances at baseline, which may explain the lack of improvement.

Six of the 27 studies evaluated the effects of physical activity on functional ability. There was one good quality randomized control trial that showed improvements in ADLs, balance, timed get up and go, and a physical performance test.⁶⁸ Among the additional five studies that looked at functional ability, only one showed a positive result and this was only in the participants who were most dysfunctional at baseline. The authors note that each of these five trials used interventions of shorter duration compared with the positive RCT.

Overall, Eggermont et al.'s (2006) review⁵⁷ includes a wider range of trials that were of varying quality compared to the Cochrane review.⁵⁶ Though a number of studies found that exercise improved affective and functional outcomes, the overall strength of this conclusion is limited by inconsistencies among trials. On the other hand, a moderate body of consistent evidence showed that exercise programs can improve sleep in persons with dementia. Using the higher quality studies to make their conclusions, the reviewers posited that exercise activities that included walking were more likely to have a positive effect on mood compared to interventions without, and that frequent exercise sessions were more likely to lead to improvements in sleep compared to more sporadic sessions. Interventions of longer duration may have a benefit on functional ability in dementia patients. The authors also note that impairments in affective, functional, and sleep outcomes can have a disproportionate impact on caregivers, yet most of these studies did not evaluate outcomes such as caregiver satisfaction, which may be an important direction for future research in this field.

In a third systematic review on exercise and dementia, Heyn et al. (2004) opted to take a more quantitative approach and conducted a meta-analysis of the effects of physical exercise on dementia.⁵⁸ The analysis included RCTs of older patients with dementia as defined by MMSE scores or a physician diagnosis. Studies were excluded if they did not contain enough statistical information to compute an effect size, or if outcomes other than those specified were evaluated. Thirty trials were found that met these criteria, and they were grouped by outcome including cardiovascular fitness, strength, flexibility, Body Mass Index (BMI), functional status, cognition, and behavior.

The meta-analysis found significant heterogeneity in the data which may have led to inaccurate conclusions. While Heyn et al. (2004) used rigorous methodology in their search, little descriptive information was provided regarding the types of exercise interventions and the outcome measures. Moreover, it is difficult to translate the effect size determined by this review into real life outcomes. The overall results suggest that exercise has a positive effect on dementia patients' functional and behavioral status, but the details remain elusive.

Wandering

Summary: Overall, quality evidence is lacking to determine if subjective barriers prevent or reduce wandering by cognitively impaired people in an institutional or domestic setting, and possible adverse effects remain unknown. There is insufficient evidence to draw any conclusions about the effectiveness of multisensory stimulation, exercise, therapeutic touch, aromatherapy, or music therapy for wandering among patients with dementia. Uncontrolled studies suggest that GPS location systems for wandering behavior may improve patient safety. More rigorous trials are needed to assess the feasibility and effectiveness of these devices in broader use within VA.

Details: The wandering behavior of cognitively impaired people presents risk and places additional demands on caretakers. The prevalence of wandering by people with dementia is difficult to assess. Wandering is not a simple or static behavior, and the reasons why people wander remain unclear: The same behavior or types of wandering might occur for different reasons in different individuals.⁶⁹ Traditional measures to reduce wandering include drugs, restraints, locked doors, and other barriers; but such interventions can be harmful.⁷⁰ It has been hypothesized that non-pharmacological treatments for wandering may provide safe and ethical alternatives.

We located five systematic reviews that focused on interventions for wandering.^69-73 Two publications by the same authors represent the same body of work: one is a journal article ⁷² based on a comprehensive report compiled for the Health Technology Assessment Program of the UK National Health Service.⁷¹ The reviews included studies of a variety of interventions including subjective barriers, wandering in the domestic setting, and multiple interventions for the treatment of wandering.

One review conducted by the Cochrane Collaboration examined the use of subjective barriers, defined as barriers that appear as an obstruction only to persons with cognitive impairment. Examples of subjective barriers include mirrors, floor stripes or grids, camouflage of doors or doorknobs, and concealment of view through door windows. The literature review sought to identify RCTs on the use of subjective barriers but found no available RCTs. The authors therefore concluded that evidence evaluating the effect of subjective barriers is lacking, and the possibility that such barriers cause psychological harm remains unknown.⁷⁰

Another Cochrane review sought to examine interventions for wandering of people with dementia in the domestic setting, as opposed to the institutional setting.⁶⁹ Although the literature search for RCTs found no RCTs conducted in the domestic setting, two RCTs conducted in institutional settings determined that exercise and walking therapies had no impact on wandering. The review also described the growing interest in the use of wander gardens in long-term care settings, but that the effects of such gardens on wandering behaviors are largely anecdotal.⁶⁹

A third systematic review⁷¹ on wandering examined the effectiveness of a variety of non-pharmacological interventions for wandering and included 11 studies (N=594), of which 8 were RCTs. Interventions for wandering included multisensory stimulation, exercise, therapeutic touch, aromatherapy, and music. Range of follow-up was three days to one year, with a mean duration of six weeks. The pooled results of two multisensory stimulation (MSS) studies showed a small, significant reduction in scores for restlessness 10 minutes after the intervention. Results of an exercise intervention showed a significant reduction in wandering in one study, but standard deviation scores were not reported and, therefore, results should be interpreted with caution. One of three studies focusing on therapeutic touch found a significant decrease in pacing but not on wandering or escaping from restraints. One study found that patients who received essential oils (type of oil not listed) compared to a control oil showed a decrease in wandering (P=0.05), while an additional study reported no significant difference in wandering behavior compared to controls. Music therapy showed no effect on wandering behavior. Overall, it is inconclusive as to whether multisensory stimulation, exercise, therapeutic touch, aromatherapy, or music therapy has a measurable effect on the behavioral symptoms of wandering associated with dementia.

A descriptive review of information and communication technology (ICT) devices identified 13 interventions that focused largely on wandering behaviors.⁷³ These examples of smart home technologies included Global Positioning System (GPS) location systems, boundary alarms activated by wristband, floor-lighting systems activated upon wandering detection, communication systems instructing the patient to return to bed after failure to return for a pre-defined period of time, and alarms alerting the caregiver of wandering behavior. The evidence consisted of case studies; cross-sectional studies; or single-group, pre- and post-test/post-test only studies. The settings included residential homes, nursing homes, and hospital settings. The devices were generally found to be effective, reliable, and successful in detecting wandering, locating lost patients, and reducing patient and caregiver stress. The intervention studies were generally limited in design by the lack of a control group, or by lack of blinding when a control group was used. Uncontrolled studies suggest that GPS location systems for wandering behavior may improve patient safety. More rigorous trials are needed to assess the feasibility and effectiveness of these devices in broader use within VA.

Agitation

Summary: Overall, there is no evidence demonstrating an effect of social contact, environmental modification, caregiver training, combination therapy, or behavior therapy on the behavioral symptoms of agitation in dementia. A weak body of evidence suggests sensory interventions may improve agitation. One recent primary study provides preliminary evidence suggesting that systematic individualized intervention may be effective in improving the symptom of agitation, though additional evidence is needed.

Details: Agitation is defined as an inappropriate verbal, vocal, or motor activity that is not explained by needs or confusion.⁷⁴ We found one review that focused on the behavioral symptoms of agitation for dementia.⁷⁴ The review identified 14 randomized trials (combined number of subjects=586) that included six types of intervention: sensory interventions, social contact, environmental modification, caregiver training, combination therapy, and behavior therapy. Study designs included randomized controlled parallel and randomized cross-over study designs, and usual care constituted the comparator in each study. The duration of treatment ranged across studies from ten minutes to one year. Four studies included follow-up at longer than two months and were thus able to examine the long-term effects of interventions. In addition to the one review, we included one recently conducted primary study suggested to us by reviewers.

Among the seven types of interventions tested in the studies included in the review, sensory interventions (aromatherapy, thermal bath, calming music, and hand massage) were found to be effective: pooled data from three studies (N=120), which included two RCTs and one randomized cross-over design (RCO), showed a statistically significant decrease in agitation between treatment groups and control groups. These findings should be interpreted with caution, however. Several factors limit the conclusions that can be drawn from the pooled findings: there was a small number of studies in each intervention category; there was substantial variability in the duration of the intervention programs (including one study that used a single 10-minute exposure) and outcome measures used; and the definitions of agitation were inconsistent across studies.

Of the four studies that tested long-term effects (> 2-month follow-up) of interventions, there were no significant differences in agitation between treatment groups and control groups for caregiver training, combination therapy, and behavioral therapy.⁷⁴

One primary study was included based on reviewer feedback. This study documented a randomized, placebo-controlled trial of a systematic individualized intervention designed to target the symptom of agitation.⁷⁵ The authors described a decision tree intervention model designed to target unmet needs in individuals exhibiting agitation; therefore, the intervention was individualized to participants and included a potentially unlimited variety of specific intervention strategies. The systematic individualized intervention was described as a decision tree model to assist providers and caregivers in identifying unmet needs that could cause behavioral symptoms of dementia, and the individually tailored treatments were left to the discretion of the care professional. Examples of specific treatments that were implemented included altering the environment for increased familiarity and comfort, engagement in meaningful activities, and using safety devices. Participants were 167 residents in 12 nursing homes. Randomization was at the level of nursing home, with six nursing homes receiving the treatment condition and six receiving the placebo control. The study was randomized and included a strong placebo control condition (i.e., the control condition consisted of an educational intervention to assure that control group staff was unaware of control group status). The authors do not adequately describe blinding procedures, however, and it appears as though raters who assessed agitation were not blind to treatment condition. Therefore, though this research provides preliminary results supporting the use of systematic individualized intervention to treat the symptom of agitation, these findings must be interpreted with caution due to the possibility of inadequate blinding which could affect the validity of the study.

Inappropriate Sexual Behavior

There were no systematic reviews that examined the topic of inappropriate sexual behavior among individuals with dementia. Currently, the effectiveness of non-pharmacological treatments for inappropriate sexual behavior remains unknown.

Animal-assisted Therapy

Although we found no studies addressing the safety of animal-assisted therapy, the guidelines of the American Veterinary Medical Association describe potential physical and emotional harms associated with animal-assisted therapy.⁷⁷ Human injury can result because of lack of supervision, inadequate participant training, or inappropriate handling. Zoonotic disease transmission is also of concern any time animals and humans interact, and can pose a threat to high-risk populations if good hygiene is not utilized. Moreover, participants can have potential allergic reactions to animal dander or saliva. Emotional risks for patients include grief or guilt should a therapy animal pass away. Program participants may become possessive of the animals, creating an atmosphere of competition rather than social well-being. Patients may perceive that an animal has rejected them, and the interaction could potentially exacerbate mood or behavioral symptoms.⁷⁷

Exercise

Few studies discussed adverse events. Potential harms of exercise programs include the increased risk of falls or other adverse outcomes.