Table 3.

Summary of studies examining non-pharmacological treatments for NPS in moderately severe to severe dementia (MMSE 0–17; Tombaugh and McIntyre, 1992)

AUTHORS AND LOCATION	SEVERITY OF COGNITIVE IMPAIRMENT	TREATMENT AND COMPARISON GROUPS	NPS SYMPTOMS AND OUTCOME MEASURES	TIMING OF DATA COLLECTION PERIODS AND FOLLOW-UP	RESEARCH DESIGN	RESULTS	STRENGTH / QUALITY
EMOTION-ORIENTED TREATMENTS
Finnema et al. (2005) Netherlands: 16 psychogeriatric wards in 14 nursing homes	Stratified by severity: Severe (GDS 5–6): n = 70 Moderate (GDS 3–4): n = 69 Mild (GDS 1–2): n = 7	Integrated   emotion-oriented care: n = 67 Usual care: n = 79 146/194 completed: 25% attrition	Behavioral and mood disturbances Measures: CSDD CMAI	Baseline, 3, and 7 months.	Pretest-posttest, cluster (by ward), RCT. Matched nursing assistants, blinded to which residents were participating, were trained to administer either protocol and integrate it into 24 hr care. (High attrition, mostly due to death, was equally distributed.)	No benefit over usual care for participants with severe dementia. Participants with mild and moderate severity of dementia benefited from emotion-focused care, showing greater emotional adaptation than those in usual care.	Level I / Moderate
Magai et al. (2002) U.S.A.: 3 nursing homes	MMSE 3.4 ± 5.0	1. Non-verbal sensitivity: n = 41 2. Behavioral placebo: n = 23 3. Control (waitlist): n = 27 8% attrition.	Affect & Behavior Measures: BEHAVE-AD CMAI CSDD Facial expression	Baseline and every three weeks until 12 wk post-training (of caregivers)	Double-blind, cluster (by nursing home) RCT with repeated measures. Manualized caregiver training administered over 2 weeks by a psychologist who was blind to condition and hypotheses. Blinded research assistants completed all ratings.	No differences in behaviors between groups. Positive affect increased sharply during the first 6 wk following non-verbal sensitivity training*, but no differences between groups remained by 12 wks.	Level I / High
• Simulated Presence (SP)
Camberg et al. (1999) U.S.A.: 9 nursing homes	MMSE 5.1 ± 4.4 Excluded residents who did not have verbal interactive capacity.	1. SP 2. Placebo 3. Usual care N = 54. Partial attrition (n = 5) did not affect analyses.	Agitation, withdrawal Measures: Direct observation Weekly staff survey included: Short CMAI MOSES	Direct observation on pre-determined schedule for 3 hr, 20min/wk. Staff documented responses to treatments. Weekly staff surveys.	Double-blind, Latin-square, 3-factor with restrictive randomization of treatments. Treatments: were each continued for 17 days over a 4-wk period with a 10-day washout. Nursing staff observers were blinded to the interventions.	Staff observations: SP was better in reducing agitation and withdrawal than usual care*** or placebo***. Weekly staff surveys on CMAI and MOSES did not show any benefit from SP over usual care and both resulted in more positive affect than placebo***.	Level I / High
Garland et al., 2007 Australia: 9 nursing homes	MMSE 2.5, range 0–12 Excluded residents who did not have verbal interactive capacity.	1. SP 2. Preferred music 3. Placebo 4. Usual care N = 30. No attrition.	Agitation Measures: CMAI	Direct observation before during and after exposure to 15 minute tapes.	Repeated measures with randomized crossover. Random assignment to groups that received treatments in different orders. Conditions delivered by 15 min. audiotape 3days/wk for each condition. Researchers were blinded to tape content.	Decreased physical agitation during treatment with SP compared to placebo** and usual care**. Decreased verbal agitation during treatment with SP compared to usual care*. No difference between SP and music.	Level I/High
BEHAVIORAL AND ENVIRONMENTAL TREATMENTS
Bellelli et al. (1998) Italy: 8 SCUs	MMSE 6.1 ± 5.0, range 0–14	Consecutive patients: N = 55 Attrition not reported.	Behavioral and mood disturbances Measures: NPI	Measurements at baseline, 3 months, and 6 months after admission.	Single-group pretest-posttest. Special training of nursing staff provide gentle care while reducing high auditory stimuli and fast movements.	Decreases in agitation*, apathy**, and aberrant motor*** at 3 mos. Decreases in agitation***, apathy*, and aberrant motor*** at 6 mos.	Level II / Low
Frisoni et al. (1998) Italy: 43 nursing homes, 25 with SCUs	MMSE range 0–16	SCU: n = 31 NH usual care: n = 35 Attrition not reported.	Behavioral disturbances Measures: NPI, CMAI, CSDD.	Baseline and 3 months after admission	Non-equivalent groups, pretest-posttest. Treatment not described.	Reduction in NPI motor subscale** and CSDD* in both groups after 3 mos., although the patterns of specific NPS reductions differed.	Level II / Low
Morgan and Stewart (1998) Canada: 2 long-term care facilities	GDS 5–6 Excluded GDS 7 (due to immobility)	Low density SCU n = 39 Traditional SCU n = 11 53/59 completed: 10% attrition.	Disruptive and non-disruptive behavior Measures: EBIC	Baseline, 6 months and 12 months following re-location.	Non-equivalent groups, 2×3 factorial. Convenience sample of nursing home residents moving from their SCU to other SCUs with lower social and spatial densities. Comparison group sample remained in the traditional SCU.	Greater decrease over time in disruptive behaviors in the experimental (low-density) group than in the comparison (constant high density) group**.	Level II / Moderate
SENSORY-ORIENTED TREATMENTS
• Aromatherapy
Ballard et al. (2002) U.K.: 8 nursing homes	CDR3	Melissa oil: n = 36 (35 completed) Sunflower oil: n = 36 71/72 completed: 3% attrition	Agitation Measures: CMAI NPI (Aberrant motor subscale)	Baseline, and weekly for 4 wk.	Double-blinded cluster (by facility) RCT. Eight facilities, randomly assigned to treatment or placebo. The oils were applied within a skin cream to face and arms twice per day over a 4 wk period.	Reductions in agitation** in both groups. Irritability and aberrant motor improved to a greater extent with aromatherapy compared to placebo***. Greater reduction in social withdrawal and increase in time spent in constructive activities with aromatherapy compared to placebo**.	Level I / High
Holmes et al. (2002) U.K.: Long-term stay unit for patients with behavioral problems.	ICD-10 severe dementia	1. Lavender oil 2. Water N = 15	Agitation Measures: PAS	During treatment only. No baseline or follow-up.	Single-group repeated measures, with alternating daily aroma treatments 2 hr/day for 10 days. Aroma-streams were administered in a communal area. Raters were blinded (nose calipers) to treatment.	The median PAS score was lower (reduced agitation) during aromatherapy compared with placebo*.	Level II / Moderate
Lin et al. (2007) Hong Kong: Care and attention homes	CMMSE 7.8 ± 3.4, range 0–14	1. Lavender aroma 2. Sunflower aroma N = 70 No attrition.	Agitation Measures: Chinese versions of CMAI and NPI	Before and after each treatment period.	Repeated measures with randomized crossover. Aromas were delivered by diffuser at night for at least one hour for 3 wk, with 2 wk washout between conditions.	Decrease in agitation with lavender treatment with reduced scores on both C-CMAI and C-NPI***. No change following sunflower treatment.	Level I / Moderate
Snow et al. (2004) U.S.A.: Nursing home	SIRS 13.2 ± 5.25, range 8–18	3 Oils: A. Lavender B. Thyme C. Grapeseed (unscented) N = 7. No attrition.	Agitation Measure: CMAI	Every other day during the 4 wk baseline, 10 wk intervention and 2 wk post-treatment.	Single-group repeated measures (ABCBA). Oils were worn for 3 hr on a sachet near the collarbone on treatment days. Following 4 wk baseline, each treatment was given for 2 wks in the same order.	Total absence of treatment effect.	Level II / Low
• Bright Light Therapy
Mishima et al. (1998) Japan: 1 long-term care facility	MMSE range 3–17	Light 1. Bright 2. Dim N = 22 with sleep and behavioral disturbances No attrition.	Symptom: Rest-activity rhythm Measure: Actigraph	Baseline, wk 1, wk 2, and post-treatment. Continuous 1 min rest-activity monitoring.	Repeated measures with randomized crossover. Compared therapeutic effect of morning bright light and dim light, each presented for 2 wk period, with 4 wk washout. No NPS measures.	Reduction in nighttime activity and percentage of nighttime activity to total activity with bright light for Ss with vascular dementia** but not for those with Alzheimer’s dementia.	Level I / Low
Skjerve et al. (2004) Norway: 2 psychogeriatric institutions	MMSE range 0–11 CDR 3	Bright Light Therapy N = 11 10 completed: 9% attrition	Agitation and behavioral symptoms Measures: CMAI BEHAVE-AD, and Actigraph	2 wk baseline, during, and 2 wk after treatment.	Single-group repeated measures. Bright light for 45 min each morning for 4 wk. Continuous activity monitoring for 6 wk (one week of baseline and post-treatment.	Decrease in agitation and behavioral symptoms from pre to post-treatment**. No improvement in sleep-wake measures (actigraph). (One participant was dropped due to increased agitation.)	Level I / Low
• Movement Therapy
Heyn (2003) U.S.A.: Nursing home	MMSE 7.25 ± 3.4, range 1–12	Multi-sensory exercise program: N = 13 No attrition.	Engagement and mood Measures: MPES CMR	Direct assessment of engagement and mood during exercise program.	Single-group pretest-posttest. All participants received the MSS exercise program 3 times per wk for 8 wk. Duration of exercise increased over time from 15 min. to 70 min.	69% of the participants engaged in more than half of the activity (MPES). 61.5% of the participants showed improvement ratings of facial expression/mood (CMR).	Level II / Low
Holliman et al. (2001) U.S.A.: Geriatric psychiatry facility	MMSE 4.6 ± 4.9, range 0–13	Interactive physical activity (E) Unspecified control N = 12. 12/14 completed: 14% attrition	Behavioral disturbances Measures: PGDRS (behavior subscale) PBRS (E group only)	Baseline, twice during intervention sessions, and once at post-test (total = 4 times) for each session.	Pretest–post-test with random assignment to either the interactive physical activity (E) or control group. E group met for 30 min. 3/wk for 2 wk. Socialization with snack followed activity. Repeated measures on PBRS for E group only. Control group was not described.	E group participants had less disruptive behavior and more positive behavior during group sessions than before (PBRS). No lasting benefits: E group had more disruptive behavior than control group (PGDRS) following sessions*.	Level II / Low
• Music Therapy
Garland et al. (2007) See emotion-oriented treatments for full summary.						Decreased physical agitation during preferred music compared to usual care (no treatment)*. Decreased verbal agitation after preferred music compared to placebo**.	Level I / High
Holmes et al. (2006) U.K.: 4 residential and nursing homes	Stratified by severity ICD-10: moderate (n = 14), and severe (n = 18) dementia	Music: 1. Live 2. Pre-recorded 3. Silence N = 32 No attrition	Apathy Measures: Participant videos were rated for engagement (category E) on the DCM	DCM category E scores were obtained 10 times during each condition for each participant.	Repeated measures with randomized crossover. Each of the three musical conditions was presented in one session lasting 1 1/2 hr (30 min per condition). Attempt to blind observer raters was ineffective.	Greater positive engagement during live music than silence**. Greater engagement during live music than pre-recorded music**. Engagement during pre-recorded music was not significantly different than silence.	Level I / Moderate
Svansdottir et al. (2006) Iceland: 2 nursing homes and 2 psychogeriatric wards	GDS 5–7	Music therapy: n = 23 (20 completed) Usual care: n = 23 (18 completed) 17% attrition.	Behavioral disturbances Measures: BEHAVE-AD	Baseline, 6 wk and 4 wk post-treatment	Pretest-posttest with random assignment to group. Interactive music group received 18 sessions (singing familiar music with guitar), 30 min each, 3 times/wk × 6 wk. Usual care not described. Raters blinded to condition.	Reduction in combined symptom scores for activity disturbance, aggressiveness, and anxiety**. No change in control group. Benefits of music therapy disappeared by 4 wk follow-up.	Level I / Moderate
• Multi-sensory Stimulation (MSS)
Baker et al. (2001) U.K.: Day hospital	MSS group: MMSE 10.96 ± 6.5 Activity group: MMSE 6.08±5.07 MMSE range 0–17	MSS: n = 25 (23 completed)   Activity: n = 25   48/50 completed: 4% attrition	Behavior and mood Measures: INTERACT REHAB BMD BRS	Baseline, mid-trial and post-trial. Before, during, and after sessions. Follow-up at 1 month post-treatment.	RCT with repeated measures. Two 30 min sessions / wk. over 4 wk period (8 total). Both treatments were individualized according to preferences and functional abilities.	Improved mood and interest after both treatments**. Greater increase in attentiveness to environment after MSS than activity sessions*. Greater improvement in mood and behavior at home compared to the activity group whose behavior deteriorated*. Benefits disappeared by 1 month follow-up.	Level I / High
Baker et al. (2003) U.K.: Day hospital. Netherlands and Sweden: psychogeriatric wards.	MMSE 0–17 with post-hoc stratification by severity level.	MSS: n = 65 (62 completed) Activity: n = 71 (65 completed) 127/136 completed: 7% attrition	Behavior and mood Measures: INTERACT REHAB BMD BRS	Baseline, mid-trial and post-trial. Before, during, and after each session. Follow-up at 1 month post-treatment.	RCT with repeated measures. Two 30 min sessions / wk. over 4 wk period (8 total). All but 20 participants were randomized to treatment groups. MSS treatments were non-directive and sensory focused. Activities were focused on tasks that demanded intellectual or physical involvement.	Apathy decreased in both groups***. Severity by time interaction**. MMSE 0–9 were less apathetic at post-trial following MSS and more apathetic following activity group. MMSE 10–17 had the opposite pattern. Benefits disappeared by 1 month follow-up.	Level I / High
• Touch Therapy
Gerdner et al. (2008) U.S.A.: 2 nursing homes	GDS 6.25, range 5–7	Craniosacral still point technique N = 11 9/11 completed: 18% attrition	Agitation Measures: Modified CMAI	Weekly assessments during 3 wk baseline, 6 wk of treatment, and 3 wk of post-treatment.	Single-group repeated measures. Mean treatment length was 5 minutes delivered by a certified craniosacral therapist in conjunction with Progressively Lower Stress Threshold (PLST) model of care. The M-CMAI was administered by CNAs.	Reduction in mean M-CMAI total*** and subscale scores (physically aggressive**, non-aggressive***, and verbal agitation***) at post-test. Reduction continued through post-treatment period for physically non-aggressive agitation*** and verbal agitation**.	Level II / Low
• Balancing Arousal
Kovach et al. (2004) U.S.A.: 13 long-term care facilities	MMSE 0–15 FAST 6–7	BACE: n = 36 Usual care: n = 42 78/102 completed: 24% attrition	Agitation Measures: ASD Visual analog of the CMAI	Direct observation in Phases 1 and 3 of baseline, treatment and post-treatment for 3 min every 15 min from 8 am–8 pm.	Double-blind, pretest-posttest, with random assignment. BACE individualizes activity schedule to balance high-arousal and low-arousal states. Phase 1: 12hr observation, Phase 2: individualization of activity schedule, Phase 3: 12 hr. of observation.	BACE resulted in reduced agitation between pretest and posttest***, with no change in the control group. Effects mostly gone by 10 wk.	Level I / Moderate

BACE = Balancing Arousal Controls Excesses; CNA = certified nursing assistant; MSS = multi-sensory stimulation; RCT = randomized controlled trial; SCU = Special Care Unit.

Outcome measures ASD= Arousal States in Dementia Scale; BEHAVE-AD = Behavior Pathology in Alzheimer’s Disease Rating Scale; BRS = Behaviour Rating Scale; BMD = Behaviour and Mood Disturbance Scale; CMR = Caregiver Mood Report; CMAI = Cohen-Mansfield Agitation Inventory; CMMSE = Chinese Mini-mental State Examination; CNPI = Chinese Neuropsychiatric Inventory; CSDD = Cornell Scale for Depression in Dementia; DCM = Dementia Care Mapping; DS-DAT = Discomfort-Dementia of the Alzheimer’s Type; EBIC = Environment-Behavior Interaction Code; FAST = Functional Assessment of Alzheimer Disease; MPES = Menorah Park Engagement Scale; MMSE = Mini-mental State Examination; MOSES = Multi-dimensional Observation Scale for Elderly Subjects; NPI = Neuropsychiatric Inventory; PBRS = Patient Behavior Rating Scale; PAS = Pittsburg Agitation Scale; PARS = Philadelphia Geriatric Center Affect Rating Scale; PGDRS = Psychogeriatric Dependency Rating Scale; REHAB = Rehabilitation Evaluation.

^*p < 0.05,

^**p < 0.01,

^***p < .001.