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176 to 200 of 2,047Self-management intervention for head and neck cancer couples: Results of a randomized pilot trial.
Background: Patients with head and neck cancer (HNC) experience significant physical and psychological morbidity during radiotherapy (RT) that contributes to treatment interruptions and a poor quality of life. Although spouses/partners can help by encouraging patient self-management (eg, self-care) during RT, they often experience high psychological distress rates, lack basic health care knowledge and skills, and report increased marital conflict regarding patient self-management. The current pilot study examined the feasibility and acceptability of a 6-session telephone-based intervention called Spouses coping with the Head And neck Radiation Experience (SHARE), which teaches self-management, communication, and coping skills to patients with HNC and their spouses. The treatment effects of SHARE compared with usual medical care (UMC) in controlling patient physical symptoms and improving…
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Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, Hooper SM, Allen IE, Braley T, Bernstein A, Rosa TD, Harrison K, Begert-Hellings H, Kornak J, Kahn JG, Naasan G, Lanata S, Clark AM, Chodos A, Gearhart R, Ritchie C, Miller BL (2019)randomised controlled trialMEDLINE-indexed journal, not yet read by usJAMA internal medicine202 citations Effect of Collaborative Dementia Care via Telephone and Internet on Quality of Life, Caregiver Well-being, and Health Care Use: The Care Ecosystem Randomized Clinical Trial.
Importance: Few health systems have adopted effective dementia care management programs. The Care Ecosystem is a model for delivering care from centralized hubs across broad geographic areas to caregivers and persons with dementia (PWDs) independently of their health system affiliations.
Objective: To determine whether the Care Ecosystem is effective in improving outcomes important to PWDs, their caregivers, and payers beyond those achieved with usual care.
Design, setting, and participants: A single-blind, randomized clinical trial with a pragmatic design was conducted among PWDs and their caregivers. Each PWD-caregiver dyad was enrolled for 12 months between March 20, 2015, and February 28, 2017. Data were collected until March 5, 2018. Study interventions and assessments were administered over the telephone and internet by clinical and research teams in San Francisco, California, and …
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Wilson LS, Blonquist TM, Hong F, Halpenny B, Wolpin S, Chang P, Filson CP, Master VA, Sanda MG, Chien GW, Jones RA, Krupski TL, Berry DL (2019)randomised controlled trialMEDLINE-indexed journal, not yet read by usBMC medical informatics and decision making7 citations Assigning value to preparation for prostate cancer decision making: a willingness to pay analysis.
Background: The Personal Patient Profile-Prostate (P3P) is a web-based decision support system for men newly diagnosed with localized prostate cancer that has demonstrated efficacy in reducing decisional conflict. Our objective was to estimate willingness-to-pay (WTP) for men's decisional preparation activities.
Methods: In a multicenter, randomized trial of P3P, usual care group participants received typical preparation for decision making plus referral to publicly-available, educational websites. Intervention group participants received the same, plus online P3P educational media specific to the user's personal preferences and values, and a communication coaching component tailored to race\ethnicity, age and language. WTP data were collected one week after physician consultation. An iterative bidding direct contingent valuation survey format was used, randomly assigning participants to…
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Bucci S, Barrowclough C, Ainsworth J, Machin M, Morris R, Berry K, Emsley R, Lewis S, Edge D, Buchan I, Haddock G (2018)randomised controlled trialMEDLINE-indexed journal, not yet read by usSchizophrenia bulletin143 citations Actissist: Proof-of-Concept Trial of a Theory-Driven Digital Intervention for Psychosis.
Background: Timely access to intervention for psychosis is crucial yet problematic. As such, health care providers are forming digital strategies for addressing mental health challenges. A theory-driven digital intervention that monitors distressing experiences and provides real-time active management strategies could improve the speed and quality of recovery in psychosis, over and above conventional treatments. This study assesses the feasibility and acceptability of Actissist, a digital health intervention grounded in the cognitive model of psychosis that targets key early psychosis domains.
Methods: A proof-of-concept, single, blind, randomized controlled trial of Actissist, compared to a symptom-monitoring control. Thirty-six early psychosis patients were randomized on a 2:1 ratio to each arm of the trial. Actissist was delivered via a smartphone app over 12-weeks; clinical and funct…
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Expressive writing intervention and self-reported physical health out-comes - Results from a nationwide randomized controlled trial with breast cancer patients.
The objective was to examine the effect of Expressive Writing Intervention (EWI) on self-reported physical symptoms and healthcare utilization in a nationwide randomized controlled trial with Danish women treated for primary breast cancer, and to explore participant characteristics related to emotion regulation as possible moderators of the effect. Women who had recently completed treatment for primary breast cancer (n = 507) were randomly assigned to three 20 min. home-based writing exercises, one week apart, focusing on emotional disclosure (EWI) of a distressing experience (their cancer or a non-cancer topic) or a non-disclosing topic (control). Outcomes were self-reported physical symptoms and healthcare utilization (visits and telephone contacts with GP) 3 and 9 months post-intervention. Potential moderators were repressive coping, alexithymia, rumination, social constraints, and wr…
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Crawley R, Ayers S, Button S, Thornton A, Field AP, Lee S, Eagle A, Bradley R, Moore D, Gyte G, Smith H (2018)randomised controlled trialMEDLINE-indexed journal, not yet read by usBMC pregnancy and childbirth7 citations Feasibility and acceptability of expressive writing with postpartum women: a randomised controlled trial.
Background: Pregnancy, birth and adjusting to a new baby is a potentially stressful time that can negatively affect women's mental and physical health. Expressive writing, where people write about a stressful event for at least 15 min on three consecutive days, has been associated with improved health in some groups but it is not clear whether it is feasible and acceptable for use with postpartum women. This study therefore examined the feasibility and acceptability of expressive writing for postpartum women as part of a randomised controlled trial (RCT).
Methods: The Health After Birth Trial (HABiT) was an RCT evaluating expressive writing for postpartum women which included measures of feasibility and acceptability. At 6 to 12 weeks after birth 854 women were randomised to expressive writing, a control writing task or normal care, and outcome measures of health were measured at baselin…
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Effect of a Health Care Professional Communication Training Intervention on Adolescent Human Papillomavirus Vaccination: A Cluster Randomized Clinical Trial.
Importance: The incidence of human papillomavirus (HPV)-related cancers is more than 35 000 cases in the United States each year. Effective HPV vaccines have been available in the United States for several years but are underused among adolescents, the target population for vaccination. Interventions to increase uptake are needed.
Objective: To evaluate the effect of a 5-component health care professional HPV vaccine communication intervention on adolescent HPV vaccination.
Design, setting, and participants: A cluster randomized clinical trial using covariate-constrained randomization to assign study arms and an intent-to-treat protocol was conducted in 16 primary care practices in the Denver, Colorado, metropolitan area. Participants included 188 medical professionals and 43 132 adolescents.
Interventions: The 5 components of the intervention were an HPV fact sheet library to create cus…
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Twohig MP, Abramowitz JS, Smith BM, Fabricant LE, Jacoby RJ, Morrison KL, Bluett EJ, Reuman L, Blakey SM, Ledermann T (2018)randomised controlled trialMEDLINE-indexed journal, not yet read by usBehaviour research and therapy62 citations Adding acceptance and commitment therapy to exposure and response prevention for obsessive-compulsive disorder: A randomized controlled trial.
The objective of this study was to test whether treatment acceptability, exposure engagement, and completion rates could be increased by integrating acceptance and commitment therapy (ACT) with traditional exposure and response prevention (ERP). 58 adults (68% female) diagnosed with obsessive-compulsive disorder (OCD; M age = 27, 80% white) engaged in a multisite randomized controlled trial of 16 individual twice-weekly sessions of either ERP or ACT + ERP. Assessors unaware of treatment condition administered assessments of OCD, depression, psychological flexibility, and obsessional beliefs at pretreatment, posttreatment, and six-month follow-up. Treatment acceptability, credibility/expectancy, and exposure engagement were also assessed. Exposure engagement was high in both conditions and there were no significant differences in exposure engagement, treatment acceptability, or dropout ra…
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Richards D, Duffy D, Blackburn B, Earley C, Enrique A, Palacios J, Franklin M, Clarke G, Sollesse S, Connell S, Timulak L (2018)randomised controlled trialMEDLINE-indexed journal, not yet read by usBMC psychiatry39 citations Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial.
Background: Depression and anxiety are common mental health disorders worldwide. The UK's Improving Access to Psychological Therapies (IAPT) programme is part of the National Health Service (NHS) designed to provide a stepped care approach to treating people with anxiety and depressive disorders. Cognitive Behavioural Therapy (CBT) is widely used, with computerised and internet-delivered cognitive behavioural therapy (cCBT and iCBT, respectively) being a suitable IAPT approved treatment alternative for step 2, low- intensity treatment. iCBT has accumulated a large empirical base for treating depression and anxiety disorders. However, the cost-effectiveness and impact of these interventions in the longer-term is not routinely assessed by IAPT services. The current study aims to evaluate the clinical and cost-effectiveness of internet-delivered interventions for symptoms of depression and …
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Group-Based Compassion-Focused Therapy as an Adjunct to Outpatient Treatment for Eating Disorders: A Pilot Randomized Controlled Trial.
The current study sought to assess the acceptability and feasibility of a compassion-focused therapy (CFT) group as an adjunct to evidence-based outpatient treatment for eating disorders, and to examine its preliminary efficacy relative to treatment as usual (TAU). Twenty-two outpatients with various types of eating disorders were randomly assigned to 12 weeks of TAU (n = 11) or TAU plus weekly CFT groups adapted for an eating disorder population (CFT + TAU; n = 11). Participants in both conditions completed measures of self-compassion, fears of compassion, shame and eating disorder pathology at baseline, week 4, week 8 and week 12. Additionally, participants receiving the CFT group completed measures assessing acceptability and feasibility of the group. Results indicated that the CFT group demonstrated strong acceptability; attendance was high and the group retained over 80% of particip…
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Kerrigan D, Mbwambo J, Likindikoki S, Beckham S, Mwampashi A, Shembilu C, Mantsios A, Leddy A, Davis W, Galai N (2017)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of acquired immune deficiency syndromes (1999)55 citations Project Shikamana: Baseline Findings From a Community Empowerment-Based Combination HIV Prevention Trial Among Female Sex Workers in Iringa, Tanzania.
Background: Community empowerment approaches have been found to be effective in responding to HIV among female sex workers (FSWs) in South Asia and Latin America. To date, limited rigorous evaluations of these approaches have been conducted in sub-Saharan Africa.
Methods: A phase II community randomized controlled trial is being conducted in Iringa, Tanzania, to evaluate the effectiveness of a community empowerment-based combination HIV prevention model (Project Shikamana) among a stratified sample of HIV-infected and HIV-uninfected FSWs. Cohort members were recruited from entertainment venues across 2 communities in the region using time-location sampling. All study participants gave consent, and were surveyed and screened for HIV at baseline. Primary biological study outcomes are viral suppression among the HIV-infected and remaining free of HIV among HIV-uninfected women.
Results: A c…
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A randomized pilot trial of a positive affect skill intervention (lessons in linking affect and coping) for women with metastatic breast cancer.
Background: We conducted a randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of a 5 week positive affect skills intervention (LILAC: lessons in linking affect and coping) for women with metastatic breast cancer. Additionally, we examined whether online delivery of the intervention would offer comparable benefits as in-person delivery.
Methods: Women with metastatic breast cancer (N = 39) were randomized to an in-person intervention, online intervention, or in-person attention-matched control. Psychological well-being (depression [Center for Epidemiologic Studies Depression Scale], positive and negative affect [Differential Emotions Scale], cancer-specific quality of life [Multidimensional Quality of Life Scale-Cancer Version]), and positive coping (mindfulness, positive-affect skill use, and self-compassion [Self-Compassion Scale: Short-Form]) wer…
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A randomized trial of motivational interviewing and facilitated contraceptive access to prevent rapid repeat pregnancy among adolescent mothers.
Background: Most interventions designed to reduce teen pregnancy rates have not focused on pregnant and/or parenting adolescents. Therefore, a large randomized controlled trial was conducted regarding a motivational interviewing program entitled Teen Options to Prevent Pregnancy in a low-income sample of adolescent mothers. This program recommended monthly sessions between a participant and a registered nurse over 18 months. This program also featured facilitated birth control access through transportation assistance and a part-time contraceptive clinic.
Objective: The impact of this program on rapid repeat pregnancies at 18 months after enrollment was evaluated.
Study design: Five hundred ninety-eight adolescent females were enrolled from 7 obstetrics-gynecology clinics and 5 postpartum units of a large hospital system in a Midwestern city. Each participant was enrolled at least 28 week…
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Chum J, Kim MS, Zielinski L, Bhatt M, Chung D, Yeung S, Litke K, McCabe K, Whattam J, Garrick L, O'Neill L, Goyert S, Merrifield C, Patel Y, Samaan Z (2017)randomised controlled trialMEDLINE-indexed journal, not yet read by usEvidence-based mental health30 citations Acceptability of the Fitbit in behavioural activation therapy for depression: a qualitative study.
Introduction: Major depressive disorder is characterised by low mood and poor motivation. Literature suggests that increased physical activity has positive effects on alleviating depression. Fitness-tracking devices may complement behavioural activation (BA) therapy to improve physical activity and mental health in patients with depression.
Objectives: To understand patients' perceived benefit from the Fitbit and explore themes associated with patient experiences. To compare perceived benefit, patient factors, Fitbit usage and Beck's Depression Inventory (BDI) scores.
Methods: Semistructured interviews were conducted with patients (n=36) who completed a 28-week BA group programme in a mood disorders outpatient clinic. All patients were asked to carry a Fitbit One device. We conducted thematic analyses on the interviews and exploratory quantitative analyses on patient characteristics, Fit…
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Downs JA, Mwakisole AH, Chandika AB, Lugoba S, Kassim R, Laizer E, Magambo KA, Lee MH, Kalluvya SE, Downs DJ, Fitzgerald DW (2017)randomised controlled trialMEDLINE-indexed journal, not yet read by usLancet (London, England)31 citations Educating religious leaders to promote uptake of male circumcision in Tanzania: a cluster randomised trial.
Background: Male circumcision is being widely deployed as an HIV prevention strategy in countries with high HIV incidence, but its uptake in sub-Saharan Africa has been below targets. We did a study to establish whether educating religious leaders about male circumcision would increase uptake in their village.
Methods: In this cluster randomised trial in northwest Tanzania, eligible villages were paired by proximity (<60 km) and the time that a free male circumcision outreach campaign from the Tanzanian Ministry of Health became available in their village. All villages received the standard male circumcision outreach activities provided by the Ministry of Health. Within the village pairs, villages were randomly assigned by coin toss to receive either additional education for Christian church leaders on scientific, religious, and cultural aspects of male circumcision (intervention group),…
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Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial.
Background: Depression has become one of the leading contributors to the global disease burden. Evidence-based treatments for depression are available, but access to them is still limited in some instances. As technology has become more integrated into mental health care, computerized cognitive behavioral therapy (CBT) protocols have become available and have been recently transposed to mobile environments (e.g., smartphones) in the form of "apps." Preliminary research on some depression apps has shown promising results in reducing subthreshold or mild to moderate depressive symptoms. However, this small number of studies reports a low statistical power and they have not yet been replicated. Moreover, none of them included an active placebo comparison group. This is problematic, as a "digital placebo effect" may explain some of the positive effects documented until now. The aim of this s…
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Wardle J, von Wagner C, Kralj-Hans I, Halloran SP, Smith SG, McGregor LM, Vart G, Howe R, Snowball J, Handley G, Logan RF, Rainbow S, Smith S, Thomas MC, Counsell N, Morris S, Duffy SW, Hackshaw A, Moss S, Atkin W, Raine R (2016)randomised controlled trialMEDLINE-indexed journal, not yet read by usLancet (London, England)112 citations Effects of evidence-based strategies to reduce the socioeconomic gradient of uptake in the English NHS Bowel Cancer Screening Programme (ASCEND): four cluster-randomised controlled trials.
Background: Uptake in the national colorectal cancer screening programme in England varies by socioeconomic status. We assessed four interventions aimed at reducing this gradient, with the intention of improving the health benefits of screening.
Methods: All people eligible for screening (men and women aged 60-74 years) across England were included in four cluster-randomised trials. Randomisation was based on day of invitation. Each trial compared the standard information with the standard information plus the following supplementary interventions: trial 1 (November, 2012), a supplementary leaflet summarising the gist of the key information; trial 2 (March, 2012), a supplementary narrative leaflet describing people's stories; trial 3 (June, 2013), general practice endorsement of the programme on the invitation letter; and trial 4 (July-August, 2013) an enhanced reminder letter with a ban…
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Feasibility, acceptability, and potential efficacy of the PTSD Coach app: A pilot randomized controlled trial with community trauma survivors.
Objective: Posttraumatic stress disorder (PTSD) is a major public health concern. Although effective treatments exist, affected individuals face many barriers to receiving traditional care. Smartphones are carried by nearly 2 thirds of the U.S. population, offering a promising new option to overcome many of these barriers by delivering self-help interventions through applications (apps). As there is limited research on apps for trauma survivors with PTSD symptoms, we conducted a pilot feasibility, acceptability, and potential efficacy trial of PTSD Coach, a self-management smartphone app for PTSD.
Method: A community sample of trauma survivors with PTSD symptoms (N = 49) were randomized to 1 month using PTSD Coach or a waitlist condition. Self-report assessments were completed at baseline, postcondition, and 1-month follow-up. Following the postcondition assessment, waitlist participants…
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Morriss R, Lobban F, Riste L, Davies L, Holland F, Long R, Lykomitrou G, Peters S, Roberts C, Robinson H, Jones S, NIHR PARADES Psychoeducation Study Group (2016)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe lancet. Psychiatry42 citations Clinical effectiveness and acceptability of structured group psychoeducation versus optimised unstructured peer support for patients with remitted bipolar disorder (PARADES): a pragmatic, multicentre, observer-blind, randomised controlled superiority trial.
Background: Group psychoeducation is a low-cost National Institute for Health and Care Excellence-recommended treatment for bipolar disorder. However, the clinical effectiveness and acceptability of this intervention are unclear compared with unstructured peer support matched for delivery and aim of treatment, and for previous bipolar history. We aimed to assess the clinical effectiveness and acceptability of structured group psychoeducation versus optimised unstructured peer support for patients with remitted bipolar disorder.
Methods: We did this pragmatic, multicentre, parallel-group, observer-blind, randomised controlled superiority trial at eight community sites in two regions in England. Participants aged 18 years or older with bipolar disorder and no episode in the preceding 4 weeks were recruited via self-referral or secondary care referral. Participants were individually randoml…
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Receiving care for intimate partner violence in primary care: Barriers and enablers for women participating in the weave randomised controlled trial.
Background: Interventions in health settings for intimate partner violence (IPV) are being increasingly recognised as part of a response to addressing this global public health problem. However, interventions targeting this sensitive social phenomenon are complex and highly susceptible to context. This study aimed to elucidate factors involved in women's uptake of a counselling intervention delivered by family doctors in the weave primary care trial (Victoria, Australia).
Methods: We analysed associations between women's and doctors' baseline characteristics and uptake of the intervention. We interviewed a random selection of 20 women from an intervention group women to explore cognitions relating to intervention uptake. Interviews were audio-recorded, transcribed, coded in NVivo 10 and analysed using the theory of planned behaviour (TPB).
Results: Abuse severity and socio-demographic ch…
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El-Jawahri A, Paasche-Orlow MK, Matlock D, Stevenson LW, Lewis EF, Stewart G, Semigran M, Chang Y, Parks K, Walker-Corkery ES, Temel JS, Bohossian H, Ooi H, Mann E, Volandes AE (2016)randomised controlled trialMEDLINE-indexed journal, not yet read by usCirculation88 citations Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients With Advanced Heart Failure.
Background: Conversations about goals of care and cardiopulmonary resuscitation (CPR)/intubation for patients with advanced heart failure can be difficult. This study examined the impact of a video decision support tool and patient checklist on advance care planning for patients with heart failure.
Methods: This was a multisite, randomized, controlled trial of a video-assisted intervention and advance care planning checklist versus a verbal description in 246 patients ≥64 years of age with heart failure and an estimated likelihood of death of >50% within 2 years. Intervention participants received a verbal description for goals of care (life-prolonging care, limited care, and comfort care) and CPR/intubation plus a 6-minute video depicting the 3 levels of care, CPR/intubation, and an advance care planning checklist. Control subjects received only the verbal description. The primary analy…
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Clare L, Nelis SM, Jones IR, Hindle JV, Thom JM, Nixon JA, Cooney J, Jones CL, Tudor Edwards R, Whitaker CJ (2015)randomised controlled trialMEDLINE-indexed journal, not yet read by usBMC psychiatry39 citations The Agewell trial: a pilot randomised controlled trial of a behaviour change intervention to promote healthy ageing and reduce risk of dementia in later life.
Background: Lifestyle factors represent prime targets for behaviour change interventions to promote healthy ageing and reduce dementia risk. We evaluated a goal-setting intervention aimed at promoting increased cognitive and physical activity and improving mental and physical fitness, diet and health.
Methods: This was a pilot randomised controlled trial designed to guide planning for a larger-scale investigation, provide preliminary evidence regarding efficacy, and explore feasibility and acceptability. Primary outcomes were engagement in physical and cognitive activity. Participants aged over 50 living independently in the community were recruited through a community Agewell Centre. Following baseline assessment participants were randomly allocated to one of three conditions: control (IC) had an interview in which information about activities and health was discussed; goal-setting (GS …
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The Spear and Shield intervention to increase the availability and acceptability of voluntary medical male circumcision in Zambia: a cluster randomised controlled trial.
Background: Widespread voluntary medical male circumcision in Africa could avert an estimated 3·436 million HIV infections and 300,000 deaths over the next 10 years. Most Zambian men have expressed little interest in the procedure. We tested the effect of the Spear and Shield intervention designed to increase demand for voluntary medical male circumcision among these hard-to-reach men.
Methods: This cluster randomised controlled trial was done between Feb 1, 2012, and Oct 31, 2014, in Lusaka, Zambia, where HIV prevalence is 20·8%. 13 community health centres were stratified by HIV voluntary counselling and testing rates and patient census, and randomly assigned (5:5:3) to experimental (the intervention), control, or observation-only conditions. Community health centre health-care providers at all 13 sites received training in voluntary medical male circumcision. Eligible participants wer…
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Rosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng'ambi W, Miller WC, Hoffman I, Hosseinipour M (2015)randomised controlled trialMEDLINE-indexed journal, not yet read by usThe lancet. HIV122 citations Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial.
Background: Couples HIV testing and counselling (CHTC) is encouraged but is not widely done in sub-Saharan Africa. We aimed to compare two strategies for recruiting male partners for CHTC in Malawi's option B+ prevention of mother-to-child transmission programme: invitation only versus invitation plus tracing and postulated that invitation plus tracing would be more effective.
Methods: We did an unblinded, randomised, controlled trial assessing uptake of CHTC in the antenatal unit at Bwaila District Hospital, a maternity hospital in Lilongwe, Malawi. Women were eligible if they were pregnant, had just tested HIV-positive and therefore could initiate antiretroviral therapy, had not yet had CHTC, were older than 18 years or 16-17 years and married, reported a male sex partner in Lilongwe, and intended to remain in Lilongwe for at least 1 month. Women were randomly assigned (1:1) to either …
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Effect of an interactive therapeutic robotic animal on engagement, mood states, agitation and psychotropic drug use in people with dementia: a cluster-randomised controlled trial protocol.
Introduction: Apathy, agitated behaviours, loneliness and depression are common consequences of dementia. This trial aims to evaluate the effect of a robotic animal on behavioural and psychological symptoms of dementia in people with dementia living in long-term aged care.
Methods and analysis: A cluster-randomised controlled trial with three treatment groups: PARO (robotic animal), Plush-Toy (non-robotic PARO) or Usual Care (Control). The nursing home sites are Australian Government approved and accredited facilities of 60 or more beds. The sites are located in South-East Queensland, Australia. A sample of 380 adults with a diagnosis of dementia, aged 60 years or older living in one of the participating facilities will be recruited. The intervention consists of three individual 15 min non-facilitated sessions with PARO or Plush-Toy per week, for a period of 10 weeks. The primary outcome…
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