Objectives To assess feasibility and to conduct a preliminary evaluation of outcomes following Peaceful Mind, a CBT-based intervention for anxiety in dementia, relative to usual care (UC). Design Pilot randomized controlled trial including assessments at baseline, 3 and 6 months Setting Houston, TX Participants 32 outpatients diagnosed with mild (47%) or moderate (53%) dementia receiving care through outpatient clinics at the Veterans Affairs medical center, Baylor College of Medicine, Harris County Hospital District and community day centers for dementia, and their collaterals, who spent at least 8 hours a week with them. Intervention Peaceful Mind included up to 12 weekly in-home sessions (mean = 8.7, SD = 2.27) during the initial 3 months and up to eight brief telephone sessions (mean = 5.4, SD = 3.17) during months 3 to 6, involving self-monitoring for anxiety, deep breathing, and optional skills (coping self-statements, behavioral activation and sleep management). Patients learned skills, and collaterals served as coaches. In UC, patients received diagnostic feedback; and providers were informed of inclusion status. Measurements Neuropsychiatric Inventory-Anxiety subscale, Rating Anxiety in Dementia scale, Penn State Worry Questionnaire-Abbreviated, Geriatric Anxiety Inventory, Geriatric Depression Scale, Quality of Life in Alzheimer’s disease, Patient Health Questionnaire, Client Satisfaction Questionnaire Results Feasibility was demonstrated with regard to recruitment, attrition, and treatment characteristics. At 3 months, clinicians rated patients receiving Peaceful Mind as less anxious, and patients rated themselves as having higher quality of life; collaterals reported less distress related to loved ones’ anxiety. Although significant positive effects were not noted in other outcomes or at 6-month follow-up, the pilot nature of the trial prohibits conclusions about efficacy. Conclusions Results support that Peaceful Mind is ready for future comparative clinical trials.

Lay providers, working under the supervision of licensed providers, can deliver effective CBT.

Background Anxiety has a high prevalence among individuals with dementia, and it has a significant negative impact on their functioning; yet intervention studies are lacking. We developed Peaceful Mind, a cognitive-behavioral intervention for persons with dementia. In this article, we describe the intervention and results of an open trial evaluating the feasibility and utility of the intervention and assessment procedures. Methods Peaceful Mind is implemented over a period of 3 months in the participant's home with involvement of a caregiver or “collateral.” Dyads are followed for an additional 3 months via telephone. An assortment of simplified skills is offered, including self-awareness, breathing, behavioral activation, calming thoughts, and sleep skills. Results Nine participants were enrolled, eight completed the 3-month assessment, and seven completed the 6-month assessment. Overall, participants and collaterals were satisfied with the intervention and reported that they benefited in terms of anxiety, depression, and collateral distress. Conclusions A randomized controlled trial would help determine whether this promising new treatment has a statistically significant impact on anxiety in this population.