OBJECTIVES:: To assess feasibility and to conduct a preliminary evaluation of outcomes following Peaceful Mind, a cognitive-behavioral therapy-based intervention for anxiety in dementia, relative to usual care. DESIGN:: Pilot randomized controlled trial including assessments at baseline and 3 and 6 months. SETTING:: Houston, TX. PARTICIPANTS:: Thirty-two 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 3-6, 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 usual care, 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 disease, Patient Health Questionnaire, and 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.