Electroconvulsive therapy for the acute management of severe agitation in dementia (ECT-AD): A modified study protocol.

OBJECTIVE: This study began as a single-blind randomized controlled trial (RCT) to investigate the efficacy and safety of electroconvulsive therapy (ECT) for severe treatment-refractory agitation in advanced dementia. The aims are to assess agitation reduction using the Cohen-Mansfield Agitation Inventory (CMAI), evaluate tolerability and safety outcomes, and explore the long-term stability of agitation reduction and global functioning. Due to challenges encountered during implementation, including recruitment obstacles and operational difficulties, the study design was modified to an open-label format and other protocol amendments were implemented. METHODS: Initially, the RCT randomized participants 1:1 to either ECT plus usual care or simulated ECT plus usual care (S-ECT) groups. As patients were enrolled, data were collected from both ECT and simulated ECT (S-ECT) patients. The study now continues in an open-label study design where all patients receive actual ECT, reducing the targeted sample size from 200 to 50 participants. RESULTS: Study is ongoing and open to enrollment. CONCLUSION: The transition of the ECT-AD study design from an RCT to open-label design exemplifies adaptive research methodologies in response to real-world challenges. Data from both the RCT and open-label phases of the study will provide a unique perspective on the role of ECT in managing severe treatment-refractory agitation in dementia, potentially influencing future clinical practices and research approaches.

Music Therapy Intervention to Reduce Symptom Burden in Hospice Patients: A Descriptive Study.

Background: Music therapy (MT) offers benefits of improved symptom relief and quality of life at the end of life, but its impact on hospice patients and caregivers needs more research. Objective: To assess the impact of MT intervention on symptom burden and well-being of hospice patients and caregivers. Methods: A total of 18 hospice patients, selected based on scores ≥4 on the revised Edmonton Symptom Assessment System (ESAS-r) items on pain, depression, anxiety, or well-being, participated in MT sessions provided by a board-certified music therapist. Over a period of 2-3 weeks, 3-4 MT sessions were conducted for each. Patient Quality of life (QOL) was assessed using the Linear Analogue Self-Assessment (LASA). Depression and anxiety were measured with the Patient Health Questionnaire-4 (PHQ-4). For the 7 caregivers enrolled, stress levels were measured using the Pearlin role overload measure and LASA. Results: Patients reported a reduction in symptom severity and emotional distress and an increase in QOL. All patients endorsed satisfaction with music therapy, describing it as particularly beneficial for stress relief, relaxation, spiritual support, emotional support, and well-being. Scores on overall QOL and stress were worse for caregivers. Conclusion: This study provides evidence that MT reduces symptom burden and enhances the quality of life for hospice patients. Hospice patients and their caregivers endorsed satisfaction with MT. Given the benefits observed, integrating MT into hospice care regimens could potentially improve patient and caregiver outcomes. Larger studies should be conducted to better assess the impact of MT in this population.

Music Therapy Intervention to Reduce Caregiver Distress at End of Life: A Feasibility Study.

BACKGROUND: Music therapy (MT) can relieve distressing end-of-life symptoms, but little is known regarding its effect on caregivers who are at risk for emotional distress as their loved ones approach death. MEASURES: Quality of life (Linear Analogue Self-Assessment), depressive and anxiety symptoms (Patient Health Questionnaire for Depression and Anxiety), and stress (Role Overload Measure) pre-MT, post-MT and at 6-month follow-up, as well as a satisfaction survey post-MT. INTERVENTION: Single MT session for 20-45 minutes OUTCOMES: 15/20 completed MT intervention, 14 also completed pre-MT and post-MT assessments, and 9 completed assessments at all 3 timepoints. Post-MT satisfaction survey (n=14) showed 100% of caregivers were very satisfied with MT and would recommend to others, and found MT very effective for emotional support (85.7%), stress relief (78.6%), spiritual support (71.4%), general feeling of wellness (71.4%), relaxation (69.2%), and pain relief (33.3%). CONCLUSIONS: Research on MT is feasible for caregivers of inpatient hospice patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03322228.

Impact of Massage Therapy on the Quality of Life of Hospice Patients and Their Caregivers: A Pilot Study.

Evidence for massage therapy (MT) in hospice patients remains limited. We conducted a prospective pilot study on MTs impact on quality of life of hospice patients and caregivers. Patient-caregiver dyads were enrolled if patients scored ≥5 on pain, depression, anxiety, or well-being using the revised Edmonton Symptom Assessment System Revised (ESAS-r). The patient received MT weekly for up to 3 massages with assessments completed at baseline, after each massage, and 1 week after the final massage for patients and at baseline and 1 week after final massage for caregivers. A satisfaction survey was completed at study completion. A pro-rated area under the curve (AUC) was utilized to assess the primary endpoints of change in ESAS-r for patient ratings of pain, depression and anxiety as well as the Linear Analogue Self-Assessment (LASA). Median difference scores (end of study value)-(baseline value) for each participant and caregiver were calculated. Of 27 patients and caregivers enrolled, 25 patients received MT. Fifteen patients completed all 3 MT sessions and were given the final symptom assessment and satisfaction survey and their caregivers completed final assessments. The proportion of patients considered success (AUC > baseline) in the primary endpoints were the following: pain 40.9%, depression 40.9%, anxiety 54.5%, LASA 54.5%. Median difference scores were largely zero indicating no significant temporal change in symptoms. Patients were highly satisfied with MT. This pilot study indicated that MT was a feasible and well-received intervention in our population of patients with inadequately controlled symptoms.