Biofeedback Training for Dementia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dementia+4 MoreBiofeedback Training - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study how giving caregivers different amounts of control over their self-management interventions affects their physical and mental health over time.

Eligible Conditions
  • Dementia
  • Grief
  • Carer Stress Syndrome
  • Alzheimer's Disease
  • Stress

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: From T1 (baseline) to T2 (6 months) through T3 (one year)

Month 6
Change in Caregiver's Depressive Cognitions Scales
Change in Caregiver's Global Health
Change in Caregiver's Health Risk Behavior Scale
Change in Caregiver's Heart Rate Variability
Change in Caregiver's Negative Emotions Checklist
Change in Caregiver's Perceived Stress Scale
Change in Caregiver's Resourcefulness Scale

Trial Safety

Trial Design

2 Treatment Groups

Attention Control Condition
1 of 2
Self-Management
1 of 2

Active Control

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Biofeedback Training · No Placebo Group · N/A

Self-ManagementExperimental Group · 2 Interventions: Biofeedback Training, Resourcefulness Training · Intervention Types: Behavioral, Behavioral
Attention Control Condition
Behavioral
ActiveComparator Group · 1 Intervention: Diversional Activites · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biofeedback Training
2016
N/A
~420
Resourcefulness Training
2018
N/A
~750

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from t1 (baseline) to t2 (6 months) through t3 (one year)

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
275 Previous Clinical Trials
198,134 Total Patients Enrolled
4 Trials studying Dementia
20,621 Patients Enrolled for Dementia

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a primary caregiver.\n