MedTrace Logo

Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers

NCT03023332 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2023-11-15

Study results available
· View outcomes & findings →

Summary

How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with bipolar disorder? Caregivers will be randomized to: 1) a control group (no intervention); 2) education (usual care); 3) self-management intervention based on need (SM-need); or 4) self-management intervention of their preference (SM-preference).

Conditions

  • Distress
  • Caregiver

Interventions

BEHAVIORAL

Resourcefulness Training

A cognitive-behavioral intervention delivered through iPad technology that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.

BEHAVIORAL

Biofeedback training

Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and continue to influence behavior.

BEHAVIORAL

Bipolar Education

An educational program designed to teach family caregivers of about the types, causes, symptoms, episodes, warning signs, and treatments for individuals with bipolar disorder, as well as available resources for assisting a family member with bipolar disorder. The content to be presented within an audiovisual format using iPad technology follows the recommendations and guidelines developed through research and by the Depression and Bipolar Support Alliance and the National Institute of Mental Health.

Sponsors & Collaborators

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Jaclene Zauszniewski, PhD · Case Western Reserve University - Frances Payne Bolton School of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03023332 on ClinicalTrials.gov