CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 310 enrolled
Drug / intervention
Resourcefulness Training +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03023332
NCT03023332N/ACompleted
CompareCT.gov

Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers

Case Western Reserve University·interventional·Posted Jan 18, 2017·Updated Nov 15, 2023

In Brief

A clinical study evaluating Resourcefulness Training, Biofeedback training, and 1 other intervention for Distress and Caregiver. Completed, enrolled 310 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDistress, Caregiver
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 18, 2017
Enrollment StartJun 12, 2017
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.5 years ago

Interventions

Resourcefulness Trainingbehavioral

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

Biofeedback trainingbehavioral

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.

Bipolar Educationbehavioral

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.