DistressNCT03023332

Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers

A study testing Resourcefulness Training, Biofeedback training and Bipolar Education in people with Distress and Caregiver, run by Case Western Reserve University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 120 yearsHealthy volunteers can take part
Conditions the study is for: Distress, Caregiver
What is being tested?: Resourcefulness Training, Biofeedback training and Bipolar Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 310 participants
Where: 1 siteUnited States
Study dates: 12 Jun 2017to 30 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 120 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

English-speaking
At least 18 years old
Have a family member with bipolar disorder
Have cared/supported them for at least the last 6 months in the last year
Be capable of performing the informed consent and participate in interventions

Who cannot join

Does not have family member with bipolar disorder
Has not cared for family member for at least 6 months in the last year
Knowledge of another family member in the same household enrolled in the study
Is pregnant
Has a pacemaker
Lives outside of the study area (Cuyahoga, Lake, Geauga, Portage, Summit, Medina, and Lorain counties)

Trial locations and contacts

1 site in 1 country.

United States1 site

CWRU School of Nursing
Cleveland, Ohio, 44106

Other trials in United States

About this study

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).

Read the detailed description

The study has two aims: The primary aim (A1) is to examine differences across the four groups (control, usual care, SM-need, and SM-preference) on caregiver health (health risks and mental and physical health) over time. We hypothesize that the caregivers who receive a self-management intervention based on need (SM-need) or preference (SM-preference) will have better health outcomes than those in the usual care or control groups.

Secondary aims are to: A2) explore whether caregiver baseline need or preference for intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver reactions; and c) caregiving involvement, and A3) build caregiver profiles from demographic/ contextual factors that are associated with their needs and preferences for the self-management interventions.

All caregivers will complete assessment measures and measures of health risks, and physical and mental health at baseline (T1), 6 months (T2) and 12 months (T3). Caregivers will randomly assigned to one of four groups. The control group will receive no intervention. The usual care group will receive bipolar education. The SM-need group will receive a self-management intervention tailored to meet their need for bipolar education, biofeedback training, or resourcefulness training, as determined by baseline cut scores. Caregivers in the SM-preference group will choose one of the three self-management intervention according to their personal preference.

All three self-management interventions (bipolar education, biofeedback training, resourcefulness training) are delivered over four weeks (between T1 and T2). Caregivers may use the one SM intervention whenever and as often as they wish (i.e. self-tailoring) for the remainder of the study period. The bipolar education and resourcefulness training interventions will be delivered initially using an iPad. These interventions involve providing educational information about bipolar disorder or teaching self-help (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback training consists of use of a hand-held device that shows the participant their changes in heart rate based on changes in their breathing pattern (as they relax); caregivers who need or prefer the biofeedback will be given a device to use for 28 days. All study participants receiving the intervention will also be asked to keep a journal to record their experience with the intervention.

Conditions: Distress, Caregiver
Being tested: Resourcefulness Training, Biofeedback training, Bipolar Education
Keywords: Caregiver, Biofeedback, Resourcefulness, Self-Management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03023332
Study group	Role	What they receive
Self-management need	Experimental	SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any) Receives: Behavioral: Resourcefulness Training; Behavioral: Biofeedback training; Behavioral: Bipolar Education
Self-management preference	Experimental	SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention) Receives: Behavioral: Resourcefulness Training; Behavioral: Biofeedback training; Behavioral: Bipolar Education
Control	No intervention	No intervention or treatment
Usual care	Active comparator	Bipolar education Receives: Behavioral: Bipolar Education

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Caregiver Health - Health Risks
Health risks were measured using the Change in Health Risk Behavior Scale. The scale consists of 9 items measured on a 3-point scale, Scores range 9-27; higher score indicates greater risk
Measured: 12 months
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) scale. 5 items - physical health; 5 items - mental health; 5-point scale; Scores range 0-40; higher scores indicate better health.
Measured: 12 months

Secondary outcomes (3)

Change in Bipolar Knowledge Assessment Scale
The scale measures caregiver knowledge of bipolar disorder using a 16 item scale. Scores range from 0-43, with higher scores indicating greater knowledge.
Measured: 12 months
Change in Heart Rate Variability
HRV is a physiological measure of the healthy functioning of the heart. It is a well-established biomarker for detecting stress. HRV was measured using the BioRadio portable limb-lead electrocardiogram recorder. A sensor was placed on the radial area of the caregiver's forearm for 5 minutes; they were asked to remain still as possible to prevent artifacts in the readings. The data obtained via this device was analyzed with compatible VivoSense software, which automatically computed 8 HRV parameters. One of these was the SDNN score, which is the recognized and most commonly used gold standard biomarker indicative of stress. The SDNN score is the standard deviation of all normal to normal R-R intervals between heartbeats and reported in milliseconds. The SDNN was the outcome of interest for our study as a physiological indicator of stress. For each caregiver, the software produced an average score for the 5-minute measurement
Measured: 12 months
Change in Resourcefulness
Participant Resourcefulness scale score. Composite item comprising of responses to 28 items scored on a 6 point likert scale. Scores range from 0-140, with higher scores indicating greater resourcefulness.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 201730 Jun 2021

First posted18 Jan 2017 (estimated)
Study start12 Jun 2017
Primary completion30 Jun 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DistressStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 310 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03023332
Sponsor's protocol ID: 1R01NR016817-01
Status last verified: Nov 2023
First submitted: 13 Jan 2017
Last updated: 15 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zauszniewski JA, Burant CJ, Juratovac E, Jeanblanc A, Sweetko JS, Larsen C, Almutairi R, She HY, DiFranco E, Colon-Zimmerman K, Sajatovic M. Acquiring Resourcefulness Skills: Formal Versus Informal Training. West J Nurs Res. 2025 Jan;47(1):5-14. doi: 10.1177/01939459241296613. Epub 2024 Nov 13.
PubMed 39535112

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Distress trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers
ClinicalTrials.gov ID: NCT03023332
Acronym / sponsor ID: 1R01NR016817-01
Conditions: Distress, Caregiver
Keywords: Caregiver, Biofeedback, Resourcefulness, Self-Management
Study type: Interventional
Recruitment status: Completed
Enrolment: 310 participants (actual)
Lead sponsor: Case Western Reserve UniversityUniversity, hospital or other
Study start: 12 Jun 2017 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 18 Jan 2017 (estimated)
Results: Posted 15 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Self-management need	Experimental	Behavioral: Resourcefulness Training, Behavioral: Biofeedback training, Behavioral: Bipolar EducationSM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any)
Self-management preference	Experimental	Behavioral: Resourcefulness Training, Behavioral: Biofeedback training, Behavioral: Bipolar EducationSM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention)
Control	No intervention	–No intervention or treatment
Usual care	Active comparator	Behavioral: Bipolar EducationBipolar education

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

English-speaking
At least 18 years old
Have a family member with bipolar disorder
Have cared/supported them for at least the last 6 months in the last year
Be capable of performing the informed consent and participate in interventions

Key exclusion criteria (6 listed)

Does not have family member with bipolar disorder
Has not cared for family member for at least 6 months in the last year
Knowledge of another family member in the same household enrolled in the study
Is pregnant
Has a pacemaker

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Resourcefulness TrainingA cognitive-behavioral intervention delivered through iPad technology that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.	Behavioural	Self-management need, Self-management preference
Biofeedback trainingUse 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.	Behavioural	Self-management need, Self-management preference
Bipolar EducationAn 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.	Behavioural	Self-management need, Self-management preference, Usual care

Primary outcome

Change in Caregiver Health - Health Risks
Time frame: 12 months
Health risks were measured using the Change in Health Risk Behavior Scale. The scale consists of 9 items measured on a 3-point scale, Scores range 9-27; higher score indicates greater risk
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
Time frame: 12 months
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) scale. 5 items - physical health; 5 items - mental health; 5-point scale; Scores range 0-40; higher scores indicate better health.

3 secondary outcomes

Change in Bipolar Knowledge Assessment Scale
Time frame: 12 months
Change in Heart Rate Variability
Time frame: 12 months
Change in Resourcefulness
Time frame: 12 months

Results and safety

Results posted to the registry on 15 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Self-management Need	86	62
Self-management Preference	86	65
Control	70	58
Usual Care	68	48

Primary outcome: Change in Caregiver Health - Health Risks

Time frame: 12 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Self-management Need n = 59	Self-management Preference n = 60	Control n = 53	Usual Care n = 48
T1: Baseline	15.53 (2.96)	14.65 (2.85)	15.02 (2.79)	14.80 (2.91)
T3: 12 month followup	14.84 (3.31)	15.00 (3.12)	14.91 (2.86)	15.16 (3.99)

Population analysed: All participants completing T1 and T3

Primary outcome: Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)

Time frame: 12 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Self-management Need n = 59	Self-management Preference n = 84	Control n = 53	Usual Care n = 48
T1: Baseline	25.95 (5.27)	27.77 (4.99)	26.66 (4.61)	27.54 (5.37)
T3: 12 month followup	27.45 (4.97)	27.4 (5.95)	26.62 (5.46)	28.42 (5.27)

Population analysed: All participants completing T1 and T3

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data was collected for the duration of the study. Participants completed a baseline questionnaire (T1), a 1 month intervention, and followup questionnaires at 6months (Q2) and 12 months (Q3) post-intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Self-management Need	0 of 86 (0%)	0 of 86 (0%)	1 of 86
Self-management Preference	0 of 86 (0%)	0 of 86 (0%)	0 of 86
Control	0 of 70 (0%)	0 of 70 (0%)	0 of 70
Usual Care	0 of 68 (0%)	0 of 68 (0%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39535112Zauszniewski JA, Burant CJ, Juratovac E, Jeanblanc A, Sweetko JS, Larsen C, Almutairi R, She HY, DiFranco E, Colon-Zimmerman K, Sajatovic M. Acquiring Resourcefulness Skills: Formal Versus Informal Training. West J Nurs Res. 2025 Jan;47(1):5-14. doi: 10.1177/01939459241296613. Epub 2024 Nov 13.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jaclene Zauszniewski, PhD principal investigator

Case Western Reserve University - Frances Payne Bolton School of Nursing

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Resourcefulness Training, Biofeedback training and Bipolar Education in people with Distress and Caregiver, run by Case Western Reserve University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Caregiver Health - Health Risks (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03023332, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.