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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Self-management preference | Experimental | SM-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 | Bipolar education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resourcefulness Training | Behavioral | A cognitive-behavioral intervention delivered through iPad technology that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Change in Heart Rate Variability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaclene Zauszniewski, PhD | Case Western Reserve University - Frances Payne Bolton School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CWRU School of Nursing | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39535112 | Derived | 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. |
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The only participants excluded from assignment signed a consent form but withdrew or did not respond to requests to complete T1. We do not report their subdivision into self-management interventions as, per our study Aims, we were not looking at the effects of the individual self-management interventions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-management Need | SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any) 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. 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. 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. |
| FG001 | Self-management Preference | SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention) 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. 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. 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. |
| FG002 | Control | No intervention or treatment |
| FG003 | Usual Care | Bipolar education 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the baseline T1 questionnaire
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-management Need | SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any) 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All participants completing T1 and T3 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-management Need | SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any) 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. 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaclene Zauszniewski, PhD | Case Western Reserve University | 216.368.3612 | jaz@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2021 | Oct 3, 2023 | Prot_SAP_000.pdf |
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| Biofeedback training | Behavioral | 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 Education | Behavioral | 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. |
|
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
| 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. | 12 months |
| Lost to Follow-up |
|
| Death |
|
| BG001 | Self-management Preference | SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention) 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. 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. 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. |
| BG002 | Control | No intervention or treatment |
| BG003 | Usual Care | Bipolar education 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Resourcefulness | 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. | Mean | Standard Deviation | units on a scale |
|
| Bipolar knowledge score | The scale measures caregiver knowledge of bipolar disorder using a 16 item scale. Scores range from 0-43, with higher scores indicating greater knowledge. | Mean | Standard Deviation | units on a scale |
|
| 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 | Mean | Standard Deviation | units on a scale |
|
| Global Health | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Self-management Preference | SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention) 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. 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. 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. |
| OG002 | Control | No intervention or treatment |
| OG003 | Usual Care | Bipolar education 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. |
|
|
| Primary | 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. | All participants completing T1 and T3 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | 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. | All participants completing both T1 and T3 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Secondary | 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 | Participants completing both T1 and T3 questionnaires. | Posted | Mean | Standard Deviation | milliseconds | 12 months |
|
|
|
| Secondary | 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. | All participants completing T1 and T3 | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 1 |
| 86 |
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | Self-management Preference | SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention) 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. 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. 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. | 0 | 86 | 0 | 86 | 0 | 86 |
| EG002 | Control | No intervention or treatment | 0 | 70 | 0 | 70 | 0 | 70 |
| EG003 | Usual Care | Bipolar education 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. | 0 | 68 | 0 | 68 | 0 | 68 |
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| T3: 12 month followup |
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| T3: 12 month followup |
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| T3: 12 month followup |
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| T3: 12 month followup |
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