Trial Outcomes & Findings for Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers (NCT NCT03023332)
NCT ID: NCT03023332
Last Updated: 2023-11-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
310 participants
Primary outcome timeframe
12 months
Results posted on
2023-11-15
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
Control
No intervention or treatment
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
70
|
68
|
|
Overall Study
COMPLETED
|
62
|
65
|
58
|
48
|
|
Overall Study
NOT COMPLETED
|
24
|
21
|
12
|
20
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Control
No intervention or treatment
|
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
5
|
4
|
7
|
|
Overall Study
Lost to Follow-up
|
13
|
16
|
8
|
13
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers
Baseline characteristics by cohort
| Measure |
Self-management Need
n=86 Participants
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.
|
Self-management Preference
n=86 Participants
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.
|
Control
n=70 Participants
No intervention or treatment
|
Usual Care
n=68 Participants
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.
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
265 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Age, Continuous
|
51.24 years
STANDARD_DEVIATION 13.98 • n=5 Participants
|
51.14 years
STANDARD_DEVIATION 14.39 • n=7 Participants
|
51.64 years
STANDARD_DEVIATION 13.46 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 14.65 • n=4 Participants
|
50.98 years
STANDARD_DEVIATION 14.13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
235 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
172 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=5 Participants
|
86 participants
n=7 Participants
|
70 participants
n=5 Participants
|
68 participants
n=4 Participants
|
310 participants
n=21 Participants
|
|
Resourcefulness
|
90.05 units on a scale
STANDARD_DEVIATION 18.14 • n=5 Participants
|
91.10 units on a scale
STANDARD_DEVIATION 13.38 • n=7 Participants
|
91.26 units on a scale
STANDARD_DEVIATION 19.15 • n=5 Participants
|
94.78 units on a scale
STANDARD_DEVIATION 18.31 • n=4 Participants
|
93.38 units on a scale
STANDARD_DEVIATION 17.64 • n=21 Participants
|
|
Bipolar knowledge score
|
21.94 units on a scale
STANDARD_DEVIATION 3.36 • n=5 Participants
|
22.08 units on a scale
STANDARD_DEVIATION 3.55 • n=7 Participants
|
22.16 units on a scale
STANDARD_DEVIATION 3.55 • n=5 Participants
|
21.59 units on a scale
STANDARD_DEVIATION 3.39 • n=4 Participants
|
22.05 units on a scale
STANDARD_DEVIATION 3.49 • n=21 Participants
|
|
Health Risks
|
15.77 units on a scale
STANDARD_DEVIATION 2.94 • n=5 Participants
|
14.98 units on a scale
STANDARD_DEVIATION 2.89 • n=7 Participants
|
15.13 units on a scale
STANDARD_DEVIATION 2.89 • n=5 Participants
|
15.01 units on a scale
STANDARD_DEVIATION 2.67 • n=4 Participants
|
15.24 units on a scale
STANDARD_DEVIATION 2.86 • n=21 Participants
|
|
Global Health
|
25.59 units on a scale
STANDARD_DEVIATION 5.43 • n=5 Participants
|
27.28 units on a scale
STANDARD_DEVIATION 4.89 • n=7 Participants
|
26.657 units on a scale
STANDARD_DEVIATION 4.79 • n=5 Participants
|
26.43 units on a scale
STANDARD_DEVIATION 5.49 • n=4 Participants
|
26.47 units on a scale
STANDARD_DEVIATION 5.16 • n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All participants completing T1 and T3
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
Outcome measures
| Measure |
Self-management Need
n=59 Participants
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.
|
Self-management Preference
n=60 Participants
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.
|
Control
n=53 Participants
No intervention or treatment
|
Usual Care
n=48 Participants
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.
|
|---|---|---|---|---|
|
Change in Caregiver Health - Health Risks
T1: Baseline
|
15.53 score on a scale
Standard Deviation 2.96
|
14.65 score on a scale
Standard Deviation 2.85
|
15.02 score on a scale
Standard Deviation 2.79
|
14.80 score on a scale
Standard Deviation 2.91
|
|
Change in Caregiver Health - Health Risks
T3: 12 month followup
|
14.84 score on a scale
Standard Deviation 3.31
|
15.00 score on a scale
Standard Deviation 3.12
|
14.91 score on a scale
Standard Deviation 2.86
|
15.16 score on a scale
Standard Deviation 3.99
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All participants completing T1 and T3
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.
Outcome measures
| Measure |
Self-management Need
n=59 Participants
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.
|
Self-management Preference
n=84 Participants
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.
|
Control
n=53 Participants
No intervention or treatment
|
Usual Care
n=48 Participants
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.
|
|---|---|---|---|---|
|
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
T1: Baseline
|
25.95 score on a scale
Standard Deviation 5.27
|
27.77 score on a scale
Standard Deviation 4.99
|
26.66 score on a scale
Standard Deviation 4.61
|
27.54 score on a scale
Standard Deviation 5.37
|
|
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
T3: 12 month followup
|
27.45 score on a scale
Standard Deviation 4.97
|
27.4 score on a scale
Standard Deviation 5.95
|
26.62 score on a scale
Standard Deviation 5.46
|
28.42 score on a scale
Standard Deviation 5.27
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants completing both T1 and T3
The scale measures caregiver knowledge of bipolar disorder using a 16 item scale. Scores range from 0-43, with higher scores indicating greater knowledge.
Outcome measures
| Measure |
Self-management Need
n=59 Participants
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.
|
Self-management Preference
n=60 Participants
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.
|
Control
n=53 Participants
No intervention or treatment
|
Usual Care
n=48 Participants
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.
|
|---|---|---|---|---|
|
Change in Bipolar Knowledge Assessment Scale
T1: Baseline
|
21.90 score on a scale
Standard Deviation 3.62
|
22.58 score on a scale
Standard Deviation 3.31
|
22.11 score on a scale
Standard Deviation 3.64
|
21.48 score on a scale
Standard Deviation 3.37
|
|
Change in Bipolar Knowledge Assessment Scale
T3: 12 month followup
|
22.29 score on a scale
Standard Deviation 3.55
|
21.85 score on a scale
Standard Deviation 3.75
|
22.47 score on a scale
Standard Deviation 3.69
|
21.69 score on a scale
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants completing both T1 and T3 questionnaires.
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
Outcome measures
| Measure |
Self-management Need
n=59 Participants
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.
|
Self-management Preference
n=60 Participants
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.
|
Control
n=53 Participants
No intervention or treatment
|
Usual Care
n=48 Participants
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.
|
|---|---|---|---|---|
|
Change in Heart Rate Variability
T1: Baseline
|
56.64 milliseconds
Standard Deviation 57.82
|
50.41 milliseconds
Standard Deviation 30.57
|
67.94 milliseconds
Standard Deviation 147.48
|
57.07 milliseconds
Standard Deviation 36.18
|
|
Change in Heart Rate Variability
T3: 12 month followup
|
63.34 milliseconds
Standard Deviation 50.67
|
59.53 milliseconds
Standard Deviation 35.67
|
69.58 milliseconds
Standard Deviation 76.63
|
44.14 milliseconds
Standard Deviation 28.85
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All participants completing T1 and T3
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.
Outcome measures
| Measure |
Self-management Need
n=59 Participants
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.
|
Self-management Preference
n=60 Participants
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.
|
Control
n=53 Participants
No intervention or treatment
|
Usual Care
n=48 Participants
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.
|
|---|---|---|---|---|
|
Change in Resourcefulness
T1: Baseline
|
92.93 score on a scale
Standard Deviation 17.29
|
92.78 score on a scale
Standard Deviation 13.79
|
93.15 score on a scale
Standard Deviation 20.1
|
94.83 score on a scale
Standard Deviation 19.72
|
|
Change in Resourcefulness
T3: 12 month followup
|
92.82 score on a scale
Standard Deviation 19.37
|
93.81 score on a scale
Standard Deviation 15.87
|
94.29 score on a scale
Standard Deviation 19.24
|
96.49 score on a scale
Standard Deviation 17.88
|
Adverse Events
Self-management Need
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Self-management Preference
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jaclene Zauszniewski, PhD
Case Western Reserve University
Phone: 216.368.3612
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place