Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers
Condition: Distress; Caregiver
Study type: Interventional

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).
    

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.
    

Intervention name(s): Resourcefulness Training; Biofeedback training; Bipolar Education
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A cognitive-behavioral intervention delivered through iPad technology that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Caregiver; Biofeedback; Resourcefulness; Self-Management