Phase
Condition
Mood Disorders
Vascular Diseases
Stress
Treatment
iTAB-CV
Self-Monitoring
Clinical Study ID
Ages 21-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age range: from 21 to 80
Have a clinical diagnosis of either Bipolar Disorder or Major Depressive Disorder asdetermined by a standardized diagnostic interview, the Mini-InternationalNeuropsychiatric Interview (MINI)
Have elevated systolic blood pressure ≥130 at screening at least 2 different timesduring the screening period
Have received a diagnosis of hypertension per patient self-report at least 6 monthsprior to enrollment
Have been prescribed at least one regularly scheduled antihypertensive medicine for 3 or more months since diagnosis
Have difficulty with adherence to prescribed antihypertensive medication currentlyor in the past based on one of the following questions: Do you ever miss doses ofyour prescribed medications for high blood pressure? Or b. Do you ever try to manageyour high blood pressure on your own without medication?
For those with MDD, currently being prescribed an antidepressant medication
Have their own cellular phone in order to receive text messages as part of theintervention
Exclusion
Exclusion Criteria:
Unable/unwilling to participate in psychiatric interviews. This will includeindividuals, who may be too psychotic to participate in interviews/rating scales
Unable/unwilling to give written, informed consent to study participation
In the interest of patient safety, individuals who are at high immediate risk forsuicide will be excluded from study participation. The suicide risk assessment willbe informed by standardized assessments of psychiatric symptoms, theMini-International Neuropsychiatric Interview (MINI), and the Montgomery AsbergDepression Rating Scale (MADRS). Individuals with active suicidal ideation andrecent suicide attempt or current intent and plan will be excluded from studyparticipation. Individuals who score a ≥ 5 on item 10 of the MADRS will beconsidered to be at high risk for suicide, although individuals with MADRS scoreslower than 5 could potentially be excluded if either the psychologist orpsychiatrist PIs believe that the individual is at high immediate risk for suicidebased upon other input or information. In the event that a potential studyparticipant is determined to be at high risk for suicide, that individual will notbe enrolled and the study staff will immediately implement procedures for the safetyof the individual. Once that individual is no longer at risk, they may be rescreenedfor possibility enrollment in the study
Individuals who are monolingual, non-English speaking will be excluded. Given theproposed sample sizes of the iTAB-CV + SM and SM alone treatment arms in theproposed study, it would not be practical to conduct sub-group analyses. Based uponour BD adherence work and RCT, which drew upon a population similar to the proposedtrial, there were no potential subjects who were excluded from the studies due toinability to speak English. Hispanic individuals made up 3.6% of those enrolled
Upper arm circumference > 50cm
Study Design
Study Description
Connect with a study center
Case Western Reserve University
Cleveland, Ohio 44106
United StatesActive - Recruiting
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