Clinical Trials

Inclusion Criteria: 

Inclusion Criteria for SAB Members

• Age range: from 21 to 80.
• Has hypertension and bipolar disorder, a caregiver of someone with hypertension and bipolar disorder, a clinician who treats adults with hypertension and bipolar disorder as part of their practice or administrative personnel for a health system serving individuals with hypertension and bipolar disorder.

Inclusion Criteria for RCT

• Age range: from 21 to 80.
• Have a clinical diagnosis of Bipolar Disorder as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI).
• Have an elevated systolic blood pressure reading ≥130 at least 2 different times during the screening period.
• Have received a diagnosis of hypertension per patient self-report at least 6 months prior to enrollment.
• Have been prescribed at least one regularly scheduled antihypertensive medicine for 3 or more months since diagnosis.
• Be poorly adherent (defined as missing 20% or more of medication within either the past week or past month) with prescribed antihypertensive medication.
• Have their own cellular phone in order to receive text messages as part of the intervention.

Exclusion Criteria:

Exclusion Criteria for SAB Members

• Unable/unwilling to participate in SAB meetings.
• Unable/unwilling to give written, informed consent to study participation.

Exclusion Criteria for RCT

• Unable/unwilling to participate in psychiatric interviews. This will include individuals, 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 for suicide will be excluded from study participation. The suicide risk assessment will be informed by standardized assessments of psychiatric symptoms, the Mini-International Neuropsychiatric Interview (MINI), and the Montgomery Asberg Depression Rating Scale (MADRS). Individuals with active suicidal ideation and recent suicide attempt or current intent and plan will be excluded from study participation. Individuals who score a ≥ 5 on item 10 of the MADRS will be considered to be at high risk for suicide, although individuals with MADRS scores lower than 5 could potentially be excluded if either the psychologist or psychiatrist PIs believe that the individual is at high immediate risk for suicide based upon other input or information. In the event that a potential study participant is determined to be at high risk for suicide, that individual will not be enrolled and the study staff will immediately implement procedures for the safety of the individual. Once that individual is no longer at risk, they may be rescreened for possible enrollment in the study.
• Individuals who are monolingual, non-English speaking will be excluded. Given the proposed sample sizes of the iTAB-CV + SM and SM alone treatment arms in the proposed study, it would not be practical to conduct sub-group analyses. Based upon our BD adherence work and RCT, which drew upon a population similar to the proposed trial, there were no potential subjects who were excluded from the studies due to inability to speak English. Hispanic individuals made up 3.6% of those enrolled.
• Upper arm circumference > 50cm.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/24/23. Questions regarding updates should be directed to the study team contact.