Phone app helps patients with mood disorders stick to blood pressure meds
NCT ID NCT04675593
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a personalized mobile health app (iTAB-CV) plus self-monitoring helps people with bipolar disorder or major depression take their blood pressure medication more regularly and lower their blood pressure. About 176 adults aged 21-80 with both conditions and high blood pressure will be randomly assigned to use the app plus self-monitoring or self-monitoring alone. The goal is to see if the app improves medication adherence and reduces systolic blood pressure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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176 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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May 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age range: from 21 to 80 * Have a clinical diagnosis of either Bipolar Disorder or Major Depressive Disorder as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI) * Have elevated systolic blood pressure ≥130 at screening 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 * Have difficulty with adherence to prescribed antihypertensive medication currently or in the past based on one of the following questions: Do you ever miss doses of your prescribed medications for high blood pressure? Or b. Do you ever try to manage your 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 the intervention Exclusion Criteria: * 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 possibility 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Case Western Reserve University
Cleveland, Ohio, 44106, United States
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Other studies related to the condition(s) this trial covers.
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