Here is the design of a clinical trial:

Official Title: Using MHealth to Improve Adherence and Reduce Blood Pressure in Individuals with Hypertension and Mood Disorders.

Included conditions:
- Bipolar Disorder
- Non-Adherence, Medication
- Hypertension
- Major Depressive Disorder

Study Armgroups:
- {'label': 'iTAB-CV + Self Monitoring', 'type': 'EXPERIMENTAL', 'description': 'Receives iTAB-CV intervention plus self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating', 'interventionNames': ['Behavioral: iTAB-CV']}
- {'label': 'Self Monitoring', 'type': 'ACTIVE_COMPARATOR', 'description': 'Receives self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating', 'interventionNames': ['Behavioral: Self-Monitoring']}
- {'label': 'iTAB-CV + Self Monitoring - High Intensity Booster', 'type': 'EXPERIMENTAL', 'description': 'Following the 4-month assessment, subjects in the iTAB-CV group will be re-randomized to receive either a high intensity booster or low intensity booster. Those in the high intensity booster group will start off receiving 1 reminder per day and taper down to 1 reminder per week over 2 months, in addition to self monitoring.', 'interventionNames': ['Behavioral: iTAB-CV']}
- {'label': 'iTAB-CV + Self Monitoring - Low Intensity Booster', 'type': 'EXPERIMENTAL', 'description': 'Following the 4-month assessment, subjects in the iTAB-CV group will be re-randomized to receive either a high intensity booster or low intensity booster. Those in the low intensity booster group will receive 1 reminder per week for 2 months, in addition to self monitoring.', 'interventionNames': ['Behavioral: iTAB-CV']}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'iTAB-CV', 'description': 'Individualized Texting for Adherence Building - Cardiovascular (iTAB-CV): a personalized patient-centered text message-based adherence intervention', 'armGroupLabels': ['iTAB-CV + Self Monitoring', 'iTAB-CV + Self Monitoring - High Intensity Booster', 'iTAB-CV + Self Monitoring - Low Intensity Booster']}
- {'type': 'BEHAVIORAL', 'name': 'Self-Monitoring', 'description': 'The Self-Monitoring (control) group will monitor their medication adherence, take their blood pressure weekly with a home blood pressure monitor provided by the study after being trained by the study staff, and rate their mood weekly in response to a text reminder.', 'armGroupLabels': ['Self Monitoring']}

Primary Outcomes:
- {'measure': 'Change in the Tablet Routine Questionnaire (TRQ)', 'description': 'The TRQ item is a subject report of the percentage of prescribed medications not taken within the past month.', 'timeFrame': 'Baseline and Month 4'}
- {'measure': 'Change in systolic blood pressure (SBP)', 'description': 'Systolic blood pressure indicates how much pressure your blood is exerting against your artery walls when the heart beats. Higher reading implies more pressure', 'timeFrame': 'Baseline and Month 4'}
- {'measure': 'Change in Adherence based on the Electronic Monitoring Device (eCAP)', 'description': 'Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used for the antihypertensive medication that the patient missed the most frequently in the past week (in the case of multiple antihypertensive medications missed the same proportion of times, the medication dosed most often will be chosen). A dose will be counted as "taken" if the bottle is opened within six hours of the prescribed time. We will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.', 'timeFrame': 'Baseline and Month 4'}

Please estimate the sample size based on the assumption: 
Type I error levels of 0.025 for each of the two primary analyses using Bonferroni correction, 25% attrition rate, power of 0.80, autoregressive (AR(1)) model covariance structure with correlation coefficient of 0.44 and error variance of 308 for adherence, and compound symmetry correlation parameter value of 0.36 for SBP.
Sample size calculations
        Power analyses are based on computations from the Repeated Measures and Sample Size (RMASS) [72] with inputs estimated from prior study data. Our projected sample size is nâ=â200, with 100 participants per arm. In this power analysis, the research team will assume type I error levels of 0.025 for each of the two primary analyses, using Bonferroni correction to account for multiple comparisons. Conservatively, for this study, the researchers will assume 25% attrition based on a previous 12âmonth trial conducted by members of the study team with individuals with comorbid serious mental illness and diabetes [73]. For sample size requirement for aim 1, the investigators used past-month TRQ as an approximation of expected and longer-term maintenance adherence status and considered primary outcomes to be at 3âmonths. The investigators expect similar or even greater effect sizes at 4âmonths given the longer treatment duration. In the pilot study, there was 23.10% improvement in TRQ observed for iTAB-CV. The control comparator for the efficacy trial will be SM of adherence, BP, and mood. Based on the literature, no improvement in self-reported adherence was reported in a similar control arm [74]. The study staff thus assume no change in adherence. In a BD adherence RCT, 7% improvement was observed in the control arm. Hence, the investigators conservatively project a 7% mean improvement in adherence among controls. Thus, (1) there is a mean difference of 16.1% in adherence after 4âmonths between arms and (2) suppose autoregressive (AR(1)) model covariance structure with correlation coefficient of 0.44 and an error variance of 308, as estimated value from the data. With assumed attrition of 25%, for a 2-sided test of the treatment by time interaction effect being equal to zero, and with alphaâ=â0.025 and powerâ=â0.80, the required total sample size is approximately 78.
        From the pilot data, mean screen SBP was 144.81 (SD 15.46). Change from screen to 3âmonths with the iTAB-CV intervention saw a mean reduction in SBP of 8.78. Reductions in BP of at least 2âmmHg can significantly reduce the incidence of cardiovascular disease and its complications in both hypertensive and normotensive individuals, and reductions of the magnitude seen in this teamâs pilot work is well above thresholds that are considered clinically meaningful [75]. Based on our preliminary mixed model, the researchers also observed compound symmetry correlation parameter value of 0.36. This covariance model had similar model fit as with an AR(1) model in terms of AIC/BIC criteria and parameter estimate values. The researchers will assume no SBP pressure change is observed in the SM arm and estimated error standard deviation of 15.46, as observed [38]. Finally, in a linear mixed model with participant-level random effects, with two-sided type I error of 0.025, powerâ=â0.80 for the projected sample size of 182 participants. The study staff will target a sample of 200 for the study to allow for some deviation from assumptions. Thus, the researchers should have sufficient statistical power for the first 2 primary aims.