Table 1.
Summary of study design and differences between cohorts.
| Design element | Bipolar cohort | College student cohort |
| Sample size, n | 30 | 50 |
| Baseline assessments (day 0) |
A phone interviewa to complete the YMRSb [34], the SIGH-Dc [35], and the SF-36d [36] | An online assessment to complete the PSS-10e [32], the PHQ-9f [33], the PROMIS-29g [37], the AAQ-2h [38], and the CompACTi [39] |
| In-app assessments (days 1-42) |
Delivered through the app twice daily: the shortened YMRS, the shortened SIGH-D, and the ACTj Activity Surveyk | Delivered through the app twice daily: the PHQ-2l, the PSS-4m, and the ACT Activity Surveyk |
| Activity tracker assessments (days 1-42) |
Sleep, heart rate, and steps tracked through the Fitbit Alta HR | None |
| Microintervention (days 1-42) |
Randomized to receive or not receive ACT microinterventionk after in-app assessments | Randomized to receive or not receive ACT microinterventionk after in-app assessments |
| Exit assessments (day 42) |
A phone interview to complete same assessments from baseline | An online assessment to complete same assessments from baseline, along with an app engagement surveyk |
| Follow-up assessments (months 3 and 6) |
None | Online assessments to complete same assessments from baseline |
| Primary outcomes | Safety and feasibility of microintervention in terms of the following: adherence to in-app assessments (ie, feasibility); change in YMRS and SIGH-D scores from baseline to exit assessment (ie, safety) |
Effectiveness, safety, and feasibility of microintervention in terms of the following: changes in responses to ACT Activity Survey as a function of whether the microintervention was delivered at a prior time point (ie, effectiveness); adherence to in-app assessments (ie, feasibility); change in proportion of individuals who meet criteria for minor or major depression on PHQ-9 from baseline to exit and from baseline to each follow-up assessment (ie, safety) |
| Secondary outcomes | Power for larger study based on changes in responses to ACT Activity Survey as a function of whether the microintervention was delivered at a prior time point (ie, effectiveness) | Effectiveness of microintervention in terms of changes in responses to PHQ-2 and PSS-4 scores as a function of whether the microintervention was delivered at a prior time point (ie, effectiveness) |
aParticipants are recruited from the Prechter Longitudinal Study of Bipolar Disorder and have already completed interviews to determine demographic information and health and mental illness history.
bYMRS: Young Mania Rating Scale.
cSIGH-D: Structured Interview Guide for the Hamilton Depression Rating Scale.
dSF-36: 36-Item Short Form Survey.
ePSS-10: Perceived Stress Scale 10.
fPHQ-9: Patient Health Questionnaire 9.
gPROMIS-29: Patient-Reported Outcomes Measurement Information System.
hAAQ2: Acceptance and Action Questionnaire-II.
iCompACT: Comprehensive Assessment of Acceptance and Commitment Therapy Processes.
jACT: acceptance and commitment therapy.
kDeveloped for these studies.
lPHQ-2: Patient Health Questionnaire 2.
mPSS-4: Perceived Stress Scale 4.