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. 2020 Sep 23;9(9):e17086. doi: 10.2196/17086

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.