The purpose of the study is to collect data in a real-world environment, for a digital therapeutic that delivers CBT-I through a decentralized clinical trial, open to participants with chronic insomnia.
This is an open-access, open-label, decentralized clinical trial to collect real-world evidence for PEAR-003A, a digital therapeutic delivering CBT-I. Potential participants will answer an online prescreening questionnaire to determine eligibility. Qualifying participants will proceed to complete 6 weekly modules through their personal mobile phone or tablet in nine weeks. A series of the assessment and questionnaires will be administered at set points during the study. Participants will be asked to complete a follow-up module about 26 weeks, and at Days 243 (6-month), 428 (12-month), 610 (18-month) and 793 (24-month) after completing treatment. A subset of approximately 34 participants may be asked to partake in a optional user experience sub study. The participant will be asked to provide study feedback by either completing a five-day diary or an interview.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,590
PEAR-003A delivers CBT-I through a decentralized clinical trial open to participants with chronic insomnia
Pear Therapeutics, Inc.
Boston, Massachusetts, United States
Change in Insomnia Severity Index (ISI)
Change in the Insomnia Severity Index's (ISI) total score from Baseline to End of Treatment and Follow-up. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)
Time frame: From Baseline to Day 63 (End of Treatment) and Days 243, 428, 610, 793 (Follow-up)
Evaluate PEAR-003A Engagement Data
Evaluate PEAR-003A engagement rates
Time frame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
Evaluate PEAR-003A Adherence Data
Evaluate PEAR-003A adherence rates
Time frame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
Examine change in depression symptoms
Change in the eight-item Patient Health Questionnaire (PHQ-8) scores from Baseline to End of Treatment and Follow-up. The PHQ's total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Time frame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
Examine change in anxiety symptoms
Change in the Generalized Anxiety Disorder-7's (GAD-7) scores from Baseline to End of Treatment and Follow-up. The GAD-7's total score ranges from 0 (not clinically significant) to 21 (clinically significant)
Time frame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
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