DREAM: A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PEAR-003A Digital Therapeutic |
Device: PEAR-003A
PEAR-003A delivers CBT-I through a decentralized clinical trial open to participants with chronic insomnia
|
Outcome Measures
Primary Outcome Measures
- Change in Insomnia Severity Index (ISI) [From Baseline to Day 63 (End of Treatment) and Days 243, 428, 610, 793 (Follow-up)]
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)
Secondary Outcome Measures
- Evaluate PEAR-003A Engagement Data [Baseline, Day 63, Day 243, Day 428, Day 610, Day 793]
Evaluate PEAR-003A engagement rates
- Evaluate PEAR-003A Adherence Data [Baseline, Day 63, Day 243, Day 428, Day 610, Day 793]
Evaluate PEAR-003A adherence rates
- Examine change in depression symptoms [Baseline, Day 63, Day 243, Day 428, Day 610, Day 793]
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)
- Examine change in anxiety symptoms [Baseline, Day 63, Day 243, Day 428, Day 610, Day 793]
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)
Other Outcome Measures
- Examine treatment responders' data [Baseline, Day 63, Day 243, Day 428, Day 610, Day 793]
Treatment responders are those whose ISI decreased by more than 7 points. Responders ISI score will be evaluated at the end of treatment and follow-up.
- Examine Insomnia Remission [Day 63, Day 243, Day 428, Day 610, Day 793]
Subjects in treatment remission are those whose ISI score is 8 or less. Subjects in treatment remission ISI scores will be evaluated at end of treatment and follow-up
- Describe user experience surveys [Baseline, Day 63]
Summarize user experience surveys through descriptive statistics
- Describe user experience diary data [Baseline, Day 63]
Summarize qualitative diary data through descriptive statistics
- Describe user experience interviews [Baseline, Day 63]
Summarize user experience interviews through descriptive statistics
- To determine if there is a change in daytime sleepiness [Baseline, Day 63, Day 243, Day 428, Day 610, Day 793]
Change in Epworth Sleepiness Scale from baseline to end of treatment and follow-up. The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
- To determine change in quality of life [Baseline, Day 63, Day 243, Day 428, Day 610, Day 793]
Change in quality of life as measured in The Short Form 12 (SF-12). The SF-12 summary scores range from 0-100 with higher scores representing better self-reported health
- To determine change in work attendance and productivity [Baseline, Day 63, Day 243, Day 428, Day 610, Day 793]
Change in presenteeism/absenteeism work questions based on a survey. Subject answers Yes/No questions of whether continuously employed during the time period. If not, they can enter number of days employed or missed. Survey also contains a question regarding rating of productivity in %.
- To evaluate potential changes in healthcare utilization and costs identified in claims [Matched period]
Change in tokenized health claims from a specified period (up to 24 months) prior to intervention and a similar period after intervention
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provide electronic informed consent prior to any study specific assessments being performed
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Between 22 and 75 years old, inclusively
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Insomnia as defined by an ISI score of 8 or above
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Insomnia symptoms for at least 3 months
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< or = 6.5 hours of sleep per night
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Access to a mobile device
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Resident of the United States and currently living in the United States for the duration of the trial.
Exclusion Criteria:
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Presence of an active and/or progressive physical illness (e.g., congestive-heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorder (e.g., epilepsy) or neurological degenerative diseases (e.g., dementia, multiple sclerosis)
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Unstable medication regimen (change to schedule or dosage within the past 3 months)
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Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction
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Have family or work schedules that prevent them from having normal sleep schedules defined as bedtime between 8:00 pm and 2:00 am and/or waking times between 4:00 am and 10:00 am.
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Individuals who need to be alert or cautious to avoid serious accidents in their job or daily life. Examples include: Long-haul truck drivers, Long-distance bus drivers, Air traffic controllers, Operators of heavy machinery, some assembly line jobs.
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Pregnant or planning to become pregnant during the course of the trial.
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Other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias)
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Participated in an investigational research study in the past 30 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pear Therapeutics, Inc. | Boston | Massachusetts | United States | 02109 |
Sponsors and Collaborators
- Pear Therapeutics, Inc.
Investigators
- Study Director: Paula Walker, Pear Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PEAR-003-101
- DREAM Study