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| ID | Type | Description | Link |
|---|---|---|---|
| DREAM Study | Other Identifier | Pear Therapeutics |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEAR-003A | Experimental | Digital Therapeutic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEAR-003A | Device | PEAR-003A delivers CBT-I through a decentralized clinical trial open to participants with chronic insomnia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From Baseline to Day 63 (End of Treatment) and Days 243, 428, 610, 793 (Follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate PEAR-003A Engagement Data | Evaluate PEAR-003A engagement rates | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 |
| Evaluate PEAR-003A Adherence Data | Evaluate PEAR-003A adherence rates |
| Measure | Description | Time Frame |
|---|---|---|
| Examine treatment responders' data | 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. | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 |
| Examine Insomnia Remission |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abby Doctolero | Pear Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pear Therapeutics, Inc. | Boston | Massachusetts | 02109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39319356 | Derived | Thorndike FP, Morin CM, Ojile J, Edington S, Gerwien R, Ong JC, Wickwire EM, Ritterband LM, Riney H. Effect of a prescription digital therapeutic for chronic insomnia on post-treatment insomnia severity, depression, and anxiety symptoms: results from the real-world DREAM study. Front Psychiatry. 2024 Sep 10;15:1450615. doi: 10.3389/fpsyt.2024.1450615. eCollection 2024. | |
| 33682430 |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| 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) | 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) | Baseline, 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 |
| Day 63, Day 243, Day 428, Day 610, Day 793 |
| Describe user experience surveys | Summarize user experience surveys through descriptive statistics | Baseline, Day 63 |
| Describe user experience diary data | Summarize qualitative diary data through descriptive statistics | Baseline, Day 63 |
| Describe user experience interviews | Summarize user experience interviews through descriptive statistics | Baseline, Day 63 |
| To determine if there is a change in daytime sleepiness | 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) | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 |
| To determine change in quality of life | 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 | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 |
| To determine change in work attendance and productivity | 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 %. | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 |
| To evaluate potential changes in healthcare utilization and costs identified in claims | Change in tokenized health claims from a specified period (up to 24 months) prior to intervention and a similar period after intervention | Matched period |
| Derived |
| Thorndike FP, Berry RB, Gerwien R, Braun S, Maricich YA. Protocol for Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia. J Comp Eff Res. 2021 May;10(7):569-581. doi: 10.2217/cer-2021-0004. Epub 2021 Mar 8. |
| D001523 |
| Mental Disorders |