Chronic InsomniaDREAMNCT04325464
A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic
A study testing PEAR-003A in people with Chronic Insomnia, run by Pear Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- PEAR-003A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,590 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide electronic informed consent prior to any study specific assessments being performed
- Between 22 and 75 years old, inclusively
- Insomnia as defined by an ISI score of 8 or above
- Insomnia symptoms for at least 3 months
- < or = 6.5 hours of sleep per night
- Access to a mobile device
- Resident of the United States and currently living in the United States for the duration of the trial.
Who cannot join
- 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)
- Unstable medication regimen (change to schedule or dosage within the past 3 months)
- Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction
- 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.
- 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.
- Pregnant or planning to become pregnant during the course of the trial.
- Other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias)
- Participated in an investigational research study in the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Pear Therapeutics, Inc.
Boston, Massachusetts, 02109
About this study
Official title: Open-label, 9-week Treatment, De-centralized Trial to Collect Real World Evidence for a Digital Therapeutic (DT) Delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) for Participants With Chronic Insomnia
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.
Read the 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.
- Conditions
- Chronic Insomnia
- Being tested
- PEAR-003A
- Keywords
- Digital Therapeutic, CBT-I, Chronic Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAR-003ADevice
PEAR-003A delivers CBT-I through a decentralized clinical trial open to participants with chronic insomnia
| Study group | Role | What they receive |
|---|---|---|
| PEAR-003A | Experimental | Digital Therapeutic Receives: Device: PEAR-003A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From Baseline to Day 63 (End of Treatment) and Days 243, 428, 610, 793 (Follow-up)
Secondary outcomes (4)
Evaluate PEAR-003A Engagement Data
Evaluate PEAR-003A engagement rates
Measured: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
Evaluate PEAR-003A Adherence Data
Evaluate PEAR-003A adherence rates
Measured: 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)
Measured: 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)
Measured: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start18 Feb 2020
- Primary completion21 Oct 2022
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pear Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abby Doctolero, Study director, Pear Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325464
- Sponsor's protocol ID
- PEAR-003-101
- Other IDs
- DREAM Study
- Acronym
- DREAM
- Status last verified
- Jan 2023
- First submitted
- 20 Feb 2020
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39319356Thorndike 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.
PubMed 33682430
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, 9-week Treatment, De-centralized Trial to Collect Real World Evidence for a Digital Therapeutic (DT) Delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) for Participants With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT04325464
- Acronym / sponsor ID
- DREAM / PEAR-003-101
- Conditions
- Chronic Insomnia
- Keywords
- Digital Therapeutic, CBT-I, Chronic Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,590 participants (actual)
- Lead sponsor
- Pear Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEAR-003A | Experimental | Device: PEAR-003ADigital Therapeutic |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide electronic informed consent prior to any study specific assessments being performed
- Between 22 and 75 years old, inclusively
- Insomnia as defined by an ISI score of 8 or above
- Insomnia symptoms for at least 3 months
- < or = 6.5 hours of sleep per night
Key exclusion criteria (8 listed)
- 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)
- Unstable medication regimen (change to schedule or dosage within the past 3 months)
- Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEAR-003APEAR-003A delivers CBT-I through a decentralized clinical trial open to participants with chronic insomnia | Device | PEAR-003A |
Primary outcome
Change in Insomnia Severity Index (ISI)
Time frame: 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)
4 secondary outcomes
Evaluate PEAR-003A Engagement Data
Time frame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
Evaluate PEAR-003A Adherence Data
Time frame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
Examine change in depression symptoms
Time frame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
Examine change in anxiety symptoms
Time frame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Derived from this study: PubMed 39319356Thorndike 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.
- Derived from this study: PubMed 33682430Thorndike 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abby Doctolero study director
Pear Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEAR-003A in people with Chronic Insomnia, run by Pear Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (ISI) (time frame: From Baseline to Day 63 (End of Treatment) and Days 243, 428, 610, 793 (Follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04325464, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.