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A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic (DREAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04325464
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Pear Therapeutics, Inc.

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
Chronic Insomnia Device: PEAR-003A Not Applicable

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 Day 243 and Day 428 after completing treatment.

A subset of approximately 34 participants will also 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

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




Primary Outcome Measures :
  1. Change in Insomnia Severity Index (ISI) [ Time Frame: From Baseline to Day 63 (End of Treatment) and Days 243 and 428 (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 :
  1. Evaluate PEAR-003A Engagement Data [ Time Frame: Baseline, Day 63, Day 243 ]
    Evaluate PEAR-003A engagement rates

  2. Evaluate PEAR-003A Adherence Data [ Time Frame: Baseline, Day 63, Day 243 ]
    Evaluate PEAR-003A adherence rates

  3. Examine change in depression symptoms [ Time Frame: Baseline, Day 63, Day 243, Day 428 ]
    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)

  4. Examine change in anxiety symptoms [ Time Frame: Baseline, Day 63, Day 243, Day 428 ]
    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:
  1. Examine treatment responders' data [ Time Frame: Baseline, Day 63, Day 243 ]
    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.

  2. Examine Insomnia Remission [ Time Frame: Day 63, Day 243 ]
    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

  3. Describe user experience surveys [ Time Frame: Baseline, Day 63 ]
    Summarize user experience surveys through descriptive statistics

  4. Describe user experience diary data [ Time Frame: Baseline, Day 63 ]
    Summarize qualitative diary data through descriptive statistics

  5. Describe user experience interviews [ Time Frame: Baseline, Day 63 ]
    Summarize user experience interviews through descriptive statistics

  6. To determine if there is a change in daytime sleepiness [ Time Frame: Baseline, Day 63, Day 243 ]
    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)

  7. To determine change in quality of life [ Time Frame: Baseline, Day 63, Day 243, Day 428 ]
    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

  8. To determine change in work attendance and productivity [ Time Frame: Baseline, Day 63, Day 243, Day 428 ]
    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 %.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide electronic informed consent prior to any study specific assessments being performed
  2. Between 22 and 75 years old, inclusively
  3. Insomnia as defined by an ISI score of 8 or above
  4. Insomnia symptoms for at least 3 months
  5. Access to a mobile device
  6. Resident of the United States and currently living in the United States for the duration of the trial.

Exclusion Criteria:

  1. Presence of an active and 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)
  2. Unstable medication regimen (change to schedule or dosage within the past 3 months)
  3. Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction
  4. 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.
  5. 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.
  6. Pregnant or planning to become pregnant during the course of the trial.
  7. Other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias)
  8. Participated in an investigational research study in the past 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325464


Locations
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United States, Massachusetts
Pear Therapeutics, Inc.
Boston, Massachusetts, United States, 02109
Sponsors and Collaborators
Pear Therapeutics, Inc.
Investigators
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Study Director: Jessica Bautista Pear Therapeutics, Inc.
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Responsible Party: Pear Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04325464    
Other Study ID Numbers: PEAR-003-101
DREAM Study ( Other Identifier: Pear Therapeutics )
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pear Therapeutics, Inc.:
Digital Therapeutic
CBT-I
Chronic Insomnia
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders