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

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ClinicalTrials.gov Identifier: NCT04325464
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2020
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Pear Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE February 20, 2020
First Posted Date  ICMJE March 27, 2020
Last Update Posted Date August 5, 2021
Actual Study Start Date  ICMJE February 18, 2020
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
Change in Insomnia Severity Index (ISI) [ Time Frame: From Baseline to Day 63 (End of Treatment) and Day 243 (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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2020)
  • Evaluate PEAR-003A Engagement Data [ Time Frame: Baseline, Day 63, Day 243 ]
    Evaluate PEAR-003A engagement rates
  • Evaluate PEAR-003A Adherence Data [ Time Frame: Baseline, Day 63, Day 243 ]
    Evaluate PEAR-003A adherence rates
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • Evaluate PEAR-003A Engagement Data [ Time Frame: Baseline, Day 63, Day 243 ]
    Evaluate PEAR-003A engagement rates
  • Evaluate PEAR-003A Adherence Data [ Time Frame: Baseline, Day 63, Day 243 ]
    Evaluate PEAR-003A adherence rates
  • Examine change in depression symptoms [ Time Frame: Baseline, Day 63, Day 243 ]
    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 [ Time Frame: Baseline, Day 63, Day 243 ]
    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)
Current Other Pre-specified Outcome Measures
 (submitted: July 5, 2020)
  • 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.
  • 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
  • Describe user experience surveys [ Time Frame: Baseline, Day 63 ]
    Summarize user experience surveys through descriptive statistics
  • Describe user experience diary data [ Time Frame: Baseline, Day 63 ]
    Summarize qualitative diary data through descriptive statistics
  • Describe user experience interviews [ Time Frame: Baseline, Day 63 ]
    Summarize user experience interviews through descriptive statistics
  • 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)
  • 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
  • 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 %.
Original Other Pre-specified Outcome Measures
 (submitted: March 26, 2020)
  • 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.
  • 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
  • Describe user experience surveys [ Time Frame: Baseline, Day 63 ]
    Summarize user experience surveys through descriptive statistics
  • Describe user experience diary data [ Time Frame: Baseline, Day 63 ]
    Summarize qualitative diary data through descriptive statistics
  • Describe user experience interviews [ Time Frame: Baseline, Day 63 ]
    Summarize user experience interviews through descriptive statistics
  • 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)
 
Descriptive Information
Brief Title  ICMJE A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Insomnia
Intervention  ICMJE Device: PEAR-003A
PEAR-003A delivers CBT-I through a decentralized clinical trial open to participants with chronic insomnia
Study Arms  ICMJE Experimental: PEAR-003A
Digital Therapeutic
Intervention: Device: PEAR-003A
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 8, 2021)
1000
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2020)
350
Estimated Study Completion Date  ICMJE January 31, 2023
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. < or = 6.5 hours of sleep per night
  6. Access to a mobile device
  7. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04325464
Other Study ID Numbers  ICMJE PEAR-003-101
DREAM Study ( Other Identifier: Pear Therapeutics )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pear Therapeutics, Inc.
Study Sponsor  ICMJE Pear Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paula Walker Pear Therapeutics, Inc.
PRS Account Pear Therapeutics, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP