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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Device: PEAR-003A

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 Type: Interventional
• Enrollment (Actual): 1590
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02109
      • Pear Therapeutics, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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/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)
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pear Therapeutics, Inc.
• Investigators: Study Director: Abby Doctolero, Pear Therapeutics, Inc.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2020
• Primary Completion (ACTUAL): October 21, 2022
• Study Completion (ANTICIPATED): October 31, 2024

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (ACTUAL): March 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Digital Therapeutic; Chronic Insomnia; CBT-I
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: PEAR-003-101; DREAM STUDY (Pear Therapeutics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No