Clinical trial NCT04325464: A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Insomnia
Keywords: Digital Therapeutic
CBT-I
Chronic Insomnia
Lead sponsor: Pear Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 1590
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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. \< 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

Primary outcomes:
measure: Change in Insomnia Severity Index (ISI)
timeFrame: From Baseline to Day 63 (End of Treatment) and Days 243, 428, 610, 793 (Follow-up)
Secondary outcomes:
measure: Evaluate PEAR-003A Engagement Data
timeFrame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
measure: Evaluate PEAR-003A Adherence Data
timeFrame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
measure: Examine change in depression symptoms
timeFrame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
measure: Examine change in anxiety symptoms
timeFrame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
Other outcomes:
measure: Examine treatment responders' data
timeFrame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
measure: Examine Insomnia Remission
timeFrame: Day 63, Day 243, Day 428, Day 610, Day 793
measure: Describe user experience surveys
timeFrame: Baseline, Day 63
measure: Describe user experience diary data
timeFrame: Baseline, Day 63
measure: Describe user experience interviews
timeFrame: Baseline, Day 63
measure: To determine if there is a change in daytime sleepiness
timeFrame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
measure: To determine change in quality of life
timeFrame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
measure: To determine change in work attendance and productivity
timeFrame: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793
measure: To evaluate potential changes in healthcare utilization and costs identified in claims
timeFrame: Matched period
Locations:
city: Boston
country: United States
facility: Pear Therapeutics, Inc.
state: Massachusetts
Study officials:
affiliation: Pear Therapeutics, Inc.
name: Abby Doctolero
role: STUDY_DIRECTOR
References:
citation: 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.