Clinical trial NCT04909229: Prescription Digital Therapeutic for the Treatment of Insomnia
Official title: Randomized Controlled Trial Examining Real-World Effectiveness of a Prescription Digital Therapeutic for the Treatment of Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Keywords: insomnia
CBT-I
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: National Evaluation System for health Technology Coordinating Center
name: Pear Therapeutics, Inc.
First posted: 2021-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a prospective multi-center controlled trial of 100 patients conducted to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia using a novel patient-centered data-sharing platform with linkage to Fitbit for 61 weeks

Detailed description: This is a multi-center, randomized, controlled trial to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia (i.e., Somryst, herein called PEAR-003b) using a novel patient-centered data sharing platform (called Hugo), with linkage to Fitbit (Inspire 2), among 100 patients with chronic insomnia. Half of the patients with insomnia will receive the PEAR-003b digital therapeutic with linkage to the Hugo platform and Fitbit (Inspire 2) and half of the patients with insomnia will not receive the PDT but will receive a Fitbit and be enrolled in the Hugo platform. The treatment duration will be 9 weeks with a 21-, 35-, and 61-week follow-up. All patients will be evaluated at baseline, as well as prompted to complete additional assessments at weeks 9, 21, 35, and 61. The PEAR-003b intervention will deliver CBT-I via mobile devices as 6 treatment core modules over 9 weeks. Additionally, the Hugo platform will be used to collect patient-generated engagement data, healthcare utilization outcomes, and patient activity/clinical outcomes. These real-world data points and trends collected as part of this pilot investigation will help inform a future larger healthcare effectiveness and outcomes research study.

Eligibility criteria: Inclusion Criteria:

* • Age between 22-64 years

  * English-speaking (both reading and writing in English required)
  * Diagnosis of chronic insomnia
  * Participant is willing and able to give consent and participate in study
  * Participant has an email account or is willing to create one and a smartphone able to download the necessary applications
  * Participant is willing and able to use the PDT, the Hugo data sharing platform and the syncable devices (e.g. Fitbit)
  * Participant has primary care at YNHH or Mayo Clinic

Exclusion Criteria:

* Pregnancy
* Shift work or family/other commitments that interfere with establishment of regular night-time sleep patterns, and if wake/sleep time is outside the ranges of 4:00h - 10:00h (wake time) and 20:00h - 02:00h (bed time)
* Absence of a reliable internet access and smartphone
* A reported diagnosis of psychosis, schizophrenia or bipolar disorder, or any medical disorders contraindicated with sleep restriction
* Current involvement in a non-medication treatment program for insomnia (participants are still eligible if they are taking traditional sleep medications)
* Those with untreated co-existing sleep conditions (e.g. sleep apnea)
* Those who have failed CBT for insomnia in the past

Primary outcomes:
measure: Change in Insomnia Severity
timeFrame: From baseline to 9 weeks post randomization
Secondary outcomes:
measure: Change in Insomnia Severity
timeFrame: From baseline to 21 weeks post-randomization
measure: Change in Insomnia Severity
timeFrame: From baseline to 35 weeks post-randomization
measure: Change in Insomnia Severity
timeFrame: From baseline to 61 weeks post-randomization
measure: Change in Depressive Symptoms
timeFrame: From baseline to 9 weeks post-randomization
measure: Change in Depressive Symptoms
timeFrame: From baseline to 21 weeks post-randomization
measure: Change in Depressive Symptoms
timeFrame: From baseline to 35 weeks post-randomization
measure: Change in Depressive Symptoms
timeFrame: From baseline to 61 weeks post-randomization
measure: Change in Anxiety
timeFrame: From baseline to 9 weeks post-randomization
measure: Change in Anxiety
timeFrame: From baseline to 21 weeks post-randomization
measure: Change in Anxiety
timeFrame: From baseline to 35 weeks post-randomization
measure: Change in Anxiety
timeFrame: From baseline to 61 weeks post-randomization
measure: Change in Stress
timeFrame: From baseline to 9 weeks post-randomization
measure: Change in Stress
timeFrame: From baseline to 21 weeks post-randomization
measure: Change in Stress
timeFrame: From baseline to 35 weeks post-randomization
measure: Change in Stress
timeFrame: From baseline to 61 weeks post-randomization
measure: Change in Quality of Life (PCS)
timeFrame: From baseline to 9 weeks post-randomization
measure: Change in Quality of Life (PCS)
timeFrame: From baseline to 21 weeks post-randomization
measure: Change in Quality of Life (PCS)
timeFrame: From baseline to 35 weeks post-randomization
measure: Change in Quality of Life (PCS)
timeFrame: From baseline to 61 weeks post-randomization
measure: Change in Daytime Sleepiness
timeFrame: From baseline to 9 weeks post-randomization
measure: Change in Daytime Sleepiness
timeFrame: From baseline to 21 weeks post-randomization
measure: Change in Daytime Sleepiness
timeFrame: From baseline to 35 weeks post-randomization
measure: Change in Daytime Sleepiness
timeFrame: From baseline to 61 weeks post-randomization
measure: Healthcare Utilization
timeFrame: From baseline to 9 weeks post-randomization
measure: Healthcare Utilization
timeFrame: From baseline to 21 weeks post-randomization
measure: Healthcare Utilization
timeFrame: From baseline to 35 weeks post-randomization
measure: Healthcare Utilization
timeFrame: From baseline to 61 weeks post-randomization
measure: Medication Utilization
timeFrame: From baseline to 9 weeks post-randomization
measure: Medication Utilization
timeFrame: From baseline to 21 weeks post-randomization
measure: Medication Utilization
timeFrame: From baseline to 35 weeks post-randomization
measure: Medication Utilization
timeFrame: From baseline to 61 weeks post-randomization
measure: Change in Sleep Efficiency
timeFrame: From baseline to 9 weeks post-randomization
measure: Change in Sleep Efficiency
timeFrame: From baseline to 21 weeks post-randomization
measure: Change in Sleep Efficiency
timeFrame: From baseline to 35 weeks post-randomization
measure: Change in Sleep Efficiency
timeFrame: From baseline to 61 weeks post-randomization
measure: Change in Sleep Onset Latency
timeFrame: From baseline to 9 weeks post-randomization
measure: Change in Sleep Onset Latency
timeFrame: From baseline to 21 weeks post-randomization
measure: Change in Sleep Onset Latency
timeFrame: From baseline to 35 weeks post-randomization
measure: Change in Sleep Onset Latency
timeFrame: From baseline to 61 weeks post-randomization
measure: Change in Health Utility Score
timeFrame: From baseline to 9 weeks post-randomization
measure: Change in Health Utility Score
timeFrame: From baseline to 21 weeks post-randomization
measure: Change in Health Utility Score
timeFrame: From baseline to 35 weeks post-randomization
measure: Change in Health Utility Score
timeFrame: From baseline to 61 weeks post-randomization
measure: Change in Quality of Life (MCS)
timeFrame: From baseline to 9 weeks post-randomization
measure: Change in Quality of Life (MCS)
timeFrame: From baseline to 21 weeks post-randomization
measure: Change in Quality of Life (MCS)
timeFrame: From baseline to 35 weeks post-randomization
measure: Change in Quality of Life (MCS)
timeFrame: From baseline to 61 weeks post-randomization
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: Dreyer RP, Berkowitz A, Yaggi HK, Schneeberg L, Shah ND, Emanuel L, Kolla B, Jeffery MM, Deeg M, Ervin K, Thorndike F, Ross JS. PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. BMJ Open. 2022 Aug 8;12(8):e062041. doi: 10.1136/bmjopen-2022-062041.