← Back to Search

Behavioral Intervention

Digital CBTi administered for Insomnia

N/A
Waitlist Available
Research Sponsored by Palo Alto Veterans Institute for Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (end of intervention phase) and 16 weeks (follow-up)
Awards & highlights

Study Summary

This trial will test a digital form of CBT-I for veterans with co-morbid psychopathology to see if it's effective, feasible, and acceptable.

Eligible Conditions
  • Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (end of intervention phase) and 16 weeks (follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (end of intervention phase) and 16 weeks (follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Consensus Sleep Diary (CSD)
Changes in Participant Perception of the Acceptability, Perceived Value, and Feasibility of using a Digital Modality to Treat Insomnia Symptoms
Changes in the Insomnia Severity Index (ISI)
Secondary outcome measures
Changes in The Brief Inventory for Psychosocial Functioning (B-IPF)
Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9)
Changes in The Posttraumatic Checklist-5 (PCL-5)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Digital CBTi administeredExperimental Treatment1 Intervention
Participants will receive 6 sessions of digitally administered CBTi using the Sleepio platform over the course of 12 weeks. Each session lasts on average 30-60 minutes, and is tailored to participant's progress and problems. During the treatment phase, between sessions, participants complete the Consensus Sleep Diary to track their progress.

Find a Location

Who is running the clinical trial?

Palo Alto Veterans Institute for ResearchLead Sponsor
52 Previous Clinical Trials
7,895 Total Patients Enrolled
2 Trials studying Insomnia
178 Patients Enrolled for Insomnia
Big Health Inc.Industry Sponsor
11 Previous Clinical Trials
139,321 Total Patients Enrolled
3 Trials studying Insomnia
136,857 Patients Enrolled for Insomnia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for people to participate in this research?

"According to clinicaltrials.gov, this research project is no longer recruiting patients. Initially posted on February 5th 2018 and last amended on November 23rd 2021, the trial has since been closed for enrollment; however, there are 229 other trials actively seeking participants at present."

Answered by AI

What is the goal of this research endeavor?

"This trial, which is comparatively brief and lasting 12 weeks for the intervention phase with an additional 16-week follow up period, will be assessing changes in participants' perception of acceptability, value and feasibility regarding digital modality treatments for insomnia. Moreover, it will also measure general depression (PHQ-9), generalized anxiety disorder symptoms (GAD-7) as well as psychosocial functioning scores (B-IPF)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans
Shannon McCaslin 2018. "A Pilot Study of Digital Cognitive Behavioral Therapy for Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03688763.
~1 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top