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Behavioral Intervention

Cognitive Behavioral Therapy for Insomnia for Insomnia

N/A
Waitlist Available
Led By Wilfred R. Pigeon, PhD
Research Sponsored by VA Office of Research and Development
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 baseline (week 0) and 6 month follow-up (week 30)
Awards & highlights

Study Summary

This trial looks at whether treating insomnia could reduce suicidal thoughts in Veterans with other conditions that are linked to suicide.

Eligible Conditions
  • Insomnia
  • Suicidal Thoughts

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) and 6 month follow-up (week 30)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) and 6 month follow-up (week 30) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index Change
Secondary outcome measures
PTSD Symptom Checklist-DSM 5 Change
Patient Health Questionnaire-Depression Change
Scale for Suicidal ideation Change

Side effects data

From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624
1%
Hematoma R side abdomen
1%
Severe vaginal bleeding and pain
1%
Chest pain in a patient with CAD
1%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Antidepressant + Desensitization
Antidepressant + Cognitive Behavioral

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CBT-IExperimental Treatment1 Intervention
Four individual sessions that will last approximately 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary.
Group II: SHActive Control1 Intervention
Four individual sessions that will last 15-30 minutes each across a 6-week time period, with the option to deliver sessions over the telephone as necessary.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1800

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,409 Total Patients Enrolled
26 Trials studying Insomnia
4,003 Patients Enrolled for Insomnia
Wilfred R. Pigeon, PhDPrincipal InvestigatorVA Finger Lakes Healthcare System, Canandaigua, NY

Frequently Asked Questions

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

Are the elderly being accepted into this research program?

"The age range for this study is from 18 to 70 years old."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
New York
What site did they apply to?
VA Western New York Healthcare System, Buffalo, NY
Syracuse VA Medical Center, Syracuse, NY
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+

What questions have other patients asked about this trial?

How long do screening takes? What are the selection criteria and how long do screening visits take?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I'm hoping this clinical trial will help me manage chronic insomnia. I have struggled with severe insomnia from last 14 months and mostly rely on sleeping pills to sleep through the night.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
RCT of Brief CBT-I in Primary Care Veterans With Suicidal Thoughts
2019. "RCT of Brief CBT-I in Primary Care Veterans With Suicidal Thoughts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03603717.
~31 spots leftby Apr 2025
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