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Behavioural Intervention

Cognitive Behavioral Therapy for Insomnia

N/A
Recruiting
Led By Henry J. Orff, 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 week 0 (baseline) and week 20 (follow-up)
Awards & highlights

Study Summary

This trial seeks to compare a brief 4-session version of Cognitive-Behavioral Therapy for Insomnia (CBT-I) to a standard 6-session version to see if it can help Veterans with insomnia.

Who is the study for?
This trial is for Veterans with insomnia who have an Insomnia Severity Index score over 7, meet the criteria for a mental health disorder, haven't had CBT-I therapy in 2 years, and are on stable meds. It's not for those with certain severe mental illnesses, high suicide risk, other sleep disorders, or recent substance abuse.Check my eligibility
What is being tested?
The study compares two types of Cognitive-Behavioral Therapy for Insomnia (CBT-I): a brief version with four sessions and the standard VA version with six sessions. The goal is to see if the shorter treatment works as well as the longer one in improving sleep and overall functioning.See study design
What are the potential side effects?
Since CBT-I involves behavioral changes rather than medication, side effects are minimal but can include temporary increases in anxiety or stress due to changes in sleeping habits or frustration during adjustment periods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 (baseline) and week 20 (follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 (baseline) and week 20 (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
Change in Insomnia Severity Index (ISI) scores from pretreatment to follow-up
Secondary outcome measures
Change in Brief Inventory of Psychosocial Functioning (B-IPF)
Change in Functional Outcomes of Sleep Questionnaire 10 (FOSQ-10)
Change in Generalized Anxiety Disorder Scale 7 (GAD-7)
+4 more

Trial Design

2Treatment groups
Active Control
Group I: Cognitive-Behavioral Therapy for Insomnia (CBT-I)Active Control2 Interventions
Compare two behavioral interventions for insomnia
Group II: Standard Cognitive-Behavioral Therapy for Insomnia (CBT-I)Active Control2 Interventions
Standard VA 6 session version of CBT-I

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,183 Total Patients Enrolled
26 Trials studying Insomnia
3,947 Patients Enrolled for Insomnia
VA Finger Lakes Healthcare SystemUNKNOWN
1 Previous Clinical Trials
95 Total Patients Enrolled
Henry J. Orff, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
73 Total Patients Enrolled
1 Trials studying Insomnia
73 Patients Enrolled for Insomnia

Media Library

Brief CBT-I (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05724498 — N/A
Insomnia Research Study Groups: Cognitive-Behavioral Therapy for Insomnia (CBT-I), Standard Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Insomnia Clinical Trial 2023: Brief CBT-I Highlights & Side Effects. Trial Name: NCT05724498 — N/A
Brief CBT-I (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05724498 — N/A

Frequently Asked Questions

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

Is there still availability for participants in this clinical trial?

"The clinicaltrials.gov database reveals that the initial post for this study was made on April 1st, 2023 and has since been updated lastly in February 2nd of the same year. Unfortunately, no new candidates are being accepted at present; however, 214 other medical trials are recruiting patients now."

Answered by AI

Who else is applying?

What site did they apply to?
VA San Diego Healthcare System, San Diego, CA
What portion of applicants met pre-screening criteria?
Met criteria

What questions have other patients asked about this trial?

Can I be enrolled?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Insomnia is affecting every aspect of my life.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Brief Versus Standard Cognitive Behavioral Therapy for Insomnia in Veterans
2023. "Brief Versus Standard Cognitive Behavioral Therapy for Insomnia in Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05724498.
All > Insomnia
~167 spots leftby Jul 2026
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