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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
No Placebo-Only Group

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Insomnia Severity Index (ISI) scores from pretreatment to follow-up
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,668 Previous Clinical Trials
3,765,616 Total Patients Enrolled
25 Trials studying Insomnia
3,966 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
~125 spots leftby Jul 2026
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