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Cognitive Behavioral Therapy for Insomnia for Insomnia (Project SAVE Trial)

N/A
Waitlist Available
Led By Mary Beth Miller, PhD
Research Sponsored by University of Missouri-Columbia
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 change from baseline to post-treatment (week 6) to follow up (week 12)
Awards & highlights

Project SAVE Trial Summary

This study is evaluating whether a cognitive behavioral therapy intervention may help reduce alcohol consumption for veterans.

Eligible Conditions
  • Insomnia
  • Alcoholism

Project SAVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to post-treatment (week 6) to follow up (week 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to post-treatment (week 6) to follow up (week 12) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol problems
Insomnia severity
Percent of heavy-drinking days
Secondary outcome measures
Alcohol craving
Attention
Delay discounting
+10 more

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

Project SAVE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CBT-I + AUD-TAUExperimental Treatment2 Interventions
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
Group II: Sleep Hygiene + AUD-TAUActive Control2 Interventions
Sleep hygiene education delivered once to all participants
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1800
Alcohol Use Disorder Treatment as Usual
2019
N/A
~70

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,047 Total Patients Enrolled
9 Trials studying Insomnia
967 Patients Enrolled for Insomnia
Harry S. Truman Memorial Veterans' HospitalFED
3 Previous Clinical Trials
396 Total Patients Enrolled
Mary Beth Miller, PhDPrincipal InvestigatorUniversity of Missouri-Columbia
2 Previous Clinical Trials
218 Total Patients Enrolled
1 Trials studying Insomnia
56 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.
Recent research and studies
clinicaltrials.govStudy
CBT-I on Alcohol Treatment Outcomes Among Veterans
Mary E Miller 2019. "CBT-I on Alcohol Treatment Outcomes Among Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03806491.
~12 spots leftby Apr 2025
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