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Sleep Hygeine for Insomnia (iTAP-V Trial)
N/A
Waitlist Available
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 (weeks 7-8) and 3 month follow-up (weeks 21-22)
Awards & highlights
iTAP-V Trial Summary
This trial will help researchers understand if treating insomnia can also help treat alcohol use disorder.
Eligible Conditions
- Insomnia
- Alcohol Abuse
iTAP-V Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alcohol-related consequences
Client satisfaction
Drinking quantity
+5 moreSecondary outcome measures
Alcohol craving
Autonomic arousal
Delay discounting
+7 moreiTAP-V Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CBT-IExperimental Treatment2 Interventions
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks.
Group II: Sleep HygieneActive Control1 Intervention
Sleep hygiene handout 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
Sleep Hygeine
2019
N/A
~80
Find a Location
Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,440 Total Patients Enrolled
3 Trials studying Insomnia
359 Patients Enrolled for Insomnia
University of Missouri-ColumbiaLead Sponsor
361 Previous Clinical Trials
627,923 Total Patients Enrolled
9 Trials studying Insomnia
963 Patients Enrolled for Insomnia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious untreated mental illness that needs urgent medical attention.You are currently receiving treatment for insomnia or alcohol use.You have started taking medication to help you sleep in the last 6 weeks.You have a sleep disorder that needs more than just behavioral treatment for insomnia, and it has not been treated yet.You have difficulties with thinking, memory, or understanding information.You have trouble falling asleep or staying asleep, and meet the criteria for Insomnia Disorder as outlined by the DSM-5 and research guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: CBT-I
- Group 2: Sleep Hygiene
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently available for this trial?
"Affirmative. Per the clinicaltrials.gov data, this research trial remains open for enrollment with an initial post date of April 4th 2019 and a last update on October 6th 2022. 68 volunteers are required from 1 location."
Answered by AI
What are the major aims of this medical experiment?
"The primary purpose of this clinical trial is to monitor the changes in drinking quantity before and after treatment, as well as 3 months post-treatment. Additionally, Autonomic arousal will be measured using holter monitoring devices; alcohol craving with the Penn Alcohol Craving Scale (PACS); and sleep patterns through daily diaries."
Answered by AI
What is the current enrollment of this clinical research?
"Affirmative. The trial's details, which were inaugurated on April 4th 2019 and recently revised on October 6th 2022, have been published to clinicaltrials.gov where it is actively recruiting 68 volunteers from a single site."
Answered by AI
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