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Cognitive Behavioral Therapy
Internet Cognitive Behavioral Therapy for HIV-related Insomnia
N/A
Waitlist Available
Led By Samir K Gupta, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Use of sleeping aids/medications is permitted as long as the ISI score criterion is met
Age equal to or greater than 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,12 and 24 weeks
Awards & highlights
Study Summary
This trial will test if internet cognitive behavioral therapy can help HIV-positive people receiving antiretroviral therapy by reducing systemic inflammation.
Who is the study for?
This trial is for adults over 18 with HIV who are on stable antiretroviral therapy and have insomnia, as shown by an ISI score of at least 11. They must not be pregnant, breastfeeding, or have conditions causing inflammation or severe kidney disease. People using sleep aids can join if they meet the insomnia criteria.Check my eligibility
What is being tested?
The study tests whether internet-based cognitive behavioral therapy (SHUTi) can reduce systemic inflammation in people with HIV-related insomnia. Participants will either receive SHUTi or sleep education/hygiene advice to see which method is more effective.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like online therapy and education, side effects may include discomfort from changing sleep habits but no physical drug-related side effects are expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I use sleeping aids but meet the required sleep quality score.
Select...
I am 18 years old or older.
Select...
I have been on a consistent HIV treatment for at least 6 months.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline,12 and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,12 and 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in hsCRP levels at 24 weeks
Secondary outcome measures
Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 and 24 weeks
Change in CD14+CD16+ monocytes at 12 and 24 weeks
Change in Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) at 12 and 24 weeks
+13 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CBT-IExperimental Treatment1 Intervention
This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.
Group II: Sleep Education/HygieneActive Control1 Intervention
This arm will receive best practices education on sleep hygiene.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SHUTi
2018
N/A
~380
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
976 Previous Clinical Trials
983,327 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,775 Previous Clinical Trials
2,674,341 Total Patients Enrolled
Samir K Gupta, MDPrincipal InvestigatorIndiana University School of Medicine
2 Previous Clinical Trials
62 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: CBT-I
- Group 2: Sleep Education/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.
How many participants can join this research endeavor?
"Affirmative, the data hosted on clinicaltrials.gov points to this research endeavor actively recruiting participants. The trial was initially published in December 2021 and last updated in October 2022 with a goal of enrolling 50 patients from one particular medical centre."
Answered by AI
Are there any available posts in this clinical research experiment?
"The clinical trial is still actively searching for participants. The details were initially posted on December 2nd 2021, and the page was last edited October 10th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
How old are they?
18 - 65
What site did they apply to?
Indiana University Infectious Diseases Research
What portion of applicants met pre-screening criteria?
Met criteria
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