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Behavioral Intervention
Adapted CBT-I for Insomnia
N/A
Recruiting
Led By Wilfred R Pigeon, PhD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months following the baseline assessment
Awards & highlights
Study Summary
This trial will test an adapted form of cognitive behavioral therapy for people with insomnia and hazardous alcohol use to see if it helps reduce these problems.
Who is the study for?
This trial is for adults in Monroe County, NY or nearby who drink more alcohol than low-risk guidelines suggest and have insomnia. They must speak English and not be getting treatment for alcohol issues, pregnant, planning pregnancy soon, or using IV drugs. People with serious medical conditions or significant sleep disorders other than insomnia are also excluded.Check my eligibility
What is being tested?
The study tests a new phone-delivered cognitive behavioral therapy (CBT) specifically designed for people who drink hazardously and have trouble sleeping. Participants will either receive this adapted CBT-I over four sessions or get education about sleep and alcohol as a control comparison.See study design
What are the potential side effects?
Since the interventions involve therapy and education without medications, there aren't typical side effects like you'd see with drugs. However, participants might experience discomfort discussing personal habits or feelings during sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months following the baseline assessment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months following the baseline assessment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abstinence
Drinks per Drinking Day
Insomnia Severity
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Insomnia TreatmentExperimental Treatment1 Intervention
Cognitive-behavioral therapy for insomnia adapted to hazardous alcohol users comprised of four telephone-based sessions delivered over six weeks.
Group II: Education ControlPlacebo Group1 Intervention
A combination of alcohol education and sleep hygiene education comprised of four telephone-based sessions delivered over six weeks.
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Who is running the clinical trial?
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,180 Total Patients Enrolled
7 Trials studying Insomnia
1,818 Patients Enrolled for Insomnia
Wilfred R Pigeon, PhDPrincipal InvestigatorUniversity of Rochester
1 Previous Clinical Trials
54 Total Patients Enrolled
1 Trials studying Insomnia
54 Patients Enrolled for Insomnia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not in hospice, undergoing cancer treatment, having surgery soon, or have a serious health or mental condition.I have undergone Cognitive Behavioral Therapy for Insomnia.I have started or been in alcohol treatment in the last year.I have a sleep disorder other than insomnia, but I am being treated for it if it's sleep apnea.
Research Study Groups:
This trial has the following groups:- Group 1: Education Control
- Group 2: Insomnia Treatment
Awards:
This trial has 0 awards, including: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 this research endeavor actively seeking participants?
"This particular trial is not seeking enrollees at this time. It was initially posted on October 1st, 2023 and its information has been updated most recently on July 25th, 2023. Nonetheless, there are 159 other clinical trials that are actively recruiting patients currently."
Answered by AI
Could I be accepted for participation in this clinical research?
"This investigation necessitates that participants are between 25 and 64 years of age, suffer from insomnia, and is limited to a cohort size of 70 individuals."
Answered by AI
Does your research include participants above the age of fifty?
"According to the criteria for participation, potential patients must fall in the 25-64 age range. Nevertheless, 19 studies are available for minors and 115 can be accessed by folks over 65 years old."
Answered by AI
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