- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02038556
Exploring the Outcomes and Financial Impact of a CBT-I Group Program Provided by Registered Nurses for Adults With Insomnia
May 7, 2015 updated by: Wendy R. Moore, Mayo Clinic
The purpose of this pilot study is to evaluate our RN CBT-I program outcomes and determine utility of this program as a high-value care model targeted specifically to our sleep center patient population.
Hypothesis: PIRS will improve from baseline to 2 month follow up
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Able to speak english
- Referred to Mayo Center for Sleep medicine Cognitive behaviorial therapy program for insomnia
- no dementia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: cognitive behaviorial therapy for insomnia group program
Behavioral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pittsburg insomnia rating scale
Time Frame: up to 2 months
|
up to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wendy Moore, RN, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
June 10, 2013
First Submitted That Met QC Criteria
January 15, 2014
First Posted (Estimate)
January 16, 2014
Study Record Updates
Last Update Posted (Estimate)
May 8, 2015
Last Update Submitted That Met QC Criteria
May 7, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-006921
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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