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Exploring the Outcomes and Financial Impact of a CBT-I Group Program Provided by Registered Nurses for Adults With Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive behaviorial therapy -Insomnia
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Able to speak english
  • Referred to Mayo Center for Sleep medicine Cognitive behaviorial therapy program for insomnia
  • no dementia

Sites / Locations

  • Mayo Clinic in Rochester
  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cognitive behaviorial therapy for insomnia group program

Arm Description

Behavioral

Outcomes

Primary Outcome Measures

Pittsburg insomnia rating scale

Secondary Outcome Measures

Full Information

First Posted
June 10, 2013
Last Updated
May 7, 2015
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02038556
Brief Title
Exploring the Outcomes and Financial Impact of a CBT-I Group Program Provided by Registered Nurses for Adults With Insomnia
Official Title
Exploring the Outcomes and Financial Impact of a CBT-I Group Program Provided by Registered Nurses for Adults With Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cognitive behaviorial therapy for insomnia group program
Arm Type
Experimental
Arm Description
Behavioral
Intervention Type
Behavioral
Intervention Name(s)
cognitive behaviorial therapy -Insomnia
Primary Outcome Measure Information:
Title
Pittsburg insomnia rating scale
Time Frame
up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Able to speak english Referred to Mayo Center for Sleep medicine Cognitive behaviorial therapy program for insomnia no dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Moore, RN
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Exploring the Outcomes and Financial Impact of a CBT-I Group Program Provided by Registered Nurses for Adults With Insomnia

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