NCT02038556

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

June 10, 2013

Last Update Submit

May 7, 2015

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Pittsburg insomnia rating scale

    up to 2 months

Study Arms (1)

cognitive behaviorial therapy for insomnia group program

EXPERIMENTAL

Behavioral

Behavioral: cognitive behaviorial therapy -Insomnia

Interventions

cognitive behaviorial therapy -InsomniaBEHAVIORAL
cognitive behaviorial therapy for insomnia group program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Able to speak english * Referred to Mayo Center for Sleep medicine Cognitive behaviorial therapy program for insomnia * no dementia

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Wendy Moore, RN

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

June 10, 2013

First Posted

January 16, 2014

Study Start

May 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

US(2)