CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients
February 9, 2016 updated by: Virginia Commonwealth University
Testing an Accessible Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention in Newly Diagnosed Cancer Patients
To determine the efficacy of a CBT-I intervention in improving sleep and other quality of life outcomes during cancer treatment.
To assess the feasibility and acceptability of a CBT-I intervention among newly diagnosed cancer patients.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The proposed study will be a randomized controlled trial design.
Participants will be randomized to either a CBTI treatment or a wait list control condition.
The intervention is SHUTi, a validated web based version of CBTI, which will take place over seven weeks and will include a combination of face to face and telephone sessions, and email updates.
All participants will have a face to face meeting with the doctoral student at enrollment.
During the intervention period, all participants will be contacted by telephone at week 1, 3, and 6 to check in and to encourage participant engagement.
However, during phone calls with control participants, no advice regarding sleep will be given and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study.
Participants in SHUTi will additionally be provided the the doctoral student's phone number and will be encouraged to contact her if they have any questions during the intervention.
They will also have the option of setting up appointments for face to face meetings during a clinic appointment if they desire additional therapist guidance.
Pretreatment, all participants will complete a two week sleep diary and multiple self report measures.
At the end of the intervention, all participants will complete a two week sleep diary and multiple self report measures again.
Study Type
Interventional
Enrollment (Actual)
29
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
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University/Massey Cancer Center
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-
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
Inclusion criteria:
- newly diagnosed with I-III non-metastatic cancer
- scheduled to begin chemotherapy or radiotherapy
- chemotherapy or radiotherapynaïve
- meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)
- Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minuteSOL, ≥ 60minute wake after sleep onset (WASO), or ≤ 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month.
- interested in behavioral sleep treatment
- have the permission of their oncologists to participate.
Exclusion criteria:
- untreated alcohol or substance abuse or dependence, bipolar, or psychotic disorder
- medical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease
- untreated sleep disorders such as sleep apnea
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: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: CBTI treatment
cognitive behavioral therapy for insomnia (CBTI) treatment is a validated web based version of CBT-I, which will take place over seven weeks and will include a combination of face-to-face and telephone sessions, and email updates
|
SHUTi program is made up of six, weekly treatment Cores modeled after weekly facetoface(CBTI).
Each Core begins by providing a rationale for learning the material, explains main content, homework page with suggestions for improving sleep, and a summarized review of main points.
The main content each Core addresses myths about sleep, indepth information about topics, vignettes, and quizzes to evaluate users learning in an interactive.
As well as being interactive, SHUTi allows for personalization.Modifications are made to sleep recommendations based in sleep diary data and individually set treatment goals.
The cores include Overview, Sleep Behavior Core, Sleep Behavior Core 2, Sleep Education Core, Sleep Thoughts Core, and Problem Prevention Core.
Each Core takes approximately 45 to 60 minutes to complete.
Cores are presented one at a time; next Core becomes available to users a week after they complete one Core.
Other Names:
|
|
PLACEBO_COMPARATOR: Waitlist control condition
No advice regarding sleep will be given to the control group and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study.
|
Phone calls with control participants, no advice regarding sleep will be given and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To determine the efficacy of a CBT-I intervention that improves sleep and quality of life outcomes during cancer treatment.
Time Frame: 1 year
|
CBT-I is a cognitive behavioral therapy for insomnia.
Pretreatment,all participants will complete a two week sleep diary and multiple self report measures.
At the end of the intervention, all participants will complete a two week sleep diary and multiple self report measures again.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess the feasibility of a CBT--I intervention among newly diagnosed cancer patients.
Time Frame: 1 year
|
1 year
|
|
To assess the acceptability of a CBT--I intervention among newly diagnosed cancer patients.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bruce Rybarczyk, PhD, Virginia Commonwealth University
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
December 1, 2014
Primary Completion (ACTUAL)
July 1, 2015
Study Completion (ACTUAL)
January 1, 2016
Study Registration Dates
First Submitted
March 11, 2015
First Submitted That Met QC Criteria
April 6, 2015
First Posted (ESTIMATE)
April 7, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
February 10, 2016
Last Update Submitted That Met QC Criteria
February 9, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-14-10761
- HM20002827
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.