CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients

Not Applicable

Terminated

• Conditions: Cancer; Chronic Insomnia
• Interventions: Behavioral: cognitive behavioral therapy for insomnia (CBTI); Behavioral: Waitlist control condition

• Registration Number: NCT02410564
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-07
• Primary Completion: 2015-07
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CBTI treatment	cognitive behavioral therapy for insomnia (CBTI)	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
Waitlist control condition	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.

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of a CBT-I intervention that improves sleep and quality of life outcomes during cancer treatment.	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.

Secondary Outcome Measures

Name	Time	Method
To assess the feasibility of a CBT--I intervention among newly diagnosed cancer patients.	1 year
To assess the acceptability of a CBT--I intervention among newly diagnosed cancer patients.	1 year

Trial Locations

Locations (1)

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States