An interventional study of CBTI-CS and Sleep Hygiene in Insomnia, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-11.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Treatment
This research study is evaluating the effectiveness of a 3-session behavioral intervention for insomnia in cancer survivors. This is a behavioral intervention study, and no medications are involved.
This study is being done to test the usefulness of a 3-session cognitive-behavioral intervention for improving insomnia in cancer survivors. In this study, the investigators are testing whether this 3-session intervention (Cognitive Behavior Therapy for Insomnia in Cancer Survivors: CBTI-CS) will improve insomnia in cancer survivors whose continue to have insomnia symptoms after receiving sleep hygiene education.
In addition to the participants who will be offered sleep hygiene education and the 3-session CBTI-CS,10 additional participants will be recruited to participate in a pilot evaluation of the CBTI-CS intervention delivered via telehealth. This will be a pilot aspect of the study and data from these participants will be for descriptive purposes.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 56 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
-≥ 18 years of age
Exclusion Criteria:
Participants receive a single educational session describing principles of Sleep Hygiene for Cancer Survivors. Those who continue to have significant symptoms of insomnia then receive 3 groups CBTI-CS sessions
Behavioral: CBTI-CS · Behavioral: Sleep Hygiene
Descriptive data collected on 10 participants (non-randomized) receiving CBTI-CS via Telehealth.
Behavioral: CBTI-CS via Telehealth
CBTI-CS is a multi-modal intervention designed to address both cognitive and behavioral factors that perpetuate insomnia. Cognitive factors are addressed via cognitive restructuring and psychoeducation. Behavioral factors are addressed by structured sleep restriction, stimulus control and sleep hygiene techniques. Cancer treatment late-effects affecting sleep are addressed as potential contributors to these cognitive and behavioral factors, and as symptoms that may benefit from referral for medical evaluation/management. Participants are instructed in these cognitive-behavioral strategies as a group, but using analysis of personal sleep-log data, symptom self-reports and targeted workbook exercises, they are helped to tailor the intervention to address their specific needs.
Also known as: Cognitive Behavioral Therapy for Insomnia -Cancer Survivors
Education on health behaviors, sleep habits and environmental practices intended to promote good quality sleep. Recommendations target exercise and natural light exposure,use of stimulants and alcohol, daytime napping, timing of meals, creating a comfortable non-stimulating sleep space, and creating sleep rituals.
The CBTI-CS intervention, a multi-modal intervention designed to address both cognitive and behavioral factors that perpetuate insomnia, will be administered via live video. conferencing. Participants will have a single in-person training session and subsequent CBTI-CS group sessions will be conducted by live video conference.
The Insomnia Severity Index (ISI)
The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.
Time frame: Change from Baseline to 4-weeks post-intervention
Profile of Mood States - Short Form (POMS-SF)
A 35-item measure which assesses mood states along several dimensions including Total Mood Disturbance.
Time frame: Change from Baseline to 4 & 8 weeks post-intervention
The Insomnia Severity Index (ISI)
The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.
Time frame: Change from Baseline to 8 weeks post-intervention
Plan to share: No
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Dana-Farber Cancer Institute