CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: CBTI-CS via Telehealth; Behavioral: CBTI-CS; Behavioral: Sleep Hygiene

• Registration Number: NCT02756390
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-29
• Primary Completion: 2018-05-14
• Study Completion: 2018-05-14
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

-≥ 18 years of age

• History of a cancer diagnosis
• No active cancer therapy (excluding chemoprevention) in the past year, and no cancer therapy planned in the next 6 months
• No surgery planned in the next 6 months
• Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
• Able to read and write in English
• Willing to attend study group sessions
• Motivated and able to follow the demands of the CBTI-CS program, to keep sleep records, complete self-report symptom reports and make changes in their sleep schedule, including restricting their sleep.

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Exclusion Criteria

• Survivors who report ever being diagnosed with Bipolar Disorder will be excluded.
• Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months will be excluded.
• Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter medications that can affect sleep during the study period.
• Have diagnosed, untreated sleep apnea, or sleep apnea suspected by a physician but which has not been evaluated, or other sleep disorder
• Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
• Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individual's sleep.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm B (Telehealth Pilot of CBTI-CS)	CBTI-CS via Telehealth	Descriptive data collected on 10 participants (non-randomized) receiving CBTI-CS via Telehealth.
Arm A (Sleep Hygiene & CBTI-CS)	CBTI-CS	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
Arm A (Sleep Hygiene & CBTI-CS)	Sleep Hygiene	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

Primary Outcome Measures

Name	Time	Method
The Insomnia Severity Index (ISI)	Change from Baseline to 4-weeks post-intervention	The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.

Secondary Outcome Measures

Name	Time	Method
Profile of Mood States - Short Form (POMS-SF)	Change from Baseline to 4 & 8 weeks post-intervention	A 35-item measure which assesses mood states along several dimensions including Total Mood Disturbance.
The Insomnia Severity Index (ISI)	Change from Baseline to 8 weeks post-intervention	The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States