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

December 10, 2018 updated by: Christopher Recklitis, Ph.D, Dana-Farber Cancer Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute

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:

-≥ 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.

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.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (Sleep Hygiene & 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
Behavioral: CBTI-CS
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.
Other Names:
  • Cognitive Behavioral Therapy for Insomnia -Cancer Survivors
Behavioral: Sleep Hygiene
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.
Other: Arm B (Telehealth Pilot of CBTI-CS)
Descriptive data collected on 10 participants (non-randomized) receiving CBTI-CS via Telehealth.
Behavioral: CBTI-CS via Telehealth
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Christopher Recklitis, PhD, MPH, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2015

Primary Completion (Actual)

May 14, 2018

Study Completion (Actual)

May 14, 2018

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 10, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-336
  • R03CA201459-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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