InsomniaNCT02756390
CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors
A study testing CBTI-CS, Sleep Hygiene and CBTI-CS via Telehealth in people with Insomnia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- CBTI-CS, Sleep Hygiene and CBTI-CS via Telehealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 14 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- CBTI-CS, Sleep Hygiene, CBTI-CS via Telehealth
- Keywords
- Insomnia cancer Survivor
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTI-CSBehavioural
Also called Cognitive Behavioral Therapy for Insomnia -Cancer Survivors
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.
Sleep HygieneBehavioural
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.
CBTI-CS via TelehealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Sleep Hygiene & CBTI-CS) | Experimental | 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 Receives: Behavioral: CBTI-CS; Behavioral: Sleep Hygiene |
| Arm B (Telehealth Pilot of CBTI-CS) | Other | Descriptive data collected on 10 participants (non-randomized) receiving CBTI-CS via Telehealth. Receives: Behavioral: CBTI-CS via Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Insomnia Severity Index (ISI)
The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.
Measured: Change from Baseline to 4-weeks post-intervention
Secondary outcomes (2)
Profile of Mood States - Short Form (POMS-SF)
A 35-item measure which assesses mood states along several dimensions including Total Mood Disturbance.
Measured: 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.
Measured: Change from Baseline to 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startDec 2015
- Primary completion14 May 2018
- Study completion14 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christopher Recklitis, Ph.D, Dana-Farber Cancer Institute
- Investigators
- Christopher Recklitis, PhD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756390
- Sponsor's protocol ID
- 15-336
- Other IDs
- R03CA201459-01
- Status last verified
- Dec 2018
- First submitted
- 26 Apr 2016
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhou ES, Partridge AH, Recklitis CJ. A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Psychooncology. 2017 Jun;26(6):843-848. doi: 10.1002/pon.4096. Epub 2016 Feb 12.
PubMed 26872123
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors
- ClinicalTrials.gov ID
- NCT02756390
- Acronym / sponsor ID
- 15-336
- Conditions
- Insomnia
- Keywords
- Insomnia cancer Survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2015
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Sleep Hygiene & CBTI-CS) | Experimental | Behavioral: CBTI-CS, Behavioral: Sleep HygieneParticipants 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 B (Telehealth Pilot of CBTI-CS) | Other | Behavioral: CBTI-CS via TelehealthDescriptive data collected on 10 participants (non-randomized) receiving CBTI-CS via Telehealth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -≥ 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBTI-CSAlso: Cognitive Behavioral Therapy for Insomnia -Cancer SurvivorsCBTI-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. | Behavioural | Arm A (Sleep Hygiene & CBTI-CS) |
| Sleep HygieneEducation 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. | Behavioural | Arm A (Sleep Hygiene & CBTI-CS) |
| CBTI-CS via TelehealthThe 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. | Behavioural | Arm B (Telehealth Pilot of CBTI-CS) |
Primary outcome
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.
2 secondary outcomes
Profile of Mood States - Short Form (POMS-SF)
Time frame: Change from Baseline to 4 & 8 weeks post-intervention
The Insomnia Severity Index (ISI)
Time frame: Change from Baseline to 8 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Background: PubMed 26872123Zhou ES, Partridge AH, Recklitis CJ. A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Psychooncology. 2017 Jun;26(6):843-848. doi: 10.1002/pon.4096. Epub 2016 Feb 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Recklitis, PhD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBTI-CS, Sleep Hygiene and CBTI-CS via Telehealth in people with Insomnia, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Insomnia Severity Index (ISI) (time frame: Change from Baseline to 4-weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.