Chronic InsomniaNCT02121652
Cognitive Behavioral Therapy (CBT)-Insomnia for Lung Cancer
A study testing Cognitive behavioral therapy for insomnia in people with Chronic Insomnia, run by State University of New York at Buffalo at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective for insomnia in lung cancer survivors. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Cognitive behavioral therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6 weeks from surgery for stage 1 or 2 Non Small Cell Lung Cancer
- chronic insomnia
Who cannot join
- Other preexisting sleep disorders
- Unstable medical illnesses
Trial locations and contacts
2 sites in 1 country.
United States2 sites
SUNY University at Buffalo
Buffalo, New York, 14214
Roswell Park Cancer Institute Thoracic Clinic
Buffalo, New York, 14263
About this study
Official title: Translating CBT-Insomnia for Lung Cancer Into Practice: A RCT
The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective for insomnia in lung cancer survivors.
Read the detailed description
A randomized controlled clinical trial will be used to test the efficacy of this brief CBT-I compared to attention control on sleep, mood, functional status and quality of life in lung cancer survivors and evaluate the feasibility of translating an evidence-based CBT-I into the clinical setting.
- Conditions
- Chronic Insomnia
- Being tested
- Cognitive behavioral therapy for insomnia, Healthy eating control
- Keywords
- lung cancer survivors, insomnia treatment, cognitive behavioral therapy
- 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.
Cognitive behavioral therapy for insomniaBehavioural
Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls.
Healthy eating controlBehavioural
Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.
| Study group | Role | What they receive |
|---|---|---|
| Healthy eating control | Active comparator | Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. Receives: Behavioral: Healthy eating control |
| Cognitive behavioral therapy | Experimental | Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls. Receives: Behavioral: Cognitive behavioral therapy for insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
Sleep Efficiency > 85% measured with a seven-day sleep diary. The score is calculated based on participants' recording of time asleep (minutes) divided by time in bed (minutes).
Sleep Efficiency greater than or equal to 85% indicates good sleep quality, and values less than 85% indicate poor sleep quality.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Suzanne Dickerson, State University of New York at Buffalo
- Investigators
- Suzanne Dickerson, RN, PhD, Principal investigator, SUNY University at Buffalo School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121652
- Sponsor's protocol ID
- 517176-3
- Other IDs
- 517176-1, 1R15NR013779-01A1
- Status last verified
- Feb 2023
- First submitted
- 25 Oct 2013
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data have been prepared for sharing with other investigators. All collected individual participant data (IPD) can be accessed at our data repository.
Publications
Edinger JD, Wohlgemuth WK, Radtke RA, Coffman CJ, Carney CE. Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial. Sleep. 2007 Feb;30(2):203-12. doi: 10.1093/sleep/30.2.203.
PubMed 17326546Edinger JD, Sampson WS. A primary care "friendly" cognitive behavioral insomnia therapy. Sleep. 2003 Mar 15;26(2):177-82. doi: 10.1093/sleep/26.2.177.
PubMed 12683477Germain A, Shear MK, Hall M, Buysse DJ. Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study. Behav Res Ther. 2007 Mar;45(3):627-32. doi: 10.1016/j.brat.2006.04.009. Epub 2006 Jun 14.
PubMed 16777060Espie CA, Fleming L, Cassidy J, Samuel L, Taylor LM, White CA, Douglas NJ, Engleman HM, Kelly HL, Paul J. Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer. J Clin Oncol. 2008 Oct 1;26(28):4651-8. doi: 10.1200/JCO.2007.13.9006. Epub 2008 Jun 30.
PubMed 18591549Vena C, Parker K, Allen R, Bliwise D, Jain S, Kimble L. Sleep-wake disturbances and quality of life in patients with advanced lung cancer. Oncol Nurs Forum. 2006 Jul 1;33(4):761-9. doi: 10.1188/06.ONF.761-769.
PubMed 16858458Davidson JR, Feldman-Stewart D, Brennenstuhl S, Ram S. How to provide insomnia interventions to people with cancer: insights from patients. Psychooncology. 2007 Nov;16(11):1028-38. doi: 10.1002/pon.1183.
PubMed 17352006Dean GE, Redeker NS, Wang YJ, Rogers AE, Dickerson SS, Steinbrenner LM, Gooneratne NS. Sleep, mood, and quality of life in patients receiving treatment for lung cancer. Oncol Nurs Forum. 2013 Sep;40(5):441-51. doi: 10.1188/13.ONF.441-451.
PubMed 23989018Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PubMed 41170811Dean GE, Weiss C, Jungquist CR, Klimpt ML, Alameri R, Ziegler PA, Steinbrenner LM, Dexter EU, Dhillon SS, Lucke JF, Dickerson SS. Nurse-Delivered Brief Behavioral Treatment for Insomnia in Lung Cancer Survivors: A Pilot RCT. Behav Sleep Med. 2020 Nov-Dec;18(6):774-786. doi: 10.1080/15402002.2019.1685523. Epub 2019 Oct 31.
PubMed 31672070
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating CBT-Insomnia for Lung Cancer Into Practice: A RCT
- ClinicalTrials.gov ID
- NCT02121652
- Acronym / sponsor ID
- 517176-3
- Conditions
- Chronic Insomnia
- Keywords
- lung cancer survivors, insomnia treatment, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Apr 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective for insomnia in lung cancer survivors.
Detailed description
A randomized controlled clinical trial will be used to test the efficacy of this brief CBT-I compared to attention control on sleep, mood, functional status and quality of life in lung cancer survivors and evaluate the feasibility of translating an evidence-based CBT-I into the clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy eating control | Active comparator | Behavioral: Healthy eating controlHealthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. |
| Cognitive behavioral therapy | Experimental | Behavioral: Cognitive behavioral therapy for insomniaCognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 6 weeks from surgery for stage 1 or 2 Non Small Cell Lung Cancer
- chronic insomnia
Key exclusion criteria (2 listed)
- Other preexisting sleep disorders
- Unstable medical illnesses
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 |
|---|---|---|
| Cognitive behavioral therapy for insomniaCognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls. | Behavioural | Cognitive behavioral therapy |
| Healthy eating controlHealthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls. | Behavioural | Healthy eating control |
Primary outcome
Sleep Efficiency
Time frame: 5 weeks
Sleep Efficiency > 85% measured with a seven-day sleep diary. The score is calculated based on participants' recording of time asleep (minutes) divided by time in bed (minutes). Sleep Efficiency greater than or equal to 85% indicates good sleep quality, and values less than 85% indicate poor sleep quality.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17326546Edinger JD, Wohlgemuth WK, Radtke RA, Coffman CJ, Carney CE. Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial. Sleep. 2007 Feb;30(2):203-12. doi: 10.1093/sleep/30.2.203.
- Background: PubMed 12683477Edinger JD, Sampson WS. A primary care "friendly" cognitive behavioral insomnia therapy. Sleep. 2003 Mar 15;26(2):177-82. doi: 10.1093/sleep/26.2.177.
- Background: PubMed 16777060Germain A, Shear MK, Hall M, Buysse DJ. Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study. Behav Res Ther. 2007 Mar;45(3):627-32. doi: 10.1016/j.brat.2006.04.009. Epub 2006 Jun 14.
- Background: PubMed 18591549Espie CA, Fleming L, Cassidy J, Samuel L, Taylor LM, White CA, Douglas NJ, Engleman HM, Kelly HL, Paul J. Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer. J Clin Oncol. 2008 Oct 1;26(28):4651-8. doi: 10.1200/JCO.2007.13.9006. Epub 2008 Jun 30.
- Background: PubMed 16858458Vena C, Parker K, Allen R, Bliwise D, Jain S, Kimble L. Sleep-wake disturbances and quality of life in patients with advanced lung cancer. Oncol Nurs Forum. 2006 Jul 1;33(4):761-9. doi: 10.1188/06.ONF.761-769.
- Background: PubMed 17352006Davidson JR, Feldman-Stewart D, Brennenstuhl S, Ram S. How to provide insomnia interventions to people with cancer: insights from patients. Psychooncology. 2007 Nov;16(11):1028-38. doi: 10.1002/pon.1183.
- Background: PubMed 23989018Dean GE, Redeker NS, Wang YJ, Rogers AE, Dickerson SS, Steinbrenner LM, Gooneratne NS. Sleep, mood, and quality of life in patients receiving treatment for lung cancer. Oncol Nurs Forum. 2013 Sep;40(5):441-51. doi: 10.1188/13.ONF.441-451.
- Derived from this study: PubMed 41170811Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
- Derived from this study: PubMed 31672070Dean GE, Weiss C, Jungquist CR, Klimpt ML, Alameri R, Ziegler PA, Steinbrenner LM, Dexter EU, Dhillon SS, Lucke JF, Dickerson SS. Nurse-Delivered Brief Behavioral Treatment for Insomnia in Lung Cancer Survivors: A Pilot RCT. Behav Sleep Med. 2020 Nov-Dec;18(6):774-786. doi: 10.1080/15402002.2019.1685523. Epub 2019 Oct 31.
- Individual participant dataSharing planned: Yes. Data have been prepared for sharing with other investigators. All collected individual participant data (IPD) can be accessed at our data repository.
Related trials for Chronic Insomnia
Not yet recruitingPhase 2
A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study
Chronic Insomnia
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
Active, not recruiting
Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
Insomnia
Not yet recruiting
Effects of Connective Tissue Massage in Patients With Chronic Insomnia
Chronic Insomnia
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
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.
Suzanne Dickerson, RN, PhD principal investigator
SUNY University at Buffalo School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy for insomnia in people with Chronic Insomnia, run by State University of New York at Buffalo at 2 sites 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 2 inclusion and 2 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 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 7 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sleep Efficiency (time frame: 5 weeks). 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 NCT02121652, which also lists 9 linked publications.
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 7 Mar 2023.