Chronic InsomniaNCT05226078
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
A study testing Cognitive Behavioral Therapy for Insomnia in people with Chronic Insomnia and Cancer-related Problem/Condition, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to de-creases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. Read more about this study
- Who is it for?
- Ages 25 to 85 years, women only
- Conditions the study is for
- Chronic Insomnia, Cancer-related Problem/Condition, Cancer-Related Syndrome
- 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
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 30 Nov 2026
- Phase
- Interventional
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 25 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of organ-confined BC;
- Treatment with RT;
- Willingness and ability to provide informed consent;
- They endorse problems with both insomnia and CRF, as determined by a score within the significant ranges on the ISI, PROMIS 7a, BFI, and FACIT-F;
- and/or they do not have any significant medical (e.g., OSA; COPD) and/or psychiatric diagnoses (e.g., PTSD).
Who cannot join
- History of untreated obstructive sleep apnea (OSA [defined as an apnea-hypopnea index ≥ 10]) or above threshold scores on the STOP-BANG;
- History of narcolepsy;
- Night shift work;
- Distant metastatic disease at presentation;
- Active alcohol and/or drug dependence;
- They do not have a diagnosis of BC;
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- They do not endorse insomnia, CRF and/or do not score within the significant ranges on the ISI, PROMIS 7a and/or the FACIT;
- They have a current diagnosis of significant medical and/or psychiatric disorders;
- And/or they are not between the ages of 25-85 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to de-creases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to CBT-I in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.
Read the detailed description
Subjects will be randomized into one of four groups, four, eight, ten or twelve sessions. Sessions will be con-ducted weekly by Telehealth and will be modified based on the duration of treatment but all will include the following, evaluation and orientation; data acquisition and delivery of sleep restriction therapy \& stimulus control instructions; review of sleep hygiene; cognitive therapy [decatastrophization]; managing non-adherence and relapse prevention), and, finally, the final sessions will be largely focused on time-in-bed titration. Treatment will be conducted by a master therapist via a HIPAA compliant video link.
All CBT-I related data will be obtained via dedicated internet websites built with RedCap, where subjects will be asked to complete weekly and monthly questionnaires. One website will be for use by subjects. One website will be for use by the therapist. The patient and therapist website will have a landing page (password entry), a login page, and an activities page (what questionnaires are due when). For an example of such a website, please see our pilot study, https://redcap.med.upenn.edu/surveys/?s=RXLLA7C4KJ (access using password "sleepstudy"). The patient website will contain daily sleep diaries, weekly severity measures of insomnia (ISI), sleepiness (ESS), fatigue (PROMIS 7a, Brief Fatigue Inventory, and FACIT-F), depression (PHQ-9), anxiety (GAD-7), a medical symptoms checklist.
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Keywords
- Insomnia, Fatigue, CBT-I, Dose Response, Cancer-Related Fatigue
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBT-I
Cognitive behavioral treatment of insomnia
| Study group | Role | What they receive |
|---|---|---|
| Four Sessions of CBT-I | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Eight Sessions of CBT-I | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Ten Sessions of CBT-I | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Twelve Sessions of CBT-I | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Proportion of screened eligible subjects who: complete a screener; enroll; and accept randomization.
Measured: Baseline to End of Treatment (Up to 12 weeks)
Adherence
Average adherence to Sleep Restriction Therapy (SRT) and Stimulus Control Therapy (SCT) [overall and by week] as measured by deviations between prescribed and actual times (from sleep diaries), overall and by group.
Measured: Baseline to End of Treatment (Up to 12 weeks)
Treatment Acceptability
Average Insomnia Treatment Acceptability Scale (ITAS) scores, overall and by group.
Total score for each subscale is the average of the 8 items, with higher scores indicating greater willingness to utilize the treatment.
Measured: End of Treatment
Retention
Percent of subjects who complete the study, overall and by group.
Measured: Baseline to End of Treatment (Up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Mar 2023
- Primary completion31 Aug 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alexandria Muench, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226078
- Sponsor's protocol ID
- UPCC 22121
- Other IDs
- IRB #850366
- Status last verified
- Aug 2026
- First submitted
- 7 Dec 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No