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Primary Brain TumorNCT04919993

CBT for Insomnia in Primary Brain Tumor Patients

A study testing Cognitive Behavioral Therapy-Insomnia in people with Primary Brain Tumor and PBT, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Cognitive Behavior Therapy for Insomnia (CBT-I) in primary brain tumor patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Brain Tumor, PBT
What is being tested?
Cognitive Behavioral Therapy-Insomnia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
1 Jun 2021to 15 Aug 2022
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 old
  • Confirmed primary brain tumor diagnosis
  • >/= 1 month removed from radiation therapy (if applicable)
  • Able to readily read and understand English
  • Meeting DSM-V diagnostic criteria for insomnia as measured by the Structured Clinical Interview for DSM-5
  • Sleep Disorders (SCISD) insomnia subsection
  • Cognitively intact as measured by a score >20 on the Telephone Interview for Cognitive Status (TICS)
  • Have a stable internet connection and video-capable device for Zoom sessions

Who cannot join

  • Inability to attend weekly group in-person meetings
  • Patients must also meet the inclusion criteria listed above.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients

The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Cognitive Behavior Therapy for Insomnia (CBT-I) in primary brain tumor patients. Researchers hope to better understand the feasibility and acceptability of this intervention in neuro-oncology, as well as the preliminary potential benefits of this intervention on brain tumor patients' sleep, fatigue, mood, quality of life, and chronic inflammation. This may lead to improvements in treating insomnia in primary brain tumor patients.

Read the detailed description

The present study design is a pilot within-subjects pre-/post-evaluation of feasibility, acceptability, and preliminary efficacy of the Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention for primary brain tumor patients. In this study, participants will be asked to do the following things:

  • Meet with a trained interventionist six times (biweekly) for group CBT-I sessions via Zoom, lasting 90 minutes each. Participants will be asked to only use first names and will complete weekly sleep diaries as part of the intervention.
  • Complete ~20-minute online surveys before the program, immediately after the program (6 weeks), and at follow-up (3 months). Questions will ask about subjective sleep, fatigue, mood, and quality of life. The follow-up time point will also ask about the patient's satisfaction with the CBT-I program.
  • Complete a brief (15 minute) cognitive evaluation before and immediately following the program.
  • Wear a wrist-worn actigraphy monitor one week prior to the 6-week CBT-I intervention and one week following completion of the intervention.
  • Patients currently receiving regular blood draws as part of their care at Massey Cancer Center will have an IL-6 added to their regular blood draw. THose who are not receiving regular blood draws as part of their standard of care OR those who are not patients at Massey Cancer Center will forego this part of the intervention.
Being tested
Cognitive Behavioral Therapy-Insomnia
Keywords
Cognitive Behavioral Therapy-Insomnia, CBT-I
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy-InsomniaBehavioural

    Also called CBT-I

    Group presentation

Study groups in NCT04919993
Study groupRoleWhat they receive
Cognitive Behavioral Therapy for Insomnia (CBT-I)ExperimentalGroup intervention; topics include psychoeducation about sleep, sleep restriction, stimulus control, relaxation strategies, and cognitive restructuring.
Receives: Behavioral: Cognitive Behavioral Therapy-Insomnia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility for CBT-I as measured by the rates of participant screening, eligibility, and consent

    Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.

    Measured: 12 months

  2. Attendance at CBT-I sessions

    Percent of sessions attended by consented participants

    Measured: 6 weeks

  3. Post-session assessment completion

    Percent of post-session surveys completed by participants immediately after the intervention

    Measured: 2 months

  4. Follow-up assessment completion

    Percent of follow-up surveys completed by participants three months after the intervention

    Measured: 5 months

  5. Program Satisfaction as measured by participant responses to researcher-developed questions (e.g., How satisfied were you with the program overall?) measured on a Likert scale

    Program satisfaction questions are measured on a 10-point Likert scale with 1 being not at all satisfied and 10 being very much satisfied. Higher scores indicate greater program satisfaction.

    Measured: 7 months

Secondary outcomes (18)

  1. Objective Sleep

    Total sleep time gathered by the participant from a wrist-worn Actigraph

    Measured: 7 months

  2. Sleep Efficiency

    Percent of time spent in bed / time asleep gathered by the participant from a wrist-worn Actigraph

    Measured: 7 months

  3. Subjective Sleep

    Total sleep time gathered from a participant-reported sleep diary

    Measured: 7 months

  4. Subjective Insomnia

    Determine the degree of participant insomnia using the Insomnia Severity Index, a brief self-report questionnaire measured on a 5-point Likert scale (0 = None, 4 = Very Severe). Higher scores indicate greater subjective insomnia.

    Measured: 7 Months

  5. Subjective Sleep Disturbance

    Determine the degree of participant sleep disturbance using the Pittsburgh Sleep Quality Index, a brief self-report questionnaire. Higher scores indicate greater global sleep disturbance.

    Measured: 7 Months

  6. Napping

    Request that participants self report how many hours a day they nap on average using one self-report question (During the past month, how many hours did you nap during a typical day?)

    Measured: 7 Months

  7. Fatigue

    Determine participants' level of fatigue using the Brief Fatigue Inventory, a self-report questionnaire measured on a 11-point Likert scale (0 = No Fatigue/Does Not Interfere; 10 = As Bad as You Can Imagine/Completely Interferes). Higher scores indicate greater symptoms of fatigue.

    Measured: 7 Months

  8. Depression

    Determine the extent of depressive symptoms using the Patient Health Questionnaire-9, a brief-self report questionnaire measured on a 4-point Likert scale (0 = Not at All; 3 = Nearly Everyday) Higher scores indicate greater symptoms of depression.

    Measured: 7 Months

  9. Anxiety

    Determine the extent of anxiety symptoms using the Generalized Anxiety Disorder-7, a self-report questionnaire measured on a 4-point Likert scale (0 = Not at All; 3 = Nearly Everyday). Higher scores indicate greater symptoms of anxiety.

    Measured: 7 Months

  10. Death Anxiety

    Determine the level of participant's death anxiety using the Death and Dying Distress Scale, a self-report questionnaire measured on a 6-point Likert scale (0 = Not Distress; 5 = Extreme Distress). Higher scores indicate greater symptoms of death anxiety.

    Measured: 7 Months

  11. Subjective Quality of Life as measured by participants' responses on the European Organization Research and Treatment of Cancer - Quality of Life - Cancer 30 (EORTC-QoL-C30) form.

    Determine participants' level of quality of life using the EORTC-QoL-C30, a self-report questionnaire measured on a 4-point Likert scale (1 = Not at All; 4 = Very Much). Higher scores indicate lower overall quality of life.

    Measured: 7 Months

  12. Inflammation

    Determine the level of inflammation as measured by the amount of Cytokine Interleukin-6 (IL-6) in the participant's blood; only participants receiving regular blood draws as part of their routine will have this data

    Measured: 7 Months

  13. Processing Speed

    Participants' speed of thinking will be assessed by administering the Trail Making Test A, a neuropsychological assessment tool

    Measured: 7 months

  14. Executive Function

    Measure executive functioning by administering the Trail Making Test B, a neuropsychological assessment tool

    Measured: 7 months

  15. Language Fluency

    Participants' language fluency will be measured using the Controlled Oral Word Association Test, a neuropsychological assessment tool

    Measured: 7 months

  16. Learning/Memory

    Participants' ability learn/ memory will be assessed by administering the Hopkins Verbal Learning Test, a neuropsychological assessment tool

    Measured: 7 months

  17. Sociodemographics

    Participants are requested to self-report on their age, gender identity, race/ethnicity, and level of education

    Measured: 7 months

  18. Primary Brain Tumor Characteristics

    Information on participants' tumor diagnosis, treatment history, and medications will be from the participants' medical charts to determine brain tumor characteristics

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start1 Jun 2021
  3. Primary completion15 Aug 2022
  4. Study completion15 Aug 2022

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Phase IIa Proof-of-Concept Trial
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04919993
Sponsor's protocol ID
MCC-20-16188
Status last verified
Jan 2023
First submitted
24 May 2021
Last updated
13 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Currently there is no plan in place to share data with other researchers.

Publications

  • Loughan AR, Lanoye A, Willis KD, Fox A, Ravyts SG, Zukas A, Kim Y. Telehealth group Cognitive-Behavioral Therapy for Insomnia (CBT-I) in primary brain tumor: Primary outcomes from a single-arm phase II feasibility and proof-of-concept trial. Neuro Oncol. 2024 Mar 4;26(3):516-527. doi: 10.1093/neuonc/noad193.

    PubMed 37796017

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy-Insomnia in people with Primary Brain Tumor and PBT, run by Virginia Commonwealth University 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 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 13 Jan 2023. 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?

Feasibility for CBT-I as measured by the rates of participant screening, eligibility, and consent (time frame: 12 months). The study lists 5 primary outcomes in all. 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 NCT04919993, 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 13 Jan 2023.

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