CBT for Insomnia in Primary Brain Tumor Patients

NCT ID: NCT04919993

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-08-15

Brief 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. 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.

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.

Conditions

Primary Brain Tumor; PBT

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Group intervention; topics include psychoeducation about sleep, sleep restriction, stimulus control, relaxation strategies, and cognitive restructuring.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy-Insomnia

Intervention Type: BEHAVIORAL

Group presentation

Interventions

Cognitive Behavioral Therapy-Insomnia

Group presentation

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT-I

Eligibility Criteria

Inclusion Criteria

• >/= 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

Exclusion Criteria

• Inability to attend weekly group in-person meetings

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashlee Loughan, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37796017 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

MCC-20-16188

Identifier Type: -

Identifier Source: org_study_id