CBT for Insomnia in Primary Brain Tumor Patients

NCT04919993 | Completed

• 1 other identifier: MCC-20-16188
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Brain Tumor; PBT

Keywords

Cognitive Behavioral Therapy-Insomnia; CBT-I

Outcome Measures

Primary Outcomes (5)

• 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.

  12 months

• Attendance at CBT-I sessions

  Percent of sessions attended by consented participants

  6 weeks

• Post-session assessment completion

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

  2 months

• Follow-up assessment completion

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

  5 months

• 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.

  7 months

Secondary Outcomes (18)

• Objective Sleep

  7 months

• Sleep Efficiency

  7 months

• Subjective Sleep

  7 months

• Subjective Insomnia

  7 Months

• Subjective Sleep Disturbance

  7 Months

Study Arms (1)

Cognitive Behavioral Therapy for Insomnia (CBT-I)

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy-Insomnia

Interventions

Cognitive Behavioral Therapy-Insomnia BEHAVIORAL

Group presentation

Also known as: CBT-I

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/= 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

You may not qualify if:

• Inability to attend weekly group in-person meetings

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 37796017 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ashlee Loughan, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase IIa Proof-of-Concept Trial

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 9, 2021
• Study Start: June 1, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)