CBT for Insomnia in Primary Brain Tumor Patients

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: PBT; Primary Brain Tumor

Treatments: Behavioral: Cognitive Behavioral Therapy-Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT04919993

MCC-20-16188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Patients must also meet the inclusion criteria listed above.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Therapy-Insomnia