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Behavioural Intervention

Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients (CBT-I in PBT Trial)

Phase 2
Recruiting
Led By Ashlee Loughan, Ph.D
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary brain tumor diagnosis (grade I-IV)
Be older than 18 years old
Must not have
Inability to attend weekly virtual group meetings
Inability to understand and provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 18
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study a type of therapy called Cognitive Behavioral Therapy for Insomnia (CBT-I) in individuals with primary brain tumors who also have insomnia. The study will look at how feasible it

Who is the study for?
This trial is for individuals with primary brain tumors like glioblastoma, oligodendroglioma, astrocytoma, meningioma, or brain lymphoma who are also experiencing insomnia. Details about specific inclusion and exclusion criteria are not provided.
What is being tested?
The study tests Cognitive Behavioral Therapy for Insomnia (CBT-I) in patients with primary brain tumors to see if it's feasible and acceptable. It will look at how well the therapy works to improve sleep and overall wellbeing.
What are the potential side effects?
Since CBT-I is a non-medical treatment involving behavioral changes to improve sleep, it typically does not have physical side effects but may include temporary increases in anxiety or stress during adjustment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a brain tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot attend weekly online meetings.
Select...
I am able to understand and sign the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of duration of assessments
Acceptability of quantity of assessments
Acceptability of timing of assessments
+6 more

Side effects data

From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624
1%
Hematoma R side abdomen
1%
Severe vaginal bleeding and pain
1%
Chest pain in a patient with CAD
1%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Antidepressant + Desensitization
Antidepressant + Cognitive Behavioral

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Telehealth Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 Intervention
Group II: Enhanced Treatment as UsualActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
716 Previous Clinical Trials
22,888,438 Total Patients Enrolled
Ashlee Loughan, Ph.DPrincipal InvestigatorVirginia Commonwealth University
1 Previous Clinical Trials
60 Total Patients Enrolled
~40 spots leftby Nov 2026
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