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CBT + MBSR for Insomnia in Cancer Survivors

N/A
Waitlist Available
Research Sponsored by The Cooper Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not currently taking any medications to treat insomnia
Age 18 and over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 weeks and 6 weeks to 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests two different methods for treating insomnia in cancer survivors.

Who is the study for?
This trial is for adult cancer survivors (breast, colon, lung, prostate, gynecologic) who are not currently metastatic and are treated at MD Anderson Cancer Center at Cooper. Participants should have self-reported insomnia but aren't taking any sleep meds. They must be able to follow the study plan as judged by the researcher.
What is being tested?
The study compares two treatments for insomnia in cancer survivors: Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR). It aims to see which method is more effective in improving sleep quality.
What are the potential side effects?
While CBT and MBSR typically have minimal side effects compared to medication, some may experience temporary increases in distress or anxiety when confronting difficult thoughts or feelings during these therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not taking any medications for insomnia.
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I am 18 years old or older.
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My cancer is in the breast, colon, lung, prostate, or a gynecologic area and has not spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 weeks and 6 weeks to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 weeks and 6 weeks to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Insomnia Severity Index
Secondary study objectives
Change in Brief Fatigue Inventory (BFI)
Change in Depression, Anxiety and Stress Scale 21 (DASS21)
Number of patients who respond to CBT vs MBSR based on Ethnicity

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Group I: Arm 1Active Control1 Intervention
Cognitive Behavioral Therapy (CBT)
Group II: Arm 2Active Control1 Intervention
Mindfulness Based Stress Reduction (MBSR)

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor
80 Previous Clinical Trials
35,317 Total Patients Enrolled

Media Library

CBT Clinical Trial Eligibility Overview. Trial Name: NCT02783079 — N/A
Insomnia Research Study Groups: Arm 1, Arm 2
Insomnia Clinical Trial 2023: CBT Highlights & Side Effects. Trial Name: NCT02783079 — N/A
CBT 2023 Treatment Timeline for Medical Study. Trial Name: NCT02783079 — N/A
~22 spots leftby Nov 2025
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