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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

Study 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.Check my eligibility

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.See study design

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

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 weeks and 6 weeks to 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Insomnia Severity Index

Secondary outcome measures

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

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)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor

75 Previous Clinical Trials

23,903 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial still recruiting participants?

"The clinicaltrials.gov database confirms that this trial is no longer actively recruiting patients; the initial listing was posted on May 1st 2016 and it has not been updated since then. However, there are currently 228 other active trials searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Insomnia Interventions in Cancer Survivors

2016. "Insomnia Interventions in Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02783079.

All > Sleep Disorders > Insomnia