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Arm A (Sleep Hygiene & CBTI-CS) for Insomnia

N/A

Waitlist Available

Led By Christopher Recklitis, PhD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 4 & 8 weeks post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This research study is evaluating the effectiveness of a 3-session behavioral intervention for insomnia in cancer survivors. This is a behavioral intervention study, and no medications are involved.

Eligible Conditions

Insomnia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 4 & 8 weeks post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 4 & 8 weeks post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 4 & 8 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Profile of Mood States - Short Form (POMS-SF)

The Insomnia Severity Index (ISI)

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

Group I: Arm B (Telehealth Pilot of CBTI-CS)Experimental Treatment1 Intervention

Descriptive data collected on 10 participants (non-randomized) receiving CBTI-CS via Telehealth.

Group II: Arm A (Sleep Hygiene & CBTI-CS)Experimental Treatment2 Interventions

Participants receive a single educational session describing principles of Sleep Hygiene for Cancer Survivors. Those who continue to have significant symptoms of insomnia then receive 3 groups CBTI-CS sessions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBTI-CS

2015

N/A

~60

Sleep Hygiene

2018

Completed Phase 2

~1120