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Cognitive Behavioral Therapy for Insomnia in Childhood Cancer Survivors

N/A

Recruiting

Led By Tara Brinkman, PhD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

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

Must have

Between the ages of 18 and 65 years old

Clinically significant insomnia (i.e. score >15 on the Insomnia Severity Index)

Must not have

Behavioral treatment for insomnia in the past 12 months

History of a brain tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post-intervention follow up (approximately 10 weeks after baseline)]

Awards & highlights

No Placebo-Only Group

Summary

This trial will use an accepted, established, efficacious internet-delivered CBTi insomnia treatment program to evaluate the efficacy of this program in adult survivors of childhood cancer.

Who is the study for?

This trial is for adult survivors of childhood cancer aged 18-65 who are enrolled in the CCSS, have regular internet access, and can read and speak English. Participants must have significant insomnia and some neurocognitive impairment but not be currently pregnant or breastfeeding, nor have a history of brain tumors, psychotic disorders, other sleep disorders like apnea or restless leg syndrome, recent substance abuse issues, or irregular schedules that conflict with treatment.

What is being tested?

The study tests an eHealth intervention called SHUTi to improve insomnia symptoms against an online patient education control group. It aims to see if treating insomnia helps with neurocognitive function and overall quality of life among these survivors. The impact on emotional distress and cardiovascular health will also be explored.

What are the potential side effects?

As this is a non-pharmacological intervention focusing on cognitive behavioral therapy delivered via the internet (CBTi), typical medication side effects are not expected. However, participants may experience temporary increases in anxiety or stress as they adjust to new sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have severe insomnia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received therapy for insomnia in the last year.

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I have had a brain tumor in the past.

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I do not have other sleep disorders like narcolepsy or sleep apnea.

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I am currently receiving treatment for cognitive issues.

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I have been diagnosed with schizophrenia or a psychotic disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post-intervention follow up (approximately 10 weeks after baseline)]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and post-intervention follow up (approximately 10 weeks after baseline)]

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-intervention follow up (approximately 10 weeks after baseline)] 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 (ISI) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline)

Secondary study objectives

Change in Childhood Cancer Survivor Study-Neurocognitive questionnaire (CCSS-NCQ) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline)

Change in Generalized Anxiety Disorder-7 (GAD-7) scores from Baseline to Post-Intervention (approximately 6 months after Baseline)

Change in Patient Health Questionnaire (PHQ-9) scores from Baseline to Post-Intervention (approximately 6 months after Baseline)

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