Cognitive Behavioral Therapy for Insomnia in Childhood Cancer Survivors

Overseen By Tara Brinkman, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Must not be taking: Stimulants

Disqualifiers: Brain tumor, Schizophrenia, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 9 weeks

352 Participants Needed

Trial Summary

What is the purpose of this trial?

There is evidence that survivors of childhood cancer have a high prevalence of poor sleep, including symptoms of insomnia. Insomnia is highly comorbid and has been associated with impaired cognitive performance, a range of psychiatric disorders, cardiovascular disease, and reduced quality of life. However, we still lack knowledge about the direct impact of available internet-based insomnia treatment programs for survivors of childhood cancer experiencing insomnia, in addition to how improving insomnia symptoms impacts neurocognitive function and late health morbidities in this population. Therefore, in this study, we will utilize the resources available in the Childhood Cancer Survivor Study (CCSS) to use an accepted, established, efficacious internet-delivered CBTi insomnia treatment program and evaluate the efficacy of this program in adult survivors of childhood cancer. Positive results from this study and our use of an internet-based intervention are likely generalizable and be scalable to the large and geographically diverse population of childhood cancer survivors with chronic health conditions. Primary Objective To examine the efficacy of an eHealth intervention for improving symptoms of insomnia among adult survivors of childhood cancer. Secondary Objectives To examine the impact of an eHealth intervention for insomnia on the clinical severity of insomnia symptoms in adult survivors of childhood cancer. To determine whether treatment of insomnia symptoms will improve neurocognitive function in adult survivors of childhood cancer with both insomnia and neurocognitive impairment. To explore the mediating effects of improved neurocognitive function, emotional distress, and cardiovascular health on the association between insomnia symptoms and quality of life.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently receiving treatment for cognitive impairment, such as stimulant medication, you would not be eligible to participate.

What data supports the idea that Cognitive Behavioral Therapy for Insomnia in Childhood Cancer Survivors is an effective treatment?

The available research shows that Internet-delivered Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for improving sleep and quality of life in adolescent and young adult cancer survivors. In one study, nearly all participants reported improvements in their sleep and overall quality of life after using the online program SHUTi. Additionally, a study on breast cancer survivors found that Internet-delivered CBT-I was effective in reducing sleep disturbances. These findings suggest that this treatment can be a helpful option for childhood cancer survivors dealing with insomnia. ^{1 2 3 4 5}

What safety data exists for online CBT for insomnia?

The studies reviewed indicate that Internet-based cognitive-behavioral therapy for insomnia (CBT-I), specifically the SHUTi program, is generally perceived as safe and effective. Participants in various trials, including those with comorbid conditions like asthma, reported improvements in insomnia severity, sleep quality, and overall quality of life. The interventions were well-received, with high completion rates and positive feedback on convenience and usefulness. However, specific safety data or adverse effects were not detailed in the abstracts provided. ^{2 4 5 6 7}

Is the Sleep Healthy Using the Internet (SHUTi) treatment a promising treatment for insomnia in childhood cancer survivors?

Yes, the Sleep Healthy Using the Internet (SHUTi) treatment is promising for childhood cancer survivors with insomnia. It is an internet-based version of cognitive behavioral therapy, which is considered the best treatment for insomnia. This approach makes it easier for survivors to access help, especially since many cancer centers lack sleep experts. Studies show that internet-delivered CBT-I can improve sleep and quality of life for cancer survivors, including adolescents and young adults. ^{1 3 8 9 10}

Research Team

Tara Brinkman, PHD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

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.

Inclusion Criteria

Regular access to the internet (at least 2-3 days per week)

Enrollment in CCSS

Neurocognitive impairment (i.e. score >84th %ile of sibling normative data in at least one domain on the CCSS-NCQ)

Exclusion Criteria

I have received therapy for insomnia in the last year.

An irregular schedule that would prevent adoption of intervention strategies (i.e. work schedule resulting in usual bedtime earlier than 8 PM or later than 2 AM or arising time earlier than 4 AM or later than 10 AM)

I have had a brain tumor in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 9-week internet-based insomnia treatment program (SHUTi) or receive sleep education

9 weeks

Home-based assessments at baseline, post-intervention, and 6 months

Follow-up

Participants are monitored for changes in insomnia symptoms, neurocognitive function, and quality of life

6 months

Home visits for assessments at each time point

Treatment Details

Interventions

• Online Patient Education (PE) Control Group
• Sleep Healthy Using the Internet (SHUTi) Intervention Group

Trial Overview 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.

Participant Groups

Group I: Sleep Healthy Using the Internet (SHUTi) Intervention Group Active Control 1 Intervention

Participants will receive a direct link to access the SHUTi program (per randomization) from the study team.

Group II: Online Patient Education (PE) Control Group Active Control 1 Intervention

Participants will receive a direct link to access online patient education (per randomization) from the study team.

Sleep Healthy Using the Internet (SHUTi) Intervention Group is already approved in United States for the following indications:

Approved in United States as SHUTi for:

• Insomnia in adult survivors of childhood cancer

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) significantly improved sleep outcomes in 255 breast cancer survivors with clinically significant sleep disturbances, showing a strong effect on insomnia severity (Cohen's d = 1.17).

The benefits of iCBT-I were not only immediate but also sustained at follow-up, indicating its potential as a low-cost and effective treatment option that could be integrated into cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. Zachariae, R., Amidi, A., Damholdt, MF., et al.[2023]

The SHUTi (Sleep Healthy Using The Internet) program, an interactive online intervention for insomnia, was rated highly by participants for its convenience and usefulness, with 95% reporting improvements in sleep and quality of life.

In a small sample of 21 participants, 90% perceived SHUTi as effective, suggesting that Internet-based cognitive-behavioral therapy could be a promising solution to address the lack of access to trained clinicians for insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. Thorndike, FP., Saylor, DK., Bailey, ET., et al.[2022]

An Internet-delivered cognitive-behavioral therapy for insomnia (CBT-I) program tailored for adolescent and young adult (AYA) cancer survivors showed significant improvements in insomnia severity, daytime sleepiness, fatigue, and quality of life after 8 and 16 weeks, indicating its efficacy for this population.

Despite the positive outcomes, only 27.3% of participants completed all six sessions of the program, suggesting a need for strategies to enhance treatment adherence among AYA cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered insomnia intervention improves sleep and quality of life for adolescent and young adult cancer survivors. Zhou, ES., Recklitis, CJ.[2020]

A study involving 23 adults with asthma and insomnia showed that an Internet-based cognitive-behavioral therapy program (SHUTi) was feasible and well-accepted, with 83% completing the program.

Participants reported significant improvements in insomnia severity, sleep quality, asthma control, and asthma-related quality of life after using SHUTi, indicating its potential as an effective treatment for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Cognitive-Behavioral Therapy for Insomnia in Adults With Asthma: A Pilot Study. Luyster, FS., Ritterband, LM., Sereika, SM., et al.[2021]

The unguided Internet-based cognitive-behavioral treatment program for insomnia (SHUTi) significantly improved sleep outcomes in 181 participants over a nine-week period, outperforming a web-based patient education group.

Improvements in insomnia severity were maintained at a six-month follow-up for those who completed the SHUTi program, suggesting its potential as a first-line treatment option, although high dropout rates may affect the overall applicability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Short-Term Efficacy of an Unguided Internet-Based Cognitive-Behavioral Therapy for Insomnia: A Randomized Controlled Trial With a Six-Month Nonrandomized Follow-Up. Hagatun, S., Vedaa, Ø., Nordgreen, T., et al.[2022]

In a study of 303 participants, an online cognitive behavioral therapy intervention for insomnia (SHUTi) significantly improved insomnia knowledge and reduced dysfunctional beliefs about sleep, which were linked to better long-term sleep outcomes after 12 months.

The changes in cognitive variables, such as insomnia knowledge and beliefs about sleep, were found to mediate the effectiveness of the SHUTi intervention, suggesting that addressing these cognitive factors is crucial for achieving lasting improvements in sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia. Chow, PI., Ingersoll, KS., Thorndike, FP., et al.[2019]

This clinical trial involves 625 adults with hypertension and insomnia, comparing the efficacy of two cognitive behavioral treatments for insomnia (BBTI and SHUTi) against enhanced usual care over a period of 12 months.

The study aims to assess not only sleep disturbances but also the impact of these treatments on comorbid conditions like blood pressure and quality of life, potentially influencing real-world treatment delivery for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial. Levenson, JC., Rollman, BL., Ritterband, LM., et al.[2019]

The Survivorship Sleep Program (SSP), a synchronous virtual cognitive behavioral therapy for insomnia (CBT-I) tailored for cancer survivors, demonstrated high feasibility and acceptability, with 90% retention and 100% attendance among participants.

The SSP led to significant reductions in insomnia severity compared to enhanced usual care, with a large effect size (Cohen d = 1.19) that was maintained at a 1-month follow-up, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. Hall, DL., Arditte Hall, KA., Gorman, MJ., et al.[2023]

A pilot study involving 38 cancer survivors showed that a brief, group-based cognitive-behavioral therapy for insomnia (CBT-Insomnia) program significantly improved sleep efficiency, quality, and insomnia symptoms after just three sessions over one month.

Despite experiencing insomnia symptoms for an average of 2.4 years, many survivors had not discussed their sleep issues with healthcare providers, highlighting the need for increased awareness and access to insomnia treatments in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. Zhou, ES., Partridge, AH., Recklitis, CJ.[2022]

Adolescents and young adults who survived childhood cancer experience high rates of insomnia (26-29%), which negatively affects their quality of life and overall health, highlighting the need for effective treatments.

The study aims to evaluate the effectiveness of a guided online cognitive behavioral therapy for insomnia (iCBT-I) specifically designed for this population, with a randomized controlled trial involving 70 participants to assess improvements in sleep and related health outcomes over 3, 6, and 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the guided online cognitive behavioral therapy for insomnia "i-Sleep youth" improve sleep of adolescents and young adults with insomnia after childhood cancer? (MICADO-study): study protocol of a randomized controlled trial. Peersmann, SHM., van Straten, A., Kaspers, GJL., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Internet-delivered insomnia intervention improves sleep and quality of life for adolescent and young adult cancer survivors. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Internet-Based Cognitive-Behavioral Therapy for Insomnia in Adults With Asthma: A Pilot Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The Short-Term Efficacy of an Unguided Internet-Based Cognitive-Behavioral Therapy for Insomnia: A Randomized Controlled Trial With a Six-Month Nonrandomized Follow-Up. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. [2023]

9. England pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Does the guided online cognitive behavioral therapy for insomnia "i-Sleep youth" improve sleep of adolescents and young adults with insomnia after childhood cancer? (MICADO-study): study protocol of a randomized controlled trial. [2021]