Cognitive Behavioral Therapy for Caregiver Insomnia

Overseen By Jennifer Pinto-Martin

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Epilepsy, Diabetes, Down Syndrome, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests two types of sleep therapy for caregivers of children with Autism Spectrum Disorder (ASD) who have trouble sleeping. One therapy is done at home, and the other is done online. The goal is to see which method helps improve sleep for both the caregivers and their children.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires that you keep your medication doses stable and consistent.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) for caregiver insomnia?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective in treating persistent insomnia, including among caregivers who often face unique stressors that contribute to sleep problems. Studies suggest that CBT-I can help improve sleep and overall mental health in caregivers, enhancing their quality of life and ability to provide care. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered safe and effective for treating insomnia without the risks associated with sleeping medications. ^{3 6 7 8 9}

How is the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) unique for caregiver insomnia?

CBT-I is unique for caregiver insomnia because it is tailored to address the specific stressors and responsibilities that caregivers face, which contribute to their sleep disturbances. This therapy can be delivered through the internet, making it more accessible for caregivers who have limited time and resources. ^{1 2 4 5 10}

Eligibility Criteria

This trial is for caregivers over 18 years old with insomnia, who are caring for a child aged 3-17 with Autism Spectrum Disorder. Participants must have telephone and web access, agree to keep their child's medication doses stable, and provide consent for the child.

Inclusion Criteria

I have been diagnosed with insomnia related to behavior or autism.

I will keep my medication doses consistent and unchanged.

You have access to a phone and the internet.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a home-based tailored CBT-I intervention or a web-based Way to Health CBT-I intervention for insomnia

8 weeks

Weekly sessions (virtual or in-person)

Follow-up

Participants are monitored for changes in sleep patterns, caregiver mental health, and child behavior post-intervention

4 weeks

Treatment Details

Interventions

• Cognitive behavioral therapy for Insomnia

Trial Overview The study tests Cognitive Behavioral Therapy for Insomnia (CBT-I) tailored to caregivers of children with autism. It compares home-based CBT-I against a web-based program to see which improves sleep quality better.

Participant Groups

Group I: web-based Experimental Treatment 1 Intervention

web-based CBT-Insomnia intervention

Group II: Home-based Experimental Treatment 1 Intervention

home- based CBT-Insomnia intervention

Cognitive behavioral therapy for Insomnia is already approved in United States, European Union for the following indications:

Approved in United States as CBT-I for:

• Insomnia
• Chronic pain management in osteoarthritis

Approved in European Union as CBT-I for:

• Insomnia
• Chronic pain management in osteoarthritis

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Findings from Research

The study aims to evaluate the effectiveness of the internet-delivered cognitive behavioral therapy program, SHUTi, for insomnia among 100 higher-intensity caregivers, focusing on how their caregiving context affects their engagement with the program.

By understanding the barriers and motivations for caregivers' engagement with SHUTi, the research seeks to tailor the intervention to better meet the unique needs of caregivers, potentially improving access to effective insomnia treatment for this underserved population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study. Shaffer, KM., Ritterband, LM., You, W., et al.[2022]

A significant percentage (40-76%) of caregivers for cancer patients experience sleep disturbances, which can negatively impact their mental and physical health due to the unique stressors of caregiving.

Cognitive-behavioral therapy for insomnia (CBT-I) can be tailored to address the specific needs of cancer caregivers, and developing effective treatments could improve their quality of life and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia among Cancer Caregivers: A Proposal for Tailored Cognitive Behavioral Therapy. Shaffer, KM., Garland, SN., Mao, JJ., et al.[2023]

Cognitive behavioral therapy for insomnia (CBT-I) was effective in improving insomnia symptoms over a 24-month follow-up among 59 media workers, with 62% of participants showing moderate improvement.

The study found that working hour arrangements did not impact the effectiveness of CBT-I, indicating that this treatment can benefit both daytime and shift workers with chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. Järnefelt, H., Sallinen, M., Luukkonen, R., et al.[2018]

Cognitive Behavioral Therapy for Insomnia (CBT-I) and acupuncture show promise as effective non-pharmacological treatments for insomnia in informal caregivers of cancer patients, highlighting their potential benefits in this population.

The study faced challenges in recruiting eligible participants, indicating that understanding caregivers' perceptions of these interventions is crucial for improving retention and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of cognitive behavioral therapy for insomnia (CBT-I) or acupuncture for insomnia and related distress among cancer caregivers. Applebaum, AJ., Buda, K., Hoyt, MA., et al.[2021]

Cognitive-behavioral therapy for insomnia (CBT-I) showed positive effects on sleep quality and depressive symptoms in a study of 30 psychiatric outpatients, with 38% achieving normal sleep after treatment.

While CBT-I led to significant improvements within the treatment group over 4 and 8 weeks, there were no significant differences when compared to the control group, suggesting that while beneficial, the effects may not be strong enough to outperform standard care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. Wagley, JN., Rybarczyk, B., Nay, WT., et al.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia symptoms, with 36% of patients achieving remission compared to only 16.9% in control groups, indicating its efficacy for those with comorbid conditions.

CBT-I shows medium to large effect sizes for various sleep parameters, such as sleep efficiency and sleep onset latency, and has a small positive effect on comorbid symptoms, particularly benefiting patients with psychiatric conditions more than those with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. Wu, JQ., Appleman, ER., Salazar, RD., et al.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective alternative to sleeping medications, but many patients are unaware or reluctant to engage with it, preferring sedative hypnotics instead.

Focus groups with 29 Veterans revealed that patients prefer a stepped-care approach to CBT-I, starting with self-management tools and progressing to provider-delivered therapy if necessary, highlighting the need for multiple outreach efforts and delivery options to increase engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). Koffel, E., Branson, M., Amundson, E., et al.[2021]

Cognitive behavior therapy for insomnia (CBT-I) shows moderate to large treatment effects (Cohen's d range of 0.35-2.2) for patients with insomnia related to various medical and psychiatric conditions, indicating its efficacy beyond primary insomnia.

Improving sleep through CBT-I may also lead to better outcomes in managing comorbid medical and psychological conditions, highlighting the need for further research on adapting CBT-I for specific disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Smith, MT., Huang, MI., Manber, R.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

A single 4-hour group workshop on cognitive behavioral treatment for insomnia (CBT-I) significantly improved insomnia symptoms in 45 participants, with Insomnia Severity Index scores dropping from an average of 20.09 to 11.89 after one month.

Participants also reported a reduction in sleep aid use, with 80% indicating better sleep quality and 20% achieving remission of insomnia, highlighting the effectiveness of this accessible treatment format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. Okun, ML., Glidewell, RN.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study. [2022]

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

Insomnia among Cancer Caregivers: A Proposal for Tailored Cognitive Behavioral Therapy. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. [2018]

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

Feasibility and acceptability of cognitive behavioral therapy for insomnia (CBT-I) or acupuncture for insomnia and related distress among cancer caregivers. [2021]

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

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]

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

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]

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

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). [2021]

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

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]

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

We know CBT-I works, now what? [2022]

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

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]