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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist caregivers of children with Autism Spectrum Disorder (ASD) who experience insomnia. It compares two types of cognitive behavioral therapy (CBT) for insomnia: a web-based version and a home-based version. The goal is to determine which method more effectively improves sleep for caregivers, who often face sleep challenges due to the demands of caring for a child with ASD. Caregivers with insomnia, stable health, and consistent medication conditions may find this trial suitable. As an unphased trial, it offers caregivers the chance to explore innovative solutions for enhancing their sleep quality.

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 prior data suggests that these CBT-I interventions are safe for caregivers with insomnia?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) is safe and effective for adults. Studies have found that online CBT-I programs improve sleep and reduce insomnia symptoms, even for individuals with ongoing health issues like pain and heart disease. This suggests that the therapy is generally well-received and helps many improve their sleep without medication.

For CBT-I conducted at home, similar results have been observed. Participants in studies often continue with the program, demonstrating adherence to the treatment. These studies indicate that home-based CBT-I effectively and safely improves sleep in people with insomnia, even those with other health problems like depression.

In summary, both online and home-based CBT-I are safe treatments for insomnia, with many experiencing better sleep and fewer symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for caregiver insomnia because they offer flexible, innovative approaches to managing sleep issues. Unlike traditional in-person therapy sessions, which can be time-consuming and difficult to schedule, these cognitive behavioral therapy interventions are delivered either through a web-based platform or a home-based module. This means caregivers can access therapy at their convenience, fitting it around their demanding schedules. These methods aim to improve accessibility and adherence, potentially leading to better sleep outcomes for caregivers struggling with insomnia.

What evidence suggests that this trial's treatments could be effective for caregiver insomnia?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively treats long-term insomnia, especially for caregivers. In this trial, participants will join one of two treatment arms: a web-based CBT-I intervention or a home-based CBT-I intervention. The online version of CBT-I shows promise, particularly for people in rural areas who can't easily access in-person treatments. One study found that this method helps prevent short-term insomnia from becoming long-term. Similarly, home-based CBT-I has proven effective, with participants reducing their insomnia severity by 4.3 points on the Insomnia Severity Index, and nearly 19% experiencing complete relief. Both the online and home-based options offer valuable ways for caregivers to improve their sleep. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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) 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) 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) 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) 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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9978641/

The Implementation and Effectiveness of Digital Cognitive ... Among enrollees, digital CBTi was acceptable and the Insomnia Severity Index decreased by 4.3 points (t = 6.41, p < 0.001) and 13 (18.6%) reached remission. The ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2823423

Nurse-Supported Self-Directed Cognitive Behavioral ... This randomized clinical trial examines the effectiveness of a nurse-supported, self-directed behavioral insomnia intervention for ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178123000197

A two-arm, multi-center, randomized controlled trial This one-week internet-delivered CBT-I program is an effective tool to prevent the chronicity of acute insomnia.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10485710/

Development and Initial Evaluation of Web-Based Cognitive ... Web-based delivery promises to improve insomnia, particularly for rural caregivers who have limited access to traditional in-person treatments.

5. withpower.com withpower.com/trial/phase-sleep-initiation-and-maintenance-disorders-4-2022-3729b

Cognitive Behavioral Therapy 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10911999/

Telehealth group Cognitive–Behavioral Therapy for Insomnia ... Overall, there was an 80% retention rate for the 6-session telehealth group CBT-I intervention. All participants endorsed moderate-to-strong treatment adherence ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7378630/

The Clinical Effectiveness of Cognitive Behavioral Therapy ... Currently, findings support that CBT-I seems to be effective and safe for insomnia comorbid with depression to improve the insomnia condition.

8. researchprotocols.org researchprotocols.org/2022/6/e37874/

Impact of Web-Based Cognitive Behavioral Therapy for ... We hypothesize that cognitive behavioral therapy for insomnia (CBT-I) will reverse those downstream effects by improving insomnia and restoring ...

9. mdpi.com mdpi.com/2077-0383/14/7/2265

Digital and AI-Enhanced Cognitive Behavioral Therapy for ... Results: The findings suggest that digital and AI-enhanced CBT significantly improves sleep parameters, patient adherence, satisfaction, and the personalization ...