What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally well-tolerated with minimal side effects, primarily involving temporary increases in fatigue or sleepiness as sleep patterns adjust. In contrast, pharmacologic treatments such as sedative-hypnotics can cause side effects including daytime drowsiness, dizziness, dependency, and cognitive impairment. Antidepressants used for insomnia may also cause weight gain, dry mouth, and sexual dysfunction.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of chronic insomnia, including nonbenzodiazepine sedative-hypnotics like zolpidem, eszopiclone, and zaleplon, as well as benzodiazepines such as temazepam. These medications primarily target sleep onset and maintenance. However, Cognitive Behavioral Therapy for Insomnia (CBT-I) is a non-pharmacologic, structured program that has been shown to be effective in treating chronic insomnia by identifying and replacing thoughts and behaviors that cause or worsen sleep problems. While CBT-I itself is not a drug and thus not subject to FDA approval, it is recommended as a first-line treatment for chronic insomnia due to its efficacy and safety profile.

What other types of research exist?

Promising novel alternatives to CBT-I for chronic insomnia patients include: 1) Hypnosis, which has shown effectiveness in reducing insomnia severity and improving sleep quality. 2) Mind-body-based therapies, which have demonstrated potential benefits in small studies. 3) Pharmacologic treatments such as melatonin, particularly in combination with behavioral interventions, which have been effective in reducing sleep onset latency and improving sleep quality in specific populations.

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Behavioral Intervention

Cognitive Behavioral Therapy for Caregiver Insomnia

N/A

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Diagnosis of Behavioral Insomnia or Insomnia due to ASD (Insomnia due to internal

Children age 3 to 17 years and one of their parents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves therapy rather than medication, traditional side effects are not expected. However, participants may experience temporary increases in stress or anxiety as they adjust to new sleep routines.

Eligibility Criteria

Inclusion Criteria

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

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

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I am a child aged 3-17 or their parent.

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I have been diagnosed with insomnia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Caregiver Acceptability Opinion Survey

Feasibility of pilot study

Secondary study objectives

Change in Caregiver behaviors

Change in Child Daytime behaviors

Change in Maternal Self-efficacy

+7 more

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: web-basedExperimental Treatment1 Intervention

web-based CBT-Insomnia intervention

Group II: Home-basedExperimental Treatment1 Intervention

home- based CBT-Insomnia intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a structured program that addresses chronic insomnia by targeting the underlying psychological and behavioral factors. It involves cognitive restructuring to change negative thoughts about sleep, stimulus control to associate the bed with sleep, sleep restriction to consolidate sleep, and relaxation techniques to reduce arousal. These mechanisms are crucial as they address the root causes of insomnia, leading to more sustainable improvements in sleep quality and overall well-being for chronic insomnia patients.