Cognitive Training for Autism and Insomnia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of South Florida
Must not be taking: Psychotropics, Beta-blockers
Disqualifiers: Sleep apnea, Bipolar, Seizure, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The proposed study will test the usability and feasibility of a novel cognitive training (COGMUSE) for autistic adults with co-occurring insomnia (COGMUSE- AUT). Participants (n=15) will complete the cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours. Weekly check-ins will be conducted by study staff over Teams to ensure adherence to the treatment and provide an opportunity for qualitative feedback on the game sessions played. During these 6 weeks, participants will fill out daily (2x/day) electronic sleep diaries and wear an actigraph device (GENEActiv). GENEActiv is a watch-like device that monitors light and movement activity.
Do I need to stop taking my current medications for this trial?
The trial requires that participants have not used sleep medications for at least one month or have been stable on their medications for six weeks. If you are taking medications that alter sleep, you may not be eligible to participate.
What data supports the effectiveness of the treatment COGMUSE for autism and insomnia?
Research shows that cognitive behavioral treatment for childhood insomnia (CBT-CI) can improve sleep and reduce challenging behaviors in children with autism, suggesting that similar treatments like COGMUSE might also be effective.
12345Is cognitive training for insomnia safe for humans?
Cognitive-behavioral therapy for insomnia (CBT-i), a non-drug treatment, is considered safe and effective for treating insomnia, with no reported side effects and long-term benefits.
678910How does the COGMUSE treatment for autism and insomnia differ from other treatments?
The COGMUSE treatment is unique because it combines cognitive training specifically designed for individuals with autism and insomnia, potentially addressing both cognitive and sleep-related challenges simultaneously. This approach is novel compared to traditional treatments that may focus solely on either cognitive or sleep issues separately.
123411Eligibility Criteria
This trial is for adults over 18 with Autism Spectrum Disorder (ASD) and insomnia. Participants must have a verbal IQ of at least 70, be able to read English, and not use sleep medications or have stable medication use for six weeks. They should also have documented ASD diagnosis confirmed by clinical tools like ADOS or ADI-R.Inclusion Criteria
I am 18 years old or older.
I have been diagnosed with Autism Spectrum Disorder (ASD).
My verbal IQ is 70 or above, ensuring I can participate in treatment discussions.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants complete the cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home, totaling 18 hours. Weekly check-ins are conducted by study staff over Teams.
6 weeks
6 visits (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including the completion of various assessments and questionnaires.
4 weeks
Participant Groups
The study tests COGMUSE-AUT, a cognitive training program designed for autistic adults with insomnia. It involves playing the game at home for an hour per day, three times a week over six weeks while wearing an actigraph device to monitor sleep patterns.
1Treatment groups
Experimental Treatment
Group I: COGMUSE-AUTExperimental Treatment1 Intervention
Participants will complete the computerized cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of South FloridaTampa, FL
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Who Is Running the Clinical Trial?
University of South FloridaLead Sponsor
References
Protocol for targeting insomnia in school-aged children with autism spectrum disorder without intellectual disability: a randomised control trial. [2021]Insomnia affects up to 80% of children with autism spectrum disorder (ASD). Negative consequences of insomnia in ASD include decreased quality of life (QOL), impaired learning and cognition, increased stereotypic and challenging behaviours, and increased parental stress. Cognitive behavioural treatment for childhood insomnia (CBT-CI) is a promising treatment for dealing with insomnia and its negative consequences but has not yet been studied in school-aged children with ASD and comorbid insomnia. Access to healthcare is another challenge for children with ASD, particularly in rural and underserved regions. Previous studies indicate that ASD and insomnia share common arousal-based underpinnings, and we hypothesise that CBT-CI will reduce the hyperarousal associated with insomnia and ASD. This trial will be the first to examine CBT-CI adapted for children with ASD and will provide new information about two different modes of delivery across a variety of primary and secondary child and parent sleep and related outcomes. Knowledge obtained from this trial might allow us to develop new or modify current treatments to better target childhood insomnia and ASD.
Cognitive behavioral treatment of insomnia in school-aged children with autism spectrum disorder: A pilot feasibility study. [2020]Insomnia is common in autism and associated with challenging behavior and worse parent sleep. Cognitive behavioral treatment for childhood insomnia (CBT-CI) is efficacious in typically developing children, but not yet tested in school-aged children with autism. This single arm pilot tested 8-session CBT-CI in 17 children with autism and insomnia (M age = 8.76 years, SD = 1.99) and their parent(s) (M age = 39.50 years, SD = 4.83). Treatment integrity was assessed for each session [delivery (by therapist), receipt (participant understanding), and enactment (home practice)]. Children and parents wore actigraphs and completed electronic diaries for 2-weeks to obtain objective and subjective sleep onset latency (SOL), total sleep/wake times (TST/TWT), and sleep efficiency (SE) at pre/post/1-month follow-up. Parents also completed the Aberrant Behavior Checklist [irritability, lethargy, stereotypy, hyperactivity, inappropriate speech (e.g., excessive/repetitive, loud self-talk)] at pre/post/1-month. Fifteen children completed all sessions. Average integrity scores were high [90%-delivery/receipt, 87.5%-enactment]. Parents found CBT-CI helpful, age-appropriate, and autism-friendly. Paired samples t-tests (family-wise error controlled) found CBT-CI improved child sleep (objective SOL-18 min, TWT- 34 min, SE-5%; subjective SOL-29 min, TST-63 min, TWT-45 min, SE-8%), and decreased irritability, lethargy, stereotypy, and hyperactivity. At 1-month, objective TST improved, inappropriate speech decreased, but hyperactivity was no longer decreased. Other gains were maintained. Parent sleep (objective SOL-12 min, TST-35 min, TWT-21 min, SE-4%; subjective SOL-11 min, TWT- 31min, SE-11%) and fatigue also improved. At 1-month, gains were maintained. This pilot shows CBT-CI is a feasible treatment that holds promise for improving child and parent sleep and functioning and suggests a randomized controlled trial in school-aged children with autism is worth conducting. Autism Res 2020, 13: 167-176. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Insomnia is common in autism and associated with challenging behaviors and poor parent sleep and stress. Cognitive behavioral treatment for childhood insomnia (CBT-CI) has not been tested in school-aged children with autism. This pilot study shows therapists, parents, and children were able to use CBT-CI to improve child and parent sleep, child behavior, and parent fatigue. Parents found CBT-CI helpful, age-appropriate, and autism-friendly. CBT-CI holds promise for treating insomnia in school-aged children with autism and deserves further testing.
Case study: A case-series evaluation of a behavioral sleep intervention for three children with autism and primary insomnia. [2015]To assess the effectiveness of a manualized multi-component behavioral sleep intervention for children with autism spectrum disorder (ASD) and primary insomnia.
Insomnia subtypes and clinical impairment in hospitalized children with autism spectrum disorder. [2021]Insomnia subtypes are not well understood in the most severely affected children with autism spectrum disorder. We examined length of hospital stay, autism severity, nonverbal intelligence quotient, and behavioral functioning across insomnia subtypes in 427 psychiatrically hospitalized children with autism spectrum disorder (mean age = 12.8 ± 3.4; 81.3% male). Per parent report, 60% (n = 257) of children had at least one type of insomnia. The distribution of subtypes was difficulty falling asleep (26.1%, n = 67), difficulty staying asleep (24.9%, n = 64), early morning awakening (4.3%, n = 11), and multiple insomnia symptoms (44.7%, n = 115). Difficulty staying asleep and early morning awakenings were associated with longer hospital stays. Early morning awakening was also associated with higher autism symptom severity. In general, children with difficulty staying asleep or multiple insomnia symptoms scored lower on adaptive behaviors (e.g. communication, self-care, socialization) and higher on maladaptive behaviors (e.g. irritability, hyperactivity, emotional reactivity, and emotional dysphoria). Difficulty staying asleep or having multiple insomnia symptoms appears to be most strongly related to impaired behavioral functioning. Conversely, early morning awakenings may be more closely tied with autism spectrum disorder itself. Further research is needed regarding insomnia subtypes at the severe end of the autism spectrum.
Insomnia in Children with Autism Spectrum Disorder: A Cross-Sectional Study on Clinical Correlates and Parental Stress. [2023]Insomnia is one of the most common co-occurring disorders in children with autism spectrum disorder (ASD). The purpose of this cross-sectional cohort study of 270 children with ASD was to assess the prevalence of insomnia using the Pediatric Sleep Clinical Global Impression Scale and to correlate sleep problems with cognitive level, adaptive behavior, parental stress, behavioral and emotional problems, and severity of core symptoms. Our findings revealed that one-third of children had insomnia and were related to reduced adaptive behaviors and higher levels of parental stress and behavioral and emotional problems. Insomnia must be evaluated in children with ASD to define an appropriate intervention to potentially alleviate the severity of clinical correlates and parental burden.
Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. [2020]Sleep disturbance is a major health concern among US veterans who have served since 2001 in a combat theater in Iraq or Afghanistan. We report subjective and objective sleep results from a pilot trial assessing self-management-guided use of a mobile app (CBT-i Coach, which is based on cognitive behavioral therapy for insomnia) as an intervention for insomnia in military veterans.
The effect of sleep medications on cognitive recovery from traumatic brain injury. [2013]To summarize the literature on the available pharmacotherapy for insomnia and the adverse cognitive effects of those options in persons with traumatic brain injury (TBI).
Cognitive-Behavioral Therapy for Insomnia: An Effective and Underutilized Treatment for Insomnia. [2020]Sleep difficulties are an extremely prevalent health problem, with about 33% to 50% of adults reporting regular difficulty falling asleep or staying asleep. About 7% to 18% of adults meet the criteria for an insomnia disorder.1,2 Sleep disruptions contribute to a variety of medical problems, including cognitive impairment, reduced immune function, metabolic imbalance, and exacerbation of psychiatric conditions.3 The most effective nonpharmacological treatment for chronic insomnia is cognitive-behavioral therapy for insomnia (CBT-i). CBT-i produces results that are equivalent to sleep medication, with no side effects, fewer episodes of relapse, and a tendency for sleep to continue to improve long past the end of treatment. The long-term improvements seem to result from the patient learning how to support and promote the body's natural sleep mechanism. The five key components of CBT-i are sleep consolidation, stimulus control, cognitive restructuring, sleep hygiene, and relaxation techniques. Although CBT-i is a safe and highly effective treatment for insomnia, unfortunately, it is underutilized, primarily because of two reasons: (1) There is currently a shortage of trained CBT-i practitioners. (2) Patient are much more likely to learn about sleep medication as a treatment for their insomnia (via drug advertisements and prescribing physicians) than CBT-i. Physicians and health care providers can play an important role in educating their patients about CBT-i and recommending it as a first-line treatment for chronic insomnia.
The assessment and management of insomnia: an update. [2020]Insomnia poses significant challenges to public health. It is a common condition associated with marked impairment in function and quality of life, psychiatric and physical morbidity, and accidents. As such, it is important that effective treatment is provided in clinical practice. To this end, this paper reviews critical aspects of the assessment of insomnia and the available treatment options. These options include both non-medication treatments, most notably cognitive behavioral therapy for insomnia, and a variety of pharmacologic therapies such as benzodiazepines, "z-drugs", melatonin receptor agonists, selective histamine H1 antagonists, orexin antagonists, antidepressants, antipsychotics, anticonvulsants, and non-selective antihistamines. A review of the available research indicates that rigorous double-blind, randomized, controlled trials are lacking for some of the most commonly administered insomnia therapies. However, there are an array of interventions which have been demonstrated to have therapeutic effects in insomnia in trials with the above features, and whose risk/benefit profiles have been well characterized. These interventions can form the basis for systematic, evidence-based treatment of insomnia in clinical practice. We review this evidence base and highlight areas where more studies are needed, with the aim of providing a resource for improving the clinical management of the many patients with insomnia.
A hybrid type I trial to increase Veterans' access to insomnia care: study protocol for a randomized controlled trial. [2022]Chronic insomnia is among the most reported complaints of Veterans and military personnel referred for mental health services. It is highly comorbid with medical and psychiatric disorders, and is associated with significantly increased healthcare utilization and costs. Evidence-based psychotherapy, namely Cognitive Behavioral Therapy for Insomnia (CBTI), is an effective treatment and recommended over prescription sleep medications. While CBTI is part of a nationwide rollout in the Veterans Health Administration to train hundreds of providers, access to treatment is still limited for many Veterans due to limited treatment availability, low patient and provider knowledge about treatment options, and Veteran barriers such as distance and travel, work schedules, and childcare. Uptake of a briefer, more primary-care-friendly treatment into routine clinical care in Veterans Affairs (VA) primary care settings, where insomnia is typically first recognized and diagnosed, may effectively and efficiently increase access to effective insomnia interventions and help decrease the risks and burdens related to chronic insomnia.
Insomnia Severity in Adults with Autism Spectrum Disorder is Associated with sensory Hyper-Reactivity and Social Skill Impairment. [2020]Insomnia is a common source of distress in adults with autism spectrum disorder (ASD). Two characteristics of ASD could be relevant to insomnia complaints by hampering the entrainment of a circadian sleep-wake rhythm. First, sensory hyper-reactivity could lead to bright light avoidance and thus affect photoperiodic input to the circadian system. Second, impaired social skills complicate the establishment of a social interactions and thus affect scheduled social-behavioral input to the circadian system. We investigated the association of insomnia severity with sensory reactivity and social skills in 631 adults (18-65 years) with ASD. Results revealed positive associations of insomnia severity with general and visual sensory hyper-reactivity and with impairment of social skills. The findings warrant further studies which (1) directly assess whether a suboptimal functioning of the biological clock underlies these associations and (2) identify other factors that could contribute to observed sleep problems.