Online Therapy + Sauna Blanket for Insomnia
(SLEEPS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Disqualifiers: Night shift, Pregnancy, Sleep disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This single-arm feasibility trial will provide digital cognitive behavioral therapy for insomnia (CBT-I) and passive body heating (PBH) sessions using a sauna blanket over a 9-week treatment period to adults aged 18 years or older with insomnia disorder.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Online Therapy + Sauna Blanket for Insomnia?
Digital cognitive behavioral therapy for insomnia (CBT-I) has been shown to greatly improve insomnia symptoms and is considered a gold standard treatment. Additionally, passive body heating (PBH) through hot baths has been found to improve sleep quality in older adults with insomnia, suggesting that combining these approaches could be beneficial.
12345Is the combination of online therapy and sauna blanket safe for treating insomnia?
Online therapy for insomnia, like digital cognitive behavioral therapy (dCBT-I), is generally considered safe and can improve sleep and well-being. Passive body heating (PBH), such as using hot baths, has been shown to improve sleep in older adults without reported safety issues.
25678How is the Online Therapy + Sauna Blanket treatment for insomnia different from other treatments?
This treatment combines digital cognitive behavioral therapy for insomnia (dCBT-I), which is a first-line, non-drug approach delivered online, with passive body heating (PBH) using a sauna blanket, which can enhance sleep quality by increasing slow-wave sleep. This unique combination offers a non-pharmacological option that addresses both psychological and physiological aspects of insomnia.
125910Eligibility Criteria
Adults aged 18 or older with insomnia disorder can join this study. It's designed to see if a special therapy using digital sessions and sauna blankets helps improve sleep.Inclusion Criteria
Ability to fit in the sauna blanket (no taller than 6' 3", no greater than 250 lbs)
Elevated insomnia symptoms as indexed by a score of 11 or greater on the Insomnia Severity Index (ISI)
English-speaking
+6 more
Exclusion Criteria
Night shift worker
Pregnant or plans to become pregnant during the participation period
I have been diagnosed with or suspect I have a sleep disorder.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket
9 weeks
At least 3 PBH sessions per week
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing whether combining digital cognitive behavioral therapy for insomnia (CBT-I) with passive body heating (PBH) using a sauna blanket over nine weeks can help treat insomnia.
1Treatment groups
Experimental Treatment
Group I: Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH)Experimental Treatment2 Interventions
Participants will receive both digital Cognitive Behavioral Therapy for Insomnia (CBT-I) and Passive Body Heating (PBH) using a sauna blanket.
Cognitive Behavioral Therapy for Insomnia is already approved in United States, European Union, United States, United Kingdom for the following indications:
🇺🇸 Approved in United States as CBT-I for:
- Insomnia
- Depression
🇪🇺 Approved in European Union as CBT-I for:
- Insomnia
- Depression
🇺🇸 Approved in United States as Somryst for:
- Chronic Insomnia
🇬🇧 Approved in United Kingdom as Sleepio for:
- Insomnia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)Collaborator
References
Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. [2023]Digital cognitive behavioral therapy for insomnia (DCBT-I) requires adaptation to different sociocultural contexts. Moreover, studies comparing DCBT-I and sleep education in the same operating interface are lacking.
Effects of passive body heating on the sleep of older female insomniacs. [2017]The purpose of this study was to evaluate passive body heating (PBH) as a treatment for insomnia in older adults. Polysomnographic recordings of older adults routinely show an increase in sleep fragmentation and a substantial decrease in slow-wave sleep (SWS) consistent with complaints of "lighter" more disturbed sleep. An increase in body temperature in young adults early in the evening by way of PBH has been shown to produce an increase in SWS in the early part of the sleep period. In a crossover design, nine female insomniacs (aged 60-72 yr) participated in two consecutive nights of PBH, involving hot (40-40.5 degrees C) and luke-warm (37.5-38.5 degrees C) baths 1.5 hours before bedtime. Significant improvement in sleep continuity and a trend toward an increase in SWS occurred after hot baths. Results of subjective measures showed that subjects experienced significantly "deeper" and more restful sleep after hot baths. In addition, hot baths resulted in a significant delay of temperature nadir in comparison to baseline nights.
Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2020]Chronic insomnia is preferably treated with cognitive behavioral therapy for insomnia (CBTI), but many insomnia sufferers receive medication instead, likely because of high costs, lack of knowledge about optimal insomnia treatment among physicians, and lack of CBTI-trained professionals in mental health care. A possible solution is to offer CBTI through the Internet: I-CBTI. I-CBTI is generally acceptable to patients and greatly improves insomnia symptoms. We review the state of knowledge around I-CBTI and its effects. CBTI's effectiveness is influenced by treatment characteristics and patient-specific factors. We review potential factors that help identify which patients may benefit from I-CBTI.
Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2019]Chronic insomnia is preferably treated with cognitive behavioral therapy for insomnia (CBTI), but many insomnia sufferers receive medication instead, likely because of high costs, lack of knowledge about optimal insomnia treatment among physicians, and lack of CBTI-trained professionals in mental health care. A possible solution is to offer CBTI through the Internet: I-CBTI. I-CBTI is generally acceptable to patients and greatly improves insomnia symptoms. We review the state of knowledge around I-CBTI and its effects. CBTI's effectiveness is influenced by treatment characteristics and patient-specific factors. We review potential factors that help identify which patients may benefit from I-CBTI.
The Use of Evaluation Panels During the Development of a Digital Intervention for Veterans Based on Cognitive Behavioral Therapy for Insomnia: Qualitative Evaluation Study. [2023]Individuals enrolling in the Veterans Health Administration frequently report symptoms consistent with insomnia disorder. Cognitive behavioral therapy for insomnia (CBT-I) is a gold standard treatment for insomnia disorder. While the Veterans Health Administration has successfully implemented a large dissemination effort to train providers in CBT-I, the limited number of trained CBT-I providers continues to restrict the number of individuals who can receive CBT-I. Digital mental health intervention adaptations of CBT-I have been found to have similar efficacy as traditional CBT-I. To help address the unmet need for insomnia disorder treatment, the VA commissioned the creation of a freely available, internet-delivered digital mental health intervention adaptation of CBT-I known as Path to Better Sleep (PTBS).
A novel forehead temperature-regulating device for insomnia: a randomized clinical trial. [2019]Insomnia is one of the most common disorders in the general population. Hypnotic medications are efficacious, but their use is limited by adverse events (AEs). This study evaluated the safety and efficacy of a novel forehead temperature-regulating device that delivers frontal cerebral thermal therapy (maintained at 14-16°C, equivalent to 57-61°F) for the treatment of insomnia.
French Language Online Cognitive Behavioral Therapy for Insomnia Disorder: A Randomized Controlled Trial. [2023]Background: Despite cognitive-behavioral therapy for insomnia (CBT-I) being the recommended treatment for insomnia disorder, its access remains very limited. Automated Internet-delivered CBT-I (eCBT-I) is an emerging cost-effective strategy for adults with insomnia, however no such program is currently available in French Language. We evaluated a French-speaking, eCBT-I intervention to improve insomnia disorder in comparison to minimal psychoeducation therapy (mPT). Methods: Forty-six adults with insomnia disorder were randomly allocated to eCBT-I or mPT. The eCBT-I program consisted of seven sessions that delivered the typical components of CBT-I during 12 weeks. The mPT provided structured and non-tailored information about sleep and insomnia during a 1 h session. Insomnia severity Index (ISI, primary outcome), measures of fatigue, sleepiness, anxiety, depressive symptoms and quality of life were collected at baseline and endpoint. Electronic sleep diaries were completed over 2 week periods pre- and post-intervention. Results: Compared to mPT, eCBT-I resulted in greater decrease in ISI scores between baseline and endpoint. Sleep diaries parameters improved in both groups, with a greater improvement in the eCBT-I group. Patients allocated to eCBT-I group also improved depressive, fatigue, anxiety symptoms, and quality of life. Among patients with CNS-active drug at baseline, 91.7% reduced or stopped their hypnotic medication, and 16.7% in the mPT group. Conclusions: The present eCBT-I program seems feasible, acceptable and effective in reducing insomnia severity and insomnia-related functional outcomes in this small clinically-derived population. Given the high prevalence of insomnia, our data are supportive of the use of such program as an effective alternative to treat insomnia in daily clinical practice in French speaking countries.
Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. [2021]Digital cognitive behavioural therapy (dCBT) is an effective treatment for chronic insomnia and also improves well-being and quality of life (QoL). We assessed whether these benefits are sustained and if the effects of dCBT extend to the use of sleep medication and healthcare. In total 1,711 adults (48.0 ± 13.8 years, 77.6% female) with complaints of chronic insomnia participated in a previously published randomized controlled trial (ISRCTN 60530898) comparing dCBT (n = 853) with sleep hygiene education (SHE, n = 858). At weeks 0, 4, 8, 24, 36 and 48, we assessed functional health (Patient-Reported Outcomes Measurement Information System: Global Health Scale); psychological well-being (Warwick-Edinburgh Mental Well-being Scale) and sleep-related QoL (Glasgow Sleep Impact Index), prescribed and non-prescribed sleep medication use, and healthcare utilization. At week 25, those who received SHE at baseline were offered dCBT. dCBT improved functional health (difference: 2.45, 95% confidence interval [CI]: 2.03; 2.88, Cohen's d: 0.50, p
[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]Cognitive-behavioral therapy for insomnia (CBT-I) is the treatment of choice for chronic insomnia. Together with advantages it has such limitations like shortage of trained staff and low response rate. That is why the alternative methods of CBT-I induce high interest: bibliotherapy, phone psychotherapy, brief behavioral therapy and online-CBT-I. Hypnotics administration is recommended as adjuvant to extent the CBT-I effect. It may also be used as monotherapy when CBT-I is unavailable.
Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. [2023]Although digital cognitive behavioral therapy for insomnia (dCBT-I) has been studied in many randomized clinical trials and is recommended as a first-line treatment option, few studies have systematically examined its effectiveness, engagement, durability, and adaptability in clinical settings.