Virtual Assistant for Insomnia in Breast Cancer Survivors
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Must not be taking: Prescribed sleep medication
Disqualifiers: Sleep apnea, Shiftwork, Psychosis, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This clinical trial evaluates the effect of conversational agent, Cecebot, on improving insomnia in stage I-III breast cancer survivors. Sleep disturbance ranks among the top concerns reported by breast cancer survivors and is associated with poor quality of life. Many breast cancer survivors also have decreased physical activity, which may also have a negative impact on sleep and quality of life. Cognitive behavioral therapy for insomnia (CBTi) and physical activity interventions have individually been reported to improve sleep and to have a positive impact on quality of life. Cecebot is a personalized short messaging service (SMS)-based behavioral intervention that combines CBTi and physical activity strategies that may improve sleep for breast cancer survivors.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who use prescribed sleep medication more than 3 times a week.
What data supports the effectiveness of the treatment Cecebot, a virtual assistant for insomnia in breast cancer survivors?
Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I), which is part of Cecebot's approach, is effective for improving sleep in breast cancer survivors. A study found that eHealth CBT-I led to significant improvements in insomnia symptoms, sleep disturbance, and sleep efficiency among Spanish-speaking breast cancer survivors.
12345Is the Virtual Assistant for Insomnia in Breast Cancer Survivors safe for humans?
The studies on cognitive behavioral therapy for insomnia (CBT-I), including digital and telemedicine versions, show that it is generally safe and well-accepted by participants, with high satisfaction and retention rates.
12456How is the treatment Cecebot different from other insomnia treatments for breast cancer survivors?
Cecebot is unique because it uses a virtual assistant to deliver cognitive behavioral therapy for insomnia (CBT-I) through SMS, making it more accessible and convenient compared to traditional in-person therapy sessions.
24578Eligibility Criteria
This trial is for stage I-III breast cancer survivors who are experiencing insomnia. It aims to help improve their sleep and quality of life by using a conversational agent called Cecebot, which provides support via text messages.Inclusion Criteria
I can participate using my smartphone.
I have severe insomnia symptoms.
I am female.
+6 more
Exclusion Criteria
I have undergone CBTi therapy with a professional.
Current shiftwork
I have sleep apnea, whether or not I'm being treated for it.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention (Group I)
Participants receive sleep education SMS conversations, access to website content modules, sleep compression SMS conversations, and wear an activity tracker daily
6 weeks
2-4 times per week (virtual)
Waitlist Control (Group II)
Participants receive sleep education SMS conversations, access to website content modules, sleep compression SMS conversations, and wear an activity tracker daily
6 weeks
2-4 times per week (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the effectiveness of Cecebot in delivering cognitive behavioral therapy for insomnia (CBTi) and encouraging physical activity. Participants will also use medical devices, answer questionnaires, and may receive other internet-based interventions.
2Treatment groups
Experimental Treatment
Group I: GROUP II (waitlist control, Cecebot intervention)Experimental Treatment5 Interventions
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 7-12.
Group II: GROUP I (Cecebot intervention)Experimental Treatment5 Interventions
Patients receive sleep education SMS conversations and access to website content modules over 10 minutes 2-4 times per week, sleep compression SMS conversations QW, and wear activity tracker daily on weeks 1-6.
Cecebot is already approved in United States for the following indications:
🇺🇸 Approved in United States as Cecebot for:
- Insomnia in Stage I-III Breast Cancer Survivors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fred Hutch/University of Washington Cancer ConsortiumSeattle, WA
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
The Hope FoundationCollaborator
References
Feasibility of a Telemedicine-Delivered Cognitive Behavioral Therapy for Insomnia in Rural Breast Cancer Survivors. [2019]To evaluate a nurse-led, telemedicine-delivered cognitive behavioral therapy for insomnia (CBTI) in rural breast cancer survivors (BCSs).
Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. [2023]Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the gold-standard treatment for insomnia, which is common among breast cancer survivors (BCS). This pilot randomized controlled trial tested the first CBT-I intervention for Spanish-speaking BCS delivered using eHealth. Participants (N = 30) were Spanish-speaking BCS with insomnia symptoms recruited in Puerto Rico and randomized to a 6-week eHealth CBT-I group intervention or a waitlist control. Primary outcomes were acceptability (recruitment, treatment satisfaction) and feasibility (retention, attendance). Secondary outcomes were group differences in sleep outcomes post-treatment (i.e., insomnia symptoms, sleep disturbance, sleep efficiency). Recruitment (95%) and retention (97%) were excellent. All CBT-I participants (100%) attended ≥ 3 of 6 sessions. Satisfaction with CBT-I was acceptable. Post-intervention, there were medium to large group differences for average insomnia symptoms (d = 1.02), sleep disturbance (d = 1.25), and sleep efficiency (d = 0.77) favoring CBT-I. There were small/medium to medium/large group differences for the proportion of participants with clinically significant insomnia symptoms (d = 0.52), sleep disturbance (d = 0.67), and low sleep efficiency (d = 0.33) favoring CBT-I. Spanish-language eHealth CBT-I for BCS was acceptable and feasible and showed preliminary efficacy.ClinicalTrials.gov TRN: NCT04101526 (Posted September 24, 2019).
Does expectancy affect insomnia treatment response in cancer survivors receiving acupuncture and cognitive behavioral therapy? [2023]Insomnia negatively affects quality of life in cancer survivors. Expectations of insomnia treatment efficacy may influence response to intervention. We sought to determine whether pre-treatment outcome expectancy predicts response to two non-pharmacological interventions for insomnia among cancer survivors.
Testing delivery of components of cognitive behavioral therapy for insomnia to breast cancer survivors by smart speaker: a study protocol. [2022]Insomnia is common in breast cancer survivors (BCS), affecting an estimated 30-50% of the 3.8 million BCS in the US. Insomnia is associated with health consequences for cardiometabolic and immune systems, neurobehavioral function, depression, fatigue, and quality of life and may put BCS at particular risk. While pharmacotherapy for insomnia may address symptoms in the short-term, cognitive behavioral therapy for insomnia (CBT-I) is considered the gold standard insomnia treatment. We describe our protocol to determine the efficacy of voice-activated delivery of CBT-I components on insomnia symptoms compared to a sleep education control among BCS.
The Sleepio after cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial. [2023]This study will assess the efficacy of digital CBT for insomnia (dCBT-I) compared to sleep hygiene education (SHE) for the management of insomnia in women with cancer.
Efficacy of cognitive behavioral therapy for insomnia in breast cancer: A meta-analysis. [2022]Insomnia is highly prevalent among patients with breast cancer (BC). Although cognitive behavioral therapy for insomnia (CBT-I) is available in integrative oncology settings, it poses unique challenges for BC survivors. Our review aimed to assess the evidence for the therapeutic effects of CBT-I on insomnia in BC. Randomized controlled trials (RCTs) that included patients/survivors with BC and insomnia, and at least one validated self-report measure of sleep quality were included in the review. Of the 14 included RCTs (total N = 1363), the most common components incorporated in CBT-I interventions were sleep hygiene, stimulus control and sleep restriction. Pooled effect sizes favored CBT-I at post-intervention (Hedges' g = -0.779, 95% CI = -0.949, -0.609), short-term follow-up (within six months, Hedges' g = -0.653, 95% CI = -0.808, -0.498), and long-term follow-up (12 mo, Hedges' g = -0.335, 95% CI = -0.532, -0.139). In sub-analyses, CBT-I had similar effect sizes regardless of potential modifiers (comparison design, delivery formats, etc.). As an integrative oncology intervention, CBT-I is efficacious for reducing insomnia and improving sleep quality in women treated for BC, with medium-to-large effect sizes that persist after intervention delivery ends. Given the variability in the CBT-I components tested in RCTs, future studies should investigate the optimal integration of CBT-I components for managing insomnia during BC survivorship.
A pilot study of sleep scholar: A single-session, internet-based insomnia intervention for college students with a history of suicide ideation. [2023]Establish the feasibility and acceptability of Sleep Scholar, a single-session, self-guided, internet-based insomnia intervention.
Smartphone apps for insomnia: examining existing apps' usability and adherence to evidence-based principles for insomnia management. [2019]Insomnia affects up to 22% of the U.S. adult population. The use of mobile health applications (mHealth apps) has been posited as one way to increase access to evidence-based interventions for insomnia, such as cognitive behavioral therapy for insomnia (CBT-I). The purpose of the current study was to summarize the availability of mHealth apps that focus on providing users with the behavioral and/or cognitive skills to manage insomnia, assess their adherence to evidence-based principles, and examine their usability. The terms "insomnia," "insomnia treatment," and "sleep treatment" were used to search the Apple iTunes and Google Play stores in November 2016. Social network query within the authors' professional networks was also conducted. Apps that met inclusion criteria for the study were downloaded and reviewed by the research team for their general characteristics; inclusion of CBT-I skills, strategies, and principles; and aesthetics and usability. Of the 357 apps initially found, 12 met criteria for further review. Overall, the apps were moderately adherent to CBT-I principles, with a mean app score of 1.44 out of 3.00, and moderately usable, with a mean usability score of 3.54 out of 5.00. Few apps currently exist that utilize evidence-based principles to help users practice the behavioral and cognitive skills shown to manage insomnia. Thus, there are exciting opportunities for clinicians, researchers, and mHealth experts to develop effective apps that can help ease the public health burden of insomnia.