Preventative CBT for Insomnia
Recruiting in Palo Alto (17 mi)
Overseen byPhilip Cheng, Ph.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Henry Ford Health System
Disqualifiers: Under 18, Bipolar, Seizure, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This study is intended to assess the efficacy of preventative Cognitive Behavioral Therapy for Insomnia (pCBT-I) on reducing the severity and stopping the progression of acute insomnia and depression. We also hope to gain a deeper understanding of the sociocultural, interpersonal, and individual factors that may have a role in development of insomnia and/or engagement with treatment plans.
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 pCBT-I for insomnia?
Research shows that cognitive-behavioral therapy for insomnia (CBT-I) is effective in reducing insomnia symptoms and improving sleep quality. Studies have found that both in-person and internet-based CBT-I can help people with chronic insomnia, and it may also reduce symptoms in those with other psychiatric conditions.
12345Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for humans?
CBT-I is considered safe and effective for treating insomnia without the risks associated with sleeping medications. It is recommended as a first-line treatment for chronic insomnia and does not have the adverse effects often seen with medication.
678910How is the treatment pCBT-I different from other treatments for insomnia?
Preventative CBT for Insomnia (pCBT-I) is unique because it focuses on preventing insomnia before it becomes chronic, unlike traditional CBT-I which is used after insomnia is established. It also addresses the shortage of trained providers by exploring alternative delivery methods like online therapy, making it more accessible.
311121314Eligibility Criteria
This trial is for adults with a low income or education level who are starting to have trouble sleeping and feel worried about it. It's not for those under 18, people who can't participate, or if they have other untreated sleep issues or serious health problems.Inclusion Criteria
I have trouble sleeping and it worries or distresses me.
Individuals with low socioeconomic position as defined by income (<35k annual household income) or education (high school diploma or less)
Exclusion Criteria
I have severe health or mental health conditions that I haven't treated.
I am not willing or able to participate in the trial.
I am under 18 years old.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either a virtual pCBT-I session with a nurse coach or digital sleep education
1 week
1 virtual session
Follow-up
Participants are monitored for insomnia and depression severity post-treatment
6 months
Extended Follow-up
Participants are further monitored for insomnia and depression severity
up to 1 year
Participant Groups
The study tests whether a one-time virtual therapy session of preventative Cognitive Behavioral Therapy for Insomnia (pCBT-I) can reduce the severity of early insomnia symptoms and prevent them from getting worse.
2Treatment groups
Experimental Treatment
Active Control
Group I: Preventative Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 Intervention
Participants in this group will complete daily sleep diary entries for one week, and then have a telehealth pCBT-I session with a nurse coach, where they will receive personalized sleep recommendations to improve sleep quality.
Group II: Digital Sleep Education ControlActive Control1 Intervention
Participants in this group will receive digital sleep education, including tips on how to improve your sleep via interactive email. These materials are selected to help prevent chronic insomnia.
pCBT-I is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Cognitive Behavioral Therapy for Insomnia for:
- Insomnia
- Acute Insomnia
- Depression
🇪🇺 Approved in European Union as CBT-I for:
- Insomnia
- Chronic Insomnia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Henry Ford Columbus Medical CenterNovi, MI
Loading ...
Who Is Running the Clinical Trial?
Henry Ford Health SystemLead Sponsor
University of MichiganCollaborator
References
Guided Internet-Based Cognitive Behavioral Therapy for Insomnia: Prognostic and Treatment-Predictive Factors. [2023]Understanding which factors predict the outcome of internet-based cognitive behavioral therapy for insomnia (iCBT-I) may help to tailor this intervention to the patient's needs. We have conducted a secondary analysis of a randomized, controlled trial comparing a multicomponent iCBT-I (MCT) and an online sleep restriction therapy (SRT) for 83 chronic insomnia patients. The difference in the Insomnia Severity Index from pre- to post-treatment and from pre-treatment to follow-up at 6 months after treatment was the dependent variable. Prognostic and treatment-predictive factors assessed at baseline were analyzed with multiple linear regression. The shorter duration of insomnia, female gender, high health-related quality of life, and the higher total number of clicks had prognostic value for a better outcome. Other factors were found to be prognostic for outcome at the follow-up assessment: treatment with benzodiazepines, sleep quality, and personal significance of sleep problems. A high level of dysfunctional beliefs and attitudes about sleep (DBAS) was a moderator for better effects in the MCT at post-treatment assessment. Various prognostic factors (e.g., duration of insomnia, gender, or quality of life) may influence the success of treatment. The DBAS scale may be recommended to select patients for MCT rather than SRT.
Internet-based cognitive-behavioural therapy for insomnia (ICBT-i): a meta-analysis of randomised controlled trials. [2019]To evaluate the effectiveness of internet-based cognitive-behavioural therapy for insomnia (ICBT-i) in adults.
Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]To test the efficacy of cogntive-behavioral therapy for insomnia (CBT-I) as a supplement treatment for psychiatric outpatients. Comorbid insomnia is prevalent among individuals with varied psychiatric disorders and evidence indicates that CBT-I may be effective for reducing insomnia and other psychiatric symptoms.
Effectiveness of mobile-delivered, therapist-assisted cognitive behavioral therapy for insomnia in nationwide routine clinical care in Finland. [2023]Internet-delivered cognitive behavioral therapies (iCBTs) are efficacious for insomnia. Few studies have as yet reported their effectiveness in routine care. The objective of this study was to examine the effectiveness of the new Finnish 7-session HUS Helsinki University Hospital-iCBT for Insomnia (HUS-iCBTI) program in nationwide routine care.
Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. [2019]Cognitive-behavioral therapy for insomnia (CBT-I) has emerged as the first-line treatment for chronic insomnia but remains massively underused relative to the prevalence of insomnia disorder. This article focuses on 3 key issues in the delivery of CBT-I in the real world. First, where and how should CBT-I be delivered and who should deliver it? Second, who is an appropriate candidate for CBT-I? Third, how do you measure quality care with CBT-I? These issues give rise to targets for future research aimed at improving the implementation science of CBT-I in the real world.
Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]Insomnia is a pervasive problem for many patients suffering from medical and psychiatric conditions. Even when the comorbid disorders are successfully treated, insomnia often fails to remit. In addition to compromising quality of life, untreated insomnia may also aggravate and complicate recovery from the comorbid disease. Cognitive behavior therapy for insomnia (CBT-I) has an established efficacy for primary insomnia, but less is known about its efficacy for insomnia occurring in the context of medical and psychiatric conditions. The purpose of this article is to present a rationale for using CBT-I in medical and psychiatric disorders, review the extant outcome literature, highlight considerations for adapting CBT-I procedures in specific populations, and suggest directions for future research. Outcome studies were identified for CBT-I in mixed medical and psychiatric conditions, cancer, chronic pain, HIV, depression, posttraumatic stress disorder, and alcoholism. Other disorders discussed include: bipolar disorder, eating disorders, generalized anxiety, and obsessive compulsive disorder. The available data demonstrate moderate to large treatment effects (Cohen's d, range=0.35-2.2) and indicate that CBT-I is a promising treatment for individuals with medical and psychiatric comorbidity. Although the literature reviewed here is limited by a paucity of randomized, controlled studies, the available data suggest that by improving sleep, CBT-I might also indirectly improve medical and psychological endpoints. This review underscores the need for future research to test the efficacy of adaptations of CBT-I to disease specific conditions and symptoms.
"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). [2021]Cognitive behavioral therapy for insomnia (CBT-I) provides safe and effective insomnia care without the risk of harm associated with sleeping medications. Unfortunately, few patients with insomnia engage with CBT-I, with most using sedative hypnotics instead. This study conducted focus groups with patients with insomnia who were treated with sleeping medication, including older adults, women, and patients with chronic pain. The goal was to explore the perspectives of high-risk, CBT-I naïve patients on increasing access and engagement with CBT-I.
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.
Who is a candidate for cognitive-behavioral therapy for insomnia? [2022]Chronic insomnia impacts 1 in 10 adults and is linked to accidents, decreased quality of life, diminished work productivity, and increased long-term risk for medical and psychiatric diseases such as diabetes and depression. Recent National Institutes of Health consensus statements and the American Academy of Sleep Medicine's Practice Parameters recommend that cognitive-behavioral therapy for insomnia (CBT-I) be considered the 1st line treatment for chronic primary insomnia. Growing research also supports the extension of CBT-I for patients with persistent insomnia occurring within the context of medical and psychiatric comorbidity. In the emerging field of behavioral sleep medicine, there has yet to be a consensus point of view about who is an appropriate candidate for CBT-I and how this determination is made. This report briefly summarizes these issues, including a discussion of potential contraindications, and provides a schematic decision-to-treat algorithm.
Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]Because psychological approaches are likely to produce sustained benefits without the risk for tolerance or adverse effects associated with pharmacologic approaches, cognitive behavioral therapy for insomnia (CBT-i) is now commonly recommended as first-line treatment for chronic insomnia.
Integrating online communities and social networks with computerised treatment for insomnia: a qualitative study. [2023]Insomnia is a common psychological complaint. Cognitive behavioural therapy for insomnia (CBT-I), although effective, is little used because of lack of trained providers. Computerised CBT-I (CCBT-I) may be a solution to this shortfall in access.
Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. [2018]Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for persistent insomnia. The purpose of this study was to examine the effectiveness of and response patterns to CBT-I among daytime and shift workers with insomnia over a 24-month follow-up in occupational health services (OHS).
[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.
We know CBT-I works, now what? [2022]Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be efficacious and now is considered the first-line treatment for insomnia for both uncomplicated insomnia and insomnia that occurs comorbidly with other chronic disorders (comorbid insomnia). The purposes of this review are to provide a comprehensive summary of the efficacy data (for example, efficacy overall and by clinical and demographic considerations and by CBT-I formulation) and to discuss the future of CBT-I (for example, what next steps should be taken in terms of research, dissemination, implementation, and practice).