Digital CBT for Insomnia and Depression
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Rochester
Must not be taking: Antipsychotics, Mood stabilizers
Disqualifiers: Pregnancy, Bipolar, Psychosis, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial uses online therapy programs to help Veterans with both sleep and mood problems. It focuses on those who have limited access to traditional therapy. The therapies work by teaching skills to change negative thoughts and behaviors affecting sleep and mood.
Will I have to stop taking my current medications?
The trial requires that you are not currently using anti-psychotic medications or mood stabilizers like lithium. If you are taking these, you would need to stop before participating.
What data supports the effectiveness of the treatment Digital CBT for Insomnia and Depression?
Research shows that digital cognitive behavioral therapy for insomnia (dCBT-I) is effective in improving sleep quality and reducing insomnia symptoms. Additionally, it has been found to have a small to moderate effect in reducing depressive symptoms, suggesting it may help with both insomnia and depression.
12345Is digital cognitive behavioral therapy for insomnia and depression safe for humans?
Digital cognitive behavioral therapy for insomnia (dCBT-I) is considered safe for reducing insomnia and depression symptoms.
16789How is digital CBT for insomnia and depression different from other treatments?
Digital CBT for insomnia and depression is unique because it is delivered online, making it more accessible and scalable compared to traditional in-person therapy. It specifically targets both insomnia and depression, which often occur together, and has been shown to improve sleep quality and alleviate depressive symptoms.
125610Eligibility Criteria
This trial is for U.S. military veterans who speak English and are experiencing both insomnia and depression, with scores indicating moderate to severe symptoms on standard questionnaires. It's not open to pregnant individuals, those with a history of bipolar disorder or psychosis, current users of antipsychotic medications or mood stabilizers like lithium, or anyone currently having suicidal thoughts with intent.Inclusion Criteria
English-speaking
U.S. Military Veterans
Endorse depression (Patient Health Questionnaire-depression score > 10)
+1 more
Exclusion Criteria
Pregnancy
History of bipolar disorder
Current suicidal ideation with active intent
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive digital CBT for insomnia and/or depression over a 12-week period, with different sequences depending on the study arm
12 weeks
Remote participation
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3-month and 6-month intervals
6 months
Remote assessments at 3 and 6 months
Participant Groups
The study is testing whether treating insomnia and depression one after the other works better than just treating one condition. It also aims to find out which treatment sequence might be best and if treatments should vary based on individual differences. Participants will receive digital Cognitive Behavioral Therapy (CBT) tailored either for insomnia or depression along with mood monitoring.
5Treatment groups
Experimental Treatment
Active Control
Group I: Single Insomnia TreatmentExperimental Treatment1 Intervention
Cognitive-behavioral therapy for insomnia delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.
Group II: Single Depression TreatmentExperimental Treatment1 Intervention
Cognitive-behavioral therapy for depression delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.
Group III: Sequenced Insomnia and Depression TreatmentExperimental Treatment2 Interventions
Cognitive-behavioral therapy for insomnia followed by cognitive-behavioral therapy for depression each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the insomnia treatment only for 4 weeks after which the access to the depression treatment is also made available. Total duration of access for 12 weeks.
Group IV: Sequenced Depression and Insomnia TreatmentExperimental Treatment2 Interventions
Cognitive-behavioral therapy for depression followed by cognitive-behavioral therapy for insomnia each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the depression treatment only for 4 weeks after which the access to the insomnia treatment is also made available. Total duration of access for 12 weeks.
Group V: ControlActive Control1 Intervention
Online Mood Monitoring for 12 weeks
Cognitive Behavioral Therapy for Depression is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as CBT-I for:
- Insomnia
- Depression
🇪🇺 Approved in European Union as CBT-I for:
- Insomnia
- Depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Rochester Sleep Research LaboratoryRochester, NY
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Who Is Running the Clinical Trial?
University of RochesterLead Sponsor
United States Department of DefenseCollaborator
University of South FloridaCollaborator
Harvard UniversityCollaborator
University of California, IrvineCollaborator
References
Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]Digital cognitive behavior therapy for insomnia (dCBT-I) is an effective treatment in alleviating insomnia. This study examined the effect of dCBT-I for improving sleep quality in patients with insomnia complaints from a clinical population in a real-world setting.
Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]Digital cognitive behavioral therapy (dCBT) is a scalable and effective intervention for treating insomnia. Most people with insomnia, however, seek help because of the daytime consequences of poor sleep, which adversely affects quality of life.
Factors influencing the effectiveness of digital cognitive behavioural therapy for chronic insomnia in clinical practice. [2023]Digital cognitive behavioural therapy for chronic insomnia (D-CBT-I) has been shown to be as efficacious as traditional CBT-I. However, not all patients achieve insomnia remission after treatment. We explored the factors influencing the effectiveness of D-CBT-I in a clinical practice. A total of 414 Asian chronic insomniacs were studied during a 6 week D-CBT-I intervention. All patients were assessed at baseline and posttreatment and were determined to be remitters or non-remitters, responders or non-responders by posttreatment criteria; Insomnia Severity Index (ISI
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
Digital cognitive behavioral therapy for insomnia on depression and anxiety: a systematic review and meta-analysis. [2023]Despite research into the development of digital cognitive behavioral therapy for insomnia (dCBT-I), research into the outcomes of dCBT-I on insomnia and the associated clinical conditions of depression and anxiety have been limited. The PubMed, PsycINFO (Ovid), Embase, and Cochrane databases were searched for randomized controlled trials (RCTs) on adult patients with insomnia also having reported measures of depressive or anxiety symptoms. In total, 2504 articles were identified after duplicate removal, and 22 RCTs were included in the final meta-analysis. At the post-treatment assessment, the dCBT-I group had a small to moderate effect in alleviating depressive (standardized mean difference (SMD) = -0.42; 95% CI: -0.56, -0.28; p
The efficacy of digital cognitive behavioral therapy for insomnia and depression: a systematic review and meta-analysis of randomized controlled trials. [2023]Insomnia and depression often co-occur. Cognitive behavioral therapy for insomnia (CBT-I) seems to be effective and safe for mitigating insomnia and depression. However, the efficacy of digitally-delivered CBT-I (dCBT-I) remains unclear. Therefore, this meta-analysis of randomized controlled trials (RCTs) was to systematically review and evaluate the efficacy of dCBT-I in adults with insomnia and depression.
Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials. [2021]Although cognitive behavioural therapy for insomnia (CBT-I) has been recommended the initial therapy for insomnia, its clinical usage remains limited due to the lack of therapists. Digital CBT-I (dCBT-I) can potentially circumvent this problem. This meta-analysis aims to evaluate the short-term and long-term efficacy of dCBT-I for adults with insomnia.
Self-efficacy in Insomnia Symptom Management after Digital CBT-I Mediates Insomnia Severity during the COVID-19 Pandemic. [2023]Digital cognitive behavioral therapy for insomnia (dCBT-I) can reduce acute insomnia and depressive symptoms and prevent symptom recurrence. The current study evaluated self-efficacy in managing insomnia symptoms as a potential mediator of the relationship between prior dCBT-I and subsequent insomnia and depressive symptoms assessed during the coronavirus 2019 (COVID-19) pandemic.
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.
Facilitating and hindering factors in Internet-delivered treatment for insomnia and depression. [2023]Insomnia and depression is a common and debilitating comorbidity, and treatment is usually given mainly for depression. Guided Internet-based cognitive behavioral therapy for insomnia (ICBT-i) was, in a recent study on which this report is based, found superior to a treatment for depression (ICBT-d) for this patient group, but many patients did not reach remission.