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Cognitive Behavioral Therapy for Cirrhosis and Insomnia

WM
Overseen ByWilliam Munroe
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Adapted Virtual Insomnia Program, a virtual cognitive behavioral therapy, can help people with cirrhosis manage insomnia. The program includes four weekly sessions and three short online check-ins. Participants will monitor their sleep patterns before and after the program. This trial suits individuals with cirrhosis who speak English and experience sleep difficulties, such as taking more than 30 minutes to fall asleep. As an unphased trial, it provides a unique opportunity to explore innovative insomnia therapy without the constraints of traditional clinical trial phases.

Do I have to stop taking my current medications for the trial?

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.

What prior data suggests that this virtual cognitive behavioral program is safe for patients with cirrhosis?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) is generally easy for people to handle. Studies have found that it significantly improves sleep quality and reduces insomnia symptoms. For instance, one study noted better sleep and a 54% remission rate in patients with chronic conditions like pain and heart disease.

Moreover, digital versions of CBT-I, such as the one used in this trial, have been tested and proven effective. A review of digital CBT-I found that it can safely improve sleep without requiring medication. No major side effects have been reported, indicating it is a safe option for managing insomnia.12345

Why are researchers excited about this trial?

Unlike traditional treatments for cirrhosis-related insomnia, which often involve medication, the Adapted Virtual Insomnia Program offers a behavioral approach through Cognitive Behavioral Therapy for Insomnia (CBT-I). This program is unique because it is delivered entirely online, making it more accessible for patients who may have difficulty attending in-person sessions. Additionally, it's specifically tailored to address the sleep issues of cirrhosis patients, incorporating weekly sessions and check-ins to provide personalized support. Researchers are excited about this treatment because it could offer a non-pharmacological, customizable option that improves sleep without the side effects associated with medication.

What evidence suggests that this adapted virtual insomnia program is effective for cirrhosis and insomnia?

Research has shown that digital cognitive behavioral therapy for insomnia (dCBT-I) can significantly reduce insomnia severity. A review of 11 studies found that dCBT-I effectively improved sleep. In another study, 81% of participants reported at least a mild improvement in sleep after completing a digital CBT program. CBT-I has also benefited individuals with long-term conditions like chronic pain and heart disease, with 54% experiencing reduced insomnia symptoms. These findings suggest that the Adapted Virtual Insomnia Program, which participants in this trial will receive, could improve sleep for patients with cirrhosis.36789

Are You a Good Fit for This Trial?

This trial is for adults with liver cirrhosis who have trouble sleeping (taking at least 30 minutes to fall asleep or staying awake at night) and are seen at MGH Liver Clinics. Participants must speak English and not have severe mental health issues, cognitive problems, untreated sleep apnea, or current alcohol misuse.

Inclusion Criteria

I am 18 or older with cirrhosis and get outpatient care at the MGH Liver Clinic.
Ability to communicate in English
I have trouble sleeping, taking 30+ minutes to fall or stay asleep, and my ISI score is 8 or higher.

Exclusion Criteria

Night/rotating shift work
Uncontrolled neuropsychiatric disorders such as severe depression, schizophrenia, or suicidal ideation which prohibits their ability to provide informed consent
Cognitive impairment, screened using the simplified Animal Naming Test
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a virtual cognitive behavioral therapy program for insomnia, consisting of 4 weekly sessions and 3 check-ins

4 weeks
4 virtual sessions, 3 virtual check-ins

Follow-up

Participants are monitored for changes in insomnia severity, sleep quality, anxiety, depression, pain severity, symptom burden, cognitive function, and health-related quality of life

4 weeks
Virtual assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Adapted Virtual Insomnia Program

Trial Overview

The study is testing a virtual behavioral program designed to help people with cirrhosis manage insomnia. The goal is to see if this online approach is practical and acceptable for these patients.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Behavioral: Intervention - Adapted Virtual Insomnia ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Citations

Effectiveness of Digital Cognitive Behavioral Therapy for ...

Fully automated dCBT-I significantly reduced insomnia severity compared to control conditions (WMD: -3.42; 95% CI: -4.35 to -2.48; P < 0.001). Subgroup analyses ...

Nurse-Supported Self-Directed Cognitive Behavioral ...

This randomized clinical trial examines the effectiveness of a nurse-supported, self-directed behavioral insomnia intervention for ...

CBT-I Effective for Insomnia in Patients with Chronic ...

CBT-I improved sleep outcomes and achieved 54% remission in patients with chronic pain, cancer, cardiovascular disease, and other chronic ...

Digitally delivered cognitive behavioral therapy for insomnia ...

While a meta-analysis of 11 trials has shown digital CBT-I to be effective in treating insomnia [23], the pain-relieving effect of digitally ...

Cognitive behavioral therapy effective for chronic insomnia

Overall, patients who underwent CBT experienced decreased time to sleep onset and time awake after falling asleep, as well as improved sleep ...

Cognitive Behavioral Therapy for Cirrhosis and Insomnia

This is a pilot trial to test the feasibility and acceptability of a virtual cognitive behavioral program for insomnia for patients with ...

A Behavioral Sleep Intervention for Patients With Cirrhosis ...

Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences of patients with cirrhosis.

Digital and AI-Enhanced Cognitive Behavioral Therapy for ...

This systematic review evaluates and synthesizes the current evidence of using AI- based approaches in personalized CBT for insomnia and related ...

Results of a pilot randomized controlled trial of CBT-I for ...

Sleep quality, insomnia, depression, anxiety, and wellbeing all significantly improved from pre- to post-intervention. Discussion: There was ...