Cognitive Behavioral Therapy for Insomnia

(RISE-UC Trial)

This trial tests whether a special online therapy, Cognitive Behavioral Therapy for Insomnia (CBT-I), can assist people with Ulcerative Colitis (UC) who experience sleep difficulties. The study aims to evaluate the accessibility and effectiveness of this online therapy in improving sleep quality and reducing insomnia severity. Participants will engage in online therapy sessions and track their sleep using diaries and questionnaires. The trial seeks individuals with UC who have experienced persistent sleep issues and maintain stable medication routines. Access to the internet or a mobile phone for telehealth sessions is required. As an unphased trial, this study provides a unique opportunity to explore innovative therapy for better sleep.

The trial requires that your sleep and ulcerative colitis medications have been stable for more than 3 months, so you should not change them during the study.

Research shows that cognitive behavioral therapy for insomnia (CBT-I) is generally safe and well-tolerated. Studies have found it to be as effective as sleep medication but with fewer side effects and a lower chance of insomnia returning. Most people who try CBT-I do not experience significant negative effects. However, some may feel a bit tired or less motivated during the therapy.

Cognitive Behavioral Therapy for Insomnia (CBT-I) is unique because it offers a non-pharmacological approach to treating insomnia, which is typically managed with medications like benzodiazepines or over-the-counter sleep aids. Unlike these standard treatments, CBT-I focuses on changing sleep habits and patterns through behavioral strategies and cognitive interventions, aiming to address the root causes of insomnia rather than just its symptoms. Researchers are excited about this treatment because it is delivered via telehealth, making it more accessible to people who may have difficulty attending in-person sessions. This approach not only has the potential to improve sleep quality but also reduces the risk of dependency and side effects associated with sleep medications.

Studies have shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively treats insomnia. It matches sleep medication in short-term effectiveness and surpasses it for long-term sleep improvements. Research indicates that after CBT-I, 70-80% of people see positive results, and about 40% experience remission, meaning their insomnia symptoms disappear. One study found that 92% of participants no longer had insomnia immediately after treatment. This trial will offer telehealth CBT-I to all participants, exploring its potential to improve sleep in adults with Ulcerative Colitis (UC).²⁴⁶⁷⁸