Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT03724305
Brief Summary:
The purpose of this research is to test whether Mindfulness-Based Therapy for Insomnia (MBTI) significantly reduces symptoms of insomnia and cognitive arousal in patients with treatment-resistant insomnia.
Detailed Description:
Cognitive-behavioral therapy and pharmacotherapy are effective interventions for insomnia. Even so, about half of patients do not adequately respond to these treatments. Non-remission has been linked to high cognitive arousal that does not improve with traditional therapies. This study will examine the effects of mindfulness-based therapy for insomnia (MBTI) in a sample of patients who previously failed cognitive behavioral therapy and/or pharmacotherapy for insomnia.
This trial utilizes a single-arm, open label trial of MBTI. MBTI is delivered via telemedicine video in an individual therapy format.
Male and female participants who have insomnia, are age 18 and older, and who are recruited into the study will complete an initial assessment of their qualifications that are based on the severity of their insomnia symptoms, depression symptoms, and physical and mental health status. Eligible participants will undergo a clinical sleep interview and then complete 8 sessions of MBTI. Study outcomes are assessed via online survey before treatment, after treatment, and then a 6-month follow-up.
Study:
NCT03724305
Study Brief:
Protocol Section:
NCT03724305