Clinical Trials Directory

Trials / Completed

CompletedNCT03724305

Reduce Emotional Symptoms of Insomnia With SleepTreatment

Reduce Emotional Symptoms of Insomnia With Sleep Treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Henry Ford Health System · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMindfulness-Based Therapy for InsomniaMindfulness-based therapy for insomnia (MBTI) will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia.

Timeline

Start date
2020-09-01
Primary completion
2022-04-10
Completion
2023-03-08
First posted
2018-10-30
Last updated
2024-08-22
Results posted
2024-08-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03724305. Inclusion in this directory is not an endorsement.