Reduce Emotional Symptoms of Insomnia With SleepTreatment

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Determination of insomnia (ISI>10)
Inadequate response to prior insomnia psychotherapy (e.g., CBTI) and/or pharmacotherapy per patient report.

Exclusion Criteria

Age < 18
Current use of antidepressants for depression
Bipolar or Seizure disorders
Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).

Arm && Interventions

Group	Intervention	Description
MBTI	Mindfulness-Based Therapy for Insomnia	Mindfulness-Based Therapy for Insomnia

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	Pre-treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment)	Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity of insomnia symptoms)
Five Facet Mindfulness Questionnaire-15 (FFMQ-15)	Pre-treatment, post-treatment (7 weeks after initiation of treatment), and 6 months follow-up (6 months following treatment conclusion)	Five Facet Mindfulness Questionnaire - 15 (total scores ranges 15-75, with higher scores indicating someone who is more mindful in their everyday life.)

Secondary Outcome Measures