Reduce Emotional Symptoms of Insomnia With SleepTreatment

Study Overview
=================
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.

Official Title
-----------------
Reduce Emotional Symptoms of Insomnia With Sleep Treatment

Conditions
-----------------
Insomnia, Rumination

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-Based Therapy for Insomnia


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBTI<br>Mindfulness-Based Therapy for Insomnia | Behavioral: Mindfulness-Based Therapy for Insomnia<br>* Mindfulness-based therapy for insomnia (MBTI) will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia.<br>* Other names: MBTI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Insomnia Symptoms - Acute Post Treatment | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity) | 10 weeks after screening | 
| Severity of Insomnia Symptoms - 6-month Post Treatment | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity) | 6-month follow up (34 weeks after screening) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on Cognitive Emotional Arousal-Nocturnal Rumination - Acute Post Treatment | Pre-Sleep Arousal Scale's Cognitive Factor (PSAS-C, total scores ranges 8-40, with higher scores indicating greater arousal) | 10 weeks after screening | 
| Effects on Cognitive Emotional Arousal-Nocturnal Rumination - 6-month Post Treatment | Pre-Sleep Arousal Scale's Cognitive Factor (PSAS-C, total scores ranges 8-40, with higher scores indicating greater arousal) | 6-month follow up (34 weeks after screening) | 
| Effects on depression - Acute Posttreatment | Patient Health Questionnaire-9 (PHQ-9). total scores range 0-30 with higher scores reflecting higher depression. | 10 weeks after screening | 
| Effects on depression - 6 months Posttreatment | Patient Health Questionnaire-9 (PHQ-9). total scores range 0-30 with higher scores reflecting higher depression. | 6-month follow-up (34 weeks after screening) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insomnia, nocturnal rumination, depression, mindfulness, mindfulness-based therapy for insomnia