Reduce Emotional Symptoms of Insomnia With SleepTreatment

Insomnia Clinical Trial

— RESIST  

Official title:

Reduce Emotional Symptoms of Insomnia With Sleep Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03724305
• Other study ID #: RESIST
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2022
• Source: Henry Ford Health System
• Contact: Cynthia Fellman-Couture, PhD
• Phone: 248-344-7362
• Email: cfellma1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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).

Related Conditions & MeSH terms

• Insomnia
• Rumination
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Mindfulness-Based Therapy for Insomnia
Mindfulness-based therapy for insomnia (MBTI) will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia.

Locations

Country	Name	City	State
United States	Henry Ford Health System - Columbus	Novi	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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)