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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03724305
Other study ID # RESIST
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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)
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