Reduce Emotional Symptoms of Insomnia With SleepTreatment (RESIST)

Reduce Emotional Symptoms of Insomnia With Sleep Treatment

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Rumination
• Intervention / Treatment: Behavioral: Mindfulness-Based Therapy for 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Novi, Michigan, United States, 48377
      • Henry Ford Health System - Columbus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBTI; Mindfulness-Based Therapy for Insomnia	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.; Other Names: MBTI

What is the study measuring?

Primary Outcome Measures

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

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)

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Christopher L Drake, PhD, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): April 10, 2022
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: depression; insomnia; mindfulness; nocturnal rumination; mindfulness-based therapy for insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Feeding and Eating Disorders; Gastrointestinal Diseases; Sleep Initiation and Maintenance Disorders; Rumination Syndrome
• Other Study ID Numbers: RESIST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No