Reduce Emotional Symptoms of Insomnia With SleepTreatment (RESIST)
Primary Purpose
Insomnia, Rumination
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Therapy for Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring insomnia, nocturnal rumination, depression, mindfulness, mindfulness-based therapy for insomnia
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).
Sites / Locations
- Henry Ford Health System - ColumbusRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MBTI
Arm Description
Mindfulness-Based Therapy for Insomnia
Outcomes
Primary Outcome Measures
Severity of Insomnia Symptoms - Acute Post Treatment
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity)
Severity of Insomnia Symptoms - 6-month Post Treatment
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity)
Secondary Outcome Measures
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)
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)
Effects on depression - Acute Posttreatment
Patient Health Questionnaire-9 (PHQ-9). total scores range 0-30 with higher scores reflecting higher depression.
Effects on depression - 6 months Posttreatment
Patient Health Questionnaire-9 (PHQ-9). total scores range 0-30 with higher scores reflecting higher depression.
Full Information
NCT ID
NCT03724305
First Posted
October 25, 2018
Last Updated
May 17, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03724305
Brief Title
Reduce Emotional Symptoms of Insomnia With SleepTreatment
Acronym
RESIST
Official Title
Reduce Emotional Symptoms of Insomnia With Sleep Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Rumination
Keywords
insomnia, nocturnal rumination, depression, mindfulness, mindfulness-based therapy for insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MBTI
Arm Type
Experimental
Arm Description
Mindfulness-Based Therapy for Insomnia
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Therapy for Insomnia
Other Intervention Name(s)
MBTI
Intervention Description
Mindfulness-based therapy for insomnia (MBTI) will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia.
Primary Outcome Measure Information:
Title
Severity of Insomnia Symptoms - Acute Post Treatment
Description
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity)
Time Frame
10 weeks after screening
Title
Severity of Insomnia Symptoms - 6-month Post Treatment
Description
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity)
Time Frame
6-month follow up (34 weeks after screening)
Secondary Outcome Measure Information:
Title
Effects on Cognitive Emotional Arousal-Nocturnal Rumination - Acute Post Treatment
Description
Pre-Sleep Arousal Scale's Cognitive Factor (PSAS-C, total scores ranges 8-40, with higher scores indicating greater arousal)
Time Frame
10 weeks after screening
Title
Effects on Cognitive Emotional Arousal-Nocturnal Rumination - 6-month Post Treatment
Description
Pre-Sleep Arousal Scale's Cognitive Factor (PSAS-C, total scores ranges 8-40, with higher scores indicating greater arousal)
Time Frame
6-month follow up (34 weeks after screening)
Title
Effects on depression - Acute Posttreatment
Description
Patient Health Questionnaire-9 (PHQ-9). total scores range 0-30 with higher scores reflecting higher depression.
Time Frame
10 weeks after screening
Title
Effects on depression - 6 months Posttreatment
Description
Patient Health Questionnaire-9 (PHQ-9). total scores range 0-30 with higher scores reflecting higher depression.
Time Frame
6-month follow-up (34 weeks after screening)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Fellman-Couture, PhD
Phone
248-344-7362
Email
cfellma1@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Chaewon Sagong, BS
Phone
248-344-2409
Email
csagong1@hfhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher L Drake, PhD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System - Columbus
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Fellman-Couture, PhD
Phone
248-344-7362
Email
cfellma1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Chaewon Sagong, BS
Phone
248-344-2409
Email
csagong1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Christopher Drake, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Reduce Emotional Symptoms of Insomnia With SleepTreatment
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