Reduce Emotional Symptoms of Insomnia With SleepTreatment

NCT03724305 | Completed Results DMC

• 1 other identifier: RESIST
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Rumination

Keywords

insomnia; nocturnal rumination; depression; mindfulness; mindfulness-based therapy for insomnia

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

MBTI

EXPERIMENTAL

Mindfulness-Based Therapy for Insomnia

Behavioral: Mindfulness-Based Therapy for Insomnia

Interventions

Mindfulness-Based Therapy for Insomnia BEHAVIORAL

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

Also known as: MBTI

MBTI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Determination of insomnia (ISI\>10)
• Inadequate response to prior insomnia psychotherapy (e.g., CBTI) and/or pharmacotherapy per patient report.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System - Columbus

Novi, Michigan, 48377, United States

Location

Related Publications (1)

• Kalmbach DA, Cheng P, Ong JC, Reffi AN, Fresco DM, Fellman-Couture C, Ruprich MK, Sultan Z, Sagong C, Drake CL. Mindfulness-based therapy for insomnia alleviates insomnia, depression, and cognitive arousal in treatment-resistant insomnia: A single-arm telemedicine trial. Front Sleep. 2023 Mar 8;2:1072752. doi: 10.3389/frsle.2023.1072752. eCollection 2023.

  PMID: 41426462 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Rumination Syndrome; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Chaewon Sagong
• Organization: Henry Ford Health

csagong1@hfhs.org

2483442409

Study Officials

• Christopher L Drake, PhD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 30, 2018
• Study Start: September 1, 2020
• Primary Completion: April 10, 2022
• Study Completion: March 8, 2023
• Last Updated: August 22, 2024
• Results First Posted: August 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)