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Trial Outcomes & Findings for Reduce Emotional Symptoms of Insomnia With SleepTreatment (NCT NCT03724305)

NCT ID: NCT03724305

Last Updated: 2024-08-22

Results Overview

Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity of insomnia symptoms)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Pre-treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment)

Results posted on

2024-08-22

Participant Flow

Participant milestones

Participant milestones
Measure
MBTI
Mindfulness-Based Therapy for Insomnia 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.
Overall Study
STARTED
21
Overall Study
COMPLETED
19
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reduce Emotional Symptoms of Insomnia With SleepTreatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MBTI
n=21 Participants
Mindfulness-Based Therapy for Insomnia 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.
Age, Continuous
57.16 years
STANDARD_DEVIATION 14.69 • n=5 Participants
Sex: Female, Male
Female
16 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
12 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Black
7 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Others
2 Participants
n=5 Participants
Insomnia Severity Index
16.42 units on a scale
STANDARD_DEVIATION 3.95 • n=5 Participants
Five Facet Mindfulness Questionnaire-15 (FFMQ-15)
52.95 units on a scale
STANDARD_DEVIATION 8.30 • n=5 Participants

PRIMARY outcome

Timeframe: Pre-treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment)

Population: Those with clinically significant insomnia symptoms (Insomnia Severity Index ≥ 11) and inadequate response to prior insomnia intervention per patient report.

Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity of insomnia symptoms)

Outcome measures

Outcome measures
Measure
MBTI
n=21 Participants
Mindfulness-Based Therapy for Insomnia 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.
Insomnia Severity Index
Pre-treatment
16.42 score on a scale
Standard Deviation 3.95
Insomnia Severity Index
Post-treatment (7 weeks following initiation of treatment)
8.37 score on a scale
Standard Deviation 4.19
Insomnia Severity Index
6 months follow-up (6 months following completion of treatment)
11.72 score on a scale
Standard Deviation 4.95

PRIMARY outcome

Timeframe: Pre-treatment, post-treatment (7 weeks after initiation of treatment), and 6 months follow-up (6 months following treatment conclusion)

Population: Those with clinically significant insomnia symptoms (Insomnia Severity Index ≥ 11) and inadequate response to prior insomnia intervention per patient report.

Five Facet Mindfulness Questionnaire - 15 (total scores ranges 15-75, with higher scores indicating someone who is more mindful in their everyday life.)

Outcome measures

Outcome measures
Measure
MBTI
n=21 Participants
Mindfulness-Based Therapy for Insomnia 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.
Five Facet Mindfulness Questionnaire-15 (FFMQ-15)
Pre-treatment
52.95 score on a scale
Standard Deviation 8.3
Five Facet Mindfulness Questionnaire-15 (FFMQ-15)
Post-treatment
57.42 score on a scale
Standard Deviation 9.87
Five Facet Mindfulness Questionnaire-15 (FFMQ-15)
6 months follow-up
55.50 score on a scale
Standard Deviation 10.29

Adverse Events

MBTI

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chaewon Sagong

Henry Ford Health

Phone: 2483442409

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place