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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBTI | Experimental | Mindfulness-Based Therapy for Insomnia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher L Drake, PhD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System - Columbus | Novi | Michigan | 48377 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41426462 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with clinically significant insomnia symptoms (Insomnia Severity Index ≥ 11) and inadequate response to prior insomnia intervention per patient report.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insomnia Severity Index | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity of insomnia symptoms) | Those with clinically significant insomnia symptoms (Insomnia Severity Index ≥ 11) and inadequate response to prior insomnia intervention per patient report. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment) |
|
Subjects' self-report during treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment)
The definition of adverse event and/or serious adverse event, used to collect adverse event information, doesn't differ from the clinical trials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chaewon Sagong | Henry Ford Health | 2483442409 | csagong1@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2023 | Jul 19, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 26, 2021 | Jul 19, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000079562 | Rumination Syndrome |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Insomnia Severity Index | Insomnia Severity Index (ISI) Scale is a self-report measure of insomnia symptom severity. Range is 0 to 28, high score indicating a greater insomnia severity. | Mean | Standard Deviation | units on a scale |
|
| Five Facet Mindfulness Questionnaire-15 (FFMQ-15) | Five Facet Mindfulness Questionnaire-15 measures everyday levels of mindfulness. Scale ranges from 15 to 75 with higher scores indicating a greater level of mindfulness. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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.) | Those with clinically significant insomnia symptoms (Insomnia Severity Index ≥ 11) and inadequate response to prior insomnia intervention per patient report. | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment, post-treatment (7 weeks after initiation of treatment), and 6 months follow-up (6 months following treatment conclusion) |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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| D001523 |
| Mental Disorders |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001068 | Feeding and Eating Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Title | Measurements |
|---|---|
|