Insomnia, Rumination
Conditions
Keywords
insomnia, nocturnal rumination, depression, mindfulness, mindfulness-based therapy for insomnia
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.
Interventions
BEHAVIORALMindfulness-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.
Sponsors
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | Pre-treatment, post-treatment (7 weeks following initiation of treatment), and 6 months follow-up (6 months following conclusion of treatment) | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity of insomnia symptoms) |
| Five Facet Mindfulness Questionnaire-15 (FFMQ-15) | Pre-treatment, post-treatment (7 weeks after initiation of treatment), and 6 months follow-up (6 months following treatment conclusion) | Five Facet Mindfulness Questionnaire - 15 (total scores ranges 15-75, with higher scores indicating someone who is more mindful in their everyday life.) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | MBTI |
|---|---|
| Age, Continuous | 57.16 years STANDARD_DEVIATION 14.69 |
| Five Facet Mindfulness Questionnaire-15 (FFMQ-15) | 52.95 units on a scale STANDARD_DEVIATION 8.3 |
| Insomnia Severity Index | 16.42 units on a scale STANDARD_DEVIATION 3.95 |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Black | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic White | 12 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Others | 2 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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.)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBTI | Five Facet Mindfulness Questionnaire-15 (FFMQ-15) | Pre-treatment | 52.95 score on a scale | Standard Deviation 8.3 |
| MBTI | Five Facet Mindfulness Questionnaire-15 (FFMQ-15) | Post-treatment | 57.42 score on a scale | Standard Deviation 9.87 |
| MBTI | Five Facet Mindfulness Questionnaire-15 (FFMQ-15) | 6 months follow-up | 55.50 score on a scale | Standard Deviation 10.29 |
Primary
Insomnia Severity Index
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores indicating greater severity of insomnia symptoms)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBTI | Insomnia Severity Index | Pre-treatment | 16.42 score on a scale | Standard Deviation 3.95 |
| MBTI | Insomnia Severity Index | Post-treatment (7 weeks following initiation of treatment) | 8.37 score on a scale | Standard Deviation 4.19 |
| MBTI | Insomnia Severity Index | 6 months follow-up (6 months following completion of treatment) | 11.72 score on a scale | Standard Deviation 4.95 |