InsomniaNCT04951466
Mindfulness Based Therapy for Insomnia in Black Women
A study testing Mindfulness-based therapy for insomnia (MBTI) and Healthy lifestyle intervention in people with Insomnia, run by Yale University at 1 site in United States.
Trial summary
The purpose of the study is to conduct an 8-week RCT to improve insomnia among black women with insomnia and evaluate its feasibility, acceptability, and efficacy of Mindfulness Based Therapy for Insomnia (MBTI) Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Mindfulness-based therapy for insomnia (MBTI) and Healthy lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 16 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- self-identified Black women
- 25-45 years old
- English speaking
- meeting DSM-5/ICSD3 diagnostic criteria for insomnia disorders defined as difficulty initiating or maintaining sleep with at least one associated daytime impairment symptom (Insomnia severity index > 7)
Who cannot join
- Psychosis or unstable/ significant depression, anxiety, or substance abuse under active care (more than 1 monthly mental healthcare visit or requiring more than 1 psychotropic medicine daily)
- significant current practice of any form of meditation (>15min per day)
- obstructive sleep apnea (OSA), restless legs syndrome (RLS), or circadian rhythm related condition (shift worker, pregnancy, use of medication that influence circadian rhythm, e.g., Parkinson's disease)
- other medical conditions that confound salivary biomarkers outcomes (e.g., radiation of salivary glands, Cushing or Addison's disease)
- active or terminal cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University - West Campus
Orange, Connecticut, 06477
About this study
The purpose of the study is to conduct an 8-week RCT to improve insomnia among black women with insomnia and evaluate its feasibility, acceptability, and efficacy of Mindfulness Based Therapy for Insomnia (MBTI)
Read the detailed description
Study design is a randomized clinical trial (RCT) with attention control. Participants will be randomly assigned to participate in either Mindfulness Based Therapy for Insomnia (MBTI) or time and attention control. Participants in the experimental group will receive the MBTI that includes mindfulness meditation and behavioral strategies for sleep. Participants in the control group will receive healthy lifestyle education that includes healthy eating, physical activity and sleep hygiene practice to mitigate insomnia.
- Conditions
- Insomnia
- Being tested
- Mindfulness-based therapy for insomnia (MBTI), Healthy lifestyle intervention
- Keywords
- Mindfulness-based therapy for insomnia (MBTI)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based therapy for insomnia (MBTI)Behavioural
Participants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.
Healthy lifestyle interventionBehavioural
Participants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based therapy for insomnia (MBTI) | Experimental | Participants randomly assigned to the MBTI will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks. Receives: Behavioral: Mindfulness-based therapy for insomnia (MBTI) |
| Healthy Lifestyle Education | Active comparator | Participants in the control group will receive sessions on the following topics: Introduction to health promotion, disease prevention and screening, healthy eating, physical activity, communication, and endings. Receives: Behavioral: Healthy lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Retention will be measured in the study. The following information will be collected: percentage of participants completing baseline and follow-up assessments, reasons for dropouts
Measured: 10 weeks
Enrollment
The refusal rate of enrollment will be used to measure enrollment to determine feasibility
Measured: 10 weeks
Change in Fidelity
Fidelity: Self-report checklist by interventionists and observers. We will use the Treatment Fidelity Tool for Mindfulness Interventions.
Measured: Baseline and week 10
Change in Insomnia severity score
The reliable and valid Insomnia severity Index (ISI) for clinical diagnosis for insomnia (ICSD) will be used to determine insomnia severity score. Clinical cut points for ISI are as follows: no insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). Response to the intervention on the ISI will be defined as a meaningful change of 7 or more points from baseline, or remission as reduction to a score less than 8.
Measured: Baseline and week 10
Change in sleep onset latency
Sleep onset latency is the amount of time, in minutes, it takes a person to fall asleep. It begins at "light out' when the lights are turned off and the person attempts to fall asleep, and ends at sleep onset. A sleep latency of 10-20 minutes is considered normal.
Measured: Baseline and week 10
Change in sleep efficiency and quality
Will be measured by a wrist sleep actigraphy and sleep diary. Sleep efficiency is defined by the ratio of total sleep time to time in bed. Normal sleep efficiency for a healthy adult is 90% or higher. Sleep quality will be collected by participant's self-report using a 0-10 numerical scale (higher score means better sleep quality)
Measured: Baseline and week 10
Change in wake after sleep onset
Wake after sleep onset (WASO) is the amount of wake time in minutes during the attempted sleeping period after sleep onset has been achieved.
Measured: Baseline and week 10
Change in total sleep time
Total sleep time or duration is computed by asking participants what time they wake-up and what time they go to bed (range from 0 min-1440 min).
Measured: Baseline and week 10
Change in perceived stress score (PSS)
The PSS has 10 items. It measures feelings and stressful thoughts for the past month. PSS ranges from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Measured: Baseline and week 10
Secondary outcomes (10)
Change in Cortisol
Cortisol measures levels of salivary stress. Within-group changes, compared with control, of cortisol biomarkers outcomes will be measured. Test volume, lower limit of sensitivity, range of calibrators are as follows: 25 ul, .007 ug/dl, .012 - 3.0 ug/dl for cortisol
Measured: Baseline and week 10
Change in C-reactive protein [CRP]
Within-group changes, compared with control, of C-reactive protein [CRP] biomarkers outcomes will be measured. Test volume, lower limit of sensitivity, range of calibrators are as follows: 100 ul, 9.72 pg/ml, 25-1600 pg/ml for CRP.
Measured: Baseline and week 10
Change in cytokines [IL-1β, IL-6, TNF- α])
Within-group changes, compared with control, of cytokines [IL-1β, IL-6, TNF- α]) biomarkers outcomes will be measured. Test volume, lower limit of sensitivity, range of calibrators are as follows: 60 ul, .07 pg/ml, 0-100 pg/ml for IL-6.
Measured: Baseline and week 10
Change in Patient Health Questionnaire (PHQ-9)
PHQ-9 assesses depression symptoms. Each item asks about the frequency of specific depressive symptoms experienced over the past two weeks. The response options are scored from 0 to 3, indicating "not at all" to "nearly every day." The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. The scoring can also be divided into categories, with scores of 0-4 indicating minimal or no depression, 5-9 indicating mild depression, 10-14 indicating moderate depression, 15-19 indicating moderately severe depression, and 20 or above indicating severe depression.
Measured: Baseline and week 10
Change in The Epworth Sleepiness Scale
The Epworth Sleepiness Scale: measures general level of daytime sleepiness. Each question is rated on a scale of 0 to 3, with 0 indicating no chance of dozing and 3 indicating a high chance of dozing. The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
Measured: Baseline and week 10
Change in The Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
DBAS is a 16 item-scale evaluates the following sleep-related cognitions: consequences of insomnia, worry about sleep, sleep expectations, and medication. Each item is rated on a 10-point scale ranging from 1 (strongly disagree) to 10 (strongly agree). For each statement, participants rated their level of agreement/disagreement by choosing "strongly disagree" (0) to "strongly agree" (10). The subscale score is calculated with the average score of items. A higher score indicates more dysfunctional beliefs and attitudes about sleep.
Measured: Baseline and week 10
Change in The Sleep Hygiene Practice Scale (SHPS)
The Sleep Hygiene Practice Scale (SHPS): assesses sleep hygiene awareness and practices. The SHPS has 19 items which include sleep-related behaviors (napping, caffeine/alcohol intake), night time activities (exercise, phone conversation), and bedroom environment (noise, light, temperature and bed partner). Respondents report on the average number of days per week in which they engaged in these activities during the previous month. Frequency scores (number of days per week) were calculated for each item, and higher frequency scores indicated worse sleep hygiene practices. The total hygiene practice scores ranged from 0 to 133.
Measured: Baseline and week 10
Change in The Trait Anxiety Scale
The Trait Anxiety Scale consists of 20 self-report items that assess how individuals generally feel and respond to various situations in their lives. Participants are asked to rate the frequency or intensity of their anxiety-related feelings, thoughts, and behaviors on a Likert scale. The scale typically ranges from 1 to 4 or 1 to 5, with higher scores indicating higher levels of trait anxiety.
Measured: Baseline and week 10
Change in Five Facet Mindfulness Questionnaire (FFMQ)
The Five Facet Mindfulness Questionnaire (FFMQ) will be used to measure adherence to the study protocol. The FFMQ Short Form has 24 items. Responses in the scale are made on a 5-point Likert Scale. Total FFMQ can be divided by 24 to get an average item score. The five facets, or five key aspects of mindfulness that the test measures acts as the mediator of therapeutic change and mindful interventions. Higher score means higher level in mindfulness practice.
Measured: Baseline and week 10
Change in Pittsburgh Sleep Quality Index (PSQI)
PSQI measures seven components: sleep quality, sleep latency, sleep duration, habitual sleep efficiency (percentage of total time in bed spent in sleep), sleep disturbances, use of sleep medications, and daytime dysfunction. Each component has a range from 0 (no difficulty) to 3 (severe difficulty). The global score of PSQI ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start18 Apr 2022
- Primary completion25 Oct 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951466
- Sponsor's protocol ID
- 2000030653
- Status last verified
- Nov 2023
- First submitted
- 28 Jun 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Therapy for Insomnia in Black Women
- ClinicalTrials.gov ID
- NCT04951466
- Acronym / sponsor ID
- 2000030653
- Conditions
- Insomnia
- Keywords
- Mindfulness-based therapy for insomnia (MBTI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to conduct an 8-week RCT to improve insomnia among black women with insomnia and evaluate its feasibility, acceptability, and efficacy of Mindfulness Based Therapy for Insomnia (MBTI)
Detailed description
Study design is a randomized clinical trial (RCT) with attention control. Participants will be randomly assigned to participate in either Mindfulness Based Therapy for Insomnia (MBTI) or time and attention control. Participants in the experimental group will receive the MBTI that includes mindfulness meditation and behavioral strategies for sleep. Participants in the control group will receive healthy lifestyle education that includes healthy eating, physical activity and sleep hygiene practice to mitigate insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based therapy for insomnia (MBTI) | Experimental | Behavioral: Mindfulness-based therapy for insomnia (MBTI)Participants randomly assigned to the MBTI will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks. |
| Healthy Lifestyle Education | Active comparator | Behavioral: Healthy lifestyle interventionParticipants in the control group will receive sessions on the following topics: Introduction to health promotion, disease prevention and screening, healthy eating, physical activity, communication, and endings. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- self-identified Black women
- 25-45 years old
- English speaking
- meeting DSM-5/ICSD3 diagnostic criteria for insomnia disorders defined as difficulty initiating or maintaining sleep with at least one associated daytime impairment symptom (Insomnia severity index > 7)
Key exclusion criteria (5 listed)
- Psychosis or unstable/ significant depression, anxiety, or substance abuse under active care (more than 1 monthly mental healthcare visit or requiring more than 1 psychotropic medicine daily)
- significant current practice of any form of meditation (>15min per day)
- obstructive sleep apnea (OSA), restless legs syndrome (RLS), or circadian rhythm related condition (shift worker, pregnancy, use of medication that influence circadian rhythm, e.g., Parkinson's disease)
- other medical conditions that confound salivary biomarkers outcomes (e.g., radiation of salivary glands, Cushing or Addison's disease)
- active or terminal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based therapy for insomnia (MBTI)Participants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks. | Behavioural | Mindfulness-based therapy for insomnia (MBTI) |
| Healthy lifestyle interventionParticipants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks. | Behavioural | Healthy Lifestyle Education |
Primary outcome
Retention
Time frame: 10 weeks
Retention will be measured in the study. The following information will be collected: percentage of participants completing baseline and follow-up assessments, reasons for dropouts
Enrollment
Time frame: 10 weeks
The refusal rate of enrollment will be used to measure enrollment to determine feasibility
Change in Fidelity
Time frame: Baseline and week 10
Fidelity: Self-report checklist by interventionists and observers. We will use the Treatment Fidelity Tool for Mindfulness Interventions.
Change in Insomnia severity score
Time frame: Baseline and week 10
The reliable and valid Insomnia severity Index (ISI) for clinical diagnosis for insomnia (ICSD) will be used to determine insomnia severity score. Clinical cut points for ISI are as follows: no insomnia (0-7), sub-threshold insomnia (8-14), moderate insomnia (15-21), and severe insomnia (22-28). Response to the intervention on the ISI will be defined as a meaningful change of 7 or more points from baseline, or remission as reduction to a score less than 8.
Change in sleep onset latency
Time frame: Baseline and week 10
Sleep onset latency is the amount of time, in minutes, it takes a person to fall asleep. It begins at "light out' when the lights are turned off and the person attempts to fall asleep, and ends at sleep onset. A sleep latency of 10-20 minutes is considered normal.
Change in sleep efficiency and quality
Time frame: Baseline and week 10
Will be measured by a wrist sleep actigraphy and sleep diary. Sleep efficiency is defined by the ratio of total sleep time to time in bed. Normal sleep efficiency for a healthy adult is 90% or higher. Sleep quality will be collected by participant's self-report using a 0-10 numerical scale (higher score means better sleep quality)
Change in wake after sleep onset
Time frame: Baseline and week 10
Wake after sleep onset (WASO) is the amount of wake time in minutes during the attempted sleeping period after sleep onset has been achieved.
Change in total sleep time
Time frame: Baseline and week 10
Total sleep time or duration is computed by asking participants what time they wake-up and what time they go to bed (range from 0 min-1440 min).
Change in perceived stress score (PSS)
Time frame: Baseline and week 10
The PSS has 10 items. It measures feelings and stressful thoughts for the past month. PSS ranges from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
10 secondary outcomes
Change in Cortisol
Time frame: Baseline and week 10
Change in C-reactive protein [CRP]
Time frame: Baseline and week 10
Change in cytokines [IL-1β, IL-6, TNF- α])
Time frame: Baseline and week 10
Change in Patient Health Questionnaire (PHQ-9)
Time frame: Baseline and week 10
Change in The Epworth Sleepiness Scale
Time frame: Baseline and week 10
Change in The Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
Time frame: Baseline and week 10
Change in The Sleep Hygiene Practice Scale (SHPS)
Time frame: Baseline and week 10
Change in The Trait Anxiety Scale
Time frame: Baseline and week 10
Change in Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Baseline and week 10
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based therapy for insomnia (MBTI) and Healthy lifestyle intervention in people with Insomnia, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 10 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.