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Mindfulness Based Therapy for Insomnia in Black Women

Primary Purpose

Insomnia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness-based therapy for insomnia (MBTI)

Healthy lifestyle intervention

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Mindfulness-based therapy for insomnia (MBTI)

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Yale University - West Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-based therapy for insomnia (MBTI)

Healthy Lifestyle Education

Arm Description

Participants randomly assigned to the MBTI will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.

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.

Outcomes

Primary Outcome Measures

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

Enrollment

The refusal rate of enrollment will be used to measure enrollment to determine feasibility

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.

Change in Daily Food and Activity Diary - Control group only

Daily Food and Activity Diary will be used to measure adherence of the control participants in their daily food intake and physical activity levels. Participants in control group will be asked to record meal/snack and type/duration of physical activity.

Change in Fidelity

Fidelity: Self-report checklist by interventionists and observers. We will use the Treatment Fidelity Tool for Mindfulness Interventions.

Change in Mindfulness Practice Log - Experimental group only

The Mindfulness practice logs: will be used to measure adhere of the experimental group participants. Participants in experimental group will be asked to record the total minutes of mindfulness practice and the number of meditation session during the intervention period.

Secondary Outcome Measures

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.

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).

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.

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.

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)

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

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.

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.

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.

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.

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.

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.

Change in The Alcohol Use Disorders Identification Test (AUDIT)

AUDIT is a screening tool designed to identify individuals who may have alcohol-related problems or alcohol use disorders (AUD). Each question is scored on a scale of 0 to 4, with a total possible score ranging from 0 to 40. Higher scores indicate a greater likelihood of alcohol-related problems or AUD.

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.

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.

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.

Full Information

NCT ID

NCT04951466

First Posted

June 28, 2021

Last Updated

June 13, 2023

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT04951466

Brief Title

Mindfulness Based Therapy for Insomnia in Black Women

Official Title

Mindfulness Based Therapy for Insomnia in Black Women

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

April 18, 2022 (Actual)

Primary Completion Date

October 25, 2022 (Actual)

Study Completion Date

November 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

Mindfulness-based therapy for insomnia (MBTI)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness-based therapy for insomnia (MBTI)

Arm Type

Experimental

Arm Description

Participants randomly assigned to the MBTI will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.

Arm Title

Healthy Lifestyle Education

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness-based therapy for insomnia (MBTI)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Healthy lifestyle intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Retention

Description

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

Time Frame

10 weeks

Title

Enrollment

Description

The refusal rate of enrollment will be used to measure enrollment to determine feasibility

Time Frame

10 weeks

Title

Change in Five Facet Mindfulness Questionnaire (FFMQ)

Description

Time Frame

Baseline and week 10

Title

Change in Daily Food and Activity Diary - Control group only

Description

Time Frame

Baseline and week 10

Title

Change in Fidelity

Description

Fidelity: Self-report checklist by interventionists and observers. We will use the Treatment Fidelity Tool for Mindfulness Interventions.

Time Frame

Baseline and week 10

Title

Change in Mindfulness Practice Log - Experimental group only

Description

Time Frame

Baseline and week 10

Secondary Outcome Measure Information:

Title

Change in Insomnia severity score

Description

Time Frame

Baseline and week 10

Title

Change in total sleep time

Description

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).

Time Frame

Baseline and week 10

Title

Change in wake after sleep onset

Description

Wake after sleep onset (WASO) is the amount of wake time in minutes during the attempted sleeping period after sleep onset has been achieved.

Time Frame

Baseline and week 10

Title

Change in sleep onset latency

Description

Time Frame

Baseline and week 10

Title

Change in sleep efficiency and quality

Description

Time Frame

Baseline and week 10

Title

Change in Cortisol

Description

Time Frame

Baseline and week 10

Title

Change in C-reactive protein [CRP]

Description

Time Frame

Baseline and week 10

Title

Change in cytokines [IL-1β, IL-6, TNF- α])

Description

Time Frame

Baseline and week 10

Title

Change in perceived stress score (PSS)

Description

Time Frame

Baseline and week 10

Title

Change in Pittsburgh Sleep Quality Index (PSQI)

Description

Time Frame

Baseline and week 10

Title

Change in Patient Health Questionnaire (PHQ-9)

Description

Time Frame

Baseline and week 10

Title

Change in The Epworth Sleepiness Scale

Description

Time Frame

Baseline and week 10

Title

Change in The Alcohol Use Disorders Identification Test (AUDIT)

Description

Time Frame

Baseline and week 10

Title

Change in The Dysfunctional Beliefs and Attitudes about Sleep (DBAS)

Description

Time Frame

Baseline and week 10

Title

Change in The Sleep Hygiene Practice Scale (SHPS)

Description

Time Frame

Baseline and week 10

Title

Change in The Trait Anxiety Scale

Description

Time Frame

Baseline and week 10

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Self-identified Black women

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Facility Information:

Facility Name

Yale University - West Campus

City

Orange

State/Province

Connecticut

ZIP/Postal Code

06477

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Mindfulness Based Therapy for Insomnia in Black Women

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