Mindfulness Based Therapy for Insomnia in Black Women

NCT04951466 | Completed DMC

• 1 other identifier: 2000030653
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Insomnia

Keywords

Mindfulness-based therapy for insomnia (MBTI)

Outcome Measures

Primary Outcomes (9)

• 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

  10 weeks

• Enrollment

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

  10 weeks

• Change in Fidelity

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

  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.

  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.

  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)

  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.

  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).

  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.

  Baseline and week 10

Secondary Outcomes (10)

• Change in Cortisol

  Baseline and week 10

• Change in C-reactive protein [CRP]

  Baseline and week 10

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

  Baseline and week 10

• Change in Patient Health Questionnaire (PHQ-9)

  Baseline and week 10

• Change in The Epworth Sleepiness Scale

  Baseline and week 10

Study Arms (2)

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.

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.

Behavioral: Healthy lifestyle intervention

Interventions

Mindfulness-based therapy for insomnia (MBTI) BEHAVIORAL

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.

Mindfulness-based therapy for insomnia (MBTI)

Healthy lifestyle intervention BEHAVIORAL

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 Education

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: Self-identified Black women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• self-identified Black women
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University - West Campus

Orange, Connecticut, 06477, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 6, 2021
• Study Start: April 18, 2022
• Primary Completion: October 25, 2022
• Study Completion: November 16, 2022
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

US (1)