Clinical trial NCT04951466: Mindfulness Based Therapy for Insomnia in Black Women
Official title: Mindfulness Based Therapy for Insomnia in Black Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Mindfulness-based therapy for insomnia (MBTI)
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Retention
timeFrame: 10 weeks
measure: Enrollment
timeFrame: 10 weeks
measure: Change in Fidelity
timeFrame: Baseline and week 10
measure: Change in Insomnia severity score
timeFrame: Baseline and week 10
measure: Change in sleep onset latency
timeFrame: Baseline and week 10
measure: Change in sleep efficiency and quality
timeFrame: Baseline and week 10
measure: Change in wake after sleep onset
timeFrame: Baseline and week 10
measure: Change in total sleep time
timeFrame: Baseline and week 10
measure: Change in perceived stress score (PSS)
timeFrame: Baseline and week 10
Secondary outcomes:
measure: Change in Cortisol
timeFrame: Baseline and week 10
measure: Change in C-reactive protein [CRP]
timeFrame: Baseline and week 10
measure: Change in cytokines [IL-1β, IL-6, TNF- α])
timeFrame: Baseline and week 10
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and week 10
measure: Change in The Epworth Sleepiness Scale
timeFrame: Baseline and week 10
measure: Change in The Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
timeFrame: Baseline and week 10
measure: Change in The Sleep Hygiene Practice Scale (SHPS)
timeFrame: Baseline and week 10
measure: Change in The Trait Anxiety Scale
timeFrame: Baseline and week 10
measure: Change in Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline and week 10
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and week 10
Other outcomes:
Locations:
city: Orange
country: United States
facility: Yale University - West Campus
state: Connecticut
Study officials:
References: