Mindfulness Based Therapy for Insomnia in Black Women

Yale University

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Mindfulness-based therapy for insomnia (MBTI); Behavioral: Healthy lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04951466

2000030653

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Mindfulness-based therapy for insomnia (MBTI)

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness-based therapy for insomnia (MBTI)

Healthy Lifestyle Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Healthy lifestyle intervention