Electrophysiologic Changes in Blacks Treated With CBT for Insomnia

Not Applicable

Completed

• Conditions: Insomnia

• Registration Number: NCT02741336
• Lead Sponsor: State University of New York - Downstate Medical Center

Brief Summary

Insomnia is a highly prevalent, often debilitating, and economically burdensome condition. Reviews of the literature indicate that there are ethnic differences in sleep behavior, with African Americans objectively and subjectively reporting more disordered sleep than Caucasian Americans.Chronic insomnia can have a significant impact on mental and physical health outcomes and has been associated with impaired cognitive performance, particularly, in areas of speed, attention, working memory, and executive function. In order to understand the brain mechanisms in sleep disorder both during resting state as well as during cognitive processing, the investigators will assess resting state EEG (during eyes-closed and eyes-open conditions) as well as ERP tasks for assessing decision-making and reward processing. The primary objective of the study is to evaluate the effect of a tailored, telephone-delivered cognitive behavioral intervention, versus a self- monitoring control condition, on symptoms of insomnia and its neurodynamic correlates.

Hypotheses: Among Blacks subjectively reporting symptoms of insomnia, those randomized to the tailored, telephone-delivered CBT-I, compared with those randomized to the self-monitoring control group, will have: Hyp. 1: Greater reduction in symptoms of insomnia as measured by the Pittsburgh Sleep Quality Index. Hyp. 2: Greater neurophysiologic improvement (ERP, ERO) in the intervention condition in response to laboratory paradigms Hyp 3: Greater improvement in psychosocial functioning including reduction in depression and increase in quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-18
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• A positive endorsement of insomnia items on the Sleep Disorders Questionnaire
• Self- reported race/ethnicity as black (men and women)
• Ages 30 to 50 years
• Accessible by telephone
• No plans to move away from the region within the year following enrollment
• Consent to participate.

Exclusion Criteria

• Documented co-existing sleep apnea
• Self-reported use of sleep medication
• Impaired cognitive or functional ability precluding meaningful participation
• Stated intention to move within the same year of enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep Diary	2 months after enrollment

Secondary Outcome Measures

Name	Time	Method
QEEG tests of cognition	2 months

Trial Locations

Locations (1)

SUNY Downstate Medical Center; 🇺🇸 Brooklyn, New York, United States