Electrophysiologic Changes in Blacks Treated With CBT for Insomnia

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I); Behavioral: Self-Monitoring

• 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

Arm && Interventions

Group	Intervention	Description
CBT-I Intervention	Cognitive Behavioral Therapy for Insomnia (CBT-I)	For those randomized to the CBT-I group, the therapist will initiate telephone-delivered cognitive-behavioral therapy within 2 weeks of baseline assessment. Participants will complete 4 telephone sessions over a period of 8 weeks. Sessions last approximately 45 minutes. CBT-I is a short-term, focused psychotherapy that is action-oriented, practical, rational, and helps the patient gain independence and effectiveness in dealing with real-life issues. Techniques utilized in CBT-I include psychoeducation, sleep hygiene, cognitive restructuring, stimulus control, sleep restriction, and relaxation training.
Self-Monitoring Control Group	Self-Monitoring	Individuals randomized to the self-monitoring control group will be asked to complete a weeklong sleep diary every other week for 8 weeks. The sleep diary will inquire about (1) the time of getting into bed; (2) the time at which the individual attempted to fall asleep; (3) sleep onset latency; (4) number of awakenings; (5) duration of awakenings; (6) time of final awakening; (7) final rise time; (8) perceived sleep quality (rated via Likert scale); and (9) an additional space for open-ended comments from the respondent. The control condition is designed to increase self-monitoring, which has been demonstrated to be an effective means of inducing change for various health behaviors such as diet and exercise.

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