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OpenTrials
Completed

NCT Number: NCT02741336

Electrophysiologic Changes in Blacks Treated With CBT for Insomnia

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.

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Key information

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral

Cognitive-behavioral therapy is a short-term, focused psychotherapy for a wide range of psychological and behavioral issues including depression, anxiety, anger, and non-compliance. The focus of the intervention is on how one thinks, behaves, and communicates in real time, as opposed to a focus on one's early childhood experiences. The therapist assists the patient in identifying specific distortions and biases in thinking and provides guidance on how to modify these beliefs. CBT helps the patient learn effective self-help skills that are used in homework assignments that ultimately help change the way one thinks, feels and behaves. The

 intervention 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

Behavioral

Primary outcomes

  1. Sleep Diary

    Time frame: 2 months after enrollment

Secondary outcomes

  1. QEEG tests of cognition

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

State University of New York - Downstate Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2016
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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