SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
NCT Number: NCT02741336
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.
Looking for future studies?
Notify Me30 year–50 year
Female
Interventional
Not applicable
Brooklyn, New York, 11203, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2 months after enrollment
Time frame: 2 months
State University of New York - Downstate Medical Center
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT05956886
Dyssomnias, Glucose Metabolism Disorders
Newark, Delaware, United States
View Trial DetailsNCT03665337
Delayed Sleep Phase, Dyssomnias
San Francisco, California, United States
View Trial DetailsNCT07417163
Cirrhosis, Dyssomnias
Boston, Massachusetts, United States
View Trial DetailsNCT04936321
Brain Diseases, Central Nervous System Diseases
Seattle, Washington, United States
View Trial Details