An interventional study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Self-Monitoring in Insomnia, sponsored by State University of New York - Downstate Medical Center. Completed at 1 site in United States. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-09-13.
Sponsored by State University of New York - Downstate Medical Center · Not applicable, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 10 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →State University of New York - Downstate Medical Center is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
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.
Behavioral: Self-Monitoring
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.
Sleep Diary
Time frame: 2 months after enrollment
QEEG tests of cognition
Time frame: 2 months
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
State University of New York - Downstate Medical Center