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Electrophysiologic Changes in Blacks Treated With CBT for Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Self-Monitoring
Sponsored by
State University of New York - Downstate Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • SUNY Downstate Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT-I Intervention

Self-Monitoring Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Sleep Diary

Secondary Outcome Measures

QEEG tests of cognition

Full Information

First Posted
April 13, 2016
Last Updated
September 12, 2017
Sponsor
State University of New York - Downstate Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02741336
Brief Title
Electrophysiologic Changes in Blacks Treated With CBT for Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Downstate Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-I Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-Monitoring Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Monitoring
Primary Outcome Measure Information:
Title
Sleep Diary
Time Frame
2 months after enrollment
Secondary Outcome Measure Information:
Title
QEEG tests of cognition
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States

12. IPD Sharing Statement

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Electrophysiologic Changes in Blacks Treated With CBT for Insomnia

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