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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD021001 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The purpose of this research study is to test whether Brief Behavioral Treatment for Insomnia (BBTI) delivered over the phone or Brief Mindfulness Training (BMT) delivered over the phone is better able to improve the symptoms of insomnia, reduce chronic pain, and slow the pace of biological aging in individuals with HIV and Chronic Pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTI) | Experimental | BBTI is comprised of four, 30-min weekly sessions, each of which will be administered via telephone. BBTI, utilizes two critical behavioral principles: sleep restriction and stimulus control. |
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| Brief Mindfulness Training (BMT) | Experimental | Brief Mindfulness Training (BMT) is comprised of four, 30-min weekly sessions, each of which will be delivered via telephone. BMT utilizes concepts of being aware of what the body is sensing and feeling in the moment in order to achieve a state of calmness and relaxation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTI) | Behavioral | BBTI is comprised of four, 30-min weekly sessions, each of which will be administered via telephone. BBTI, utilizes two critical behavioral principles: sleep restriction and stimulus control. |
| Measure | Description | Time Frame |
|---|---|---|
| sleep quality as determined by the Insomnia Severity Index (ISI) | Sleep quality as determined by the Insomnia Severity Index (ISI), a brief screening tool for insomnia, seven-item questionnaire that asks respondents to rate the nature and symptoms of their sleep problems using a Likert-type scale. Scoring: Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) = _______ your total score Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) | 4 months |
| pain severity and interference (BPI-SF). | Pain severity and interference as measured by the Brief Pain Inventory - Short Form, (BPI-SF), a self-administered questionnaire designed to assess both the severity of pain and its impact on daily function. Scoring: Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least, average. Higher scores indicate greater pain severity, range 0-10) Pain Interference Score = Mean of items 9A-9G (interference of pain with: general activity, mood, walking, normal work, relations, sleep, enjoyment of life. Higher scores indicate greater pain interference, range 0-10) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (SF-36) | Quality of life as measured by the Short Form - 36, (SF-36), a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. Scoring: The SF-36 has several scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability The sections of the questionnaire will be broken into two groups, Physical and Mental. The physical section will ask about general health, limitations of activities, pain, and physical health problems. The mental section will ask about emotional health problems, social activities, and energy and emotions. |
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Inclusion Criteria
Each subject must meet all of the following criteria and be confirmed with electronic medical records:
Exclusion Criteria
Subjects will not be enrolled if any of the following criteria exist and confirmed with electronic medical records:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dyan White-Gilliam, BS | Contact | 314-747-4317 | dyanw@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Burel Goodin, PhD | WashU Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
All de-identified IPD
Start date: 12 months following primary outcomes publication End date: No end date
Any qualified investigator will be able to access all de-identified data upon request and approval by Principal Investigator (Goodin)
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Brief Mindfulness Training (BMT) | Behavioral | Brief Mindfulness Training (BMT) is comprised of four, 30-min weekly sessions, each of which will be delivered via telephone. BMT utilizes concepts of being aware of what the body is sensing and feeling in the moment in order to achieve a state of calmness and relaxation. |
|
| 4 months |
| pace of biological aging (DunedinPACE). | DunedinPACE will allow for a measurement of the rate of biological decline. | 4 months |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |