Chronic Pain, HIV, Insomnia
Conditions
Brief summary
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.
Interventions
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.
BEHAVIORALBrief Mindfulness Training (BMT)
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.
Sponsors
Washington University School of Medicine
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Each subject must meet all of the following criteria and be confirmed with electronic medical records: 1. Confirmed HIV diagnosis and currently a patient in the WashU Infectious Disease Clinic 2. Age 25-65 years 3. All people with HIV must be currently receiving stable antiretroviral therapy 4. People with HIV with insomnia must report Insomnia Severity Index \>/= 15 at initial screening and meet DSM-5 diagnostic criteria for insomnia including sleep difficulty that occurs at least 3 times per week and has been a problem for at least 3 consecutive months 5. People with HIV must also report the presence of chronic pain on the Brief Chronic Pain Screening Questionnaire and rate their chronic pain as \>/= 3 on a 0-10 scale of intensity.
Exclusion criteria
Subjects will not be enrolled if any of the following criteria exist and confirmed with electronic medical records: 1. History of stroke in past 12 months 2. Active cancer with treatment 3. Heart disease 4. Uncontrolled hypertension 5. Epilepsy 6. Active pregnancy 7. Reynaud's disease 8. Traumatic injury or surgical procedure within the last 12 months 9. Acute infection as suggested by thermometry temperature \>100.4 10. Serious psychiatric disorder (bipolar disorder, psychotic disorder) 11. Active suicidal ideation 12. Evidence for severe obstructive sleep apnea (AHI \>30/hr) according to Home Sleep Monitoring or presence of another sleep disorder other than insomnia (i.e., not insomnia) as indicated by SCISD-R
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sleep quality as determined by the Insomnia Severity Index (ISI) | 4 months | 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) |
| pain severity and interference (BPI-SF). | 4 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (SF-36) | 4 months | 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. |
| pace of biological aging (DunedinPACE). | 4 months | DunedinPACE will allow for a measurement of the rate of biological decline. |
Countries
United States
Contacts
CONTACTDyan White-Gilliam, BS
PRINCIPAL_INVESTIGATORBurel Goodin, PhD
WashU Medicine
Outcome results
None listed