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Prevention study for Chronic Pain
Official title Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain
ClinicalTrials.gov ID: NCT07270406
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 65
You may be able to join if
- Each subject must meet all of the following criteria and be confirmed with electronic medical records:
- Confirmed HIV diagnosis and currently a patient in the WashU Infectious Disease Clinic
- Age 25-65 years
- All people with HIV must be currently receiving stable antiretroviral therapy
- People with HIV with insomnia must report Insomnia Severity Index \>/= 15 at initial screening and meet DSM-5 diagnostic criteria for insomnia...
You likely can't join if
- people will not be enrolled if any of the following criteria exist and confirmed with electronic medical records:
- History of stroke in past 12 months
- Active cancer with treatment
- Heart disease
- Uncontrolled hypertension
- Epilepsy
See the full eligibility criteria
- Each subject must meet all of the following criteria and be confirmed with electronic medical records:
- Confirmed HIV diagnosis and currently a patient in the WashU Infectious Disease Clinic
- Age 25-65 years
- All people with HIV must be currently receiving stable antiretroviral therapy
- 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...
- 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.
- people will not be enrolled if any of the following criteria exist and confirmed with electronic medical records:
- History of stroke in past 12 months
- Active cancer with treatment
- Heart disease
- Uncontrolled hypertension
- Epilepsy
- Active pregnancy
- Reynaud's disease
- Traumatic injury or surgical procedure within the last 12 months
- Acute infection as suggested by thermometry temperature \>100.4
- Serious psychiatric disorder (bipolar disorder, psychotic disorder)
- Active suicidal ideation
- 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
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.