Phone-delivered healthy behavior programs to prevent insomnia in people with HIV with chronic pain

Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain

This test compares brief phone-delivered behavioral insomnia treatment versus brief phone-delivered mindfulness training to see if they reduce insomnia, ease chronic pain, and slow biological aging in adults with HIV who have ongoing pain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 25 Years to 65 Years
• Sex: All
• Sponsor: Washington University School of Medicine (other)
• Locations: 1 site (St Louis, Missouri)
• Trial ID: NCT07270406 on ClinicalTrials.gov

What this trial studies

Adults with HIV aged 25–65 who are on stable antiretroviral therapy and report chronic pain and clinically significant insomnia are enrolled at Washington University School of Medicine. Participants receive either brief behavioral treatment for insomnia (BBTI) or brief mindfulness training (BMT), both delivered by phone, with scheduled sessions and follow-up assessments. The study measures changes in insomnia severity, pain intensity, and markers of biological aging collected through clinical assessments and blood-based tests. The approach emphasizes low-burden, phone-delivered interventions tailored to a clinic-based HIV population.

Who should consider this trial

Good fit: Ideal candidates are people with HIV aged 25–65 who are on stable antiretroviral therapy, have chronic pain rated ≥3/10, and meet insomnia criteria (Insomnia Severity Index ≥15 and DSM-5 insomnia for at least three months).

Not a fit: People without clinically significant insomnia or chronic pain, those not receiving care at the WashU Infectious Disease Clinic, or those with exclusionary conditions such as recent stroke, active cancer treatment, or heart disease are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the interventions could improve sleep, reduce chronic pain, and potentially slow biological aging for people with HIV.

How similar studies have performed: Previous research shows that brief behavioral insomnia treatments and mindfulness can improve sleep and reduce pain, although phone-delivered programs and effects on biological aging are less well-established.

Eligibility criteria

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

Where this trial is running

St Louis, Missouri

• Washington University School of Medicine — St Louis, Missouri, United States (RECRUITING)

Study contacts

• Principal investigator: Burel Goodin, PhD — WashU Medicine
• Study coordinator: Dyan White-Gilliam, BS

Conditions: Chronic Pain, Insomnia, HIV