RecruitingNot ApplicableNCT07270406

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

Sponsor

Washington University School of Medicine

Enrollment

200 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

Insomnia Chronic Pain HIV

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.

Eligibility

Min Age: 25 YearsMax Age: 65 Years

Inclusion Criteria6

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 been a problem for at least 3 consecutive months
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 Criteria13

Subjects 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

Interventions

BEHAVIORALBrief Behavioral Treatment for Insomnia (BBTI)

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.