Recruiting

BBTI & BMT

Sponsor:

Washington University School of Medicine

Code:

NCT07270406

Conditions

Chronic Pain

Insomnia

HIV

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Interventions

Brief Behavioral Treatment for Insomnia (BBTI)

Brief Mindfulness Training (BMT)

Study Details

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.

Conditions

Chronic Pain

Insomnia

HIV

Study ID

NCT07270406

Start date

Feb 16, 2026

Status verified date

Jul, 2026

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Sep 16, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brief 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.

experimental: Brief 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.

Interventions

Brief 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.

Brief 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.

Primary outcome measure

  • sleep quality as determined by the Insomnia Severity Index (ISI) [ Time Frame: 4 months ]
  • pain severity and interference (BPI-SF). [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Dyan White-Gilliam, BS

314-747-4317dyanw@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-07.