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

NCT ID: NCT07270406

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2030-06-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Brief Behavioral Treatment for Insomnia (BBTI)

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

Brief Mindfulness Training (BMT)

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Burel Goodin

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burel Goodin, PhD

Role: PRINCIPAL_INVESTIGATOR

WashU Medicine

Central Contacts

Dyan White-Gilliam, BS

Role: CONTACT

dyanw@wustl.edu

314-747-4317

Other Identifiers

R01MD021001

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202508064

Identifier Type: -

Identifier Source: org_study_id