Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain (HIP HOP)

The Washington University

Status: Not yet enrolling

Conditions: HIV; Insomnia; Chronic Pain

Treatments: Behavioral: Brief Mindfulness Training (BMT); Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07270406

R01MD021001 (U.S. NIH Grant/Contract)

202508064

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Brief Behavioral Treatment for Insomnia (BBTI)

Experimental group

Description:

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.

Treatment:

Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)

Brief Mindfulness Training (BMT)

Experimental group

Description:

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.

Treatment:

Behavioral: Brief Mindfulness Training (BMT)