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

NCT07270406 | Recruiting DMC

• 2 other identifiers: 202508064R01MD021001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• sleep quality as determined by the Insomnia Severity Index (ISI)

  Sleep quality as determined by the Insomnia Severity Index (ISI), a brief screening tool for insomnia, seven-item questionnaire that asks respondents to rate the nature and symptoms of their sleep problems using a Likert-type scale. Scoring: Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) = \_\_\_\_\_\_\_ your total score Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)

  4 months

• pain severity and interference (BPI-SF).

  Pain severity and interference as measured by the Brief Pain Inventory - Short Form, (BPI-SF), a self-administered questionnaire designed to assess both the severity of pain and its impact on daily function. Scoring: Pain Severity Score = Mean of items 3-6 (pain at its worst, pain at its least, average. Higher scores indicate greater pain severity, range 0-10) Pain Interference Score = Mean of items 9A-9G (interference of pain with: general activity, mood, walking, normal work, relations, sleep, enjoyment of life. Higher scores indicate greater pain interference, range 0-10)

  4 months

Secondary Outcomes (2)

• Quality of life (SF-36)

  4 months

• pace of biological aging (DunedinPACE).

  4 months

Study Arms (2)

Brief Behavioral Treatment for Insomnia (BBTI)

EXPERIMENTAL

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.

Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)

Brief Mindfulness Training (BMT)

EXPERIMENTAL

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.

Behavioral: Brief Mindfulness Training (BMT)

Interventions

Brief Behavioral Treatment for Insomnia (BBTI) 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 Behavioral Treatment for Insomnia (BBTI)

Brief Mindfulness Training (BMT) 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.

Brief Mindfulness Training (BMT)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Burel Goodin, PhD

  WashU Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dyan White-Gilliam, BS

CONTACT

314-747-4317; dyanw@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: February 16, 2026
• Primary Completion (Estimated): September 16, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start date: 12 months following primary outcomes publication End date: No end date
• Access Criteria: Any qualified investigator will be able to access all de-identified data upon request and approval by Principal Investigator (Goodin)

Locations

US (1)