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NCT Number: NCT07270406

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

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.

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Key information

Conditions

Chronic Pain Dyssomnias HIV Insomnia Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Dyan White-Gilliam

CONTACT

[email protected]

314-747-4317

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: 4 months

    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)

  2. pain severity and interference (BPI-SF).

    Time frame: 4 months

    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)

Secondary outcomes

  1. Quality of life (SF-36)

    Time frame: 4 months

    Quality of life as measured by the Short Form - 36, (SF-36), a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being.

    Scoring: The SF-36 has several scaled scores; the scores are weighted sums of the questions in each section.

    Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability

    The sections of the questionnaire will be broken into two groups, Physical and Mental. The physical section will ask about general health, limitations of activities, pain, and physical health problems. The mental section will ask about emotional health problems, social activities, and energy and emotions.

  2. pace of biological aging (DunedinPACE).

    Time frame: 4 months

    DunedinPACE will allow for a measurement of the rate of biological decline.

Study contacts

Contact information is provided by the study sponsor or research team.

Dyan White-Gilliam, BS

CONTACT

[email protected]

314-747-4317

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: HIP HOP

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Dec 8, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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