Chronic PainHIP HOPNCT07270406
Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain
A study testing Brief Behavioral Treatment for Insomnia (BBTI) and Brief Mindfulness Training (BMT) in people with Chronic Pain and Insomnia, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Chronic Pain, Insomnia, HIV
- What is being tested?
- Brief Behavioral Treatment for Insomnia (BBTI) and Brief Mindfulness Training (BMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Dyan White-Gilliam, 314-747-4317, dyanw@wustl.edu
About this study
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
- Being tested
- Brief Behavioral Treatment for Insomnia (BBTI), Brief Mindfulness Training (BMT)
- Medical subject headings
- Chronic Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Treatment for Insomnia (BBTI)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Brief Mindfulness Training (BMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 4 months
Secondary outcomes (2)
Quality of life (SF-36)
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.
Measured: 4 months
pace of biological aging (DunedinPACE).
DunedinPACE will allow for a measurement of the rate of biological decline.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start16 Feb 2026
- Primary completion16 Sep 2029 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Burel Goodin, Washington University School of Medicine
- Investigators
- Burel Goodin, PhD, Principal investigator, WashU Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270406
- Sponsor's protocol ID
- 202508064
- Other IDs
- R01MD021001
- Acronym
- HIP HOP
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain
- ClinicalTrials.gov ID
- NCT07270406
- Acronym / sponsor ID
- HIP HOP / 202508064
- Conditions
- Chronic Pain, Insomnia, HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 16 Sep 2029 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTI) | Experimental | Behavioral: 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) | Experimental | 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Brief Behavioral Treatment for Insomnia (BBTI) |
| 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. | Behavioural | Brief Mindfulness Training (BMT) |
Primary outcome
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)
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)
2 secondary outcomes
Quality of life (SF-36)
Time frame: 4 months
pace of biological aging (DunedinPACE).
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. All de-identified IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Burel Goodin, PhD principal investigator
WashU Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Treatment for Insomnia (BBTI) and Brief Mindfulness Training (BMT) in people with Chronic Pain and Insomnia, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dyan White-Gilliam, BS (314-747-4317, dyanw@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality as determined by the Insomnia Severity Index (ISI) (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.