Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brief Behavioral Treatment for Insomnia (BBTI), Brief Mindfulness Training (BMT).
- Who it may be relevant to
- Registry conditions: Chronic Pain, Insomnia, HIV. Basic parameters: 25 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- sleep quality as determined by the Insomnia Severity Index (ISI) [Time frame: 4 months]
- pain severity and interference (BPI-SF). [Time frame: 4 months]
Secondary outcome measures (2)
- Quality of life (SF-36) [Time frame: 4 months]
- pace of biological aging (DunedinPACE). [Time frame: 4 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT07270406 · 202508064 · R01MD021001