Behavioral vs Mindfulness Treatments for Insomnia in HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two treatments to assist older adults with HIV who experience insomnia. One group will receive Brief Behavioral Treatment for Insomnia (BBTI), while the other will try Brief Mindfulness Treatment (BMT), both delivered over the phone. Researchers aim to determine how these treatments impact sleep and cognitive abilities over a year. Individuals who have experienced sleep difficulties at least three nights a week for three months or more, and are managing HIV with medication, may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to enhance understanding of effective insomnia treatments for those living with HIV.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking efavirenz as part of your HIV treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Brief Behavioral Treatment for Insomnia (BBTI) is generally easy for people to handle. In one study, 70% of participants completed the program, indicating its acceptability. Participants also reported finding the treatment acceptable. Another study found that BBTI improved sleep for people with HIV for up to a month after treatment, demonstrating its short-term safety and effectiveness.
For Brief Mindfulness Treatment (BMT), specific safety information is limited. However, mindfulness-based therapies are generally considered safe. One study suggested that mindfulness therapy can improve sleep quality in people with HIV, indicating it is likely well-tolerated.
Both treatments do not involve medication and use techniques like improving sleep habits or meditation, which typically have fewer side effects than drugs. Overall, based on available research, both BBTI and BMT appear to be safe options.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for insomnia in HIV patients because they offer non-drug approaches that could complement or provide alternatives to medications. Brief Behavioral Treatment for Insomnia (BBTI) focuses on changing sleep-related behaviors, which can help patients fall asleep faster and improve sleep quality without the side effects often associated with sleep medications. On the other hand, Brief Mindfulness Treatment (BMT) involves mindfulness practices to reduce stress and promote relaxation, addressing insomnia by calming the mind. Both treatments offer potential benefits in improving sleep health through unique methods that don't rely on pharmaceuticals, which is especially appealing for individuals managing multiple medications for HIV.
What evidence suggests that this trial's treatments could be effective for insomnia in older adults with HIV?
This trial will compare Brief Behavioral Treatment for Insomnia (BBTI) with Brief Mindfulness Treatment (BMT) to improve sleep in people with HIV. Research has shown that BBTI significantly reduces insomnia severity, with one study noting a decrease of 4.79 points in insomnia severity scores, highlighting its effectiveness. Meanwhile, BMT is promising, as mindfulness-based methods have enhanced sleep quality and social support for patients with HIV/AIDS. Both treatments offer potential benefits, but BBTI has stronger evidence supporting its ability to reduce insomnia symptoms in people living with HIV.12567
Who Is on the Research Team?
Dr. Shameka L Cody, PhD, AGNP-C, PMHNP-BC, FAAN
Principal Investigator
The University of Alabama Capstone College of Nursing
Are You a Good Fit for This Trial?
This trial is for adults aged 50 and older who are living with HIV and suffering from insomnia. They should be willing to undergo telephone-delivered treatments and attend in-person visits for assessments, including blood collection, at the start, after treatment, and one year later.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants complete 4 weeks of telephone-delivered Brief Behavioral Treatment Insomnia (BBTI) or Brief Mindfulness Treatment (BMT)
Follow-up
Participants are monitored for sleep and cognitive outcomes, with assessments at baseline, post-intervention, and 1-year post-intervention
What Are the Treatments Tested in This Trial?
Interventions
- BBTI
- BMT
Trial Overview
The study compares two treatments: Brief Behavioral Treatment Insomnia (BBTI) and Brief Mindfulness Treatment (BMT). It looks at how these affect sleep quality and cognitive function over a year in older adults with HIV. Participants will receive phone sessions of their assigned treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama, Tuscaloosa
Lead Sponsor
University of Alabama at Birmingham
Collaborator
National Institute on Aging (NIA)
Collaborator
NIH Office of AIDS Research (OAR)
Collaborator
Citations
Brief Behavioral Treatment for Insomnia in Persons Living ...
This study examined the feasibility and preliminary efficacy of brief behavioral treatment for insomnia (BBTI) for persons living with HIV (PLWH).
Healthy Behaviors for Insomnia Prevention in People With ...
The purpose of this research study is to test whether Brief Behavioral Treatment for Insomnia (BBTI) delivered over the phone or Brief ...
Improving Sleep in People with HIV and Chronic Pain
This pilot study demonstrated that BBTI improved insomnia in people with HIV for up to one-month post-treatment.
Comparative Efficacy of Brief Behavioral Therapy for Insomnia ...
Compared with usual care, BBTI significantly reduced insomnia severity (mean difference [MD] = −4.79; 95% confidence interval [CI = −6.05, −3.53]; ...
Brief Behavioral Treatment of Insomnia
In a 2011 initial efficacy study, individuals who completed BBTI demonstrated improvement in sleep over 6 months.9 The authors provide a brief overview of BBTI, ...
Improving Sleep in People with HIV and Chronic Pain - PubMed
This pilot study demonstrated that BBTI improved insomnia in people with HIV for up to one-month post-treatment.
Preliminary feasibility and efficacy of a brief behavioural ...
BBTI was found to be well tolerated, as evidenced by the high overall retention rates (70%) and positive feedback on the treatment acceptability ...
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