Study Summary
This trial is testing whether an app-based meditation intervention can reduce sleep disturbance, fatigue, emotional distress, and inflammatory markers in people with HIV who are also on stable CHC pharmacologic therapy.
- Sleep Disorder
- Fatigue
- Depression
- Inflammation
- Anxiety
- Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 4 Secondary · Reporting Duration: Changes in sleep disturbance will be measured at baseline, week 8, and week 20. This form consists of 8 items in a 1-5 Likert scale. The measure generates a total summed score, which is then converted to a standardized t-score.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Health Education Podcast
1 of 2
Calm Meditation
1 of 2
Active Control
Experimental Treatment
276 Total Participants · 2 Treatment Groups
Primary Treatment: Calm Meditation · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 11 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| California | 53.3% |
| Texas | 26.7% |
| Illinois | 6.7% |
| Other | 13.3% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Calm, Inc. | 88.9% |
| Mays Cancer Center at UT Health San Antonio | 11.1% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 37.5% |
| Met criteria | 62.5% |
How many prior treatments have patients received?
| 0 | 80.0% |
| 2 | 20.0% |
Why did patients apply to this trial?
- "Sick of poor sleep"
- Huberty, Jennifer, Nishat Bhuiyan, Ryan Eckert, Linda Larkey, Megan Petrov, Michael Todd, and Ruben Mesa. 2022. “Insomnia as an Unmet Need in Patients with Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-based Meditation App for Treatment of Sleep Disturbance”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/39007.
- 2023. "Reducing Sleep disTurbance in Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05294991.
Frequently Asked Questions
What key outcomes is this trial striving to achieve?
"According to the trial sponsor, Laboratory Corporation of America, the main objective is assessing changes in sleep disturbance over a time period. This will be measured at baseline, week 8 and week 20 using an eight item Likert scale which converts into a standardized t-score. Secondary objectives include evaluating fatigue with PROMIS Adult Cancer Fatigue Short Form 7a (7 items on 1-5 Likert scale), anxiety with PROMIS Emotional Distress-Anxiety Short Form 7a (also seven items) and depression with PROMIS Emotional Distress-Depression Short Form 8a (eight items)." - Anonymous Online Contributor
Are individuals able to enroll for this clinical experiment at present?
"Unfortunately, the clinical trial listed on clinicaltrials.gov is no longer enrolling participants; however, this information was last updated November 9th 2022. There are currently 2430 other trials actively recruiting patients in its stead." - Anonymous Online Contributor