HIV/AIDSNCT03390114
Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection
A study testing SHUTi in people with HIV/AIDS and Insomnia, run by Indiana University at 1 site in United States.
Trial summary
The goal of this preliminary study is to determine the efficacy of an internet-based treatment program for insomnia for HIV-infected persons. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SHUTi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection, documented by both: (1) any licensed rapid HIV test or HIV enzyme test kit at any time prior to study entry and (2) by at least one detectable HIV-1 antigen or at least one detectable plasma HIV-1 RNA viral load.
- Age equal to or greater than 18 years.
- Ongoing receipt of antiretroviral therapy of any kind for at least 3 months prior to the Entry Visit.
- HIV-1 RNA level < 75 copies/mL obtained during routine clinical care within 90 days of the Entry Visit.
- NOTE: There are no CD4 cell count eligibility criteria for this trial.
- ISI score ≥ 15
Who cannot join
- Inability to complete written, informed consent.
- Incarceration at the time of any study visit.
- Active suicidality, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9
- Diagnosed vascular disease (documented history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease).
- History of congestive heart failure, even if currently compensated.
- Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosis, inflammatory bowel diseases, other collagen vascular diseases).
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- Note: Hepatitis B or C co-infections are NOT exclusionary
- Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.
- NOTE: Localized treatment for skin cancers is not exclusionary.
- Uncontrolled hyperthyroidism or hypothyroidism, defined as TSH values outside of the local reference range on most recent clinical assessment.
- Last known clinic-based estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2. (calculated from the 2009 CKD-EPI equation).
- Uncontrolled diabetes defined as the last known clinic-based Hgb A1C > 8.0 g/dL.
- Last known clinic-based total cholesterol > 240 mg/dL.
- Therapy for serious medical illnesses within 14 days prior to screening.
- Note: Therapy for serious medical illnesses that overlaps with a main study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation.
- Pregnancy or breastfeeding during the course of the study.
- Receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit.
- Note: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors.
- Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- History of schizophrenia, bipolar disorder, or dementia.
- NOTE: Depression is not exclusionary as long as the severity of depression does impede ability to perform the required study procedures.
- Musculoskeletal or neurologic disorders that impede ability to perform the required study procedures.
- History of sleep apnea or restless leg syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site
Infectious Diseases Research Center
Indianapolis, Indiana, 46202
About this study
Official title: Internet-Based Cognitive Behavioral Therapy to Treat Insomnia in HIV: A Pilot Trial
The goal of this preliminary study is to determine the efficacy of an internet-based treatment program for insomnia for HIV-infected persons.
Read the detailed description
The primary objective of this pilot trial is to compare 10-week changes in Insomnia Severity Index (ISI) scores in HIV-infected adults with clinically relevant insomnia severity and who are already receiving virologically suppressive antiretroviral therapy (ART) and are then randomized to either treatment with the SHUTi cognitive behavioral therapy program or to Usual Care (UC). A total of 100 persons with HIV may be screened to identify the 32 participants to be enrolled and randomized into the pilot trial. These participants will be ≥ 18 years old, have been receiving antiretroviral therapy with an HIV viral load < 75 copies/mL within three months of the Entry Visit, and have an ISI score ≥ 15 within three months of the Entry Visit. These participants will be randomized 1:1 (stratified by age <40 vs. ≥ 40 years) to either insomnia treatment with the SHUTi cognitive behavioral therapy program (N=16) or usual care (N=16).
- Being tested
- SHUTi
- Keywords
- HIV, Insomnia, Cognitive Behavioral Therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHUTiBehavioural
SHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points.
| Study group | Role | What they receive |
|---|---|---|
| SHUTi Cognitive Behavioral Therapy | Experimental | SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia. Receives: Behavioral: SHUTi |
| Usual Care | No intervention | Patients randomized to the Usual Care group will be encouraged to follow-up with their primary care or HIV provider. There will be no formal interaction with the participants between the Entry Visit and the Week 10 Visit. However, the participants will be encouraged to contact the study team for any changes in their condition. There will be no restrictions on the care that can be received, although we will assess changes in care during the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Change in the Insomnia Severity Index (ISI) score as measured by questionnaire. The ISI score ranges from 0 to 28 with higher scores indicating greater severity in insomnia symptoms.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start1 May 2018
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Model description
- 10-week, randomized, controlled, single-blinded, two-arm, parallel group, pilot trial at a single center
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir K Gupta, MD, MS, Indiana University
- Investigators
- Samir K Gupta, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390114
- Sponsor's protocol ID
- 1712469162
- Status last verified
- Feb 2021
- First submitted
- 28 Dec 2017
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available to other researchers. These include demographics, medical history/medication history, ISI scores, and changes in ISI scores by study arm.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Cognitive Behavioral Therapy to Treat Insomnia in HIV: A Pilot Trial
- ClinicalTrials.gov ID
- NCT03390114
- Acronym / sponsor ID
- 1712469162
- Keywords
- HIV, Insomnia, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this preliminary study is to determine the efficacy of an internet-based treatment program for insomnia for HIV-infected persons.
Detailed description
The primary objective of this pilot trial is to compare 10-week changes in Insomnia Severity Index (ISI) scores in HIV-infected adults with clinically relevant insomnia severity and who are already receiving virologically suppressive antiretroviral therapy (ART) and are then randomized to either treatment with the SHUTi cognitive behavioral therapy program or to Usual Care (UC). A total of 100 persons with HIV may be screened to identify the 32 participants to be enrolled and randomized into the pilot trial. These participants will be ≥ 18 years old, have been receiving antiretroviral therapy with an HIV viral load < 75 copies/mL within three months of the Entry Visit, and have an ISI score ≥ 15 within three months of the Entry Visit. These participants will be randomized 1:1 (stratified by age <40 vs. ≥ 40 years) to either insomnia treatment with the SHUTi cognitive behavioral therapy program (N=16) or usual care (N=16).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 10-week, randomized, controlled, single-blinded, two-arm, parallel group, pilot trial at a single center
| Arm | Type | Receives |
|---|---|---|
| SHUTi Cognitive Behavioral Therapy | Experimental | Behavioral: SHUTiSHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia. |
| Usual Care | No intervention | –Patients randomized to the Usual Care group will be encouraged to follow-up with their primary care or HIV provider. There will be no formal interaction with the participants between the Entry Visit and the Week 10 Visit. However, the participants will be encouraged to contact the study team for any changes in their condition. There will be no restrictions on the care that can be received, although we will assess changes in care during the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-1 infection, documented by both: (1) any licensed rapid HIV test or HIV enzyme test kit at any time prior to study entry and (2) by at least one detectable HIV-1 antigen or at least one detectable plasma HIV-1 RNA viral load.
- Age equal to or greater than 18 years.
- Ongoing receipt of antiretroviral therapy of any kind for at least 3 months prior to the Entry Visit.
- HIV-1 RNA level < 75 copies/mL obtained during routine clinical care within 90 days of the Entry Visit.
- NOTE: There are no CD4 cell count eligibility criteria for this trial.
Key exclusion criteria (23 listed)
- Inability to complete written, informed consent.
- Incarceration at the time of any study visit.
- Active suicidality, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9
- Diagnosed vascular disease (documented history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease).
- History of congestive heart failure, even if currently compensated.
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 |
|---|---|---|
| SHUTiSHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points. | Behavioural | SHUTi Cognitive Behavioral Therapy |
Primary outcome
Insomnia Severity Index
Time frame: 10 weeks
Change in the Insomnia Severity Index (ISI) score as measured by questionnaire. The ISI score ranges from 0 to 28 with higher scores indicating greater severity in insomnia symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be made available to other researchers. These include demographics, medical history/medication history, ISI scores, and changes in ISI scores by study arm.
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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. This study is not recruiting at the moment.
Samir K Gupta, MD, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHUTi in people with HIV/AIDS and Insomnia, run by Indiana University 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 23 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: finished, as of the sponsor's last update on 21 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: 10 weeks). 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 21 Feb 2021.