Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; HIV/AIDS
• Intervention / Treatment: Behavioral: SHUTi

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Infectious Diseases Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Age equal to or greater than 18 years.
3. Ongoing receipt of antiretroviral therapy of any kind for at least 3 months prior to the Entry Visit.

4. 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.

5. ISI score ≥ 15

Exclusion Criteria:

1. Inability to complete written, informed consent.
2. Incarceration at the time of any study visit.
3. 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
4. Diagnosed vascular disease (documented history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease).
5. History of congestive heart failure, even if currently compensated.

6. 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).

   Note: Hepatitis B or C co-infections are NOT exclusionary

7. Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.

   NOTE: Localized treatment for skin cancers is not exclusionary.

8. Uncontrolled hyperthyroidism or hypothyroidism, defined as TSH values outside of the local reference range on most recent clinical assessment.
9. Last known clinic-based estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2. (calculated from the 2009 CKD-EPI equation).
10. Uncontrolled diabetes defined as the last known clinic-based Hgb A1C > 8.0 g/dL.
11. Last known clinic-based total cholesterol > 240 mg/dL.

12. 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.

13. Pregnancy or breastfeeding during the course of the study.

14. 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.

15. Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.

16. 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.

17. Musculoskeletal or neurologic disorders that impede ability to perform the required study procedures.
18. History of sleep apnea or restless leg syndrome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHUTi Cognitive Behavioral Therapy; SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia.	Behavioral: SHUTi; 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.
No Intervention: Usual Care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Samir K Gupta, MD, MS, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): January 4, 2018

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: HIV; Insomnia; Cognitive Behavioral Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 1712469162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available within 30 days of completion of final statistical analysis. There is no expiration of data availability.
• IPD Sharing Access Criteria: Please contact the study PI, Dr. Samir Gupta, for specific details on data availability.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No