Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection

NCT03390114 | Completed Results DMC

• 1 other identifier: 1712469162
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this preliminary study is to determine the efficacy of an internet-based treatment program for insomnia for HIV-infected persons.

Conditions

HIV/AIDS; Insomnia

Keywords

HIV; Insomnia; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SHUTi Cognitive Behavioral Therapy

EXPERIMENTAL

SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia.

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.

Interventions

SHUTi BEHAVIORAL

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.

SHUTi Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Infectious Diseases Research Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Samir K. Gupta, MD, MS
• Organization: Indiana University School of Medicine

sgupta1@iu.edu

3172747926

Study Officials

• Samir K Gupta, MD, MS

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The primary investigator is blinded to the treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 10-week, randomized, controlled, single-blinded, two-arm, parallel group, pilot trial at a single center

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 4, 2018
• Study Start: May 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will become available within 30 days of completion of final statistical analysis. There is no expiration of data availability.
• Access Criteria: Please contact the study PI, Dr. Samir Gupta, for specific details on data availability.

Locations

US (1)