Cognitive Behavioral Therapy to Treat Insomnia in Persons With HIV Infection

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03390114
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 20
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS; Insomnia	Behavioral: SHUTi	N/A

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

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 10-week, randomized, controlled, single-blinded, two-arm, parallel group, pilot trial at a single center10-week, randomized, controlled, single-blinded, two-arm, parallel group, pilot trial at a single center
• Masking: Single (Investigator)
• Masking Description: The primary investigator is blinded to the treatment assignment
• Primary Purpose: Treatment
• Official Title: Internet-Based Cognitive Behavioral Therapy to Treat Insomnia in HIV: A Pilot Trial
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Insomnia Severity Index [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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

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

NOTE: Localized treatment for skin cancers is not exclusionary.

1. Uncontrolled hyperthyroidism or hypothyroidism, defined as TSH values outside of the local reference range on most recent clinical assessment.

2. Last known clinic-based estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2. (calculated from the 2009 CKD-EPI equation).

3. Uncontrolled diabetes defined as the last known clinic-based Hgb A1C > 8.0 g/dL.

4. Last known clinic-based total cholesterol > 240 mg/dL.

5. 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.

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

2. 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.

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

2. 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.

1. Musculoskeletal or neurologic disorders that impede ability to perform the required study procedures.

2. History of sleep apnea or restless leg syndrome.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Infectious Diseases Research Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

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

Study Documents (Full-Text)

• Informed Consent Form - Nov 9, 2018
• Study Protocol and Statistical Analysis Plan - Feb 13, 2019

More Information

Publications

None provided.

• Responsible Party: Samir K Gupta, MD, MS, Professor of Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT03390114
• Other Study ID Numbers: 1712469162
• First Posted: Jan 4, 2018
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Samir K Gupta, MD, MS, Professor of Medicine, Indiana University: HIV; Insomnia; Cognitive Behavioral Therapy
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Arm/Group Title	SHUTi Cognitive Behavioral Therapy	Usual Care
Arm/Group Description	SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia. 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.	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.
Period Title: Overall Study
STARTED	10	10
COMPLETED	6	8
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	SHUTi Cognitive Behavioral Therapy	Usual Care	Total
Arm/Group Description	SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia. 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.	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.	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.2 (11.4)	47.0 (14.7)	46.6 (11.4)
Sex: Female, Male (Count of Participants)
Female	2 20%	1 10%	3 15%
Male	8 80%	9 90%	17 85%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	9 90%	8 80%	17 85%
White	1 10%	1 10%	2 10%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 10%	1 5%

Outcome Measures

1. Primary Outcome

Title	Insomnia Severity Index
Description	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.
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

Those who completed both pre and post assessments

Arm/Group Title	SHUTi Cognitive Behavioral Therapy	Usual Care
Arm/Group Description	SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia. 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.	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.
Measure Participants	6	8
Mean (Standard Deviation) [score on a scale]	-9.0 (9.4)	-3.4 (2.0)

Adverse Events

Time Frame	10 weeks
Arm/Group Title	SHUTi Cognitive Behavioral Therapy		Usual Care
Arm/Group Description	SHUTi (www.myshuti.com) is an evidence-based, cognitive-behavioral, online intervention for insomnia. 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.		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.
All Cause Mortality
	SHUTi Cognitive Behavioral Therapy		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	SHUTi Cognitive Behavioral Therapy		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	SHUTi Cognitive Behavioral Therapy		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.