The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV

NCT07226128 | Recruiting DMC

• 2 other identifiers: 28855R01DK141366
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if depression treatment improves insulin resistance, or how the body uses insulin to lower blood sugar, in people with HIV on HIV treatment. Researchers will compare an internet-based (online) depression treatment program called cognitive behavioral therapy with depression education. In the online group, participants will undergo 9 weekly treatment sessions. The education group will receive learning materials about depression and will be monitored every month. All participants will have 4 study visits over 12 months.

Conditions

HIV; Depression in Adults; Insulin Resistance; Cognitive Behavior Therapy

Keywords

hiv; depression; insulin resistance; diabetes; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HOMA-IR at 24 weeks

  Homeostasis Model Assessment-Insulin, where higher values indicate greater insulin resistance

  24 weeks

Study Arms (2)

Internet Cognitive Behavioral Therapy (iCBT-D)

EXPERIMENTAL

Intervention participants will receive the empirically supported, HIPAA-compliant, therapist-assisted iCBT-D called Good Days Ahead (GDA; MindStreet, Inc.). GDA uses an interactive, multimedia format (including video, exercises, calls to action, newsfeeds, and customized feedback) to deliver nine 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT. Topics include identifying and modifying automatic thoughts, using behavioral activation and other behavioral methods, identifying and modifying schemas, using effective coping strategies, and employing other core CBT methods.

Behavioral: Internet cognitive behavioral therapy (iCBT-D)

Active Control (AC)

ACTIVE COMPARATOR

Our AC comparator will include depression education and depressive symptom monitoring along with usual depression care as provided by the participants HIV clinicians. Trial staff will fist have a 30-minute call with AC participants to review depression materials, including their HIV provider's role in its management and treatment options and also provide a list of local mental health services. There are no care restrictions by the primary HIV clinicians. Trial staff will call AC participants every 4 weeks to assess depressive symptoms (PHQ-9) and will notify clinic staff to encourage additional care when indicated.

Behavioral: Active Control (AC)

Interventions

Internet cognitive behavioral therapy (iCBT-D) BEHAVIORAL

Intervention participants will receive the empirically supported, HIPAA-compliant, therapist-assisted iCBT-D called Good Days Ahead (GDA; MindStreet, Inc.). GDA uses an interactive, multimedia format (including video, exercises, calls to action, newsfeeds, and customized feedback) to deliver nine 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT. Topics include identifying and modifying automatic thoughts, using behavioral activation and other behavioral methods, identifying and modifying schemas, using effective coping strategies, and employing other core CBT methods.

Internet Cognitive Behavioral Therapy (iCBT-D)

Active Control (AC) BEHAVIORAL

Our AC comparator will include depression education and depressive symptom monitoring along with usual depression care as provided by the participants HIV clinicians. Trial staff will fist have a 30-minute call with AC participants to review depression materials, including their HIV provider's role in its management and treatment options and also provide a list of local mental health services. There are no care restrictions by the primary HIV clinicians. Trial staff will call AC participants every 4 weeks to assess depressive symptoms (PHQ-9) and will notify clinic staff to encourage additional care when indicated.

Active Control (AC)

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 as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid HIV test, (2) HIV enzyme test kit at any time prior to study entry, (3) at least one detectable HIV-1 antigen, or (4) at least one detectable plasma HIV-1 RNA viral load.
• Age ≥ 18 years.
• Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to Screening
• Meets the depression definition for this trial:
• (1) repeat PHQ-9 ≥10100 result at the Screening Visit (suggesting moderate to severe depressive symptoms), AND
• (2) PHQ-9 depressive disorder diagnosis (2 or more of the 9 depressive symptoms, including depressed mood or anhedonia, present in the past 2 weeks), AND
• (3) functional impairment (using the tenth PHQ-9 item assessing social/occupational impairment), AND
• (4) no evidence that the direct physiological effects of a substance, medication, or medical condition clearly account for the depressive symptoms, AND
• (5) no bipolar or psychotic disorders
• HbA1c \< 6.5% at Screening
• HIV-1 RNA level \< 75 copies/mL at Screening
• NOTE: There are no CD4 cell count eligibility criteria for this trial.

You may not qualify if:

• Inability to complete written, informed consent
• Inability to read and understand English as seen on a computer screen
• Diagnosed diabetes mellitus or any previously recorded HbA1c ≥6.5%
• History of bipolar disorder or a psychotic disorder, including schizophrenia
• Incarceration at the time of any study visit
• Active suicidality at Entry, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions (for Question #3, the previous attempt must be within the past 10 years) on the Patient Suicidality Form (see Appendix).
• Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases).
• End stage renal disease requiring renal replacement therapy (dialysis, transplantation).
• Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.
• Therapy for serious medical illnesses within 14 days prior to the Entry Visit
• NOTE: Therapy for serious medical illnesses that overlaps with a 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 study.
• Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit
• NOTE: Use of NSAIDS and aspirin are allowed
• Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Indiana University Health

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (2)

• Bourgi K, Kundu S, Stewart JC, So-Armah K, Freiberg M, Gupta SK. Associations of HIV and Depression with Incident Diabetes Mellitus: Veterans Aging Cohort Study. Clin Infect Dis. 2022 Feb 3;78(2):378-85. doi: 10.1093/cid/ciac085. Online ahead of print.

  PMID: 35134838 BACKGROUND

• Gupta SK, Slaven JE, Liu Z, Polanka BM, Freiberg MS, Stewart JC. Effects of Internet Cognitive-Behavioral Therapy on Depressive Symptoms and Surrogates of Cardiovascular Risk in Human Immunodeficiency Virus: A Pilot, Randomized, Controlled Trial. Open Forum Infect Dis. 2020 Jul 5;7(7):ofaa280. doi: 10.1093/ofid/ofaa280. eCollection 2020 Jul.

  PMID: 32760749 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance; Acquired Immunodeficiency Syndrome; Depression; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; 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; Behavioral Symptoms; Behavior; Endocrine System Diseases

Study Officials

• Samir K Gupta, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Grounds, RVT

CONTACT

1-317-278-0255; diground@iu.edu

Rory Duplantier, ANP-PC

CONTACT

1-317-274-8473; rldupl@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 5, 2025
• First Posted: November 10, 2025
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Start date: January 1, 2031 End Date: Indefinite
• Access Criteria: Data and sample requests will be honored after submission of a short proposal that outlines an important scientific question with an appropriate statistical analysis plan that justifies the use of these datasets. In addition, the requests must also verify that confidentiality of the datasets will be ensured. A formal data sharing agreement will be required prior to provision of any datasets.

Locations

US (1)