150 Participants NeededMy employer runs this trial

Cognitive Behavioral Therapy for Insulin Resistance and HIV

RD
DG
Overseen ByDanielle Grounds, RVT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if treating depression can improve insulin resistance (how well the body uses insulin) in people with HIV who are already receiving HIV treatment. Participants will either engage in an online program called cognitive behavioral therapy (CBT) with nine weekly sessions or receive educational materials about depression. People with HIV who have been on stable treatment for at least six months and experience moderate to severe depression might be suitable candidates for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to understanding the broader impacts of mental health treatment on physical health in people with HIV.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop taking your current medications, including antidepressants. However, you cannot receive treatment for hepatitis C during the study, and certain medications like systemic glucocorticoids or investigational agents are not allowed at the start of the trial.

What prior data suggests that internet cognitive behavioral therapy (iCBT-D) is safe for people with HIV?

Research has shown that internet-based cognitive behavioral therapy (iCBT-D) is generally safe for participants. Past studies indicate that people have tolerated iCBT-D well, with no serious side effects reported. This therapy uses an online platform to help manage depression by teaching users how to change negative thinking patterns. While some mild side effects, such as temporary emotional discomfort, may occur as individuals work through their feelings, these are usually manageable. Overall, evidence suggests that iCBT-D is a safe option for treating depression.12345

Why are researchers excited about this trial?

Researchers are excited about Internet Cognitive Behavioral Therapy (iCBT-D) for insulin resistance and HIV because it offers a new, convenient way to address mental health challenges associated with these conditions. Unlike traditional face-to-face therapy, iCBT-D is delivered online, making it more accessible for individuals who may have difficulty attending in-person sessions. This method uses an engaging, multimedia format with videos and interactive exercises, allowing participants to learn and apply cognitive behavioral techniques at their own pace. Additionally, it includes therapist assistance to ensure personalized support, which can enhance the effectiveness of the therapy. This innovative approach has the potential to improve both mental and physical health outcomes for people living with HIV.

What evidence suggests that internet cognitive behavioral therapy might be an effective treatment for insulin resistance in people with HIV?

Studies have shown that cognitive behavioral therapy (CBT) can improve symptoms of depression and may also aid in managing insulin resistance. For individuals with diabetes, CBT has improved blood sugar levels and diabetes management. Some research suggests that treating depression with CBT can enhance blood sugar control and reduce insulin resistance. In this trial, participants will receive Internet Cognitive Behavioral Therapy (iCBT-D) to evaluate its effectiveness. Online CBT, similar to the program under study, has proven effective when combined with lifestyle education to improve blood sugar levels. These findings support the idea that treating depression with CBT could help people with HIV manage insulin resistance more effectively.24678

Who Is on the Research Team?

SK

Samir K Gupta, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for adults (18+) with HIV who have been on stable HIV treatment for at least 6 months and are experiencing moderate to severe depression. Participants must not have bipolar or psychotic disorders, and their blood sugar levels should be below the diabetes range.

Inclusion Criteria

I have a documented HIV-1 infection.
I am 18 years old or older.
I have been on a stable HIV treatment for at least 6 months.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either internet-based cognitive behavioral therapy or depression education over 9 weeks

9 weeks
9 weekly sessions (online) for iCBT-D group; monthly monitoring calls for AC group

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 weeks
4 study visits over 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Internet cognitive behavioral therapy (iCBT-D)

Trial Overview

The study compares an online cognitive behavioral therapy program (9 weekly sessions) to a depression education group in people with HIV and depression, to see if treating depression can improve how the body uses insulin. Both groups are followed over 12 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Internet Cognitive Behavioral Therapy (iCBT-D)Experimental Treatment1 Intervention
Group II: Active Control (AC)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Samir Gupta, MD - Indiana University School of Medicine

Researchers will compare an internet-based (online) depression treatment program called cognitive behavioral therapy with depression education. In the ...

The Effects of Cognitive Behavioral Therapy on Insulin ...

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, ...

The evaluation of cognitive-behavioral therapy-based ... - PMC

The CBT-based intervention was beneficial in improving depression symptoms, diabetes self-care behaviors, the efficacy of CBT, and sleep quality in T2DM ...

eIMPACT-DM Pilot Trial: Depression Treatment to Reduce ...

Our primary aim is to determine the preliminary efficacy of eIMPACT-DM in improving the diabetes risk markers of hemoglobin A1c (primary outcome) and insulin ...

Examining Cognitive-Behavioral Therapy Change ... - PMC

These results tentatively suggest that CBT may be a promising intervention to address depression, and subsequently, obesity and worsening insulin resistance, ...

1 October 7, 2025

Good Days Ahead cognitive behavioral therapy program for depression in the Intervention Group or of the education and more frequent symptoms monitoring in ...

Indiana University Informed Consent Statement [and ...

This study will test whether treating depression in people with HIV can lower the risk of developing diabetes by reducing insulin resistance. Insulin resistance ...

8.

dev-multi-sponsor-trials.xogene.com

dev-multi-sponsor-trials.xogene.com/trials/7226128

The Effects of Cognitive Behavioral Therapy on ... - GoodDay

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, ...