Cognitive Behavioral Therapy for Insulin Resistance and HIV
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either internet-based cognitive behavioral therapy or depression education over 9 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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 ...
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aging.networkofcare.org
aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT07226128?keyword=%22In%20Adults%22The 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 ...
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, ...
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