The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV
NCT ID: NCT07226128
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2026-01-02
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Internet Cognitive Behavioral Therapy (iCBT-D)
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)
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.
Active Control (AC)
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)
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.
Interventions
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Internet cognitive behavioral therapy (iCBT-D)
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.
Active Control (AC)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
NOTE: The use of antidepressant medications is not exclusionary.
* 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.
Exclusion Criteria
* 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
NOTE: Depressive disorders are not exclusionary.
* 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).
NOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation
* End stage renal disease requiring renal replacement therapy (dialysis, transplantation).
* Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.
NOTE: Localized treatment for skin cancers is not exclusionary.
• 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: 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
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.
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Indiana University
OTHER
Responsible Party
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Samir K. Gupta, MD
Professor of Medicine
Principal Investigators
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Samir K Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Central Contacts
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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28855
Identifier Type: -
Identifier Source: org_study_id