[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07226128":3,"trial-entities:NCT07226128":150,"trial-summary:NCT07226128":155},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":47,"secondary_outcomes":52,"sex":81,"minimum_age":82,"maximum_age":17,"healthy_volunteers":83,"eligibility_criteria":84,"std_ages":110,"locations":113,"central_contacts":129,"overall_officials":137,"references":141,"see_also_links":149},"NCT07226128","28855","The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV","A Randomized, Controlled Trial Assessing the Effects of Cognitive Behavioral Therapy to Prevent Worsening Insulin Resistance in Depressed, Virologically-Suppressed, Antiretroviral-Treated Adults With HIV","RECRUITING","2029-08-31","2026-08","2026-08-21","2026-04-10","Indiana University","OTHER",true,"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.",null,[19,20,21,22],"HIV","Depression in Adults","Insulin Resistance","Cognitive Behavior Therapy",[24,25,26,27,28],"hiv","depression","insulin resistance","diabetes","cognitive behavioral therapy","INTERVENTIONAL","TREATMENT",[32],"NA",{"count":34,"type":35},150,"ESTIMATED",[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","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.",[42],"Internet Cognitive Behavioral Therapy (iCBT-D)",{"type":38,"name":44,"description":45,"armGroupLabels":46},"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.",[44],[48],{"measure":49,"description":50,"timeFrame":51},"Change from baseline in HOMA-IR at 24 weeks","Homeostasis Model Assessment-Insulin, where higher values indicate greater insulin resistance","24 weeks",[53,56,59,62,65,68,72,75,78],{"measure":54,"description":55,"timeFrame":51},"Change from baseline in circulating sCD14 at 24 weeks","sCD14 is a blood measure of inflammation, where higher levels indicate greater amounts specifically of monocyte activation",{"measure":57,"description":58,"timeFrame":51},"Change from baseline in circulating REG3a at 24 weeks","REG3a is a blood measure of gut integrity, where higher levels indicate greater amounts of gut wall breakdown",{"measure":60,"description":61,"timeFrame":51},"Change from baseline in circulating 16S rDNA at 24 weeks","16S rDNA is a measure of small amounts of bacteria in the blood that typically cannot be grown on blood cultures, where higher amounts indicate more bacteria in the bloodstream",{"measure":63,"description":64,"timeFrame":51},"Changes from baseline in circulating b-D-glucan at 24 weeks","b-D-glucan is a measure of small amounts of fungus in the blood that typically cannot be grown in fungal cultures, where higher amounts indicate more fungus in the bloodstream",{"measure":66,"description":50,"timeFrame":67},"Change from baseline in HOMA-IR at 48 weeks","48 weeks",{"measure":69,"description":70,"timeFrame":71},"Change from baseline in HbA1c at 24 weeks and 48 weeks","HbA1c (hemoglobin A1c) is a measure of average blood sugar control over 3 months","24, 48 weeks",{"measure":73,"description":74,"timeFrame":71},"Change from baseline in glycated albumin at 24 weeks and 48 weeks","Glycated albumin is a measure of average blood glucose control over 1 month",{"measure":76,"description":77,"timeFrame":51},"Change from baseline in circulating sCD163 at 24 weeks","sCD163 is a measure of inflammation, where higher levels indicate greater macrophage activation",{"measure":79,"description":80,"timeFrame":51},"Change from baseline in PC(P-16:0\u002F18:2) levels at 24 weeks","PC(P-16:0\u002F18:2) is a cell metabolite, where higher levels indicate greater insulin resistance","ALL","18 Years",false,{"inclusion":85,"exclusion":97,"raw_text":109},[86,87,88,89,90,91,92,93,94,95,96],"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\u002Foccupational 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 \\\u003C 6.5% at Screening","HIV-1 RNA level \\\u003C 75 copies\u002FmL at Screening",[98,99,100,101,102,103,104,105,106,107,108],"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.","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","Inclusion Criteria:\n\n* 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.\n* Age ≥ 18 years.\n* Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to Screening\n* Meets the depression definition for this trial:\n\n  * (1) repeat PHQ-9 ≥10100 result at the Screening Visit (suggesting moderate to severe depressive symptoms), AND\n  * (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\n  * (3) functional impairment (using the tenth PHQ-9 item assessing social\u002Foccupational impairment), AND\n  * (4) no evidence that the direct physiological effects of a substance, medication, or medical condition clearly account for the depressive symptoms, AND\n  * (5) no bipolar or psychotic disorders\n\nNOTE: The use of antidepressant medications is not exclusionary.\n\n* HbA1c \\\u003C 6.5% at Screening\n* HIV-1 RNA level \\\u003C 75 copies\u002FmL at Screening\n\nNOTE: There are no CD4 cell count eligibility criteria for this trial.\n\nExclusion Criteria:\n\n* Inability to complete written, informed consent\n* Inability to read and understand English as seen on a computer screen\n* Diagnosed diabetes mellitus or any previously recorded HbA1c ≥6.5%\n* History of bipolar disorder or a psychotic disorder, including schizophrenia\n\nNOTE: Depressive disorders are not exclusionary.\n\n* Incarceration at the time of any study visit\n* 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).\n* 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).\n\nNOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation\n\n* End stage renal disease requiring renal replacement therapy (dialysis, transplantation).\n* Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.\n\nNOTE: Localized treatment for skin cancers is not exclusionary.\n\n• Therapy for serious medical illnesses within 14 days prior to the Entry Visit\n\nNOTE: 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.\n\n* Pregnancy or breastfeeding during the study.\n* Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit\n\nNOTE: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled\u002Fnasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors\n\nNOTE: Use of NSAIDS and aspirin are allowed\n\n• Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.",[111,112],"ADULT","OLDER_ADULT",[114],{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":119,"contacts":120,"geoPoint":126},"Indiana University Health","Indianapolis","Indiana","46202","United States",[121],{"name":122,"role":123,"phone":124,"email":125},"Danielle Grounds","CONTACT","317-278-0255","diground@iu.edu",{"lat":127,"lon":128},39.76838,-86.15804,[130,133],{"name":131,"role":123,"phone":132,"email":125},"Danielle Grounds, RVT","1-317-278-0255",{"name":134,"role":123,"phone":135,"email":136},"Rory Duplantier, ANP-PC","1-317-274-8473","rldupl@iu.edu",[138],{"name":139,"affiliation":13,"role":140},"Samir K Gupta, MD","PRINCIPAL_INVESTIGATOR",[142,146],{"pmid":143,"type":144,"citation":145},"35134838","BACKGROUND","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\u002Fcid\u002Fciac085. Online ahead of print.",{"pmid":147,"type":144,"citation":148},"32760749","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\u002Fofid\u002Fofaa280. eCollection 2020 Jul.",[],{"nct_id":4,"conditions":151,"biomarkers":154},[152,153,21],"Depression","HIV Infection",[],{"nct_id":4,"found":15,"summary":156,"prompt_version":166},{"design":157,"status":158,"heading":159,"summary":160,"follow_up":161,"word_count":162,"commitments":163,"compensation":164,"drugs_mentioned":165},"This is an interventional study with a planned enrollment of 150 participants. It compares an online therapy program to depression education.","completed","Cognitive Behavioral Therapy for Insulin Resistance in People with HIV","This study is looking at whether treating depression can improve insulin resistance (how your body uses insulin to manage blood sugar) in people living with HIV. Researchers will compare an online program called Internet Cognitive Behavioral Therapy (iCBT-D) with depression education. If you join the iCBT-D group, you'll have 9 weekly online sessions. If you're in the education group, you'll get learning materials about depression and have monthly check-ins. All participants will have 4 study visits over 12 months. The main goal is to see if there's a change in insulin resistance after 24 weeks. You can join if you are 18 or older and have a documented HIV-1 infection. The current status of this study is unclear.","The primary endpoint is measured at 24 weeks, but participants will have study visits over 12 months.",118,"You will have 4 study visits over 12 months. Depending on your group, you will either have 9 weekly online treatment sessions or receive depression education and monthly monitoring.","Not stated in the trial record.",[39],"v2"]