Health TrialsbyHealthPanel

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

ConditionsHIVDepression in AdultsInsulin ResistanceCognitive Behavior Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

(1) repeat PHQ-9 ≥10100 result at the Screening Visit (suggesting moderate to severe depressive symptoms), AND

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Internet Cognitive Behavioral Therapy (iCBT-D)Experimental treatment 1 intervention
Group B: Active Control (AC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in HOMA-IR at 24 weeks

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

Time frame
24 weeks

Secondary outcomes

1

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

Time frame
24 weeks
2

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

Time frame
24 weeks
3

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

Time frame
24 weeks
4

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

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
Apply now