Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression

BEHAVIORAL

Unified protocol for cognitive behavioral therapy (UP-CBT)

UP-CBT consists of approximately 16 individual sessions of CBT, conducted over the course of approximately 20 weeks. The UP-CBT consists of 5 core modules targeting negative emotionality and aversive reactions to emotional experiences. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. The final module consists of relapse prevention. UP-CBT sessions will integrate a review of Continuous Glucose Monitoring (CGM) data and feedback will be provided by the therapist.

DEVICE

Continuous Glucose Monitoring (CGM)

Use of commercially available, FDA-approved continuous glucose monitoring (CGM) for 6 months post-randomization. Usual diabetes care will continue and participants can initiate a CGM review from their healthcare providers, as desired. In addition, a nurse practitioner with expertise in CGM will train each participant via video recordings in the proper placement of the device, and technical issues, and provide basic teaching at the beginning of the trial on interpretation of CGM data and self-titration of insulin/self-management. Written materials and online resources for recognizing and managing anxiety and depressive disorders, along with self-management information and treatment options to discuss with providers will also be provided.

Anxiety symptom severity

Time frame: Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline

Participant ratings will be conducted via video conference by clinicians blinded to the condition, using the Structured Interview Guide for the Hamilton Anxiety Rating Scales (SIGH-A). SIGH-A measures the severity of a patient's somatic and psychic anxiety based on 14 parameters including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each item is assigned a 5-point score ranging from 0 (not present) to 4 (severe) yielding an overall possible score of 0-56. Higher SIGH-A scores denote increased severity of anxiety.

Depressive symptom severity

Time frame: Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline

Participant ratings will be conducted via video conference by clinicians blinded to the condition, using the Structured Interview Guide for the Hamilton Depression Rating Scales (SIGH-D). SIGH-D is a 29-item clinical interview that expands the 21-item Hamilton Depression Rating Scale for Depression (HAM-D) to include eight items assessing "atypical symptoms" of depression. Ranges for individual parameters vary but a score of 0 signifies less severity (e.g., no/absent) and incrementally higher scores represent more severe symptoms. Total SIGH-D scores can range from 0 to 90. A higher overall SIGH-D score denotes increased severity of Depression.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.