Augmentation of Standard Psychotherapy With a Habit Change App

Status Withdrawn

Clinical Trial Summary

The goal of this clinical trial is to document the efficacy of using a habit change application (app) as an adjunct to standard psychotherapy among individuals with diabetes receiving mental health treatment for depression, anxiety, or substance use disorders. The main questions it aims to answer are: Question 1: When behavioral health treatment is augmented with a habit change app for between visit care, does the use of this tool improve mental and behavioral health outcomes? Question 2: Are there certain populations who benefit more from using a habit change app? Question 3: Does use of a habit change app impact healthcare utilization and costs? Exploratory Research Question: Does use of a habit change app impact physical health outcomes, including A1c levels, blood pressure, and weight? Participants selected to receive the habit change app will be asked to track goals that they set for themselves in adjunct to their current behavioral health treatment; those selected for treatment as usual will have no additional steps to take. Researchers will compare the groups to see if there are different outcomes in symptom reports and healthcare utilization.

Clinical Trial Description

As part of this research, participants with a diagnosis of diabetes and depression, anxiety, and/or substance use disorder will be randomized to one of two treatment groups: (1) Habit Change and (2) Treatment as Usual (TAU). All participants will currently be engaged in behavioral health treatment. Participants in the Habit Change arm will obtain access to a habit change app and set their personal health goals in the app to track throughout the study period. Participants in the TAU arm will continue to engage in their behavioral health treatment as usual and will not be provided access to the habit change app. Participants randomly assigned to the Habit Change arm will be asked to track behaviors related to their specific goals on a daily basis through the app and will be allowed to engage with the app freely. Outside of using the app, participants will not be asked to engage in any additional activities beyond those typically engaged in for behavioral health treatment (e.g., completion of mental and behavioral health outcome measures).We will be recruiting up to 600 participants as part of this research study (300 per treatment arm). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06110728
Study type	Interventional
Source	Weitzman Institute
Contact
Status	Withdrawn
Phase	N/A
Start date	November 6, 2023
Completion date	March 6, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.