Augmentation of Standard Psychotherapy With a Habit Change App

NCT ID: NCT06110728

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2024-03-06

Brief 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.

Detailed 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).

Conditions

Diabetes; Substance Use Disorders; Anxiety Disorders; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Habit Change

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).

Group Type: EXPERIMENTAL

Habit Change

Intervention Type: BEHAVIORAL

Participants 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. Goals can include things like reaching a step goal, sleeping for a certain number of hours, or making healthy food choices.

Treatment as Usual

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Habit Change

Participants 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. Goals can include things like reaching a step goal, sleeping for a certain number of hours, or making healthy food choices.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Type 1 or 2 Diabetes
• Are being seen by a clinician for depression, anxiety and/or substance use disorder
• Speak English
• Have an Apple device to download the habit change app

Exclusion Criteria

• Unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rebecca Tavernier

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Tavernier

Senior Research Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

Habit change app

Identifier Type: -

Identifier Source: org_study_id