Augmentation of Standard Psychotherapy With a Habit Change App

Augmentation of Standard Psychotherapy With a Habit Change App: A Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Depression; Diabetes; Anxiety Disorders; Substance Use Disorders
• Intervention / Treatment: Behavioral: Habit Change

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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of billable visits attended	Healthcare utilization (i.e., number of billable visits attended) will be extracted from the electronic health record for each participant at the end of the study period. The number of billable visits participants attended over the course of the study period (up to 3 months) will be compared between treatment groups.	Enrollment through up to three months following enrollment
Number of missed behavioral health visits	The number of missed behavioral health visits will be extracted from the electronic health record for each participant at the end of the study period. The number of missed behavioral health visits over the course of the study period (up to 3 months) will be compared between treatment groups.	Enrollment through up to three months following enrollment
Changes in depression ratings	Participants will report their depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) prior to each individual therapy session. Changes in depression scores from baseline to the end of the study period (up to 3 months after enrollment) will be evaluated. The PHQ-9 is a validated self-report measure assessing depressive symptoms over the previous 2 weeks. The PHQ-9 total score ranges from 0 to 27, with higher scores indicating worse depressive symptoms (scores of 0-4 are classified as minimal depression; 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; and ≥ 20 as severe depression).	Enrollment and up to 3 months following enrollment
Changes in anxiety ratings	Participants will report their anxiety symptoms using the Generalized Anxiety Disorder-7 (GAD-7) measure prior to each individual therapy session. Changes in anxiety scores from baseline to the end of the study period (up to 3 months after enrollment) will be evaluated. The GAD-7 is a validated self-report measure assessing anxiety symptoms over the previous 2 weeks. The GAD-7 total score ranges from 0 to 21, with higher scores indicating worse anxiety symptoms (scores of 0-4 are classified as minimal anxiety; 5-9 are classified as mild anxiety; 10-14 as moderate anxiety; and ≥ 15 as severe anxiety).	Enrollment and up to 3 months following enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in A1c levels	A1c readings will be extracted from the electronic health record at the time of enrollment and the end of the study period (up to three months after enrollment) for each participant. Changes in A1c level from enrollment to the end of the study period will be compared between treatment groups.	Enrollment and up to 3 months following enrollment
Changes in blood pressure	Blood pressure readings will be extracted from the electronic health record at the time of enrollment and the end of the study period (up to three months after enrollment) for each participant. Changes in blood pressure from enrollment to the end of the study period will be compared between treatment groups.	Enrollment and up to 3 months following enrollment
Changes in weight	Measured weight (in kilograms) will be extracted from the electronic health record at the time of enrollment and the end of the study period (up to three months after enrollment) for each participant. Changes in weight from enrollment to the end of the study period will be compared between treatment groups.	Enrollment and up to 3 months following enrollment

Collaborators and Investigators

• Sponsor: Rebecca Tavernier

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Actual): March 6, 2024
• Study Completion (Actual): March 6, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: diabetes; mobile health; mental health; randomized control trial
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Anxiety Disorders
• Other Study ID Numbers: Habit change app

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No