Augmentation of Standard Psychotherapy With a Habit Change App
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Changes in depression ratings [Enrollment and up to 3 months following enrollment]
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).
- Changes in anxiety ratings [Enrollment and up to 3 months following enrollment]
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).
- Number of billable visits attended [Enrollment through up to three months following enrollment]
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.
- Number of missed behavioral health visits [Enrollment through up to three months following enrollment]
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.
Other Outcome Measures
- Changes in A1c levels [Enrollment and up to 3 months following enrollment]
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.
- Changes in blood pressure [Enrollment and up to 3 months following enrollment]
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.
- Changes in weight [Enrollment and up to 3 months following enrollment]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Type 1 or 2 Diabetes
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Are being seen by a clinician for depression, anxiety and/or substance use disorder
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Speak English
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Have an Apple device to download the habit change app
Exclusion Criteria:
- Unable to provide informed consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rebecca Tavernier
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Habit change app