Augmentation of Standard Psychotherapy With a Habit Change App

NCT06110728 | Withdrawn

• 1 other identifier: Habit change app
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes; Substance Use Disorders; Anxiety Disorders; Depression

Keywords

mobile health; randomized control trial; mental health; diabetes

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Other Outcomes (3)

• Changes in A1c levels

  Enrollment and up to 3 months following enrollment

• Changes in blood pressure

  Enrollment and up to 3 months following enrollment

• Changes in weight

  Enrollment and up to 3 months following enrollment

Study Arms (2)

Habit Change

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

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.

Interventions

Habit Change 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.

Habit Change

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Rebecca Tavernier: lead

MeSH Terms

Conditions

Diabetes Mellitus; Substance-Related Disorders; Anxiety Disorders; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: 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) TAU.

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 1, 2023
• Study Start: November 6, 2023
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share