Clinical trial NCT06110728: Augmentation of Standard Psychotherapy With a Habit Change App
Official title: Augmentation of Standard Psychotherapy With a Habit Change App: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes
Substance Use Disorders
Anxiety Disorders
Depression
Keywords: mobile health
randomized control trial
mental health
diabetes
Lead sponsor: Weitzman Institute
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Changes in depression ratings
timeFrame: Enrollment and up to 3 months following enrollment
measure: Changes in anxiety ratings
timeFrame: Enrollment and up to 3 months following enrollment
measure: Number of billable visits attended
timeFrame: Enrollment through up to three months following enrollment
measure: Number of missed behavioral health visits
timeFrame: Enrollment through up to three months following enrollment
Secondary outcomes:
Other outcomes:
measure: Changes in A1c levels
timeFrame: Enrollment and up to 3 months following enrollment
measure: Changes in blood pressure
timeFrame: Enrollment and up to 3 months following enrollment
measure: Changes in weight
timeFrame: Enrollment and up to 3 months following enrollment
Locations:
Study officials:
References: