DiabetesNCT06110728
Augmentation of Standard Psychotherapy With a Habit Change App
A study testing Habit Change in people with Diabetes and Substance Use Disorders, run by Rebecca Tavernier.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Substance Use Disorders, Anxiety Disorders
- What is being tested?
- Habit Change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2023to 6 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
About this study
Official title: 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?
Read more
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.
Read the 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
- Being tested
- Habit Change
- Keywords
- mobile health, randomized control trial, mental health, diabetes
- Medical subject headings
- Diabetes Mellitus, Substance-Related Disorders, Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habit ChangeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Enrollment through up to three months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start6 Nov 2023
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Why it stopped: Due to lack of participant enrollment, the study was ended prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebecca Tavernier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rebecca Tavernier, Weitzman Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110728
- Sponsor's protocol ID
- Habit change app
- Status last verified
- May 2024
- First submitted
- 20 Oct 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Standard Psychotherapy With a Habit Change App: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06110728
- Acronym / sponsor ID
- Habit change app
- Conditions
- Diabetes, Substance Use Disorders, Anxiety Disorders, Depression
- Keywords
- mobile health, randomized control trial, mental health, diabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to lack of participant enrollment, the study was ended prematurely.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rebecca TavernierUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Habit Change | Experimental | Behavioral: Habit ChangeParticipants 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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Habit ChangeParticipants 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. | Behavioural | Habit Change |
Primary outcome
Changes in depression ratings
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Habit Change in people with Diabetes and Substance Use Disorders, run by Rebecca Tavernier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in depression ratings (time frame: Enrollment and up to 3 months following enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.