Depression, AnxietyNCT05360901
Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part I
A study testing IntelliCare with automated motivational messaging in people with Depression, Anxiety, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This pilot study is a precursor to a subsequent clinical trial that will test the impact of a set of automated motivational messages on patient engagement with a digital mental health intervention. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- IntelliCare with automated motivational messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2022to 17 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Patient Health Questionnaire-8 (PHQ-9) score≥10 and/or Generalized Anxiety Disorder-7 (GAD-7) Score≥8 indicating clinically significant depression or anxiety respectively
- Owns a smartphone
- Fluent in English
- Individual has a Mass General Brigham primary care provider
Who cannot join
- Diagnosis of bipolar disorder, any psychotic disorder, or a current substance use disorder per patient's report or medical record.
- Acute and/or unstable medical problem that may interfere with participation (e.g., scheduled for surgery in the next two months).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study Aimed at Developing Automated Motivational Messaging for Patient Engagement With Digital Mental Health Interventions
This pilot study is a precursor to a subsequent clinical trial that will test the impact of a set of automated motivational messages on patient engagement with a digital mental health intervention. The pilot study aims to systematically employ patient feedback to develop the automated motivational messages that will be used in the subsequent clinical trial.
Read the detailed description
This is an in situ user-centered design pilot study to generate feedback on the automated motivational messaging the investigators are developing. Participants will download a digital mental health intervention (IntelliCare) to use for three weeks. During this three-week period, participants will receive automated motivational messages on a randomized schedule. That is, each day they will be randomized to either receive an automated motivational message (60% likelihood) or not receive an automated motivational message (40% likelihood). On days when a participant receives a message, the participant will be prompted to complete a brief survey on their reaction to the message received. At the end of three weeks, participants will be asked to complete a qualitative interview to provide further feedback on messages under development.
The primary outcome in this study is participant ratings from the brief surveys provided after automated motivational message delivery. We will also, however, look at participant feedback on messages under development in the qualitative interview as well as whether receiving a message makes users more likely to engage with the DMHI (IntelliCare) during the three hours following message delivery.
- Conditions
- Depression, Anxiety
- Being tested
- IntelliCare with automated motivational messaging
- Keywords
- mHealth, Engagement, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntelliCare with automated motivational messagingBehavioural
Digital mental health intervention with automated motivational messaging
| Study group | Role | What they receive |
|---|---|---|
| IntelliCare with automated motivational messaging | Other | Digital mental health intervention with micro-randomized automated motivational messaging delivery Receives: Behavioral: IntelliCare with automated motivational messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Message Motivation Ratings
Mean Likert scale rating of how well participants felt each message motivated them to use the digital mental health intervention as rated within 24 hours of message delivery. The Likert scale will range from 1 (not at all motivating) to 10 (very motivating) with a score of 5 being neutral.
Measured: 24 hours from message delivery
Secondary outcomes (2)
Message Likability Ratings
Mean Likert scale rating of how much participants liked each message as rated within 24 hours of message delivery. The Likert scale will range from 1 (hated the message) to 10 (loved the message) with a score of 5 being neutral.
Measured: 24 hours from message delivery
Engagement
Percent of instances of message delivery that prompted user to launch the digital mental health intervention within 3 hours of delivery.
Measured: 3 hours from message delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start6 Jul 2022
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, micro-randomized pilot trial design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jessica M. Lipschitz, Ph.D., Brigham and Women's Hospital
- Investigators
- Jessica M Lipschitz, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360901
- Sponsor's protocol ID
- 2020P000444
- Other IDs
- K23MH120324
- Status last verified
- Nov 2023
- First submitted
- 29 Apr 2022
- Last updated
- 18 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Aimed at Developing Automated Motivational Messaging for Patient Engagement With Digital Mental Health Interventions
- ClinicalTrials.gov ID
- NCT05360901
- Acronym / sponsor ID
- 2020P000444
- Conditions
- Depression, Anxiety
- Keywords
- mHealth, Engagement, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is a precursor to a subsequent clinical trial that will test the impact of a set of automated motivational messages on patient engagement with a digital mental health intervention. The pilot study aims to systematically employ patient feedback to develop the automated motivational messages that will be used in the subsequent clinical trial.
Detailed description
This is an in situ user-centered design pilot study to generate feedback on the automated motivational messaging the investigators are developing. Participants will download a digital mental health intervention (IntelliCare) to use for three weeks. During this three-week period, participants will receive automated motivational messages on a randomized schedule. That is, each day they will be randomized to either receive an automated motivational message (60% likelihood) or not receive an automated motivational message (40% likelihood). On days when a participant receives a message, the participant will be prompted to complete a brief survey on their reaction to the message received. At the end of three weeks, participants will be asked to complete a qualitative interview to provide further feedback on messages under development.
The primary outcome in this study is participant ratings from the brief surveys provided after automated motivational message delivery. We will also, however, look at participant feedback on messages under development in the qualitative interview as well as whether receiving a message makes users more likely to engage with the DMHI (IntelliCare) during the three hours following message delivery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, micro-randomized pilot trial design
| Arm | Type | Receives |
|---|---|---|
| IntelliCare with automated motivational messaging | Other | Behavioral: IntelliCare with automated motivational messagingDigital mental health intervention with micro-randomized automated motivational messaging delivery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80
- Patient Health Questionnaire-8 (PHQ-9) score≥10 and/or Generalized Anxiety Disorder-7 (GAD-7) Score≥8 indicating clinically significant depression or anxiety respectively
- Owns a smartphone
- Fluent in English
- Individual has a Mass General Brigham primary care provider
Key exclusion criteria (2 listed)
- Diagnosis of bipolar disorder, any psychotic disorder, or a current substance use disorder per patient's report or medical record.
- Acute and/or unstable medical problem that may interfere with participation (e.g., scheduled for surgery in the next two months).
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 |
|---|---|---|
| IntelliCare with automated motivational messagingDigital mental health intervention with automated motivational messaging | Behavioural | IntelliCare with automated motivational messaging |
Primary outcome
Message Motivation Ratings
Time frame: 24 hours from message delivery
Mean Likert scale rating of how well participants felt each message motivated them to use the digital mental health intervention as rated within 24 hours of message delivery. The Likert scale will range from 1 (not at all motivating) to 10 (very motivating) with a score of 5 being neutral.
2 secondary outcomes
Message Likability Ratings
Time frame: 24 hours from message delivery
Engagement
Time frame: 3 hours from message delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jessica M Lipschitz, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntelliCare with automated motivational messaging in people with Depression, Anxiety, run by Brigham and Women's Hospital at 1 site in United States.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 18 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Message Motivation Ratings (time frame: 24 hours from message delivery). 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 18 Dec 2023.