Depressionjq830NCT05555875
Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part II
A study testing SilverCloud in people with Depression and Anxiety Disorders, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study is a clinical trial that evaluates what drives patient engagement and tests the impact of two strategies-automated motivational push messaging and coach support-to improve engagement with an evidence-based mobile app intervention for depression and/or anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety Disorders
- What is being tested?
- SilverCloud
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2023to 25 Jun 2025
- 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
- Mass General Brigham primary care patient
- Age 18+
- Clinically significant symptoms of depression (Patient Health Questionnaire-9 (PHQ-9) greater than or equal to 10) and/or anxiety (Generalized Anxiety Disorder-7 (GAD-7) greater than or equal to 8)
- Owns a smartphone capable of running the study applications
- Fluent in English.
Who cannot join
- Diagnosis of bipolar I or bipolar II disorder per patient report or the patient's medical record
- Diagnosis of any psychotic disorder per patient report or the patient's medical record
- Current substance use disorder per patient report or the patient's 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
Jessica Morrow Lipschitz
Boston, Massachusetts, 02115-5804
About this study
Official title: A Clinical Trial Aimed at Evaluating Factors Contributing to Patient Engagement With Digital Mental Health Interventions
This study is a clinical trial that evaluates what drives patient engagement and tests the impact of two strategies-automated motivational push messaging and coach support-to improve engagement with an evidence-based mobile app intervention for depression and/or anxiety.
Read the detailed description
This 8-week, clinical trial involves primary care patients with clinically significant depression and/or anxiety recruited via provider referral. Participants will received access to a digital mental health intervention with known efficacy and be randomized to an engagement strategy condition--a previously-validated Coach Support protocol (CS), a newly-developed automated motivational messaging protocol (AMM), both or neither. To further understand how messages in the AMM arms function, message delivery will be micro-randomized: each day participants will be randomized to receive a message or not, such that they receive an average of 4.2 messages/week. Micro-randomization allows causal inference about the near-term impact of message delivery (i.e., are AMMs a cue to action) and the relationship between message impact and context (e.g., day in study). Measured outcome data will include level of engagement (operationalized as time to disengagement and minutes of use) and weekly self-reports of clinical outcomes.
- Conditions
- Depression, Anxiety Disorders
- Being tested
- SilverCloud
- Keywords
- Mobile app, Engagement, Depression, Anxiety, Micro-randomized trial
- 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.
SilverCloudBehavioural
Digital mental health intervention for individuals struggling with depression and/or anxiety. The intervention reflects components of evidence-based psychological treatments such as cognitive-behavioral therapy.
| Study group | Role | What they receive |
|---|---|---|
| SilverCloud with Automated Motivational Messaging and Coach Support | Experimental | SilverCloud intervention with two engagement strategies, automated motivational messaging and coach support. Receives: Behavioral: SilverCloud |
| SilverCloud with Automated Motivational Messaging | Experimental | Silvercloud intervention with one engagement strategy, automated motivational messaging. Receives: Behavioral: SilverCloud |
| SilverCloud with Coach Support | Experimental | SilverCloud intervention with one engagement strategy, coach support. Receives: Behavioral: SilverCloud |
| SilverCloud Alone | Active comparator | SilverCloud intervention with no additional engagement strategy applied. Receives: Behavioral: SilverCloud |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disengagement
disengagement from the digital mental health intervention is defined as the first week of <1 minute of use after which there are no subsequent weeks with at least 1 minute of use
Measured: 8-week intervention period
Intervention Engagement Within 3 Hours Following a Decision Point - Proximal (Short-Term)
Intervention use logs will be collected continuously and automatically throughout the intervention period on the system backend. Proximal Intervention engagement will be operationalized as whether or not the intervention was used within 3 hours of a decision point (i.e., the point at which participants in the automated motivational messaging arms were randomized to receive or not receive an automated motivational message). This outcome only applies to participants randomized to receive automated motivational messaging.
Measured: For 3 hours after each decision point, over the 8-week intervention period
Secondary outcomes (1)
Minutes of Intervention Use - Distal (Long-Term)
Intervention use logs will be collected continuously and automatically throughout the intervention period on the system backend. Intervention engagement will be operationalized as minutes of active use over the intervention period.
Measured: 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start7 Jun 2023
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial trial with micro-randomization in automated motivational messaging arms
- Masking
- None (open label)
- Enrolment
- 76 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
- NCT05555875
- Sponsor's protocol ID
- 2022P001673
- Other IDs
- K23MH120324
- Acronym
- jq830
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2022
- Last updated
- 2 Sep 2026
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Aimed at Evaluating Factors Contributing to Patient Engagement With Digital Mental Health Interventions
- ClinicalTrials.gov ID
- NCT05555875
- Acronym / sponsor ID
- jq830 / 2022P001673
- Conditions
- Depression, Anxiety Disorders
- Keywords
- Mobile app, Engagement, Depression, Anxiety, Micro-randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 27 Sep 2022 (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.
This study is a clinical trial that evaluates what drives patient engagement and tests the impact of two strategies-automated motivational push messaging and coach support-to improve engagement with an evidence-based mobile app intervention for depression and/or anxiety.
Detailed description
This 8-week, clinical trial involves primary care patients with clinically significant depression and/or anxiety recruited via provider referral. Participants will received access to a digital mental health intervention with known efficacy and be randomized to an engagement strategy condition--a previously-validated Coach Support protocol (CS), a newly-developed automated motivational messaging protocol (AMM), both or neither. To further understand how messages in the AMM arms function, message delivery will be micro-randomized: each day participants will be randomized to receive a message or not, such that they receive an average of 4.2 messages/week. Micro-randomization allows causal inference about the near-term impact of message delivery (i.e., are AMMs a cue to action) and the relationship between message impact and context (e.g., day in study). Measured outcome data will include level of engagement (operationalized as time to disengagement and minutes of use) and weekly self-reports of clinical outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2 factorial trial with micro-randomization in automated motivational messaging arms
| Arm | Type | Receives |
|---|---|---|
| SilverCloud with Automated Motivational Messaging and Coach Support | Experimental | Behavioral: SilverCloudSilverCloud intervention with two engagement strategies, automated motivational messaging and coach support. |
| SilverCloud with Automated Motivational Messaging | Experimental | Behavioral: SilverCloudSilvercloud intervention with one engagement strategy, automated motivational messaging. |
| SilverCloud with Coach Support | Experimental | Behavioral: SilverCloudSilverCloud intervention with one engagement strategy, coach support. |
| SilverCloud Alone | Active comparator | Behavioral: SilverCloudSilverCloud intervention with no additional engagement strategy applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mass General Brigham primary care patient
- Age 18+
- Clinically significant symptoms of depression (Patient Health Questionnaire-9 (PHQ-9) greater than or equal to 10) and/or anxiety (Generalized Anxiety Disorder-7 (GAD-7) greater than or equal to 8)
- Owns a smartphone capable of running the study applications
- Fluent in English.
Key exclusion criteria (4 listed)
- Diagnosis of bipolar I or bipolar II disorder per patient report or the patient's medical record
- Diagnosis of any psychotic disorder per patient report or the patient's medical record
- Current substance use disorder per patient report or the patient's 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 |
|---|---|---|
| SilverCloudDigital mental health intervention for individuals struggling with depression and/or anxiety. The intervention reflects components of evidence-based psychological treatments such as cognitive-behavioral therapy. | Behavioural | SilverCloud Alone, SilverCloud with Automated Motivational Messaging, SilverCloud with Automated Motivational Messaging and Coach Support, SilverCloud with Coach Support |
Primary outcome
Time to disengagement
Time frame: 8-week intervention period
disengagement from the digital mental health intervention is defined as the first week of <1 minute of use after which there are no subsequent weeks with at least 1 minute of use
Intervention Engagement Within 3 Hours Following a Decision Point - Proximal (Short-Term)
Time frame: For 3 hours after each decision point, over the 8-week intervention period
Intervention use logs will be collected continuously and automatically throughout the intervention period on the system backend. Proximal Intervention engagement will be operationalized as whether or not the intervention was used within 3 hours of a decision point (i.e., the point at which participants in the automated motivational messaging arms were randomized to receive or not receive an automated motivational message). This outcome only applies to participants randomized to receive automated motivational messaging.
1 secondary outcome
Minutes of Intervention Use - Distal (Long-Term)
Time frame: 8-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- 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 SilverCloud in people with Depression and Anxiety Disorders, 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 4 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 2 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to disengagement (time frame: 8-week intervention period). The study lists 2 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 2 Sep 2026.