Anxiety Disorders and SymptomsNCT05567640
Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions
A study testing The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), Space for depression and Space for resilience in people with Anxiety Disorders and Symptoms and Depressive Symptoms, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Digital mental health interventions are a cost-effective and efficient approach to expanding the accessibility and impact of psychological treatments; however, little guidance exists for selecting the most effective program for a given individual. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders and Symptoms, Depressive Symptoms
- What is being tested?
- The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), Space for depression and Space for resilience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking adults
- Ages 18 or older
- Have a device that can connect to the internet.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Anxiety and Related Disorders
Boston, Massachusetts, 02115
Todd Farchione, Ph.D., 617-353-9610, tfarchio@bu.edu
About this study
Digital mental health interventions are a cost-effective and efficient approach to expanding the accessibility and impact of psychological treatments; however, little guidance exists for selecting the most effective program for a given individual. In the proposed study, decision rules will develop for selecting the digital program that is most likely to be the optimal intervention for each user. These treatment recommendations can be implemented in the context of large healthcare delivery systems to improve the delivery of digital mental health interventions at scale.
The overarching aim of the current study is to better understand for whom and how leading digital interventions work in a large healthcare setting. The study builds on the existing literature and follows expert recommendations by using machine learning (ML) methods to develop precision treatment rules (PTRs) for three leading digital interventions for emotional disorders (e.g., anxiety, depression, and related mental health disorders). Specifically, ML methods will be used to develop PTRs to optimize clinical outcomes and associated intervention engagement. This study will leverage a unique partnership between Boston University (BU), SilverCloud Health (SC)--a leading provider of digital mental health care--and Kaiser Permanente (KP)--one of America's leading health care providers.
A clinical trial (RCT) will be conducted to evaluate the relative effectiveness of three distinct empirically supported digital mental health interventions (from SC's existing library of programs) in a sample recruited from KP primary care and other clinical settings. Data from this trial will be used to develop theoretically and empirically informed, reliable selection algorithms for managing treatment delivery decisions. Algorithms will be validated in a separate "holdout" dataset by examining whether allocation to predicted optimal treatment is associated with superior outcomes compared to allocation to a non-optimal treatment. The role of user engagement will be determined, and other mechanisms in treatment outcome.
Read the detailed description
Kaiser Permanente (KP) members referred to SilverCloud Health (SC) through established operating procedures will be eligible to participate. After referral, potential participants will be informed of the study through the SC digital health platform. Interested participants will be provided information about the study through a digital version of an approved consent form. After signing consent, participants will complete baseline assessment questionnaires through Qualtrics, an online data collection platform.
After completing the baseline assessment, eligible participants will be randomly assigned to one of three existing digital mental health interventions hosted by SC: (1) Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), (2) Space from Depression (SFD), and (3) Space for Resilience (SFR). A SC program supporter will also be established at that time.
This differs from standard operating procedures at SC in that participants are generally able to select their preferred program from SC's offerings. There is nothing that would preclude participants from seeking a different SC treatment following study participation.
Potential participants will have up to two weeks to enroll in the study, complete the baseline assessment, and begin a treatment program. If the participant does not initiate treatment within two weeks, they will be withdrawn from the study though they may continue with clinical services at SC.
Following randomization, study staff at BU will send participants Qualtrics questionnaires via email throughout the treatment phase of the study, at 4-, 8-, and 12-weeks after treatment is initiated. The participant completes these questionnaires online. Regular asynchronous written support will be provided by SC supporters, consistent with their standard procedures.
- Being tested
- The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), Space for depression, Space for resilience
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)Behavioural
This is a cognitive behavioral treatment (CBT) for emotional disorders. This transdiagnostic intervention consists of eight modules and can be effectively applied to various disorders and problems.
Space for depressionBehavioural
Digital CBT program designed to minimize the impact of depression symptoms. Emphasizes CBT strategies and mindfulness through a series of seven structured modules.
Space for resilienceBehavioural
This program is built from positive psychology principles and is designed to promote resilience and well-being through seven modules.
| Study group | Role | What they receive |
|---|---|---|
| The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) | Experimental | Digital, transdiagnostic, emotion-focused CBT intervention that consists of five "core" modules or components that have been shown to target temperamental characteristics (i.e., neuroticism) and resulting emotion dysregulation that are believed to underlie all anxiety, depressive, and emotional disorders. The core components of the program are psychoeducation, mindfulness, cognitive flexibility, behavioral strategies to counter emotion-driven behaviors, interoceptive, and emotion exposures. Receives: Behavioral: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) |
| Space from Depression (SFD) | Active comparator | Digital CBT program designed to minimize the impact of depressive symptoms. This program emphasizes the use of cognitive behavioral strategies as well as mindfulness through a series of seven structured modules. The core components of the program include psychoeducation around the relationship between thoughts, feelings, and behaviors; cognitive behavioral practices aimed at restructuring negative beliefs; behavioral strategies to improve self-esteem; and mindfulness techniques that focus attention on the present moment. Receives: Behavioral: Space for depression |
| Space for Resilience (SFR) | Active comparator | Digital program based on positive psychology principles and designed to promote resilience and well-being through a series of seven modules. The core components of the program include psychoeducation, values exploration, building relationships, promoting self-esteem and self-efficacy, and building gratitude and optimism. Receives: Behavioral: Space for resilience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline well-being at week 12
World Health Organization-Five (WHO-5) is a 5-item self-report questionnaire of psychological well being. The WHO-5 has demonstrated good validity and utility as an outcome measure in clinical trials including several digital intervention trials. Respondents rate each statement in relation to the past two weeks on a scale ranging from 0= At no time to 5= All the time (Ware, 1995).
Measured: Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Secondary outcomes (2)
Change from baseline anxiety at week 12
Generalized Anxiety Disorder-7 (GAD-7) is a reliable and valid self-report measure of symptoms of generalized anxiety that is widely used in clinical research. This measures consists of 7 questions in a likert scale format, and respondents rate each question on a scale ranging 0=Not at all or 3= Nearly every day, indicating how often they experience anxiety-related problems (Spitzer, Kroenke, Williams, Lowe, 2006).
Measured: Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Change in baseline depression at week 12
Patient Health Questionnaire 9 (PHQ-9) is a reliable and valid self-report measure of depression symptoms that is widely used in clinical research. Consisting of 9 questions, respondents rate each question on a scale ranging 0= Not at all or 3= Nearly every day, indicating how often they experience depression-related problems (Pfizer, 1999).
Measured: Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start12 Apr 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorders and SymptomsStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Silver Cloud Health, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Todd Farchione, Ph.D., Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567640
- Sponsor's protocol ID
- MH127469
- Other IDs
- 6481E, 5R01MH127469-04
- Status last verified
- Jul 2026
- First submitted
- 13 Sep 2022
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions
- ClinicalTrials.gov ID
- NCT05567640
- Acronym / sponsor ID
- MH127469
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Silver Cloud Health, Kaiser Permanente
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 Oct 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.
Digital mental health interventions are a cost-effective and efficient approach to expanding the accessibility and impact of psychological treatments; however, little guidance exists for selecting the most effective program for a given individual. In the proposed study, decision rules will develop for selecting the digital program that is most likely to be the optimal intervention for each user. These treatment recommendations can be implemented in the context of large healthcare delivery systems to improve the delivery of digital mental health interventions at scale.
The overarching aim of the current study is to better understand for whom and how leading digital interventions work in a large healthcare setting. The study builds on the existing literature and follows expert recommendations by using machine learning (ML) methods to develop precision treatment rules (PTRs) for three leading digital interventions for emotional disorders (e.g., anxiety, depression, and related mental health disorders). Specifically, ML methods will be used to develop PTRs to optimize clinical outcomes and associated intervention engagement. This study will leverage a unique partnership between Boston University (BU), SilverCloud Health (SC)--a leading provider of digital mental health care--and Kaiser Permanente (KP)--one of America's leading health care providers.
A clinical trial (RCT) will be conducted to evaluate the relative effectiveness of three distinct empirically supported digital mental health interventions (from SC's existing library of programs) in a sample recruited from KP primary care and other clinical settings. Data from this trial will be used to develop theoretically and empirically informed, reliable selection algorithms for managing treatment delivery decisions. Algorithms will be validated in a separate "holdout" dataset by examining whether allocation to predicted optimal treatment is associated with superior outcomes compared to allocation to a non-optimal treatment. The role of user engagement will be determined, and other mechanisms in treatment outcome.
Detailed description
Kaiser Permanente (KP) members referred to SilverCloud Health (SC) through established operating procedures will be eligible to participate. After referral, potential participants will be informed of the study through the SC digital health platform. Interested participants will be provided information about the study through a digital version of an approved consent form. After signing consent, participants will complete baseline assessment questionnaires through Qualtrics, an online data collection platform.
After completing the baseline assessment, eligible participants will be randomly assigned to one of three existing digital mental health interventions hosted by SC: (1) Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), (2) Space from Depression (SFD), and (3) Space for Resilience (SFR). A SC program supporter will also be established at that time.
This differs from standard operating procedures at SC in that participants are generally able to select their preferred program from SC's offerings. There is nothing that would preclude participants from seeking a different SC treatment following study participation.
Potential participants will have up to two weeks to enroll in the study, complete the baseline assessment, and begin a treatment program. If the participant does not initiate treatment within two weeks, they will be withdrawn from the study though they may continue with clinical services at SC.
Following randomization, study staff at BU will send participants Qualtrics questionnaires via email throughout the treatment phase of the study, at 4-, 8-, and 12-weeks after treatment is initiated. The participant completes these questionnaires online. Regular asynchronous written support will be provided by SC supporters, consistent with their standard procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) | Experimental | Behavioral: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)Digital, transdiagnostic, emotion-focused CBT intervention that consists of five "core" modules or components that have been shown to target temperamental characteristics (i.e., neuroticism) and resulting emotion dysregulation that are believed to underlie all anxiety, depressive, and emotional disorders. The core components of the program are psychoeducation, mindfulness, cognitive flexibility, behavioral strategies to counter emotion-driven behaviors, interoceptive, and emotion exposures. |
| Space from Depression (SFD) | Active comparator | Behavioral: Space for depressionDigital CBT program designed to minimize the impact of depressive symptoms. This program emphasizes the use of cognitive behavioral strategies as well as mindfulness through a series of seven structured modules. The core components of the program include psychoeducation around the relationship between thoughts, feelings, and behaviors; cognitive behavioral practices aimed at restructuring negative beliefs; behavioral strategies to improve self-esteem; and mindfulness techniques that focus attention on the present moment. |
| Space for Resilience (SFR) | Active comparator | Behavioral: Space for resilienceDigital program based on positive psychology principles and designed to promote resilience and well-being through a series of seven modules. The core components of the program include psychoeducation, values exploration, building relationships, promoting self-esteem and self-efficacy, and building gratitude and optimism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking adults
- Ages 18 or older
- Have a device that can connect to the internet.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)This is a cognitive behavioral treatment (CBT) for emotional disorders. This transdiagnostic intervention consists of eight modules and can be effectively applied to various disorders and problems. | Behavioural | The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) |
| Space for depressionDigital CBT program designed to minimize the impact of depression symptoms. Emphasizes CBT strategies and mindfulness through a series of seven structured modules. | Behavioural | Space from Depression (SFD) |
| Space for resilienceThis program is built from positive psychology principles and is designed to promote resilience and well-being through seven modules. | Behavioural | Space for Resilience (SFR) |
Primary outcome
Change from baseline well-being at week 12
Time frame: Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
World Health Organization-Five (WHO-5) is a 5-item self-report questionnaire of psychological well being. The WHO-5 has demonstrated good validity and utility as an outcome measure in clinical trials including several digital intervention trials. Respondents rate each statement in relation to the past two weeks on a scale ranging from 0= At no time to 5= All the time (Ware, 1995).
2 secondary outcomes
Change from baseline anxiety at week 12
Time frame: Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Change in baseline depression at week 12
Time frame: Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
Todd Farchione, Ph.D. principal investigator
Boston University Charles River Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), Space for depression and Space for resilience in people with Anxiety Disorders and Symptoms and Depressive Symptoms, run by Boston University Charles River Campus 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 3 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 31 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Todd Farchione, Ph.D. ((617) 353-9610, tfarchio@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline well-being at week 12 (time frame: Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline). 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 31 Jul 2026.