Generalized Anxiety Disorder (GAD)NCT07430800
Personalized AI-Driven Models in Cognitive Behavioral Therapy for Anxiety
A study testing Explicit CBT SAR Personalization for 6 weeks and Implicit CBT SAR Personalization for 6 weeks in people with Generalized Anxiety Disorder (GAD), run by University of Southern California at 1 site in United States.
Trial summary
Untreated anxiety undermines long-term physical and emotional wellbeing, especially among college students, with rates worsening since the onset of the COVID-19 pandemic. Cognitive Behavioral Therapy (CBT) is the leading evidence-based intervention for anxiety, but many students fail to complete exercises between CBT… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder (GAD)
- What is being tested?
- Explicit CBT SAR Personalization for 6 weeks and Implicit CBT SAR Personalization for 6 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2026to 15 Aug 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 18 years of age or older
- Are university students
- Are able to communicate in English
- Have corrected-to-normal vision and hearing
- Consent to have audio/video/interaction data recorded as part of the study
- Have a GAD-7 (Generalized Anxiety Disorder-7 item) score of 5 or greater, indicating mild to elevated levels of self-reported symptoms of anxiety
- Have a lower than minimal level of suicidality risk as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) during screening ("NO" responses to items 3, 4, 5, and 6 on C-SSRS)
- Having access to home WiFi
Who cannot join
- Are less than 18 years of age
- Are not university students
- Are not able to communicate in English
- Do not have corrected-to-normal vision and hearing
- Do not consent to have audio/video/interaction data recorded as part of the study
- Have a GAD-7 (Generalized Anxiety Disorder-7 item) score of 4 or lower.
- Higher than a minimal level of suicidality risk as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) during screening ("YES" responses to items 3, 4, 5, or 6 on C-SSRS)
- Don't have access to home WiFi
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
University of Southern California
Los Angeles, California, 90089
Lydia Ignatova, 714-855-7076, lignatov@usc.edu
Emily Weiss, 402-237-2492, emilymwe@usc.edu
About this study
Official title: SCH: Personalized AI-Driven Models for Supporting User Engagement and Adherence in Health Interventions: Validation in Cognitive Behavioral Therapy for Anxiety
Untreated anxiety undermines long-term physical and emotional wellbeing, especially among college students, with rates worsening since the onset of the COVID-19 pandemic. Cognitive Behavioral Therapy (CBT) is the leading evidence-based intervention for anxiety, but many students fail to complete exercises between CBT sessions, reducing its effectiveness. Socially assistive robots (SARs) help promote adherence to home-based practice in the context of elder care, social skill learning, and physical therapy, but it is unknown how SARs can enhance CBT. The specific objective of this research is to develop personalized CBT SARs that can support CBT compliance for college students with anxiety. To meet the goals of the proposed work, these studies will determine how SAR personalization based on implicit and explicit feedback can help promote greater CBT compliance and anxiety reduction outcomes for students.
Read the detailed description
The investigators will conduct a Phase 1 parallel intervention study with random assignment. The investigators will randomly assign consented college students reporting anxiety symptoms to one of two 6-week Cognitive Behavioral Therapy (CBT) exercise conditions that were validated in our preliminary studies. The participant will be randomly assigned to a condition (personalized versus not personalized socially assistive robot (SAR) CBT) and will be informed of their condition by the investigators when the participant is ready to start their home practice with the SAR CBT companion. During the initial baseline in-home visit, participants will be provided with a SAR and instructions for how to complete their SAR CBT exercises daily for 6 weeks. During the 6-week home-based study period that follows the baseline visit, the participant will be reminded daily to complete a CBT exercise with their SAR. The investigators will be the point of contact via phone or email for all participants who need assistance (e.g., with SAR/software issues).
The investigators will evaluate personalized re-engagement strategies derived from implicit feedback from individuals with clinically elevated anxiety. This will be done through an in-home between-subjects user study involving 60 student participants who will be randomly assigned to either a control condition without re-engagement feedback or a personalized feedback condition with personalized re-engagement feedback. Quantitative behavioral and subjective metrics will be compared between the conditions to assess the impact of personalized feedback on feelings of relatedness with the robot, intrinsic motivation, engagement, and adherence, guided by self-determination theory. The study aims to determine whether personalized re-engagement feedback enhances the intrinsic motivation, engagement, and adherence when using the SAR companion to deliver CBT concepts to individuals with clinically elevated anxiety.
The second aim is to evaluate the personalization of robot attributes based on explicit user feedback in individuals with clinically elevated anxiety. This will be done through an in-home between-subjects user study where 60 participants are randomly assigned to either a control condition without the capability to personalize the robot's attributes or a personalization condition where the participant can modify the robot's attributes at the start of the study and between CBT sessions. This study aims to determine whether granting users the ability to choose the robot's attributes will lead to higher levels of intrinsic motivation, engagement, and adherence during interaction with the SAR companion.
- Conditions
- Generalized Anxiety Disorder (GAD)
- Being tested
- Explicit CBT SAR Personalization for 6 weeks, Implicit CBT SAR Personalization for 6 weeks, Control CBT SAR for 6 weeks
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explicit CBT SAR Personalization for 6 weeksBehavioural
College student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with an explicitly personalized CBT SAR in the participants' homes. Participants will receive personalized re-engagement feedback delivered by the SAR will be based on explicit user feedback regarding their subjective preferences related to the robot attributes and engagement features.
Implicit CBT SAR Personalization for 6 weeksBehavioural
College student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBI daily exercises with an implicitly personalized CBT SAR in the participants' homes. The personalized re-engagement feedback provided by the SAR will be based on machine learning methods applied to implicit visual and auditory cues.
Control CBT SAR for 6 weeksBehavioural
College student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with a non-personalized CBT SAR. Participants will not have the capability to personalize the robot's attributes, and this condition will be a control baseline comparison group for the personalized intervention conditions described above.
| Study group | Role | What they receive |
|---|---|---|
| Explicit CBT SAR Personalization for 6 weeks | Experimental | College student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with an explicitly personalized CBT SAR in the participants' homes. Each participant will receive personalized re-engagement feedback delivered by the SAR will be based on explicit user feedback regarding the participant's subjective preferences related to the robot attributes and engagement features. Receives: Behavioral: Explicit CBT SAR Personalization for 6 weeks |
| Implicit CBT SAR Personalization for 6 weeks | Experimental | College student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBI daily exercises with an implicitly personalized CBT SAR in the participants' homes. The personalized re-engagement feedback provided by the SAR will be based on machine learning methods applied to implicit visual and auditory cues. Receives: Behavioral: Implicit CBT SAR Personalization for 6 weeks |
| Control CBT SAR for 6 weeks | Placebo comparator | College student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with a non-personalized CBT SAR in the participants' homes. Participants will not have the capability to personalize the robot's attributes, and this condition will be a control baseline comparison group for the personalized intervention conditions described above. Receives: Behavioral: Control CBT SAR for 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of user-spoken words during interactions with SAR
Using transcriptions of the interactions, the investigators will count the number of words uttered by the participant.
Measured: During each session, through study completion, approximately 6 weeks.
Overall length of interaction sessions
Using the interaction data from the robot interface, the investigators will collect the time that the participant started the interaction with the robot and the time that the interaction ended.
Measured: Through the duration of the study, approximately 6 weeks.
Number of days participants complete CBT exercises (adherence)
Using the interaction data from the robot interface, the investigators will collect the number of days that the participant interacts with the system at least once during the day
Measured: Through study completion, approximately 6 weeks.
Outcomes Questionnaire-45.2
The total reported symptom distress value from the symptom distress subscale. Question scale (0-4). A higher total score indicates higher distress overall, and higher scores for question subsets indicate worse outcomes for symptom distress, interpersonal relations, and social role.
Measured: Once in weeks 1, 3, 6 of the study.
Modified Working Alliance Inventory-Short Revised
Repeated daily measure for assessing the quality of the relationship with the SAR companion. Question scale (1-5). Higher scores indicate stronger alliance.
Measured: Once in weeks 2, 4, 6 of study.
Sustem Usability Scale
The total reported usability score for evaluating participant perception of SAR companion's usability. Question responses scale from strongly agree to strongly disagree. Responses should not indicate trends in participant outcomes, but should instead help the investigators understand participants' perception of the system.
Measured: Once on Week 2 Day 4 and Week 6 Day 4.
Semi-structured interview
Focus group interviews with the investigators and participants will be used to process for collecting qualitative feedback and insights. The investigators will use this data to perform thematic analysis of participant responses while using the system.
Measured: One interview for 30 minutes - 120 minutes at the end of the 6 week study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start30 Mar 2026
- Primary completion14 Feb 2028 (estimated)
- Study completion15 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Maja Mataric, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430800
- Sponsor's protocol ID
- R01MH139134-At-Home
- Other IDs
- R01MH139134
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCH: Personalized AI-Driven Models for Supporting User Engagement and Adherence in Health Interventions: Validation in Cognitive Behavioral Therapy for Anxiety
- ClinicalTrials.gov ID
- NCT07430800
- Acronym / sponsor ID
- R01MH139134-At-Home
- Conditions
- Generalized Anxiety Disorder (GAD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 14 Feb 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 24 Feb 2026 (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.
Untreated anxiety undermines long-term physical and emotional wellbeing, especially among college students, with rates worsening since the onset of the COVID-19 pandemic. Cognitive Behavioral Therapy (CBT) is the leading evidence-based intervention for anxiety, but many students fail to complete exercises between CBT sessions, reducing its effectiveness. Socially assistive robots (SARs) help promote adherence to home-based practice in the context of elder care, social skill learning, and physical therapy, but it is unknown how SARs can enhance CBT. The specific objective of this research is to develop personalized CBT SARs that can support CBT compliance for college students with anxiety. To meet the goals of the proposed work, these studies will determine how SAR personalization based on implicit and explicit feedback can help promote greater CBT compliance and anxiety reduction outcomes for students.
Detailed description
The investigators will conduct a Phase 1 parallel intervention study with random assignment. The investigators will randomly assign consented college students reporting anxiety symptoms to one of two 6-week Cognitive Behavioral Therapy (CBT) exercise conditions that were validated in our preliminary studies. The participant will be randomly assigned to a condition (personalized versus not personalized socially assistive robot (SAR) CBT) and will be informed of their condition by the investigators when the participant is ready to start their home practice with the SAR CBT companion. During the initial baseline in-home visit, participants will be provided with a SAR and instructions for how to complete their SAR CBT exercises daily for 6 weeks. During the 6-week home-based study period that follows the baseline visit, the participant will be reminded daily to complete a CBT exercise with their SAR. The investigators will be the point of contact via phone or email for all participants who need assistance (e.g., with SAR/software issues).
The investigators will evaluate personalized re-engagement strategies derived from implicit feedback from individuals with clinically elevated anxiety. This will be done through an in-home between-subjects user study involving 60 student participants who will be randomly assigned to either a control condition without re-engagement feedback or a personalized feedback condition with personalized re-engagement feedback. Quantitative behavioral and subjective metrics will be compared between the conditions to assess the impact of personalized feedback on feelings of relatedness with the robot, intrinsic motivation, engagement, and adherence, guided by self-determination theory. The study aims to determine whether personalized re-engagement feedback enhances the intrinsic motivation, engagement, and adherence when using the SAR companion to deliver CBT concepts to individuals with clinically elevated anxiety.
The second aim is to evaluate the personalization of robot attributes based on explicit user feedback in individuals with clinically elevated anxiety. This will be done through an in-home between-subjects user study where 60 participants are randomly assigned to either a control condition without the capability to personalize the robot's attributes or a personalization condition where the participant can modify the robot's attributes at the start of the study and between CBT sessions. This study aims to determine whether granting users the ability to choose the robot's attributes will lead to higher levels of intrinsic motivation, engagement, and adherence during interaction with the SAR companion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Explicit CBT SAR Personalization for 6 weeks | Experimental | Behavioral: Explicit CBT SAR Personalization for 6 weeksCollege student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with an explicitly personalized CBT SAR in the participants' homes. Each participant will receive personalized re-engagement feedback delivered by the SAR will be based on explicit user feedback regarding the participant's subjective preferences related to the robot attributes and engagement features. |
| Implicit CBT SAR Personalization for 6 weeks | Experimental | Behavioral: Implicit CBT SAR Personalization for 6 weeksCollege student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBI daily exercises with an implicitly personalized CBT SAR in the participants' homes. The personalized re-engagement feedback provided by the SAR will be based on machine learning methods applied to implicit visual and auditory cues. |
| Control CBT SAR for 6 weeks | Placebo comparator | Behavioral: Control CBT SAR for 6 weeksCollege student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with a non-personalized CBT SAR in the participants' homes. Participants will not have the capability to personalize the robot's attributes, and this condition will be a control baseline comparison group for the personalized intervention conditions described above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are 18 years of age or older
- Are university students
- Are able to communicate in English
- Have corrected-to-normal vision and hearing
- Consent to have audio/video/interaction data recorded as part of the study
Key exclusion criteria (8 listed)
- Are less than 18 years of age
- Are not university students
- Are not able to communicate in English
- Do not have corrected-to-normal vision and hearing
- Do not consent to have audio/video/interaction data recorded as part of the study
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 |
|---|---|---|
| Explicit CBT SAR Personalization for 6 weeksCollege student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with an explicitly personalized CBT SAR in the participants' homes. Participants will receive personalized re-engagement feedback delivered by the SAR will be based on explicit user feedback regarding their subjective preferences related to the robot attributes and engagement features. | Behavioural | Explicit CBT SAR Personalization for 6 weeks |
| Implicit CBT SAR Personalization for 6 weeksCollege student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBI daily exercises with an implicitly personalized CBT SAR in the participants' homes. The personalized re-engagement feedback provided by the SAR will be based on machine learning methods applied to implicit visual and auditory cues. | Behavioural | Implicit CBT SAR Personalization for 6 weeks |
| Control CBT SAR for 6 weeksCollege student participants with clinically elevated anxiety will engage in 6 weeks of in-home CBT daily exercises with a non-personalized CBT SAR. Participants will not have the capability to personalize the robot's attributes, and this condition will be a control baseline comparison group for the personalized intervention conditions described above. | Behavioural | Control CBT SAR for 6 weeks |
Primary outcome
Number of user-spoken words during interactions with SAR
Time frame: During each session, through study completion, approximately 6 weeks.
Using transcriptions of the interactions, the investigators will count the number of words uttered by the participant.
Overall length of interaction sessions
Time frame: Through the duration of the study, approximately 6 weeks.
Using the interaction data from the robot interface, the investigators will collect the time that the participant started the interaction with the robot and the time that the interaction ended.
Number of days participants complete CBT exercises (adherence)
Time frame: Through study completion, approximately 6 weeks.
Using the interaction data from the robot interface, the investigators will collect the number of days that the participant interacts with the system at least once during the day
Outcomes Questionnaire-45.2
Time frame: Once in weeks 1, 3, 6 of the study.
The total reported symptom distress value from the symptom distress subscale. Question scale (0-4). A higher total score indicates higher distress overall, and higher scores for question subsets indicate worse outcomes for symptom distress, interpersonal relations, and social role.
Modified Working Alliance Inventory-Short Revised
Time frame: Once in weeks 2, 4, 6 of study.
Repeated daily measure for assessing the quality of the relationship with the SAR companion. Question scale (1-5). Higher scores indicate stronger alliance.
Sustem Usability Scale
Time frame: Once on Week 2 Day 4 and Week 6 Day 4.
The total reported usability score for evaluating participant perception of SAR companion's usability. Question responses scale from strongly agree to strongly disagree. Responses should not indicate trends in participant outcomes, but should instead help the investigators understand participants' perception of the system.
Semi-structured interview
Time frame: One interview for 30 minutes - 120 minutes at the end of the 6 week study.
Focus group interviews with the investigators and participants will be used to process for collecting qualitative feedback and insights. The investigators will use this data to perform thematic analysis of participant responses while using the system.
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 8 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explicit CBT SAR Personalization for 6 weeks and Implicit CBT SAR Personalization for 6 weeks in people with Generalized Anxiety Disorder (GAD), run by University of Southern California 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 8 inclusion and 8 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 8 Jun 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of user-spoken words during interactions with SAR (time frame: During each session, through study completion, approximately 6 weeks.). The study lists 7 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 8 Jun 2026.