Mental IllnessNCT07519083
Behavioral Health Referrals Study
A study testing Express Access in people with Mental Illness, run by Outcome Referrals, Inc. at 1 site in United States.
Trial summary
This is a Stepped Wedge Cluster Randomized Trial (SW-CRT) to evaluate Express Access -- a new behavioral health referral application to support PCP referrals to behavioral health therapists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness
- What is being tested?
- Express Access
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2026to Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults seeking behavioral health referrals from licensed primary care providers.
Who cannot join
- None
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
Outcome Referrals, Inc.
Framingham, Massachusetts, 01701
About this study
Official title: Consumer-Therapist-Connector: Increasing Access to Quality Behavioral Healthcare
This is a Stepped Wedge Cluster Randomized Trial (SW-CRT) to evaluate Express Access -- a new behavioral health referral application to support PCP referrals to behavioral health therapists. The hypotheses are that clients who use Express Access for behavioral health referrals will have better overall well-being (primary outcome), as well as higher satisfaction with the referral process and faster speed to behavioral health care (secondary outcomes), than those who experience the usual standard referral processes.
Read the detailed description
The United States is experiencing a major mental health crisis. The gap between need and access to behavioral health services is rapidly increasing. Given that about ~50% of patients who have a behavioral health diagnosis will have had that condition first identified by a primary care physician (Hill et al., 2015; Reeves et al., 2011), the primary care setting is an ideal site to conduct an efficacy test of a new online behavioral health referral system called Express Access.
Stepped wedge cluster randomized trial (SW-CRT) is a preferred approach when it is difficult to randomize individual patients within a clinical practice (cluster) to a specific condition (e.g., Li \& Wang, 2022). In this SW-CRT, all patients requesting, or recommended for, behavioral health referrals from their Primary Care Providers (PCPs) will be exposed to the Control condition (standard behavioral health referral processes) at the start of the study. Over time each PCP individual or practice (cluster) is randomized to a specific sequence (i.e., "step" or time point); all subsequent patients requesting a behavioral health referral will then be exposed to the Experimental condition (Express Access with TOP Match) at the beginning of the sequence to which each PCP was randomized.
RECRUITMENT PROCEDURES
The American Academy of Family Physicians (AAFP) will recruit PCPs from their membership to refer their patients to the study during routine visits (i.e., via verbal script or a flyer with a QR code linking to the consent form and study information).
METHODS AND PROCEDURES
Patients will review the study information by scanning the QR code provided by their PCP. Patients who sign the informed consent form will be sent weekly assessments (via email) until the patient reports that they found a therapist and scheduled an appointment. These assessments will ask about: how they searched for a therapist; satisfaction with the search method; challenges encountered during the search; confidence in finding a therapist within the next week (approximately 5-10 minutes per week). In addition, participants will complete the behavioral health well-being assessment (Treatment Outcome Package; TOP suite) at baseline and at one-month, two-month, and three-month intervals. The assessment includes demographic questions; questions about stressful life events, physical health, and medication use; ratings of behavioral health symptoms across 12 domains (approximately 10 minutes per assessment). PCPs will have access to this information to help connect the patient to a mental health provider. These data will remain confidential between the patient and their health treatment team to the extent allowed by law.
- Conditions
- Mental Illness
- Being tested
- Express Access
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Express AccessBehavioural
Patients will access Express Access via a QR code on a flyer that their PCP will give them. When they open the application, patients will be asked to select the name of the PCP who referred them and then complete a behavioral health assessment to help to identify therapists who treat patients with similar behavioral health needs.
| Study group | Role | What they receive |
|---|---|---|
| Express Access | Experimental | Not described Receives: Behavioral: Express Access |
| Standard Referral Processes | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant average score on the Clinical Scale of the Treatment Outcome Package (TOP-CS)
TOP is a comprehensive well-being assessment that is used in behavioral health settings. The Adult TOP-CS is a 58-item scale for individuals aged 18 and over that assesses the client's past 2-week experience on 12 domains (e.g., quality of life, depression, anxiety, and suicidality). The z-scores (standard deviation units relative to the general population mean for each domain) will be averaged together to create one summary score. Higher scores suggest higher severity.
Measured: Baseline and a TOP-CS every month up to Month 3.
Secondary outcomes (2)
Satisfaction score
Satisfaction will be measured with this item: "How frustrated are you with the search methods you used during the past week compared to other things you have tried in the past?" Response options are: 1=A lot more frustrated; 2=A little more frustrated; 3=No difference in frustration; 4=A little less frustrated; 5=Much less frustrated. Scores range between 1 and 5 (higher scores indicate higher satisfaction).
Measured: Time Frame: Every week until the client makes an appointment with a therapist, maximum of 12 weeks
Number of days until first therapist appointment
Days between study start and report of first scheduled therapist appointment (fewer days indicate faster speed to treatment).
Measured: Time Frame: Every week until the client makes an appointment with a therapist, maximum of 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start30 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped wedge cluster randomized trial (SW-CRT) is a preferred approach when it is difficult to randomize individual patients within a clinical practice (cluster) to a specific condition (e.g., Li \& Wang, 2022). In this SW-CRT, all new patients requesting, or recommended for, behavioral health referrals from their PCPs will be exposed to the Control condition (standard behavioral health referral processes) at the start of the study. Over time each PCP individual or practice (cluster) is randomized to a specific sequence (i.e., "step" or time point); all subsequent new patients requesting a behavioral health referral will then be exposed to the Experimental condition (Express Access) at the beginning of the sequence to which each PCP was randomized.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Outcome Referrals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American Academy of Family Physicians, SUNY Research Foundation, University of Massachusetts, Amherst
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519083
- Sponsor's protocol ID
- 2R44MH132156-02
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data generated in this SBIR Phase II project is considered proprietary.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumer-Therapist-Connector: Increasing Access to Quality Behavioral Healthcare
- ClinicalTrials.gov ID
- NCT07519083
- Acronym / sponsor ID
- 2R44MH132156-02
- Conditions
- Mental Illness
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Outcome Referrals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- American Academy of Family Physicians, SUNY Research Foundation, University of Massachusetts, Amherst
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Apr 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.
This is a Stepped Wedge Cluster Randomized Trial (SW-CRT) to evaluate Express Access -- a new behavioral health referral application to support PCP referrals to behavioral health therapists. The hypotheses are that clients who use Express Access for behavioral health referrals will have better overall well-being (primary outcome), as well as higher satisfaction with the referral process and faster speed to behavioral health care (secondary outcomes), than those who experience the usual standard referral processes.
Detailed description
The United States is experiencing a major mental health crisis. The gap between need and access to behavioral health services is rapidly increasing. Given that about ~50% of patients who have a behavioral health diagnosis will have had that condition first identified by a primary care physician (Hill et al., 2015; Reeves et al., 2011), the primary care setting is an ideal site to conduct an efficacy test of a new online behavioral health referral system called Express Access.
Stepped wedge cluster randomized trial (SW-CRT) is a preferred approach when it is difficult to randomize individual patients within a clinical practice (cluster) to a specific condition (e.g., Li \& Wang, 2022). In this SW-CRT, all patients requesting, or recommended for, behavioral health referrals from their Primary Care Providers (PCPs) will be exposed to the Control condition (standard behavioral health referral processes) at the start of the study. Over time each PCP individual or practice (cluster) is randomized to a specific sequence (i.e., "step" or time point); all subsequent patients requesting a behavioral health referral will then be exposed to the Experimental condition (Express Access with TOP Match) at the beginning of the sequence to which each PCP was randomized.
RECRUITMENT PROCEDURES
The American Academy of Family Physicians (AAFP) will recruit PCPs from their membership to refer their patients to the study during routine visits (i.e., via verbal script or a flyer with a QR code linking to the consent form and study information).
METHODS AND PROCEDURES
Patients will review the study information by scanning the QR code provided by their PCP. Patients who sign the informed consent form will be sent weekly assessments (via email) until the patient reports that they found a therapist and scheduled an appointment. These assessments will ask about: how they searched for a therapist; satisfaction with the search method; challenges encountered during the search; confidence in finding a therapist within the next week (approximately 5-10 minutes per week). In addition, participants will complete the behavioral health well-being assessment (Treatment Outcome Package; TOP suite) at baseline and at one-month, two-month, and three-month intervals. The assessment includes demographic questions; questions about stressful life events, physical health, and medication use; ratings of behavioral health symptoms across 12 domains (approximately 10 minutes per assessment). PCPs will have access to this information to help connect the patient to a mental health provider. These data will remain confidential between the patient and their health treatment team to the extent allowed by law.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized trial (SW-CRT) is a preferred approach when it is difficult to randomize individual patients within a clinical practice (cluster) to a specific condition (e.g., Li \& Wang, 2022). In this SW-CRT, all new patients requesting, or recommended for, behavioral health referrals from their PCPs will be exposed to the Control condition (standard behavioral health referral processes) at the start of the study. Over time each PCP individual or practice (cluster) is randomized to a specific sequence (i.e., "step" or time point); all subsequent new patients requesting a behavioral health referral will then be exposed to the Experimental condition (Express Access) at the beginning of the sequence to which each PCP was randomized.
| Arm | Type | Receives |
|---|---|---|
| Express Access | Experimental | Behavioral: Express Access |
| Standard Referral Processes | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults seeking behavioral health referrals from licensed primary care providers.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Express AccessPatients will access Express Access via a QR code on a flyer that their PCP will give them. When they open the application, patients will be asked to select the name of the PCP who referred them and then complete a behavioral health assessment to help to identify therapists who treat patients with similar behavioral health needs. | Behavioural | Express Access |
Primary outcome
Participant average score on the Clinical Scale of the Treatment Outcome Package (TOP-CS)
Time frame: Baseline and a TOP-CS every month up to Month 3.
TOP is a comprehensive well-being assessment that is used in behavioral health settings. The Adult TOP-CS is a 58-item scale for individuals aged 18 and over that assesses the client's past 2-week experience on 12 domains (e.g., quality of life, depression, anxiety, and suicidality). The z-scores (standard deviation units relative to the general population mean for each domain) will be averaged together to create one summary score. Higher scores suggest higher severity.
2 secondary outcomes
Satisfaction score
Time frame: Time Frame: Every week until the client makes an appointment with a therapist, maximum of 12 weeks
Number of days until first therapist appointment
Time frame: Time Frame: Every week until the client makes an appointment with a therapist, maximum of 12 weeks)
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 9 Apr 2026.
- Individual participant dataSharing planned: No. All data generated in this SBIR Phase II project is considered proprietary.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Express Access in people with Mental Illness, run by Outcome Referrals, Inc. 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 1 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: enrolling by invitation, as of the sponsor's last update on 9 Apr 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?
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?
Participant average score on the Clinical Scale of the Treatment Outcome Package (TOP-CS) (time frame: Baseline and a TOP-CS every month up to Month 3.). 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 9 Apr 2026.