Mental HealthNCT04390451
Initial Testing of Whole Health STEPS
A study testing Whole Health STEPS in people with Mental Health, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This clinical trial is evaluating Whole Health STEPS (Structured Tiered Engagement with Peer Support), a package of services designed to improve functional outcomes for primary care Veterans with mental health concerns who are not actively engaged in mental health services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Whole Health STEPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 3 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran status
- Enrolled in primary care at a participating site
- Have at least mild functional impairment
- Screen positive on at least one primary care mental health screener
Who cannot join
- Actively engaged with an equivalent or higher level of care
- Preference for direct referral to mental health care
- Recent changes to psychotropic medications
- Severe impairment preventing engagement in the intervention or warranting a direct referral to a licensed independent provider
- Inability to independently communicate in verbal and written English
- Inability to complete the research tasks or intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
About this study
Official title: Initial Testing of Whole Health STEPS (Structured Tiered Engagement With Peer Support)
This clinical trial is evaluating Whole Health STEPS (Structured Tiered Engagement with Peer Support), a package of services designed to improve functional outcomes for primary care Veterans with mental health concerns who are not actively engaged in mental health services. Whole Health STEPS uses a Peer Support Specialist, or Peer, to provide support for Veterans to make progress on wellness goals using the Whole Health model. The level of support provided will be determined based on Veterans' progress and will be stepped-up until Veterans receive the level of support they need. Whole Health STEPS offers a non-mental health referral option for primary care Veterans with mental health concerns, provides a structured package of existing Whole Health services, and provides a structured service for peers in primary care settings.
- Conditions
- Mental Health
- Being tested
- Whole Health STEPS
- Keywords
- Primary Health Care, Mental Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Health STEPSBehavioural
Also called Whole Health Structured Tiered Engagement with Peer Support
A peer-delivered package of Whole Health services.
| Study group | Role | What they receive |
|---|---|---|
| Whole Health STEPS | Experimental | Participants will immediately receive Whole Health STEPS. Receives: Behavioral: Whole Health STEPS |
| Waitlist | Other | Participants will receive Whole Health STEPS after a defined waiting period. Receives: Behavioral: Whole Health STEPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of Psychosocial Functioning (IPF)
This 80 item self-report inventory measures several domains of psychosocial functioning (e.g., family relationships, work, self-care) on a 0-100 scale with lower scores indicating better outcomes.
Measured: Assessed at Baseline (at enrollment), Mid (2-3 months after enrollment), and Final (2-3 months after Mid). Open Trial participants only completed Baseline and Mid assessments. Pre-intervention and Post-Intervention timepoints are relative to trial arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start25 Apr 2022
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
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 Mental HealthStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study compares Whole Health STEPS to a waitlist control.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Emily M. Johnson, PhD, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390451
- Sponsor's protocol ID
- D3390-W
- Status last verified
- Mar 2026
- First submitted
- 13 May 2020
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be created and shared upon written request for appropriate scientific reasons.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Testing of Whole Health STEPS (Structured Tiered Engagement With Peer Support)
- ClinicalTrials.gov ID
- NCT04390451
- Acronym / sponsor ID
- D3390-W
- Conditions
- Mental Health
- Keywords
- Primary Health Care, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Posted 16 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is evaluating Whole Health STEPS (Structured Tiered Engagement with Peer Support), a package of services designed to improve functional outcomes for primary care Veterans with mental health concerns who are not actively engaged in mental health services. Whole Health STEPS uses a Peer Support Specialist, or Peer, to provide support for Veterans to make progress on wellness goals using the Whole Health model. The level of support provided will be determined based on Veterans' progress and will be stepped-up until Veterans receive the level of support they need. Whole Health STEPS offers a non-mental health referral option for primary care Veterans with mental health concerns, provides a structured package of existing Whole Health services, and provides a structured service for peers in primary care settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study compares Whole Health STEPS to a waitlist control.
| Arm | Type | Receives |
|---|---|---|
| Whole Health STEPS | Experimental | Behavioral: Whole Health STEPSParticipants will immediately receive Whole Health STEPS. |
| Waitlist | Other | Behavioral: Whole Health STEPSParticipants will receive Whole Health STEPS after a defined waiting period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veteran status
- Enrolled in primary care at a participating site
- Have at least mild functional impairment
- Screen positive on at least one primary care mental health screener
Key exclusion criteria (6 listed)
- Actively engaged with an equivalent or higher level of care
- Preference for direct referral to mental health care
- Recent changes to psychotropic medications
- Severe impairment preventing engagement in the intervention or warranting a direct referral to a licensed independent provider
- Inability to independently communicate in verbal and written English
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 |
|---|---|---|
| Whole Health STEPSAlso: Whole Health Structured Tiered Engagement with Peer SupportA peer-delivered package of Whole Health services. | Behavioural | Waitlist, Whole Health STEPS |
Primary outcome
Inventory of Psychosocial Functioning (IPF)
Time frame: Assessed at Baseline (at enrollment), Mid (2-3 months after enrollment), and Final (2-3 months after Mid). Open Trial participants only completed Baseline and Mid assessments. Pre-intervention and Post-Intervention timepoints are relative to trial arm.
This 80 item self-report inventory measures several domains of psychosocial functioning (e.g., family relationships, work, self-care) on a 0-100 scale with lower scores indicating better outcomes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be created and shared upon written request for appropriate scientific reasons.
Related trials for Mental Health
Not yet recruiting
Short, Wordless Animated Storytelling to Promote Mental Health Help-Seeking in Young Adults: A U.S. Online Randomized Controlled Trial
Mental Health Help-Seeking
Active, not recruiting
MEST : A School- Based Health Literacy Intervention Trial
Health Literacy, Adolescent Health
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
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.
Emily M. Johnson, PhD principal investigator
Syracuse VA Medical Center, Syracuse, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Health STEPS in people with Mental Health, run by VA Office of Research and Development 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 4 inclusion and 6 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 16 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?
Yes. Results are posted in the registry (first posted 16 Apr 2026). 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?
Inventory of Psychosocial Functioning (IPF) (time frame: Assessed at Baseline (at enrollment), Mid (2-3 months after enrollment), and Final (2-3 months after Mid). Open Trial participants only completed Baseline and Mid assessments. Pre-intervention and Post-Intervention timepoints are relative to trial arm.). 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 16 Apr 2026.