Recruiting

Digital Laboratory

Sponsor:

Columbia University

Code:

NCT06774417

Conditions

Clinical High Risk

Early Psychosis

First Episode Psychosis

Eligibility Criteria

Sex: All

Age: 12 - 29

Healthy Volunteers: Not accepted

Interventions

Digital nudge

Study Details

Brief summary:

This proposal aims to establish a Digital Laboratory focused on advancing help-seeking and expediting treatment initiation in youth ages 12-29 who are at Clinical High-Risk (CHR) for developing psychosis. Leveraging the Health Action Process Approach (HAPA) model, this study will identify help-seeking subtypes in 25,000 youth who screen positive for psychosis-risk on Mental Health America's national online screening platform, iteratively develop and test theory and data-driven, personalized strategies to advance help-seeking using Micro-Randomized Trials and a Sequential Multiple Assignment Randomized Trial, identify the most accurate CHR screening threshold in an online environment, and link youth, when indicated, to local clinical care via AMP-SCZ, a NIH funded national network of CHR programs throughout the US. This academic-industry partnership aims to curate one of the largest datasets of youth with CHR, and to develop effective strategies to enhance early help-seeking, in a population where help-seeking is critical and a significant barrier to care.

Conditions

Clinical High Risk

Early Psychosis

First Episode Psychosis

Study ID

NCT06774417

Start date

Feb 2, 2026

Status verified date

Jun, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 29

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 12-29 years
  • Living within a 50-mile radius of a US based AMP-SCZ site
  • Able to complete the English language PQ-B on MHA's screening platform

Study Design

Enrollment

25000 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Self-Efficacy Nudge

Participants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care

active comparator: Needs/Risks Nudge

Participants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care

active comparator: Outcome expectations

Participants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care

no intervention: Neutral nudge

Participants will be randomized with equal probability into a unique HAPA construct category at baseline and this randomization process will continue as participants advance towards care

Interventions

Digital nudge

Digital help seeking advancement strategies over text and online.

Primary outcome measure

  • Proportion of youth who initiate a text or schedule an assessment after scoring PQ-B (Prodromal-Questionnaire) positive [ Time Frame: 2 weeks ]
  • Proportion of youth who advance to complete a clinical assessment [ Time Frame: 2 weeks ]
  • Proportion of youth who advance to care [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Michael Birnbaum, MD

212-523-2154mlb2216@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Michael Birnbaum, MD

212-523-2154mlb2216@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-18.