NCT06909422

Brief Summary

This study will test the inital efficacy of a brief mobile intervention targeting biased thinking.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
32mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Dec 2028

First Submitted

Initial submission to the registry

March 27, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

March 27, 2025

Last Update Submit

December 22, 2025

Conditions

SchizophreniaClinical High Risk for Psychosis (CHR)

Outcome Measures

Primary Outcomes (2)

  • Defeatist Beliefs Scale - 15

    Measure of Defeatist Performance Beliefs

    Measured at Baseline and post intervention (6 weeks)

  • Brief Negative Symptoms Scale

    Measure of negative symptoms

    Measured at Baseline and post intervention (6 weeks)

Study Arms (1)

Mobile Intervention to Target Biased Thinking

EXPERIMENTAL
Behavioral: Mobile Intervention for Biased Thinking

Interventions

Mobile Intervention for Biased ThinkingBEHAVIORAL

This intervention will be delivered via a mobile application.

Mobile Intervention to Target Biased Thinking

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of schizophrenia or related psychotic disorder OR
  • Identified as being at clinical high risk for psychosis in symptom interviews

You may not qualify if:

  • Recent changes in mental health treatment in past month or two months if on depot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35223-1517, United States

Location

Related Publications (1)

  • Granholm E, Holden J, Dwyer K, Mikhael T, Link P, Depp C. Mobile-Assisted Cognitive Behavioral Therapy for Negative Symptoms: Open Single-Arm Trial With Schizophrenia Patients. JMIR Ment Health. 2020 Dec 1;7(12):e24406. doi: 10.2196/24406.

    PMID: 33258792BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Lauren Luther

CONTACT

205-530-1117cas-treatlab@uab.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 3, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

US(1)