Recruiting

Mobile Intervention

Sponsor:

VA Office of Research and Development

Code:

NCT06138054

Conditions

Schizophrenia Spectrum Disorders

Psychotic Affective Disorders

Psychotic Mood Disorders

Homelessness

Ill-Housed Persons

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

MI-CBTech

Mindfulness control

Study Details

Brief summary:

This study aims to test the feasibility and acceptability of a brief behavioral intervention that combines two treatments, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), that have been shown to work in prior research studies. The format of the intervention will be a combination of in-person sessions and remote elements delivered via mobile phone (together called MI-CBTech). The goal of the intervention is to improve community integration in Veterans with serious mental illness (SMI) who have experienced homelessness. A time- and format-matched control arm will include remote mindfulness training. 50 Veterans with SMI experiencing homelessness will be randomized to one of the two arms (25 per arm).

Conditions

Schizophrenia Spectrum Disorders

Psychotic Affective Disorders

Psychotic Mood Disorders

Homelessness

Ill-Housed Persons

Study ID

NCT06138054

Start date

Apr 1, 2024

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Veterans currently residing at the VA Greater Los Angeles Mental Health Residential Rehabilitation Treatment Program (Domiciliary)
  • age 18-65 years
  • diagnosis of non-affective or affective psychotic illness as confirmed by chart review
  • history of homelessness
  • sufficiently fluent in English to consent, understand procedures, and complete assessments and intervention
  • medically and clinically stable (i.e. able to participate in and complete assessments and intervention).

Exclusion Criteria:

  • history of clinically significant neurological disorder determined by medical history (e.g., epilepsy)
  • history of serious head injury (i.e., loss of consciousness > 1 hr, neuropsychological sequelae, cognitive rehabilitation post head injury)
  • evidence of IQ < 70 or developmental disability
  • moderate or severe substance use disorder in the past month based on chart review

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: MI-CBTech

An 8-week experimental intervention that combines two treatments, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT). The format of the intervention will be a combination of in-person sessions and remote elements (together called MI-CBTech) delivered via mobile phone or other smart device.

active comparator: Mindfulness control

An 8-week active control intervention that combines supportive therapy and mindfulness training. The format of the intervention will be a combination of in-person sessions and remote elements delivered via mobile phone or other smart device.

Interventions

MI-CBTech

Three in-person MI sessions focused on identifying goals for community integration (in the areas of vocational, recreational, social, or independent living activities) and unhelpful thinking that tends to get in the way of those goals, building motivation for goals, introducing participants to the CBT model and its potential benefits, and downloading and orienting them to the mobile phone application.

Six weeks of mobile phone application use to guide participants through CBT. Weekly content will be provided to learn and practice CBT skills to address unhelpful thinking and problem solving to address obstacles to goal attainment. There will be brief content pages worksheets to guide participants through practice. The worksheets will be tailored to each participant, framing the skills around their pre-identified goals and unhelpful thinking patterns. The application will also include access to crisis resources.

Mindfulness control

Three in-person supportive therapy sessions focused on empathic listening during client-led discussions of presenting concerns, introducing participants to mindfulness (defined as noticing and paying attention to the present moment without judgment), and downloading and orienting them to the mobile phone application. Participants will be informed of potential benefits of mindfulness, including stress reduction and increased self-awareness.

Six weeks of mindfulness training mobile application use to help participants learn to practice mindfulness through a gradual, self-guided training program. The application offers a library of information about mindfulness, 12 different audio-guided mindfulness exercises, goal-setting and tracking, customizable reminders, and access to crisis resources.

Primary outcome measure

  • Baseline assessment completion rate [ Time Frame: At baseline, prior to randomization ]
  • End of treatment assessment completion rate [ Time Frame: End of 8-week treatment phase ]
  • Remote treatment adherence rate [ Time Frame: End of 8-week treatment phase ]
  • Satisfaction rating index [ Time Frame: At study completion, typically 16 weeks after randomization ]

Central Contacts and Locations

Central contacts

Locations

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Recruiting

West Los Angeles, California, United States, 90073-1003

Contacts

Principal Investigator:

Amy M Jimenez, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • Community Integration
  • Telerehabilitation
  • Telemedicine
  • Cognitive Behavioral Therapy
  • Motivational Interviewing
  • Mobile Applications
  • Smartphone
  • Smartphone Apps

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-11-10.