Recruiting

mSITE

Sponsor:

UCLA

Code:

NCT06865937

Conditions

Schizophenia Disorder

Schizoaffective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE)

Supportive Contact (SC)

Study Details

Brief summary:

This randomized clinical trial will test a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social engagement in consumers with serious mental illness.

Conditions

Schizophenia Disorder

Schizoaffective Disorder

Study ID

NCT06865937

Start date

Jul 1, 2025

Status verified date

Feb, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Voluntary informed consent to participate and capacity to consent; Age 18 to 65;
  • Diagnosis of schizophrenia, schizoaffective, bipolar I disorder or major depression with history of psychosis based on a diagnostic interview and available medical record review;
  • Minimum level of social avoidance defined by a score of ≥ 2 on the Scale for the Assessment of Negative Symptoms (SANS) asociality item;
  • Be willing and able to speak English at ≥ 6th grade reading level (to read intervention workbook).

Exclusion Criteria:

  • Prior cognitive-behavioral therapy in the past 2 years;
  • Greater than moderate disorganization on the PANSS (P2- Disorganization item >5);
  • Alcohol or substance dependence in past 3 months based on the diagnostic interview;
  • Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness);
  • Unable to adequately see or manually manipulate a phone;
  • Resident of an integrated housing facility that also provides treatment services.

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mobile Social Interaction Therapy by Exposure (mSITE)

mSITE is a blended intervention that integrates a brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching.

active comparator: Supportive Contact (SC)

The SC arm is a contact condition that will provide the same amount of individual in-person and coaching, and mobile device contact as the mSITE condition.

Interventions

Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE)

mSITE is a blended intervention that integrates a brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching. Participants will attend weekly, in-person sessions for 8 weeks and then 15-minute, remote coaching sessions for 10 weeks. The intervention begins with setting a meaningful recovery goal and then the generic cognitive model is introduced and a simple thought challenging skill is trained to specifically address social avoidance behaviors and facilitate work toward recovery goals. Defeatist attitudes, social threat and avoidance behaviors that interfere with working on the goal are then modified using cognitive-behavioral therapy skills and practiced using role-plays.

Supportive Contact (SC)

The SC arm will match the mSITE arm on the same amount of individual in-person and coaching, and mobile device contact. Coaching sessions will be semi-structured and consist of setting recovery goals, check-in about symptoms and potential crisis management, flexible discussion involving psychoeducation, instructions for accessing community crisis lines and community resources, and symptom management behaviors that grow out of discussions, with only minimal therapist guidance.

Primary outcome measure

  • Ecological Momentary Assessment [ Time Frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30. ]
  • Clinical Assessment Interview for Negative Symptoms [ Time Frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30. ]
  • Birchwood Social Functioning Scale [ Time Frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30. ]
  • Positive And Negative Syndrome Scale [ Time Frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30. ]
  • Passive sensing mobile application [ Time Frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30. ]

Central Contacts and Locations

Central contacts

Jason Holden, PhD

858-246-2517jlholden@health.ucsd.edu

Eric Granholm, PhD

858-534-2542egranholm@health.ucsd.edu

Locations

University of California - San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Jason Holden, PhD

858-246-2517jlholden@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • schizophrenia
  • serious mental illness
  • social engagement
  • randomized clinical trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-02-23.