Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)

NCT06865937 | Recruiting DMC

• 2 other identifiers: R33MH1260944R33MH126094-03
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Ecological Momentary Assessment

  Ecological Momentary Assessment (EMA) is a method of remote data collection that involves repeatedly sampling a participant's current behaviors, thoughts, mood, and experiences in real time, in their natural environments. The primary outcome in this study will be the number of social interactions.

  Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.

• Clinical Assessment Interview for Negative Symptoms

  Measure changes in motivational negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS). The CAINS is a 13-item interview-based assessment of negative symptoms, and each item is rated from 0 (no impairment) to 4 (severe deficit) measuring the two negative symptom factors recommended in consensus reports: Expression and Motivation and Pleasure (MAP) across social, vocational and recreational domains. Total scores for each factor are computed. The range for the MAP is 0 - 36, and the range for the Expression factor is 0 - 16. Higher scores indicate more severe negative symptoms for both factors.

  Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.

• Birchwood Social Functioning Scale

  Measure changes in functioning on the Birchwood Social Functioning Scale (SFS). The SFS is a self-report assessment of functioning with 7 subscales, and each item is rated from 0 to 3 with the exception of the Occupation/Employment subscale if a participant is in regular employment (scores range from 7-10 based upon type of work). The subscales and score ranges are: Social Engagement Withdrawal (0-15), Interpersonal Communication/Relationships (0-30), Prosocial Activities (0-66), Recreation (0-48), Independence-Performance (0-39), Independence-Competence (0-39), and Occupation/Employment (0-10). Higher scores indicate better functioning for all subscales.

  Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.

• Positive And Negative Syndrome Scale

  The Positive And Negative Syndrome Scale (PANSS) is a 30-item interview that provides balanced representation of positive and negative symptoms and gauges their relationship to one another and to global psychopathology. Items are rated 1 (Absent) to 7 (Extreme) and summed across items for a total range of scores of 30-210. Higher scores indicate the presence of more severe symptoms.

  Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.

• Passive sensing mobile application

  The passive sensing mobile application will measure the number of conversations. The conversations or specific content will not be recorded.

  Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.

Study Arms (2)

mobile Social Interaction Therapy by Exposure (mSITE)

EXPERIMENTAL

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

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

Supportive Contact (SC)

ACTIVE COMPARATOR

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.

Behavioral: Supportive Contact (SC)

Interventions

Supportive Contact (SC) BEHAVIORAL

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.

Supportive Contact (SC)

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

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.

mobile Social Interaction Therapy by Exposure (mSITE)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California - San Diego

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Eric Granholm, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Holden, PhD

CONTACT

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

Eric Granholm, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be uploaded according to NDA standard data submission periods. These periods are currently twice each year.
• Access Criteria: Data access is outlined in the current NDA Policy.

Locations

US (1)