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

NCT05660070 | Completed DMC

• 1 other identifier: R61MH126094
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This open 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

Schizophrenia; Schizoaffective Disorder; Mood Disorder, Psychotic

Outcome Measures

Primary Outcomes (5)

• 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, 12, 18, and 24

• Clinical Assessment Interview for Negative Symptoms

  Measure changes in motivational negative symptoms on the 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 expression and motivation and pleasure at Weeks 0, 8, 12, 18, and 24

• 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 social functioning at Weeks 0, 8, 12, 18, and 24

• Positive And Negative Syndrome Scale

  The 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 positive and negative symptoms at Weeks 0, 8, 12, 18, and 24

• 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 conversations at Weeks 0, 8, 12, 18, and 24

Study Arms (1)

mobile Social Interaction Therapy by Exposure (mSITE)

EXPERIMENTAL

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

Behavioral: mobile Social Interaction Therapy by Exposure (mSITE)

Interventions

mobile Social Interaction Therapy by Exposure (mSITE) BEHAVIORAL

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

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;
• DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar I disorder or major depression with history of psychosis based on a SCID-5 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;
• ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (to read therapy workbook).

You may not qualify if:

• Prior CBT in the past 2 years;
• Greater than moderate disorganization on the PANSS (P2- Disorganization item \>5);
• DSM-5 alcohol or substance dependence in past 3 months based on the SCID;
• 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

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Affective Disorders, Psychotic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Eric Granholm, PhD

  University of California, San Diego; San Diego Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 21, 2022
• Study Start: July 1, 2022
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

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)