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OpenTrials
Completed

NCT Number: NCT05660070

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

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.

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Key information

Conditions

Schizophrenia Affective Disorders, Psychotic Mental Disorders Mood Disorder, Psychotic Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego

La Jolla, California, 92093, United States

About this study

Social isolation is common in serious mental illness and has a profound negative impact on recovery. This study evaluates a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social behavior, and it also validates several new techniques for measuring social behavior. mSITE blends brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching. The investigators will conduct an open trial of mSITE, evaluating whether the intervention leads to clinically significant changes in the frequency of social interactions. The investigators will also determine the dose of app plus remote coaching necessary to achieve this effect, by evaluating change at 12, 18, or 24 weeks. If found to be effective, a scalable intervention that reduces social isolation in serious mental illness would have significant personal, societal, and economic impact.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Ecological Momentary Assessment

    Time frame: Assess change from baseline in number of social interactions at Weeks 0, 8, 12, 18, and 24

    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.

  2. Clinical Assessment Interview for Negative Symptoms

    Time frame: Assess change from baseline in expression and motivation and pleasure at Weeks 0, 8, 12, 18, and 24

    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.

  3. Birchwood Social Functioning Scale

    Time frame: Assess change from baseline in social functioning at Weeks 0, 8, 12, 18, and 24

    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.

  4. Positive And Negative Syndrome Scale

    Time frame: Assess change from baseline in positive and negative symptoms at Weeks 0, 8, 12, 18, and 24

    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.

  5. Passive sensing mobile application

    Time frame: Assess change from baseline in number of conversations at Weeks 0, 8, 12, 18, and 24

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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: mSITE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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