Back to resultsContext-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE)
Primary Purpose
Schizophrenia, Schizoaffective Disorder, Mood Disorder, Psychotic
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mobile Social Interaction Therapy by Exposure (mSITE)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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.
Sites / Locations
- UC San DiegoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mobile Social Interaction Therapy by Exposure (mSITE)
Arm Description
mSITE is a blended intervention that integrates brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Passive sensing mobile application
The passive sensing mobile application will measure the number of conversations. The conversations or specific content will not be recorded.
Secondary Outcome Measures
Full Information
NCT ID
NCT05660070
First Posted
December 5, 2022
Last Updated
December 13, 2022
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT05660070
Brief Title
Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness
Acronym
mSITE
Official Title
Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Mood Disorder, Psychotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mobile Social Interaction Therapy by Exposure (mSITE)
Arm Type
Experimental
Arm Description
mSITE is a blended intervention that integrates brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching.
Intervention Type
Behavioral
Intervention Name(s)
mobile Social Interaction Therapy by Exposure (mSITE)
Intervention Description
mSITE is a blended intervention that integrates brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching.
Primary Outcome Measure Information:
Title
Ecological Momentary Assessment
Description
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.
Time Frame
Assess change from baseline in number of social interactions at Weeks 0, 8, 12, 18, and 24
Title
Clinical Assessment Interview for Negative Symptoms
Description
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.
Time Frame
Assess change from baseline in expression and motivation and pleasure at Weeks 0, 8, 12, 18, and 24
Title
Birchwood Social Functioning Scale
Description
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.
Time Frame
Assess change from baseline in social functioning at Weeks 0, 8, 12, 18, and 24
Title
Positive And Negative Syndrome Scale
Description
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.
Time Frame
Assess change from baseline in positive and negative symptoms at Weeks 0, 8, 12, 18, and 24
Title
Passive sensing mobile application
Description
The passive sensing mobile application will measure the number of conversations. The conversations or specific content will not be recorded.
Time Frame
Assess change from baseline in number of conversations at Weeks 0, 8, 12, 18, and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Holden, PhD
Phone
858-246-2517
Email
jlholden@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Granholm, PhD
Email
egranholm@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Granholm, PhD
Organizational Affiliation
University of California, San Diego; San Diego Veterans Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Holden
Phone
858-246-2517
Email
jlholden@health.ucsd.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Per terms of the award, participant-level data will be uploaded to the NIMH Data Archive (NDA).
IPD Sharing Time Frame
Data will be uploaded according to NDA standard data submission periods. These periods are currently twice each year.
IPD Sharing Access Criteria
Data access is outlined in the current NDA Policy.
IPD Sharing URL
https://nda.nih.gov/
Learn more about this trial
Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness
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