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

NCT ID: NCT05660070

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-09-06

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Mood Disorder, Psychotic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mobile Social Interaction Therapy by Exposure (mSITE)

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

Group Type: EXPERIMENTAL

mobile Social Interaction Therapy by Exposure (mSITE)

Intervention Type: BEHAVIORAL

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

Interventions

mobile Social Interaction Therapy by Exposure (mSITE)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Voluntary informed consent to participate and capacity to consent;

2. Age 18 to 65;

3. 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;

4. Minimum level of social avoidance defined by a score of ≥ 2 on the Scale for the Assessment of Negative Symptoms (SANS) asociality item;

5. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (to read therapy workbook).

Exclusion Criteria

1. Prior CBT in the past 2 years;

2. Greater than moderate disorganization on the PANSS (P2- Disorganization item >5);

3. DSM-5 alcohol or substance dependence in past 3 months based on the SCID;

4. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness)

5. Unable to adequately see or manually manipulate a phone;

6. Resident of an integrated housing facility that also provides treatment services.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Eric Granholm

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Granholm, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

UC San Diego

La Jolla, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R61MH126094

Identifier Type: NIH

Identifier Source: org_study_id

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