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

NCT ID: NCT06865937

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-09-30

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.

Detailed Description

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 a context-triggered mobile smartphone intervention and remote telephone coaching. The investigators will conduct a randomized clinical trial of mSITE, evaluating whether the intervention leads to clinically significant changes in the frequency of social interactions in comparison to a therapist and device matched condition. The investigators will changes in outcome measures at baseline and Weeks 8, 18, and 30. 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

Schizophenia Disorder; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

mobile Social Interaction Therapy by Exposure (mSITE)

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Supportive Contact (SC)

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.

Group Type: ACTIVE_COMPARATOR

Supportive Contact (SC)

Intervention Type: 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.

Interventions

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

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.

Intervention Type: BEHAVIORAL

Supportive Contact (SC)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

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

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

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

Locations

University of California - San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jason Holden, PhD

Role: CONTACT

jlholden@health.ucsd.edu

858-246-2517

Eric Granholm, PhD

Role: CONTACT

egranholm@health.ucsd.edu

858-534-2542

Facility Contacts

Jason Holden, PhD

Role: primary

jlholden@health.ucsd.edu

858-246-2517

Other Identifiers

4R33MH126094-03

Identifier Type: NIH

Identifier Source: secondary_id

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R33MH126094

Identifier Type: NIH

Identifier Source: org_study_id

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