Mobile Intervention for Schizophrenia

Overseen By Eric Granholm, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Cognitive-behavioral therapy, Substance dependence, Severe medical illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 30 weeks

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile app intervention called mSITE, designed to help individuals with serious mental illnesses such as schizophrenia, bipolar disorder, or major depression with psychosis improve their social interactions. The app integrates in-person therapy with mobile support and phone coaching to promote social engagement. Participants will either use the mSITE app or receive supportive contact, which provides similar coaching and interaction without the app. Suitable candidates have a history of these mental health conditions and experience social avoidance, characterized by a tendency to withdraw from social interactions. As an unphased trial, this study presents a unique opportunity to explore innovative support methods for enhancing social engagement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile intervention is safe for individuals with serious mental illness?

Research shows that the mobile Social Interaction Therapy by Exposure (mSITE) is being tested as a new method to help individuals with serious mental illness enhance their social skills. Although specific safety data for mSITE is not yet available, similar smartphone-based programs have proven easy to use and acceptable for those with serious mental health issues. This suggests that mSITE might also be well-received.

The trial is labeled as "Not Applicable" for phase, indicating a focus on testing the technology's functionality and effects rather than its safety. Consequently, there may be limited safety data available for mSITE specifically. However, other studies have generally considered mobile technology for mental health support safe, which is encouraging for potential participants in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE) because it offers a fresh approach to managing schizophrenia by blending in-person therapy with smartphone-based interventions and remote coaching. Unlike traditional treatments that primarily rely on medication and face-to-face therapy sessions, mSITE leverages technology to provide context-triggered support through mobile devices, which can be more accessible and flexible for patients. This innovative method aims to enhance social recovery and provide continuous support, making it a promising alternative to existing care options.

What evidence suggests that this mobile intervention is effective for social recovery in serious mental illness?

Research has shown that social media and mobile tools can assist individuals with serious mental illnesses like schizophrenia. A smartphone app called CORE improved recovery and reduced symptoms. Another study found that mobile health tools enabled better management of medical and mental health conditions. Social network tools also helped psychiatric patients function better and adhere to their treatment plans. In this trial, participants will receive either the new mobile therapy, mSITE, or supportive contact (SC). These findings suggest that mSITE could enhance social interaction and recovery for individuals with serious mental illness. ^{1 4 6 7 8}

Who Is on the Research Team?

Eric Granholm, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with serious mental illnesses like schizophrenia or schizoaffective disorder, who avoid social interaction. They must understand and agree to the study's terms. People with bipolar I or major depression can join if they've had psychosis before.

Inclusion Criteria

I avoid social situations more than usual.

I am between 18 and 65 years old and agree to participate.

I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar I, or major depression with psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the mSITE intervention, which includes brief in-person psychotherapy, context-triggered mobile smartphone intervention, and remote telephone coaching

30 weeks

In-person visits at baseline, Weeks 8, 18, and 30; ongoing mobile and telephone interactions

Follow-up

Participants are monitored for changes in social interactions and symptoms using various assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The trial is testing mSITE, a new mobile therapy aimed at improving social engagement in people with serious mental illness, against supportive contact (SC), which may be less interactive. Participants are randomly assigned to one of these two approaches.

How Is the Trial Designed?

Group I: mobile Social Interaction Therapy by Exposure (mSITE) Experimental Treatment 1 Intervention

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

Group II: Supportive Contact (SC) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4859871/

Effectiveness of Social Media Interventions for People With ... Our aim was to determine the effects of social media interventions for supporting mental health and well-being among people with schizophrenia.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05660070

Context-Aware Mobile Intervention for Social Recovery in ... This open trial will test a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social engagement ...

3. jmir.org jmir.org/2021/11/e29201/

A Smartphone Intervention for People With Serious Mental ... This study found that a novel smartphone app, CORE, proved to be usable, acceptable, and effective in improving recovery and reducing the ...

4. mhealth.amegroups.org mhealth.amegroups.org/article/view/140257/html

PeerTECH: a randomized controlled trial of a peer-led mobile ... PeerTECH, a peer-led mobile health intervention, demonstrated feasibility, acceptability, and effectiveness in improving medical and psychiatric self-management ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S027273582300079X

The effectiveness of social network interventions for ... These results indicate that social network interventions significantly improved general functioning and mental health treatment adherence in psychiatric ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8663659/

A Smartphone Intervention for People With Serious Mental ... This study found that a novel smartphone app, CORE, proved to be usable, acceptable, and effective in improving recovery and reducing the severity of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06865937?term=Eric+Small

Context-Aware Mobile Intervention for Social Recovery in ... This study evaluates a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social behavior, ...

8. c4tbh.org c4tbh.org/research-study/context-aware-mobile-intervention-for-social-recovery-in-serious-mental-illness/

Context-Aware Mobile Intervention for Social Recovery in ... We will evaluate whether mSITE leads to greater improvement in social interactions, negative symptoms and social functioning relative to SC. We ...