What side effects are associated with this type of intervention?

Common treatments for schizophrenia include antipsychotic medications, cognitive-behavioral therapy (CBT), and psychosocial interventions. Antipsychotic medications can cause side effects such as weight gain, drowsiness, dizziness, and in some cases, more severe effects like tardive dyskinesia. Cognitive-behavioral therapy and psychosocial interventions, which are similar to the mSITE approach, generally have fewer physical side effects but may cause emotional discomfort as patients confront challenging thoughts and behaviors. Overall, these therapies are considered safe and beneficial for improving social engagement and reducing symptoms.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including first-generation antipsychotics like fluphenazine and second-generation antipsychotics such as aripiprazole and risperidone. These medications primarily target positive symptoms of schizophrenia, such as hallucinations and delusions. While there is limited information on FDA-approved treatments specifically focusing on exposure therapy to improve social engagement in schizophrenia, psychosocial interventions, including cognitive-behavioral therapy (CBT) and social skills training, are commonly used alongside pharmacological treatments to enhance social functioning and overall quality of life in patients with schizophrenia.

What other types of research exist?

Promising alternatives to mSITE for schizophrenia patients include: 1) PsyLOG mobile application, which monitors antipsychotic-induced side effects and enhances patient-provider communication. 2) WeChat-based mHealth programs, which have shown potential in engaging patients through a familiar social media platform. 3) Cognitive Behavioral Therapy (CBT) for psychosis, which helps patients reframe delusions and hallucinations and develop social skills. 4) Social skills training groups, which provide structured environments for practicing social interactions. These alternatives leverage technology and evidence-based practices to support social engagement in schizophrenia patients.

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Behavioral Intervention

Mobile Social Interaction Therapy for Mental Illness (mSITE Trial)

N/A

Waitlist Available

Led By Eric Granholm, PhD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assess change from baseline in social functioning at weeks 0, 8, 12, 18, and 24

Awards & highlights

No Placebo-Only Group

Summary

This trial tests mSITE, a program using therapy, a smartphone app, and phone coaching to help people with serious mental illness improve their social interactions. It aims to reduce social isolation, which can negatively impact recovery.

Who is the study for?

This trial is for adults aged 18-65 with serious mental illnesses like schizophrenia or bipolar disorder, who avoid social interaction and can read at a 6th-grade level. It's not for those with severe disorganization, recent substance dependence, in certain housing facilities, or who've had CBT recently.

What is being tested?

The trial tests mobile Social Interaction Therapy by Exposure (mSITE), aiming to improve social engagement in people with serious mental illness using technology-supported therapy.

What are the potential side effects?

Since mSITE is a behavioral intervention rather than medication, it may not have typical drug side effects but could include increased anxiety or stress during exposure to social situations as part of the therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assess change from baseline in social functioning at weeks 0, 8, 12, 18, and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assess change from baseline in social functioning at weeks 0, 8, 12, 18, and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and assess change from baseline in social functioning at weeks 0, 8, 12, 18, and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Birchwood Social Functioning Scale

Clinical Assessment Interview for Negative Symptoms

Ecological Momentary Assessment

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: mobile Social Interaction Therapy by Exposure (mSITE)Experimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia include antipsychotic medications and psychosocial interventions. Antipsychotic medications work by modulating neurotransmitter systems, particularly dopamine and serotonin, to reduce psychotic symptoms. Psychosocial interventions, such as Cognitive Behavioral Therapy (CBT) and social skills training, aim to improve cognitive function and social engagement. The mSITE trial, which focuses on exposure therapy to enhance social interaction, is particularly important as it addresses social withdrawal—a common and debilitating symptom in schizophrenia. Improving social engagement through these therapies can significantly enhance the quality of life and functional outcomes for patients.

Social phobia. Longitudinal course and long-term outcome of cognitive-behavioral treatment.A meta-analysis of the effects of social-cognitive training in schizophrenia: The role of treatment characteristics and study quality.[Computer games and Internet addiction as well as pathological gambling. Therapy approaches].