100 Participants NeededMy employer runs this trial

Psychosocial Intervention for Schizophrenia Prevention

YM
LE
OA
Overseen ByOluwabunmi Akindona, BA
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a family-based psychosocial intervention to determine its effectiveness in preventing schizophrenia in children and young adults. The intervention aims to reduce bothersome, psychotic-like experiences in individuals with a family history of severe mental illnesses. Participants must have two or more risk factors and remain psychiatrically stable without recent medication changes. The trial excludes those who have had psychotic disorders or are at high risk for them. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could shape future preventative strategies for schizophrenia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be psychiatrically stable and have had no major changes in antidepressant, stimulant, or antipsychotic medication in the past 4 weeks.

What prior data suggests that this psychosocial intervention is safe for children and young adults?

Previous studies have shown that treatments focusing on social and psychological support are safe for individuals with conditions like schizophrenia. Research indicates that these treatments do not raise the risk of crises or emergencies for participants. This suggests that participants generally handle the treatment well without harmful side effects.

Moreover, these treatments have improved patients' quality of life by helping them manage daily activities more effectively. While participating in a clinical trial always involves some risk, the evidence suggests that these supportive treatments are well-tolerated and safe.12345

Why are researchers excited about this trial?

Researchers are excited about psychosocial interventions for schizophrenia prevention because they offer a non-pharmacological approach to managing the condition. Unlike standard treatments that often involve antipsychotic medications, which can have significant side effects, psychosocial interventions focus on improving social skills, cognitive function, and emotional regulation. This treatment aims to address the root social and psychological challenges associated with schizophrenia, potentially offering a holistic way to prevent or reduce the onset of symptoms in at-risk individuals.

What evidence suggests that this psychosocial intervention is effective for schizophrenia prevention?

Research has shown that certain therapies can help people with schizophrenia by changing harmful thoughts and behaviors. Studies have found that these treatments effectively reduce symptoms and improve daily life. For example, cognitive behavioral therapy (CBT) addresses illogical thoughts and enhances thinking. These therapies also teach patients new skills to better manage their condition. Overall, they offer promising support in managing schizophrenia symptoms. Participants in this trial will receive a psychosocial intervention designed to prevent the onset of schizophrenia by addressing these factors.678910

Who Is on the Research Team?

YM

Yizhou Ma, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for children and young adults who have a family history of schizophrenia spectrum disorders (SSD) and show certain brain patterns linked to SSD risk. Participants should not have conditions that would prevent them from joining or completing the study.

Inclusion Criteria

I have been psychiatrically stable with no major medication changes in the past 4 weeks.
Family history of SSD defined as first-degree, second-degree, or other biological relatives with SSD or related severe mental illnesses equivalent to at least 25% genetic sharing confirmed by medical record review, parent/legal guardian report, and structured interview
Screening positive for two or more risk factors targeted by the intervention
See 1 more

Exclusion Criteria

Not able to undergo MRI
Current or past history of psychotic disorders or clinical high risk for psychosis (CHR-p) per study interview
I am not able to give my consent or permission for treatment.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a brief family-based psychosocial intervention addressing modifiable SSD risk factors

16 weeks
Regular visits as per intervention protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Follow-up assessments at 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Psychosocial intervention

Trial Overview

The study tests whether a short, family-based psychosocial program can help reduce ongoing distressing psychotic-like experiences in at-risk youth compared to usual care. The focus is on prevention using support and education.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Psychosocial intervention groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

Psychosocial interventions for schizophrenia: A systematic ...

CBT for schizophrenia is a well-studied and effective psychosocial intervention. It focuses on identifying and addressing illogical ideas and mental processes, ...

Psychosocial Interventions Beneficial in Schizophrenia

Data on Expressed Emotion Accumulate. Of all the biologically determined psychosocial sensitivities believed to precipitate psychosis, the most subtle are ...

Efficacy of Psychosocial Intervention on Patients with ...

The impact of one specific psychosocial intervention alone on the lives of patient with schizophrenia is difficult to analyze, partly because psychosocial.

Psychosocial Interventions for Adults With Schizophrenia

... Several biological and psychosocial EBPs have been documented to effectively reduce symptoms and problems associated with psychosis [5][6] [ ...

What is the evidence for antipsychotic medication and ...

In this Personal View, we examine evidence for antipsychotics and alternative treatments in non-affective psychosis (schizophrenia and related syndromes), with ...

Compliance therapy for schizophrenia - PMC - NIH

Several effective psychosocial interventions are currently available for the treatment of schizophrenia ... Data analysis 4.1 Binary data For binary outcomes we ...

Value of schizophrenia treatment I: The patient journey

Recovery and social reintegration through adequate treatment and care is possible in many cases, up to 20% of patients meet defined criteria of recovery [12].

A Systematic Review

Our systematic review aimed to evaluate the safety and effectiveness of psychosocial interventions to enhance antipsychotic medication adherence.

Discussion - Collaborative care intervention for individuals with ...

... outcomes and the safety variables. In particular, there was no indication of an increase in crisis for those receiving the intervention. Therefore, although ...

Psychosocial rehabilitation interventions in the treatment of ...

Studies have shown that psychosocial interventions improve patients' functional areas and considerably increase their quality of life. This ...