What side effects are associated with this type of intervention?

Common treatments for psychosis, particularly antipsychotic medications, have several known side effects. First-generation antipsychotics can cause tardive dyskinesia, a serious movement disorder, and other extrapyramidal symptoms like tremors and rigidity. Second-generation antipsychotics, such as quetiapine and olanzapine, are associated with metabolic syndrome, weight gain, and an increased risk of diabetes. Both classes of antipsychotics can cause sedation, orthostatic hypotension, and anticholinergic effects like dry mouth and constipation. Lithium, sometimes used as an adjunct, can lead to toxicity, requiring regular monitoring of serum levels.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of psychosis, including second-generation antipsychotics such as risperidone, quetiapine, aripiprazole, olanzapine, and ziprasidone. These medications are commonly used to manage symptoms of schizophrenia and schizoaffective disorder. Additionally, interventions like repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT) have been studied for their efficacy in reducing symptoms of psychosis. While these treatments primarily target psychotic symptoms, they may also have secondary effects on emotion regulation, which is crucial for reducing suicide risk in individuals with psychotic disorders.

What other types of research exist?

Promising novel alternatives to Emotion Regulation Intervention for psychosis patients include: 1) Cognitive Behavioral Therapy (CBT) for psychosis, which has shown efficacy in reducing positive symptoms and improving overall functioning. 2) Transcranial Magnetic Stimulation (TMS), particularly for treatment-resistant cases, which has demonstrated potential in improving depressive symptoms. 3) Vagus Nerve Stimulation (VNS), which has shown some benefits in treatment-resistant bipolar depression and may be applicable to psychosis. 4) Assertive Community Treatment (ACT), which provides comprehensive, community-based psychiatric treatment and has been effective in reducing hospitalizations and improving outcomes in severe mental illness.

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Behavioral Intervention

Dialectical Behavior Therapy for Suicide Risk in Psychosis

N/A

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

At least 18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up four months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help people with psychotic disorders manage their emotions better, as they are at high risk of suicide. By improving emotional control, the treatment hopes to reduce suicidal thoughts and behaviors in this group.

Who is the study for?

This trial is for adults with a psychosis spectrum disorder confirmed by an interview, who are already receiving outpatient mental health services. They must be able to read at a 6th-grade level and have a heightened risk of suicide as indicated by specific questionnaire scores. People with intellectual disabilities, traumatic brain injury, or deafness cannot participate.

What is being tested?

The study tests Dialectical Behavior Therapy Skills Training aimed at managing emotional turmoil in people with psychotic disorders to reduce their suicide risk. It includes advanced data collection methods like Ecological Momentary Assessment for real-time tracking of emotions and behaviors.

What are the potential side effects?

Since the intervention involves therapy rather than medication, typical medical side effects are not expected. Participants may experience emotional discomfort when discussing difficult topics during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four months

This trial's timeline: 3 weeks for screening, Varies for treatment, and four months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Emotion Dysregulation

Feeling suicidal (finding)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dialectical Behavior Therapy - Skill TrainingExperimental Treatment1 Intervention

Group II: Treatment As UsualActive Control1 Intervention

0 / 1Eligibility criteria met

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 psychosis include antipsychotic medications, cognitive-behavioral therapy (CBT), and electroconvulsive therapy (ECT). Antipsychotics primarily work by blocking dopamine receptors, which helps to reduce the symptoms of psychosis such as hallucinations and delusions. CBT focuses on changing negative thought patterns and behaviors, which can improve emotional regulation and reduce distress. ECT, though its exact mechanism is not fully understood, is believed to induce changes in brain chemistry that can rapidly alleviate severe symptoms. These treatments are crucial for psychosis patients as they not only target the core symptoms but also help in managing emotional dysregulation, which is a significant factor in reducing suicide risk.

Relapse prevention in ambulant mental health care tailored to patients with schizophrenia or bipolar disorder.Pharmacologic treatment of schizophrenia.