What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) and Dialectical Behavioral Therapy (DBT) are generally well-tolerated with minimal side effects. However, some individuals may experience increased emotional distress or anxiety during the initial stages of therapy as they confront challenging thoughts and behaviors. Additionally, there may be temporary discomfort from discussing traumatic or sensitive issues. Overall, these therapies are considered safe and effective for managing various mental health conditions, including depression, anxiety, and borderline personality disorder.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of mental health conditions that are often managed with cognitive-behavioral therapy (CBT) and dialectical behavior therapy (DBT). For schizophrenia, antipsychotic drugs such as aripiprazole and clozapine have been approved. For depression, selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, as well as serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine, are commonly used. Additionally, mood stabilizers such as lithium and anticonvulsants like lamotrigine are approved for bipolar disorder. These pharmacological treatments are often used in conjunction with psychotherapeutic approaches like CBT and DBT to provide comprehensive care.

What other types of research exist?

Promising novel alternatives to Integrated CBT and DBT Skills Group for mental health patients include: 1) Transference-Focused Psychotherapy (TFP), which has shown efficacy in treating borderline personality disorder; 2) Mindfulness-Based Cognitive Therapy (MBCT), effective for treatment-resistant depression; 3) Schema Therapy, which combines elements of cognitive, behavioral, and psychodynamic therapies; and 4) Pharmacological options like Lisdexamfetamine for binge-eating disorder and Armodafinil for bipolar depression. These alternatives offer diverse approaches that can be tailored to individual patient needs.

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Combined CBT and DBT Skills Group for High-Risk Psychosis

N/A

Recruiting

Led By Leslie Horton, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

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

Must have

13-18 years of age

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months vs up to 5 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new group therapy combining CBT and DBT for teens at high risk of psychosis. The therapy includes regular sessions to help manage stress, think more flexibly, and improve social skills. The goal is to see if this approach can improve mental health and functioning in these young people.

Who is the study for?

This trial is for adolescents and young adults aged 13-18 who are at clinical high-risk (CHR) for psychosis. Participants must be receiving services from the HOPE team at the University of Pittsburgh and meet specific criteria indicating a risk for developing a psychotic disorder, such as having certain symptoms or family history.

What is being tested?

The study tests an integrated skills group that combines cognitive behavioral therapy (CBT) and dialectical behavioral therapy (DBT). It's designed to help those at CHR manage their symptoms. The feasibility and outcomes of this weekly group will be evaluated over approximately 6-7 months.

What are the potential side effects?

Since this intervention involves psychological therapies rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort or distress while discussing personal issues during sessions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 13 and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months vs up to 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months vs up to 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months vs up to 5 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

Attendance

Attrition

Change from 3 months in Satisfaction with Therapy and Therapist Scale at up to 5 months

+7 more

Secondary study objectives

Change from baseline Child and Adolescent Mindfulness Measure at up to 3 months

Change from baseline Child and Adolescent Mindfulness Measure at up to 5 months

Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 3 months

+40 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: Skills GroupExperimental Treatment1 Intervention

There will be one condition which is the group and participants will complete feasibility and outcome measures at baseline, at midpoint, and at the end of the group.

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

Cognitive Behavioral Therapy (CBT) and Dialectical Behavior Therapy (DBT) are common treatments for mental health that work by addressing negative thought patterns and behaviors. CBT helps patients identify and change these patterns to improve emotional regulation and reduce symptoms. DBT, an adaptation of CBT, adds mindfulness and stress tolerance techniques to manage intense emotions and reduce self-destructive behaviors. These therapies are crucial for mental health patients, especially those at high risk for psychosis, as they provide practical skills for coping with distress, improving emotional regulation, and enhancing interpersonal effectiveness.

Acute and one-year outcome of a randomised controlled trial of brief cognitive therapy for major depressive disorder in primary care.Problem-Focused Psychodynamic Psychotherapies.A randomised trial of dialectical behaviour therapy and the conversational model for the treatment of borderline personality disorder with recent suicidal and/or non-suicidal self-injury: An effectiveness study in an Australian public mental health service.