Combined CBT and DBT Skills Group for High-Risk Psychosis

Overseen By Tina Gupta, PHD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Current/past psychotic disorder

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

Compensation: Varies

Number of Visits: 15

Duration: 15 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy group that combines cognitive behavioral therapy (CBT) and dialectical behavioral therapy (DBT) skills. It targets adolescents and young adults at risk of developing psychosis, a mental health condition affecting perception of reality. Participants will join a weekly skills group to evaluate the effectiveness of this combined approach. Ideal candidates are aged 13-18, already receiving treatment with the HOPE team at the University of Pittsburgh, and showing signs of being at risk for psychosis. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health research and potentially benefit from a novel therapeutic approach.

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 might be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this skills group is safe for adolescents and young adults at high risk for psychosis?

Research has shown that combining cognitive behavioral therapy (CBT) and dialectical behavioral therapy (DBT) in a skills group is generally safe. These therapies are well-known and often used to help people manage stress and emotions. One study examined a DBT skills group for individuals with psychosis and found it was well-received. Another study on CBT for young people at risk of psychosis also found it to be safe and effective.

These studies reported no major side effects, suggesting that the combined therapy in the skills group is likely safe for participants. However, since this is a new approach, the study aims to test its practicality and effectiveness for teens at high risk of psychosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Skills Group for high-risk psychosis because it combines Cognitive Behavioral Therapy (CBT) and Dialectical Behavior Therapy (DBT) skills in a group setting, offering a unique approach not typically seen in conventional treatments. While standard treatments for psychosis often focus on medication and individual therapy, this group setting fosters peer support and skill-building in real-time, which can enhance learning and retention. This innovative approach aims to improve emotional regulation and coping strategies, potentially reducing symptoms and improving quality of life for participants.

What evidence suggests that this skills group is effective for high-risk psychosis?

Research shows that both cognitive behavioral therapy (CBT) and dialectical behavioral therapy (DBT) can help with psychosis. Studies have found that CBT greatly reduces symptoms like hallucinations and delusions. Another study found that DBT skills training improved stress and emotional management in people with psychosis. In this trial, participants will engage in a combined CBT and DBT Skills Group, aiming to teach skills that help those at high risk for psychosis manage stress and emotions more effectively. These therapies are based on proven methods that have shown positive results in managing psychosis symptoms. ^{1 3 6 7 8}

Who Is on the Research Team?

Leslie Horton, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am at high risk for developing a psychotic disorder.

Individuals must be enrolled in the HOPE team at the University of Pittsburgh since this group is embedded within that service

Exclusion Criteria

Group member meeting criteria for a current/past psychotic disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a weekly skills group integrating CBT and DBT for 15 weeks, focusing on stress management, self-disturbance improvement, and social skills enhancement.

15 weeks

15 weekly sessions (in-person)

Midpoint Assessment

Feasibility and outcome measures are collected to assess progress and group satisfaction.

2-3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of symptoms and functioning.

4-5 months

What Are the Treatments Tested in This Trial?

Interventions

• Skills Group

Trial Overview

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.

How Is the Trial Designed?

Group I: Skills Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Substance Abuse and Mental Health Services Administration (SAMHSA)

Collaborator

Trials

31

Recruited

23,300+

Published Research Related to This Trial

A new integrated treatment combining cognitive-behavioral therapy (CBT) and social skills training (SST) has been developed specifically for older patients with schizophrenia, addressing their unique needs.

Pilot data and two case reports indicate that this novel intervention may help improve treatment retention and skill development in older adults with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an integrated cognitive-behavioral and social skills training intervention for older patients with schizophrenia. McQuaid, JR., Granholm, E., McClure, FS., et al.[2018]

Dialectical behaviour therapy skills training (DBT-ST) shows promise as an acceptable and feasible intervention for individuals with substance use disorders (SUD), based on a review of nine studies.

Preliminary evidence suggests that DBT-ST may help reduce substance use and improve emotion regulation, but the variability in study quality and lack of rigorous controls highlight the need for more comprehensive research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behaviour therapy skills training for individuals with substance use disorder: A systematic review. Warner, N., Murphy, M.[2022]

A pilot study involving five Latinx participants indicated that online dialectical behavior therapy (DBT) skills groups significantly reduced emotional dysregulation, showing a large effect size compared to placebo sessions.

While depression symptoms improved with online DBT, anxiety levels did not show the same reduction, suggesting that while DBT is effective for emotional regulation, it may need adjustments to better address anxiety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a brief online skills group of dialectical behaviour therapy for emotional dysregulation in Latinx: a withdrawal experimental single-case design. Muñoz-Martínez, AM., Gómez, Y., Naismith, I., et al.[2023]

Patients with Borderline Personality Disorder (BPD) reported that Distress Tolerance Skills (DTS) training, part of Dialectical Behavioral Therapy (DBT), led to an immediate reduction in tension and helped them cope with challenging situations, enhancing their feelings of stability and self-confidence.

While participants experienced benefits from DTS training, they also faced challenges during the initial learning and application phases, indicating a need for improved support and strategies in clinical practice to optimize the training process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do patients with borderline personality disorder experience Distress Tolerance Skills in the context of dialectical behavioral therapy?-A qualitative study. Schaich, A., Braakmann, D., Rogg, M., et al.[2021]

Participants in an intensive dialectical behavior therapy skills training (DBT-ST) program showed significant improvements in mental health, as measured by the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), with large effect sizes observed from pre-intervention to post-intervention and at 6-month follow-up.

Despite the positive mental health outcomes, the study found no reduction in psychiatric healthcare consumption among participants, indicating that while DBT-ST is effective, it may not decrease the need for inpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Efficacy of Intensive Dialectical Behavior Therapy Skills Training in An Outpatient Setting for A Group of Patients with Extensive Care Needs - A Transdiagnostic Approach. Felix, CB., Sand, P.[2023]

Participants in the Dialectical Behavior Therapy Skills Training Group (DBT-ST) showed significant reductions in borderline personality disorder (BPD) symptoms, psychological distress, and depression after an 18-20 week program, indicating its effectiveness as a treatment.

The study also found a significant decrease in emergency department presentations post-intervention, suggesting that DBT-ST can help reduce crisis situations for individuals with BPD, although there was no significant change in psychiatric inpatient bed-days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of dialectical behavior therapy skills training group for adults with borderline personality disorder. Heerebrand, SL., Bray, J., Ulbrich, C., et al.[2021]

The Managing Emotions Group (MEG), an eight-session Dialectical Behavioural Therapy (DBT)-informed skills group for individuals with psychosis, was found to be feasible and acceptable, with 81% of participants completing the intervention and reporting high satisfaction.

Participants showed significant improvements in psychological distress, emotion regulation difficulties, and adaptive emotion regulation skills, with medium-to-large effect sizes, indicating that targeted emotion regulation interventions can positively impact daily life for individuals with psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing emotions in psychosis: Evaluation of a brief DBT-informed skills group for individuals with psychosis in routine community services. Lawlor, C., Vitoratou, S., Duffy, J., et al.[2022]

A comprehensive Dialectical Behavior Therapy (DBT) program was developed for patients with recent psychiatric hospitalization and significant emotion dysregulation, including a notable 58% of participants having a history of psychosis.

Preliminary evaluation showed that patients improved on most measures of suicidality, emotion regulation, and depression, with no hospitalizations or suicide attempts during treatment, indicating the program's potential efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description of a Dialectical Behavior Therapy program in a Veterans Affairs Health Care System. Phalen, P., Grossmann, J., Bruder, T., et al.[2022]

A blended social skills training (SST) program, combining face-to-face sessions and online modules, was found to be feasible in an inpatient psychiatric setting, with 100% of participants recommending it to others.

While the training showed a non-significant medium-sized effect on improving social skills (Cohen's d = 0.5), the study highlights the need for more research on blended care approaches in psychiatric settings, given the limited existing evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blended Care in In-Patient Acute Psychiatric Care. The Example of a Group Training for Social Competences in Adults-A Pretest-Posttest Feasibility Study. Bendig, E., Küchler, AM., Baumeister, H., et al.[2021]

A clinical curriculum for teaching Dialectical Behavior Therapy (DBT) to psychiatry residents was developed, with 87% of participants incorporating DBT into their practice after training, indicating its effectiveness in preparing them to treat borderline personality disorder (BPD) and self-harm behaviors.

Residents who underwent the year-long DBT clinical training showed significant improvements in their ability to apply DBT techniques, enhancing their confidence and willingness to treat patients with BPD, which suggests that structured training can effectively equip future psychiatrists with essential skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Dialectical Behavior Therapy to Psychiatry Residents: The Columbia Psychiatry Residency DBT Curriculum. Brodsky, BS., Cabaniss, DL., Arbuckle, M., et al.[2022]

In a study of 70 individuals with borderline personality disorder undergoing dialectical behavior therapy (DBT), those who frequently used DBT skills were less likely to self-harm and had lower dropout rates, indicating that skills practice is crucial for treatment success.

Higher self-efficacy was also linked to reduced self-harm, suggesting that building confidence in using DBT skills is important, while factors like therapeutic alliance and treatment credibility did not independently affect self-harm or dropout rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skills use and common treatment processes in dialectical behaviour therapy for borderline personality disorder. Barnicot, K., Gonzalez, R., McCabe, R., et al.[2022]

In a study of 118 individuals with borderline personality disorder (BPD), comorbidities such as Eating Disorders (ED) and Cocaine Use Disorder (CUD) were significant predictors of early dropout from dialectical behavior therapy skills training (DBT-ST).

Trait impulsiveness also showed a tendency to influence dropout rates, suggesting that addressing these comorbid conditions may improve retention in DBT-ST for patients with BPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors predicting early dropout from dialectical behaviour therapy in individuals with borderline personality disorder. Carmona I Farrés, C., Pascual, JC., Elices, M., et al.[2019]

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