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 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.

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.

Is the combined CBT and DBT Skills Group generally safe for humans?

Research on Dialectical Behavior Therapy (DBT) programs, which include skills training similar to those in the combined CBT and DBT Skills Group, shows that patients, including those with psychosis, experienced improvements without hospitalizations or suicide attempts during treatment, suggesting it is generally safe. ^{1 2 3 4 5}

How is the CBT-DBT Skills Group treatment for high-risk psychosis different from other treatments?

The CBT-DBT Skills Group treatment is unique because it combines elements of Cognitive Behavioral Therapy (CBT) and Dialectical Behavioral Therapy (DBT) to specifically target emotion regulation difficulties in individuals with psychosis, which are often a priority for these patients. This integrated approach is novel as it adapts DBT skills, originally developed for other conditions, to address the specific needs of those with psychosis. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Combined CBT and DBT Skills Group for High-Risk Psychosis?

Research shows that Dialectical Behavior Therapy (DBT) skills training can improve mental health in patients with various mental disorders, and combining Cognitive Behavioral Therapy (CBT) with social skills training has shown benefits for patients with schizophrenia. These findings suggest that integrating CBT and DBT skills could be effective for high-risk psychosis. ^{3 8 10 11 12}

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

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]

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]

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]

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]

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]

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]

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]

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 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]

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 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]

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]

Citations

1. United States 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. [2023]

2. Switzerland 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. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Skills use and common treatment processes in dialectical behaviour therapy for borderline personality disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of dialectical behavior therapy skills training group for adults with borderline personality disorder. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Development of an integrated cognitive-behavioral and social skills training intervention for older patients with schizophrenia. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Description of a Dialectical Behavior Therapy program in a Veterans Affairs Health Care System. [2022]

7. United States 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Teaching Dialectical Behavior Therapy to Psychiatry Residents: The Columbia Psychiatry Residency DBT Curriculum. [2022]

9. Spain pubmed.ncbi.nlm.nih.gov

Factors predicting early dropout from dialectical behaviour therapy in individuals with borderline personality disorder. [2019]

10. England 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. [2022]

11. United States 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. [2023]

12. Australia pubmed.ncbi.nlm.nih.gov

Dialectical behaviour therapy skills training for individuals with substance use disorder: A systematic review. [2022]