DBT Skills Group for Suicide Risk

Recruiting at 4 trial locations

Overseen By Steve Martino, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, English language, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

172 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist veterans at risk of suicide by testing a new version of Dialectical Behavior Therapy Skills Group (DBT-SG). Designed to help individuals better manage their emotions, DBT-SG is being tested alongside usual care at Veterans Health Administration (VHA) facilities. The study will compare two groups: one receiving both DBT-SG and standard VHA care, and another receiving only standard VHA care. Veterans who have attempted suicide at least twice, with one attempt in the past year, and who struggle with managing emotions may be suitable for this trial. Participants must have phone access and be able to attend group sessions. As an unphased trial, this study provides veterans the chance to access potentially beneficial therapy while contributing to important research.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual treatment, as the trial involves DBT Skills Group in addition to VHA treatment-as-usual.

What prior data suggests that DBT Skills Group is safe for reducing emotion dysregulation in veterans?

Studies have shown that Dialectical Behavior Therapy Skills Groups (DBT-SG) are generally safe. Research indicates that participants tolerate these groups well, with few reports of negative side effects. DBT-SG has been linked to reduced suicidal thoughts and improved emotional control. These groups teach essential skills such as stress management, emotional regulation, and relationship enhancement. Additionally, previous research suggests that DBT, including its skills training components, is generally safe. This means that participants in DBT-SG usually do not experience serious problems from the treatment itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DBT Skills Group for suicide risk because it offers a structured approach to teaching essential life skills that can directly impact emotional and mental well-being. Unlike the standard VHA treatment, which focuses on general mental health support, this group intervention specifically equips individuals with tools for emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness. By integrating these skills into the regular treatment regimen, it has the potential to provide more targeted support, helping individuals better manage the challenges that contribute to suicide risk.

What evidence suggests that DBT Skills Group could be effective for reducing emotion dysregulation in veterans?

Studies have shown that Dialectical Behavior Therapy (DBT) helps reduce suicidal behavior. Research indicates that the DBT Skills Group (DBT-SG) component can lessen suicidal thoughts and improve emotional management. In this trial, some participants will receive DBT-SG in addition to VHA treatment as usual. Participants in DBT programs have demonstrated significant progress in managing emotions and reducing self-harm. A review of multiple studies found that DBT effectively lowers outcomes related to suicide, making it a strong option for those at high risk. This suggests that DBT-SG may benefit Veterans dealing with emotional challenges and suicidal thoughts. ^{1 2 6 7 8}

Who Is on the Research Team?

Suzanne Decker, PhD

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Steve Martino, PhD

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Are You a Good Fit for This Trial?

This trial is for Veterans with current suicidal thoughts or past suicide attempts, who can attend group sessions and are eligible for VHA care. They must have had at least two suicide attempts, one recently, struggle with managing emotions (score of 110+ on DERS), and be able to communicate in English. Those with significant cognitive issues or plans to move within 18 months cannot join.

Inclusion Criteria

History of two or more suicide attempts in lifetime, with one in past 6 months, on Columbia-Suicide Severity Rating Scale (C-SSRS)

I can attend group sessions.

Emotion dysregulation (score 110 on DERS)

Exclusion Criteria

Significant cognitive impairment (score < 28 on modified Telephone Interview for Cognitive Status (mTICS))

Plan to move away or be unavailable in the next 18 months

I cannot read or communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dialectical Behavior Therapy Skills Group (DBT-SG) in addition to VHA treatment as usual, consisting of 24 weekly sessions

24 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of suicide risk and coping skills

18 months

What Are the Treatments Tested in This Trial?

Interventions

• DBT Skills Group
• VHA treatment as usual

Trial Overview

The study is testing if a DBT Skills Group (DBT-SG) alongside usual VHA treatments helps reduce suicide attempts more than just the usual treatment alone. It's a randomized controlled trial where participants are randomly placed into either the test group receiving DBT-SG plus standard care or a control group getting only standard care.

How Is the Trial Designed?

Group I: DBT-SG plus VHA treatment as usual Experimental Treatment 2 Interventions

Dialectical Behavior Therapy Skills Group (DBT-SG) in addition to VHA treatment as usual. Group is 24 weekly sessions teaching skills in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness.

Group II: VHA treatment as usual Active Control 1 Intervention

VHA treatment as usual for Veterans at risk for suicide attempt

DBT Skills Group is already approved in United States, European Union for the following indications:

Approved in United States as DBT Skills Group for:

• Suicidal ideation
• Emotion dysregulation
• Borderline personality disorder

Approved in European Union as DBT Skills Group for:

• Emotion dysregulation
• Borderline personality disorder
• Suicidal behavior

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A study involving 84 out-patients with borderline personality disorder (BPD) found that 20 weeks of brief dialectical behavior therapy (DBT) skills training significantly reduced suicidal and self-injurious behaviors compared to a waitlist group.

Participants receiving DBT also showed notable improvements in anger management, distress tolerance, and emotion regulation, suggesting that this brief intervention can effectively support high-risk behaviors in BPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. McMain, SF., Guimond, T., Barnhart, R., et al.[2022]

Dialectical Behavior Therapy for adolescents (DBT-A) showed significant effectiveness in reducing self-injurious behavior and preventing suicide attempts in a pilot study of 12 adolescents, with effect sizes ranging from 1.1 to 2.9.

None of the participants who had previously attempted suicide made any attempts during the treatment, highlighting the potential safety and efficacy of DBT-A in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dialectical Behaviour Therapy for adolescents (DBT-A)--a pilot study on the therapy of suicidal, parasuicidal, and self-injurious behaviour in female patients with a borderline disorder]. Fleischhaker, C., Munz, M., Böhme, 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]

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]

The pilot study involving 13 participants demonstrated that the Family Connections program, a 9-week Dialectical Behavior Therapy-based skills training, significantly reduced the burden on family members of suicide attempters and improved their mental health and well-being.

The program not only provided valuable knowledge about suicidal behavior but also facilitated interpersonal skills training and shared experiences, highlighting its importance for supporting families in crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy-based skills training for family members of suicide attempters. Rajalin, M., Wickholm-Pethrus, L., Hursti, T., et al.[2022]

Dialectical behavior therapy (DBT) is an effective treatment for individuals with borderline personality disorder, specifically targeting life-threatening behaviors like suicide attempts and self-injury.

DBT incorporates various strategies for risk management and safety planning, such as diary cards and phone coaching, to help clients commit to reducing harmful behaviors throughout their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management in dialectical behavior therapy: Treating life-threatening behaviors as problems to be solved. Alba, MC., Bailey, KT., Coniglio, KA., et al.[2022]

In a pilot study involving six participants, the modified Dialectical Behavior Therapy Skills System (DBT-SS) showed a decrease in challenging behaviors and an increase in overall functioning after 48 therapy sessions, indicating its potential effectiveness for individuals with cognitive difficulties.

Participants also experienced a reduction in hospital admissions, suggesting that DBT-SS may help improve emotional regulation and reduce the need for emergency care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy-skills system for cognitively challenged individuals with self-harm: a Swedish pilot study. Rosendahl-Santillo, A., Lantto, R., Nylander, L., et al.[2023]

In a study of 44 patients with borderline personality disorder undergoing a 5-week dialectical behavior therapy program, successful use of coping skills was linked to a significant reduction in suicidal ideation.

Patients reported lower levels of suicidal thoughts on days when they effectively applied their skills compared to days with no skill use or ineffective skill use, highlighting the importance of skill effectiveness in managing suicidal thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicidal Ideation and Skill Use During In-patient Dialectical Behavior Therapy for Borderline Personality Disorder. A Diary Card Study. Probst, T., Decker, V., Kießling, E., et al.[2020]

A pilot study involving 17 Veterans showed that Dialectical Behavior Therapy Skills Group (DBT-SG) was feasible and acceptable, with participants attending an average of 66% of sessions and reporting satisfaction with the treatment.

Results indicated significant reductions in suicidal ideation and emotion dysregulation after the 26-week program, with improvements maintained at a 3-month follow-up, suggesting that DBT-SG may effectively enhance coping skills and reduce suicide risk in Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of dialectical behaviour therapy skills groups for Veterans with suicidal ideation: pilot. Decker, SE., Adams, L., Watkins, LE., et al.[2022]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/25806661/

Dialectical behavior therapy for high suicide risk in individuals ...

Compared with the DBT-I group, interventions that included skills training resulted in greater improvements in the frequency of NSSI acts (F1,85 = 59.1 [P < .

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01193205

NCT01193205 | 20 Weeks DBT Group Skills Training Study

The aim of this study is to evaluate the effectiveness of a 20-week Dialectical Behaviour Therapy (DBT) skills training group for the treatment of chronic ...

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sciencedirect.com

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DBT has been shown to reduce suicide-related outcomes in published studies. ... This meta-analysis found that DBT was effective for reducing suicidal behavior.

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Core Evidence & Research

Marsha Linehan and her colleagues found that DBT resulted in significant improvements for chronically suicidal and self-injuring women with borderline ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6936751/

Feasibility and preliminary efficacy of dialectical behaviour ...

The skills group component of DBT (DBT-SG) has been associated with reduced suicidal ideation and emotion dysregulation. DBT-SG for Veterans at risk for suicide ...

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withpower.com

withpower.com/trial/phase-suicide-3-2024-92b8b

DBT Skills Training + Safety Planning for Suicide Risk

Research on Dialectical Behavior Therapy (DBT) and its variations, including skills training and safety planning, suggests it is generally safe for humans.

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jamanetwork.com

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Offering care management did not significantly reduce the risk of self-harm, and offering brief online dialectical behavior therapy skills training increased ...

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frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1495102/full

Mixed-methods formative evaluation of implementing an ...

Dialectical Behavior Therapy Skills Groups (DBT-SG) are well established for reducing emotion dysregulation, improving coping skills, and in some studies, ...