DBT Skills Training + Safety Planning for Suicide Risk

Overseen By Jennifer Stahler

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Major medical illnesses, DBT last 6 months, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 6 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mother's emotions might influence the likelihood of suicidal behavior in her children. It tests two approaches: Dialectical Behavior Therapy (DBT) Skills Training, which involves group sessions, and usual treatment methods. Mothers with a history of suicidal behavior and children aged 9-11 may qualify. The trial aims to determine if these treatments can help manage emotions and reduce suicide risk. Participants will be randomly assigned to different treatment groups for a fair assessment. As an unphased trial, this study offers a unique opportunity to contribute to understanding and potentially improving mental health outcomes for families.

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

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that Dialectical Behavior Therapy (DBT) Skills Training reduces self-harm and suicidal thoughts. For example, one study found that it helped participants decrease self-harm behaviors. Another study demonstrated that DBT Skills Training could reduce suicidal thoughts and improve emotional management. These studies suggest that DBT is generally well-received and beneficial for those facing emotional and suicidal challenges.

Safety Planning Intervention (SPI) has also undergone study for safety and effectiveness. Research shows that SPI can improve suicidal thoughts and behaviors. It involves creating a plan with coping strategies and support contacts to lower the risk of suicide. Studies indicate that it is effective and well-received, with improvements in depression and suicidal behaviors.

Both DBT Skills Training and Safety Planning Intervention have proven safe and helpful in previous research, making them promising options for those seeking support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative ways to manage suicide risk. Dialectical Behavior Therapy (DBT) Skills Group Training is unique as it specifically targets maternal emotion dysregulation, helping individuals develop better emotional regulation strategies. On the other hand, the Safety Planning Intervention (SPI) provides a structured approach for individuals with a history of suicidal behavior, offering immediate, actionable steps to enhance safety. These methods stand out from standard care options like medication or general talk therapy by focusing on skill-building and personalized safety planning, potentially leading to more effective and sustainable outcomes for individuals at risk.

What evidence suggests that this trial's treatments could be effective for reducing suicide risk?

Research has shown that Dialectical Behavior Therapy (DBT), which participants in this trial may receive, effectively reduces suicidal behavior. Studies have found that DBT lowers suicidal thoughts and actions, making it a strong option for treating individuals at high risk of suicide. Similarly, Safety Planning Intervention (SPI), another treatment option in this trial, has demonstrated positive results in reducing suicidal thoughts and actions. Evidence suggests that a well-prepared safety plan can lead to fewer suicide attempts. Both treatment methods are supported by data indicating they help reduce suicide-related outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Stephanie D Step, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for biological mothers with legal custody of a child aged 9-11, who have a history of suicidal behavior. It's not suitable for those with cardiac or nervous system abnormalities, recent DBT therapy, or major medical illnesses like Parkinson's Disease that affect personality or emotion regulation.

Inclusion Criteria

I am the biological mother with legal custody of a child aged 9-11.

Confirmed lifetime history of suicidal behavior for mothers of suicidal behavior for mothers

Exclusion Criteria

I, or my child, have a major illness like Parkinson's that could affect our personality or emergency reactions.

I have heart or nervous system conditions that could affect heart rate or blood pressure measurements.

I have undergone Dialectical Behavior Therapy in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a baseline assessment to initiate the intervention

1 week

1 visit (in-person)

Treatment

Participants receive either DBT Skills Training + SPI or SPI only for 6 months

6 months

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

4 follow-up assessments (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dialectical Behavior Therapy Skills Group Training
• Safety Planning Intervention

Trial Overview The study compares Dialectical Behavior Therapy (DBT) Skills Training against treatment as usual for reducing suicide risk. Mothers are randomly assigned to either attend weekly DBT sessions for six months or receive the standard care.

How Is the Trial Designed?

Group I: Safety Planning Intervention Experimental Treatment 1 Intervention

Safety Planning Intervention (SPI) or SPI only for 6 months, such that all mothers with history of suicidal behavior + ER difficulties will receive SPI.

Group II: Dialectical Behavior Therapy Skills Group Training Experimental Treatment 1 Intervention

The investigators will employ Dialectical Behavior Therapy Skills Training in order to experimentally manipulate maternal emotion dysregulation, our targeted mechanism.

Dialectical Behavior Therapy Skills Group Training is already approved in United States, European Union, Canada for the following indications:

Approved in United States as DBT Skills Training for:

• Borderline Personality Disorder
• Emotional Dysregulation
• Suicidal Behavior

Approved in European Union as Dialectical Behavior Therapy for:

• Borderline Personality Disorder
• Emotional Dysregulation
• Suicidal Behavior
• Post-Traumatic Stress Disorder

Approved in Canada as DBT Skills Training for:

• Borderline Personality Disorder
• Emotional Dysregulation
• Suicidal Behavior

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

The study evaluated the acceptability of the 'Walking the Middle Path' module in Dialectical Behavioral Therapy (DBT) for adolescents, involving 50 participants, and found high ratings of acceptability for the new skills training.

Participants perceived the Middle Path skills as particularly helpful, with validation being highlighted as the most beneficial aspect, suggesting that this module could enhance family functioning and support in DBT for adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Acceptability Study of Walking The Middle Path, a New DBT Skills Module for Adolescents and their Families. Rathus, J., Campbell, B., Miller, A., et al.[2022]

Citations

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

Dialectical behavior therapy for high suicide risk in individuals ... Results: All treatment conditions resulted in similar improvements in the frequency and severity of suicide attempts, suicide ideation, use of crisis services ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789418300492

Dialectical Behavior Therapy Is Effective for the Treatment ... DBT has been shown to reduce suicide-related outcomes in published studies. •. This meta-analysis found that DBT was effective for reducing suicidal behavior. •.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2963469/

Dialectical Behavior Therapy: Current Indications and Unique ... Dialectical behavior therapy (DBT) is a comprehensive, evidence-based treatment for borderline personality disorder (BPD).

4. behavioraltech.org behavioraltech.org/evidence/

Core Evidence & Research Full-model DBT is still the standard of treatment for highly suicidal clients, as it has the preponderance of evidence. Even clients in skills-only studies ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2789028

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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8848197/

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

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02932241

Computerized DBT Skills Training for Suicidal and Heavy ... The Computerized Dialectical Behavior Therapy Skills Training (cDBT) intervention includes 4 mindfulness, 6 emotion regulations, 2 distress tolerance, and 4 ...

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1354430/full

The use of CAMS and DBT to effectively treat patients who ... In this article, we review the Collaborative Assessment and Management of Suicidality (CAMS) and Dialectical Behavior Therapy (DBT), two clinical treatments.

9. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05876-z

Evaluation of dialectical behavior therapy for adolescents in ... The findings of the current study are promising as the participants reported considerably reduced self-harm behavior after DBT-A treatment.

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

Feasibility and preliminary efficacy of dialectical behaviour ... An uncontrolled pilot study indicated DBT-SG was feasible, acceptable, and demonstrated potential efficacy in reducing suicidal ideation and emotion ...