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

Trial Summary

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.

What data supports the effectiveness of the treatment DBT Skills Training + Safety Planning for Suicide Risk?

Research shows that Dialectical Behavior Therapy (DBT) is effective in reducing self-harm and suicidal behaviors in individuals with borderline personality disorder. Additionally, DBT-based skills training has been shown to improve mental health and well-being in family members of suicide attempters, suggesting its potential benefit in managing suicide risk. ^{1 2 3 4 5}

Is DBT Skills Training + Safety Planning safe for humans?

Research on Dialectical Behavior Therapy (DBT) and its variations, including skills training and safety planning, suggests it is generally safe for humans. Studies have shown it can reduce life-threatening behaviors and improve functioning in individuals with emotional and behavioral challenges. ^{1 3 6 7 8}

How is the DBT Skills Training + Safety Planning treatment different from other treatments for suicide risk?

DBT Skills Training + Safety Planning is unique because it combines teaching practical skills to manage emotions and improve relationships with a structured plan to ensure safety, specifically targeting life-threatening behaviors like suicidal thoughts. This approach is different from other treatments as it emphasizes skill use and commitment to reducing harmful behaviors, which has shown to lower suicidal ideation when skills are used effectively. ^{1 3 7 8 9}

What is the purpose of this trial?

The investigators are interested in learning more about how the role of mothers' emotions has on the transmission of suicide risk to children. Eligible participants will be invited to participate in a baseline assessment, and 4 follow-up assessments in the next year. This research study is a randomized control trial. Participants that choose to enroll are randomly assigned, that is by chance (like by flipping a coin) to receive DBT Skills Training or treatment as usual (TAU). Participants may also be selected for DBT skills training, it which would occur once a week for 6 months.

Research Team

Stephanie D Step, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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 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]

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]

References

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

Risk management in dialectical behavior therapy: Treating life-threatening behaviors as problems to be solved. [2022]

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

A randomized trial of brief dialectical behaviour therapy skills training in suicidal patients suffering from borderline disorder. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy-based skills training for family members of suicide attempters. [2022]

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

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

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

Treatment Acceptability Study of Walking The Middle Path, a New DBT Skills Module for Adolescents and their Families. [2022]

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

Dialectical behavior therapy-skills system for cognitively challenged individuals with self-harm: a Swedish pilot study. [2023]

7. Switzerland 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]. [2022]

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

Feasibility and preliminary efficacy of dialectical behaviour therapy skills groups for Veterans with suicidal ideation: pilot. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Suicidal Ideation and Skill Use During In-patient Dialectical Behavior Therapy for Borderline Personality Disorder. A Diary Card Study. [2020]