Group Therapy for Suicidal Thoughts

(ProjectGRRIT Trial)

Overseen By Justin Baker, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Charlotte

Disqualifiers: Psychosis, Mania, Acute intoxication, others

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

Compensation: Varies

Number of Visits: 15

Duration: 12-24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new, shorter group therapy format can reduce suicidal thoughts in active duty service members. It compares Group Brief Cognitive-Behavioral Therapy (G-BCBT), which consists of 12 sessions, to the longer Dialectical Behavior Therapy (DBT) Skills Group program. The trial focuses on enhancing coping skills and overall mental health. Suitable participants include active duty members who have recently experienced suicidal thoughts or made attempts and are seeking treatment in mental health or substance abuse programs. As an unphased trial, this study provides participants the chance to contribute to innovative mental health solutions designed for service members.

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's best to discuss this with the trial coordinators or your healthcare provider.

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

What prior data suggests that this group therapy is safe for reducing suicidal thoughts?

Studies have shown promising safety results for both treatments under consideration. Group Brief Cognitive-Behavioral Therapy (G-BCBT) has been tested in various settings and significantly reduces suicide attempts without harmful side effects. One study noted that participants experienced similar reductions in suicidal thoughts as those receiving other therapies, with no increase in negative effects.

Dialectical Behavior Therapy (DBT) is already a well-known treatment. It has proven practical and acceptable to participants. Research indicates it can effectively reduce suicidal thoughts and self-harm behavior. In studies, participants reported fewer self-harming behaviors after treatment.

Both therapies have undergone multiple tests and are generally well-tolerated. Participants in past studies did not report major safety concerns. This suggests these therapies may be safe options for addressing suicidal thoughts in group settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these therapies because they offer unique approaches to managing suicidal thoughts, particularly among active duty service members. Dialectical Behavior Therapy (DBT) Skills Group is distinct in providing a comprehensive 24-session program focusing on emotional regulation, distress tolerance, and interpersonal effectiveness, which could lead to deeper, long-lasting behavioral changes. On the other hand, Group Brief Cognitive-Behavioral Therapy (G-BCBT) offers a more concise 12-session format, which may appeal to those needing a quicker, targeted intervention. These approaches contrast with standard treatments that typically emphasize individual therapy or medication, offering fresh hope for more effective group-based strategies.

What evidence suggests that this trial's treatments could be effective for reducing suicidal thoughts?

Research has shown that Dialectical Behavior Therapy (DBT), one of the treatments in this trial, reduces suicidal thoughts and attempts. Studies have found that DBT improves management of suicide risk and emotional challenges. Patients using DBT have experienced fewer and less severe suicidal behaviors, making it especially helpful for those with ongoing suicidal thoughts.

Another treatment in this trial is Group Brief Cognitive-Behavioral Therapy (G-BCBT). Although limited information exists on G-BCBT specifically for suicidal thoughts, cognitive-behavioral methods are well-known for improving mental health by changing negative thinking and behaviors. G-BCBT is expected to offer similar benefits to DBT but in a shorter period. ^{2 6 7 8 9}

Who Is on the Research Team?

Robert J Cramer, PhD

Principal Investigator

UNC Charlotte

Are You a Good Fit for This Trial?

This trial is for active duty service members over 18 who are seeking treatment for mental health or substance abuse, can understand English, and consent to participate. They must have had suicidal thoughts with intent or a suicide attempt in the past month. Those with conditions like psychosis that prevent informed consent or outpatient treatment cannot join.

Inclusion Criteria

I have thought about or attempted suicide recently.

Be an active duty service member

I can understand and agree to the study's consent form.

Exclusion Criteria

Retired service members and family/dependents

Have a psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weekly group therapy sessions of G-BCBT or 24 weekly sessions of DBT

12-24 weeks

12 visits (G-BCBT) or 24 visits (DBT), in-person

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 3- and 6-months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Dialectical Behavior Therapy (DBT) Skills Group
• Group Brief Cognitive-Behavioral Therapy (G-BCBT)

Trial Overview The study compares two group therapies: Group Brief Cognitive-Behavioral Therapy (G-BCBT) and Dialectical Behavior Therapy (DBT) Skills Group. G-BCBT aims to reduce suicide risk through coping strategies and mental health improvement in a shorter time frame than DBT.

How Is the Trial Designed?

Group I: G-BCBT Experimental Treatment 1 Intervention

68 active duty service member participants assigned to G-BCBT will undergo 12 group therapy sessions scheduled on a weekly basis.

Group II: DBT Active Control 1 Intervention

68 active duty service member participants in the DBT condition will receive 24 weekly group therapy sessions each lasting 90 minutes.

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

Approved in United States as DBT Skills Group for:

• Borderline Personality Disorder
• Suicidal Ideation
• Emotional Dysregulation

Approved in European Union as DBT Skills Training for:

• Borderline Personality Disorder
• Emotional Dysregulation
• Self-Harm Behaviors

Approved in Canada as DBT Group Skills Training for:

• Borderline Personality Disorder
• Suicidal Ideation
• Mental Health Disorders

Who Is Running the Clinical Trial?

University of North Carolina, Charlotte

Lead Sponsor

Trials

27

Recruited

12,200+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

United States Naval Medical Center, Portsmouth

Collaborator

Trials

35

Recruited

4,900+

Published Research Related to This Trial

A scoping review identified 12 unique group therapies targeting suicidal thoughts and behaviors, showing that all reported reductions in suicide-related outcomes, although most studies lacked sufficient power to confirm effectiveness.

The findings suggest that suicide-focused group therapies are generally feasible and acceptable, highlighting the need for more rigorous randomized controlled trials to better assess their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide-Focused Group Therapy. Chalker, SA., Martinez Ceren, CS., Ehret, BC., et al.[2022]

Brief cognitive behavioral therapy (BCBT) is projected to prevent 23 to 25 more suicide attempts and 1 to 3 more suicide deaths per 100 patients compared to standard treatment for suicidal US Army soldiers, indicating its efficacy in reducing suicide risk.

BCBT is estimated to save the Department of Defense between $15,000 to $16,630 per patient compared to usual treatment, suggesting it may be a cost-effective intervention for addressing suicide risk among active-duty soldiers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic Evaluation of Brief Cognitive Behavioral Therapy vs Treatment as Usual for Suicidal US Army Soldiers. Bernecker, SL., Zuromski, KL., Curry, JC., et al.[2022]

Both the 5-day group training in DBT skills (DBT-5) and the 12-week DBT program (DBT-12) significantly improved symptoms of depression, anxiety, and borderline symptoms in a diverse group of 395 patients, with at least 43.5% showing recovery or improvement.

The low readmission rates of 5%-6.8% suggest that these brief DBT-informed treatments not only provide quick symptom relief but also help maintain treatment gains over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of brief versions of Dialectical Behaviour Therapy for diagnostically heterogeneous groups in a routine care setting. Seow, LLY., Collins, KRL., Page, AC., et al.[2022]

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 study involving 99 women with borderline personality disorder showed that all forms of Dialectical Behavior Therapy (DBT) significantly reduced suicide attempts and self-injury episodes, indicating the overall effectiveness of DBT for suicidal individuals.

However, DBT that included skills training (standard DBT and DBT-S) was more effective than DBT without skills training (DBT-I) in reducing non-suicidal self-injury and depression, and it also resulted in lower dropout rates and less use of crisis services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for high suicide risk in individuals with borderline personality disorder: a randomized clinical trial and component analysis. Linehan, MM., Korslund, KE., Harned, MS., 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]

In a study of 173 adolescents with a history of suicide attempts and self-harm, dialectical behavior therapy (DBT) showed significant improvements in emotion regulation compared to individual and group supportive therapy (IGST), both during treatment and at a 12-month follow-up.

DBT was associated with a higher rate of self-harm remission (49.3% in DBT vs. 29.7% in IGST) and also led to reductions in substance misuse and externalizing behaviors, highlighting its effectiveness in addressing multiple aspects of mental health in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical Behavior Therapy for Suicidal Self-Harming Youth: Emotion Regulation, Mechanisms, and Mediators. Asarnow, JR., Berk, MS., Bedics, J., 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]

The study identified key barriers to implementing Dialectical Behavior Therapy (DBT) skills groups, including reduced leadership support and concerns that these groups might conflict with expanding access to care for veterans.

Facilitators for successful implementation included strong leadership support, a positive provider culture, and the presence of experienced DBT practitioners, highlighting the importance of training and organizational support in delivering this suicide prevention intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to Dialectical Behavior Therapy Skills Groups in the Veterans Health Administration. Decker, SE., Matthieu, MM., Smith, BN., et al.[2023]

In a study of 173 adolescents undergoing treatment for self-harm, those with higher family conflict and more severe self-harm histories showed greater reductions in self-harm frequency after 6 months of dialectical behavior therapy (DBT) compared to individual/group supportive therapy (IGST).

Adolescents with higher levels of emotion dysregulation and parental psychopathology benefited more from DBT, indicating that these factors may be important to consider when planning treatment for suicidal adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and moderators of recurring self-harm in adolescents participating in a comparative treatment trial of psychological interventions. Adrian, M., McCauley, E., Berk, MS., 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 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]

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. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10638174/

Feasibility and Efficacy of Intensive Dialectical Behavior ... The participants had a positive outcome from the skills training program, but psychiatric healthcare consumption did not decrease. Keywords: ...

4. behavioraltech.org behavioraltech.org/evidence/

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789424000303

The State of the Science: Dialectical Behavior Therapy Dialectical behavior therapy (DBT) is an effective intervention for chronically suicidal and self-injurious adolescents that incorporates caregivers in ...

6. 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 ...

7. 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 ...

8. 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.

9. 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.