Cognitive Behavioral Therapy for Suicidal Thoughts

Overseen By Jay Fournier, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

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: 5

Duration: 12 months

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this interventional study is to develop and test a treatment prognosis calculator to identify which service members with suicidal ideation or behavior are likely to respond well to the current standard of care treatment and which should instead receive Brief Cognitive Behavioral Therapy (BCBT) as a first-line treatment. The main aims of the study are: * Aim 1: To develop a novel treatment prognostic calculator to predict response to treatment as usual (TAU) and identify treatment-seeking military personnel who are unlikely to respond adequately to TAU for the reduction of suicidal ideation. * Aim 2: To evaluate the performance of the treatment prognosis calculator in a new sample of treatment-seeking military personnel and determine whether BCBT is more effective than TAU for those patients who are predicted not to respond adequately to TAU. Participants will receive mental health treatment as it is typically administered by their mental healthcare treatment team. Members of their mental healthcare treatment team may receive intensive training in BCBT. After their provider has received this training, they may use this treatment as part of standard of care treatment. The timing of this training will be determined randomly. Participants will complete self-report assessments at the beginning of the study (baseline) as well as 3, 6, 9 and 12 months after their participant begins. These assessments will include questions about feelings, thoughts, moods, impulses, substance use, and behavior.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It seems like you will continue with your usual mental health treatment, so it's best to discuss this with your healthcare provider.

What data supports the effectiveness of the treatment Brief Cognitive Behavioral Therapy (BCBT) for reducing suicidal thoughts?

Research shows that Brief Cognitive Behavioral Therapy (BCBT) is effective in reducing the risk of suicide attempts among suicidal US Army soldiers, indicating its potential benefit in managing suicidal thoughts. ^{1 2 3 4 5}

How is Brief Cognitive Behavioral Therapy (BCBT) different from other treatments for suicidal thoughts?

Brief Cognitive Behavioral Therapy (BCBT) is unique because it is specifically designed to reduce the risk of suicide attempts, particularly in high-risk groups like US Army soldiers, and is shown to be more effective than standard treatments in improving satisfaction and reducing suicidal ideation. ^{1 2 3 4 6}

Eligibility Criteria

This trial is for active duty service members over 18 years old who are currently receiving mental health treatment and have had suicidal thoughts within the last month. Participants must understand English and be able to consent.

Inclusion Criteria

You were receiving mental health treatment at the time of your participation in this study.

You have registered a score above zero on the Columbia Suicide Severity Rating Scale (CSSRS) Screener-Recent, implying suicidal ideation within the last month.

I am an active duty service member.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete self-report assessments at the beginning of the study

1 week

1 visit (in-person)

Treatment

Participants receive mental health treatment as administered by their healthcare team, including potential BCBT sessions

12 months

Weekly or biweekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 3, 6, 9, and 12 months

12 months

4 visits (in-person or virtual)

Treatment Details

Interventions

• Brief Cognitive Behavioral Therapy (BCBT)
• Treatment as usual (TAU)

Trial Overview The study aims to develop a calculator predicting responses to standard care for reducing suicidal ideation, comparing it with Brief Cognitive Behavioral Therapy (BCBT) in those predicted not to respond well.

Participant Groups

Group I: Brief Cognitive Behavioral Therapy (BCBT) Experimental Treatment 1 Intervention

BCBT consists of 12 outpatient individual psychotherapy sessions scheduled weekly or biweekly. The first session is 90 minutes and subsequent sessions are 60 minutes. BCBT is divided into three phases. In phase 1 (5 sessions), the therapist conducts a detailed assessment of the patient's most recent suicidal episode or suicide attempt, identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase 2 (5 sessions), the therapist teaches cognitive restructuring skills to build cognitive flexibility. In phase 3 (2 sessions), a relapse prevention task is conducted, and participants must demonstrate the ability to successfully complete this task in order to terminate the treatment. Additional sessions are conducted until participants demonstrate the ability to successfully complete this task.

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

TAU may include (1) routine suicide risk screening and assessment; (2) safety planning with means restriction; and (3) the Collaborative Assessment and Management of Suicidality (CAMS), an evidence-based approach to managing and treating suicidal patients.

Brief Cognitive Behavioral Therapy (BCBT) is already approved in United States, European Union for the following indications:

Approved in United States as Brief Cognitive Behavioral Therapy (BCBT) for:

• Suicide prevention
• Reduction of suicidal ideation

Approved in European Union as Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP) for:

• Suicide prevention
• Reduction of suicidal ideation

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

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]

Cognitive behavior therapy (CBT) and problem-solving therapy (PST) both led to significant improvements in various measures related to hopelessness and suicidal ideation among suicide attempters, indicating their efficacy as treatment options.

Participants receiving CBT and PST reported higher satisfaction levels compared to those receiving treatment as usual (TAU), highlighting the potential benefits of these brief therapies in managing suicidal thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing cognitive behavior therapy, problem solving therapy, and treatment as usual in a high risk population. Stewart, CD., Quinn, A., Plever, S., et al.[2018]

In a study of 76 patients with major depressive disorder, adding behavioral activation (BA) to antidepressant treatment significantly reduced suicidal ideation compared to treatment as usual (TAU).

Trial-based cognitive therapy (TBCT) also showed a greater reduction in suicidal thoughts compared to TAU, suggesting that both BA and TBCT may be beneficial adjuncts to standard antidepressant therapy in managing suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural activation and trial-based cognitive therapy may be beneficial to reduce suicidal ideation in major depressive disorder: A post hoc study from a clinical trial. Hemanny, C., Sena, EP., de Oliveira, IR.[2022]

Cognitive-behavioral therapy (CBT) is recognized as an effective treatment for depression in children and adolescents, but there is limited evidence specifically addressing its efficacy for adolescents experiencing suicidality.

The article discusses various CBT techniques aimed at reducing suicidal thoughts and behaviors in depressed adolescents, highlighting the need for more targeted treatment trials in this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for adolescent depression and suicidality. Spirito, A., Esposito-Smythers, C., Wolff, J., et al.[2022]

In a study involving 80 breast cancer patients with major depressive disorder, both behavioral activation treatment for depression (BATD) and problem-solving therapy (PST) significantly reduced depression and suicidal ideation after 8 weeks, with benefits lasting up to 12 months.

No completed suicides were reported during a follow-up period of approximately 2 years, suggesting that these therapies may be effective in improving hopefulness and preventing suicide in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation and problem-solving therapy for depressed breast cancer patients: preliminary support for decreased suicidal ideation. Hopko, DR., Funderburk, JS., Shorey, RC., et al.[2022]

Cognitive-Behavioral Therapy (CBT) significantly reduced suicidal ideation and hopelessness in depressed adolescents aged 12 to 18 who had attempted suicide, with a 54% to 77% decrease in scores after 12 weeks of treatment.

In a clinical trial involving 30 participants, those receiving CBT showed marked improvements compared to a control group that did not receive the intervention, highlighting the efficacy of CBT in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive-behavioral therapy in decreasing suicidal ideation and hopelessness of the adolescents with previous suicidal attempts. Alavi, A., Sharifi, B., Ghanizadeh, A., et al.[2022]

References

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

Economic Evaluation of Brief Cognitive Behavioral Therapy vs Treatment as Usual for Suicidal US Army Soldiers. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Comparing cognitive behavior therapy, problem solving therapy, and treatment as usual in a high risk population. [2018]

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

Behavioural activation and trial-based cognitive therapy may be beneficial to reduce suicidal ideation in major depressive disorder: A post hoc study from a clinical trial. [2022]

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

Cognitive-behavioral therapy for adolescent depression and suicidality. [2022]

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

Behavioral activation and problem-solving therapy for depressed breast cancer patients: preliminary support for decreased suicidal ideation. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive-behavioral therapy in decreasing suicidal ideation and hopelessness of the adolescents with previous suicidal attempts. [2022]