ACT for Life Therapy for Suicide Risk

Enrolling by invitation at 1 trial location

Overseen By Sean M Barnes, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Mania, Psychosis, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two therapies to help veterans hospitalized due to suicide risk. The goal is to determine if Acceptance and Commitment Therapy (ACT for Life) can better prevent future suicidal behavior and improve life functioning compared to Present Centered Therapy. Participants will attend therapy sessions during and after their hospital stay, with follow-ups extending up to a year later. Veterans currently hospitalized for suicide risk might be suitable candidates for this study. As an unphased trial, this study provides veterans a unique opportunity to contribute to research that could enhance therapeutic approaches for suicide prevention.

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.

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

Research has shown that Acceptance and Commitment Therapy (ACT) is a promising approach to reducing suicidal thoughts. One review of studies found that ACT lowered suicidal thinking more effectively than other methods. This suggests that people generally tolerate it well, as those who received ACT reported fewer negative thoughts.

Another study found that ACT can improve safety planning, an important part of suicide prevention. This indicates that ACT might help individuals feel safer by better managing their thoughts and actions.

While these findings are promising, a full clinical trial is necessary to confirm the effectiveness and safety of ACT for Life. Current research is encouraging, and many participants in earlier studies reported benefiting from ACT-based approaches. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ACT for Life therapy for suicide risk because it offers a fresh approach by integrating Acceptance and Commitment Therapy (ACT) with traditional treatments. Unlike typical talk therapies that focus on changing problematic thoughts, ACT encourages patients to accept their thoughts and feelings while committing to actions that align with their values. This unique focus on psychological flexibility could enhance resilience and provide quicker relief for individuals at risk. Additionally, ACT for Life is combined with standard care, potentially offering a more comprehensive support system compared to current options.

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

Research shows that Acceptance and Commitment Therapy (ACT), which participants in this trial may receive as part of the ACT for Life arm, can help reduce suicidal thoughts and improve mental health. A review of several studies found that people who received ACT reported fewer suicidal thoughts than those who did not. ACT also helps manage depression and anxiety, often linked to suicide risk. Studies suggest that ACT helps people build a more meaningful life, which can be important in preventing suicide. Early results from small studies of ACT for Life showed better functioning and fewer suicidal behaviors after leaving the hospital. However, more research is needed to confirm these findings. ^{2 6 7 8 9}

Who Is on the Research Team?

Sean Michael Barnes, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

This trial is for Veterans hospitalized due to suicide risk who are eligible for VHA care and willing to participate in the study. It's not suitable for prisoners, pregnant women, those unable to consent or understand the study, or individuals with conditions like acute intoxication/withdrawal, mania, psychosis that prevent participation.

Inclusion Criteria

You agree to be randomly placed in one of two groups for the study.

Eligible for VHA care

I am currently in the hospital because I am at risk of harming myself.

Exclusion Criteria

You are currently participating in another research study that involves receiving treatment.

I understand the study and my rights as a participant.

I am mentally and physically able to participate in the study according to my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Treatment

Participants receive the ACT for Life intervention during their inpatient stay, involving 3 to 6 sessions.

1-2 weeks

3 to 6 sessions (inpatient)

Outpatient Treatment

Participants continue with 1 to 4 outpatient sessions focused on skills generalization and treatment engagement.

4 weeks

1 to 4 sessions (outpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at one-, three-, six-, and twelve-months following discharge.

12 months

Assessments at 1, 3, 6, and 12 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• ACT for Life
• Present Centered Therapy

Trial Overview The trial tests 'ACT for Life' against Present Centered Therapy in Veterans after psychiatric hospitalization. ACT aims to reduce suicide risk and improve functioning through 3-6 inpatient sessions and up to 4 outpatient sessions. The efficacy will be measured over a year.

How Is the Trial Designed?

Group I: ACT for Life Experimental Treatment 1 Intervention

ACT for Life + Treatment as Usual

Group II: Present Centered Therapy Active Control 1 Intervention

Present Centered Therapy + Treatment as Usual

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 qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., 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]

The study successfully translated and validated the 'Global Trigger Tool-Psychiatry' (GTT-P) for identifying iatrogenic adverse events in psychiatric care in Norway, incorporating insights from both health professionals and service users to enhance its effectiveness.

Implementing the GTT-P can help mental health nurses in Norway and Sweden to better identify potential triggers for adverse events, ultimately improving patient safety and reducing the risk of harm in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. Okkenhaug, A., Tritter, JQ., Landstad, BJ.[2023]

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]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

In a study of 108 active duty US Army personnel with PTSD, both group cognitive processing therapy-cognitive only version (CPT-C) and group present-centered therapy (PCT) significantly reduced rates of suicide ideation, with improvements maintained for up to 12 months post-treatment.

There were no reported suicide attempts during or after treatment in either group, and exacerbation of preexisting suicide ideation was uncommon, suggesting that group CPT-C is safe and does not increase suicide risk among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. Bryan, CJ., Clemans, TA., Hernandez, AM., et al.[2019]

The case study of a 55-year-old housewife who committed suicide after psychiatric inpatient treatment highlights the complexities of managing patients with a history of severe suicide attempts, emphasizing the need for better understanding of their social and psychological contexts.

The therapy team concluded that insights from this tragic case could lead to improved management strategies for inpatient treatment following suicide attempts, suggesting that learning from unsuccessful interventions is crucial for enhancing future care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide following attempted suicide: a study of an unsuccessful intervention. Etzersdorfer, E.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6037942/

Efficacy of Acceptance and Commitment Therapy in Reducing ... The review found that ACT is effective in reducing SI in the 2 pre–post studies but not in other studies.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07132099

Randomized Suicide Prevention Trial Using ASSIP and ... The ultimate goal of this research is to provide valuable insights into the comparative effectiveness of ASSIP and ACT interventions for suicide attempters and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29874680/

Acceptance and Commitment Therapy for the Management ... ACT effectiveness remained stable at the 3-month follow-up. We found a similar pattern of change for depressive symptomatology and anxiety, ...

4. cambridge.org cambridge.org/core/journals/acta-neuropsychiatrica/article/effectiveness-of-acceptance-and-commitment-therapy-for-suicidality-a-systematic-review-and-metaanalysis/C88E535F9FE2494CD6DEA1050DB1092E

Effectiveness of acceptance and commitment therapy for ... This systematic review and meta-analysis suggested that suicidal ideation decreased among individuals who received ACT compared to controls.

5. psycnet.apa.org psycnet.apa.org/record/2017-50621-026

ACT for life: Using Acceptance and Commitment Therapy ... ... ACT can help individuals at risk of suicide build a life worth living. The critical abilities that have made humans so successful are also responsible for ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722922000232

Safety Planning Within Acceptance and Commitment ... Use of chain analysis of suicidal behavior is introduced as a tool to inform the suicide safety plan. We describe how ACT processes can enhance safety plans and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5047846/

The Coping with Long Term Active Suicide Program (CLASP) When compared to subjects who were assigned to SAFE, subjects assigned to CLASP had lower rates of suicide attempts (13% vs. 23%: absolute risk reduction = 10%; ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9092896/

Improving Suicide Prevention Through Evidenced-Based ... Any prevention program requires outcome assessment that must include suicidal behavior and preferably mediating effects such as help-seeking behavior, treatment ...

9. contextualscience.org contextualscience.org/files/138.%20Empowering%20Clients%20to%20Thrive%20Despite%20Their%20Desire%20for%20Death%20-%20A%20Workshop%20on%20ACT%20for%20Suicide%20Prevention.pdf

A workshop on ACT for Suicide Prevention Research supports the theoretical applicability of ACT to suicide prevention based on associations between ACT processes and suicide-related outcomes. There ...