ACT for Life Therapy for Suicide Risk

Recruiting 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

278 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment ACT for Life Therapy for Suicide Risk?

Research on similar treatments, like Project Life Force, shows that structured group therapy can significantly reduce suicidal thoughts and behaviors, depression, and hopelessness. Additionally, therapies like cognitive behavior therapy and problem-solving therapy have shown significant improvements in managing suicide risk compared to usual treatment. ^{1 2 3 4 5}

Is ACT for Life Therapy for Suicide Risk safe for humans?

The available research on related therapies like the Safety Planning Intervention (SPI) suggests they are generally safe and acceptable for adults experiencing suicide-related distress, with improvements in suicidal thoughts and behaviors, depression, and hopelessness. However, there is a need for clear definitions and consistent reporting of adverse events to better evaluate safety across studies. ^{3 6 7 8 9}

How is ACT for Life Therapy for Suicide Risk different from other treatments?

ACT for Life Therapy is unique because it combines Acceptance and Commitment Therapy (ACT) principles with a focus on life values and mindfulness to address suicide risk, which may offer a novel approach compared to traditional therapies that often focus solely on symptom reduction. ^{2 3 10 11 12}

What is the purpose of this trial?

Psychiatric hospitalization is a critical opportunity to provide treatment to reduce the risk of suicide and lay the groundwork for functional recovery. In fact, the period following psychiatric hospitalization presents the greatest risk of death by suicide for Veterans. Despite psychiatric hospitalization being a vital time for intervention, there are no suicide-specific evidence-based psychotherapies (EBPs) that can be feasibly delivered during a typical VHA inpatient stay. Importantly, suicide-specific inpatient interventions are primarily focused on reducing the reoccurrence of suicidal behavior and have limited or no focus on directly targeting other aspects of functional recovery. Preventing suicide during a crisis is only a short-term solution if we fail to assist patients in building a life they deem worth living. The investigators' research over the past several years has been focused on addressing this gap and overcoming barriers to implementing psychosocial interventions in an inpatient setting. Acceptance and Commitment Therapy (ACT) is a psychosocial intervention well suited to both preventing suicide and enhancing functioning, but the investigators were not aware of any ACT-based treatment protocols designed to specifically target suicide risk. The investigators consulted with leading ACT clinicians and researchers to develop and manualize "ACT for Life", a brief, transdiagnostic, recovery-oriented, inpatient, intervention for Veterans hospitalized due to suicide risk. The individual intervention involves 3 to 6 inpatient sessions and 1 to 4 outpatient sessions focused on skills generalization and treatment engagement. The investigators conducted a randomized controlled pilot study evaluating the acceptability of ACT for Life and the feasibility of the planned design for the proposed randomized controlled efficacy trial. Results of this rigorous pilot study support the acceptability and feasibility of ACT for Life. Nearly all Veterans reported that they believed they benefitted from ACT for Life. Preliminary outcomes suggest that ACT for Life may improve functioning and reduce suicidal behavior following hospitalization due to suicide risk. However, a full-scale clinical trial will be necessary to definitively evaluate the efficacy of ACT for Life. To accomplish this goal, the investigators are proposing to conduct a randomized controlled trial of ACT for Life versus Present Centered Therapy in 278 Veterans hospitalized for suicide risk to examine outcomes of suicidal behavior and changes in functioning over a one-year period following psychiatric hospitalization. The specific aims of this study are to determine the efficacy of ACT for Life for preventing suicidal behavior and maximizing functional recovery, and to examine candidate ACT for Life treatment mechanisms. Participants will complete assessments prior to treatment, before discharge from the inpatient unit, and at one-, three-, six-, and twelve-months following discharge. The proposed randomized controlled trial of ACT for Life has the potential to fill the VHA's need for empirically-supported inpatient interventions that can be delivered during a typical inpatient stay, are recovery oriented, and prevent future suicidal behavior.

Research Team

Sean Michael Barnes, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Examining the characteristics and clinical features of in- and between-session suicide risk assessments among psychiatric outpatients. [2019]

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

Cost-effectiveness of a Brief Structured Intervention Program Aimed at Preventing Repeat Suicide Attempts Among Those Who Previously Attempted Suicide: A Secondary Analysis of the ASSIP Randomized Clinical Trial. [2020]

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

An Open Trial of a Suicide Safety Planning Group Treatment: "Project Life Force". [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

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

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

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]

7. England 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. [2023]

8. United States 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. [2019]

9. England 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Pilot study of the Collaborative Assessment and Management of Suicidality-Group. [2022]

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

Adapting Interpersonal Psychotherapy for Older Adults at Risk for Suicide: Preliminary Findings. [2021]

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

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