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SuicideNCT04829682

Testing the Efficacy of ACT for Life

A study testing ACT for Life and Present Centered Therapy in people with Suicide, run by VA Office of Research and Development at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Suicide
What is being tested?
ACT for Life and Present Centered Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
278 participants
Where
2 sitesUnited States
Study dates
1 Oct 2022to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible for VHA care
  • Currently hospitalized due to suicide risk
  • Willing to be randomized and participate in either of the two conditions

Who cannot join

  • Inability to provide informed consent (operationalized as inability to answer 7 questions about the study and research participants' rights)
  • Inability to complete study measures or participate in treatment [based on referring clinician and study staff's judgment (e.g., due to lack of time, significant acute intoxication/withdrawal symptoms, mania, psychosis, aggression, catatonia, cognitive impairment)]
  • Participation in another interventional research study
  • Membership in vulnerable population (e.g., prisoner, pregnant woman)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites
  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211

  • Battle Creek VA Medical Center, Battle Creek, MI

    Battle Creek, Michigan, 49037

Other trials in United States

About this study

Official title: Testing the Efficacy of ACT for Life: A Brief Inpatient Intervention to Maximize Recovery and Prevent Future Suicidal Behavior

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.

Read the detailed description

Veterans are most likely to die by suicide in the week following discharge from acute psychiatric care. Brief, recovery-oriented, empirically-supported, inpatient interventions are needed given the unfortunate reality that Veterans at the greatest risk for suicide may not follow up with outpatient treatment. To effectively intervene on the many pathways to suicide, VHA will need to utilize brief inpatient psychosocial treatments that are suicide-specific and transdiagnostic. Acceptance and Commitment Therapy (ACT) is an evidence-based treatment approach ideally suited for utilization among Veterans at high risk for suicide because it simultaneously targets processes to reduce risk (e.g., distress tolerance) and to increase protective factors (e.g., engage patients in building a life they value). The ACT clinician does not focus on symptom reduction, but instead directly targets functional recovery by assisting patients in identifying and engaging in values-consistent behaviors even in the presence of aversive thoughts, emotions, or sensations. Furthermore, ACT is suitable for extremely brief interventions. ACT clinicians employ experiential exercises and metaphors that facilitate rapid new learning, and overcome many of the limitations of more verbally intensive, didactic approaches to therapy. Research studies in non-Veteran-specific populations indicate that as few as three ACT contact hours are associated with approximately 50% reductions in rehospitalization among patients with psychosis. The extant literature and qualities inherent to ACT strongly suggest that ACT could be effective for improving the functioning of Veterans at risk of suicide and in-turn preventing suicidal behavior; but these assumptions have yet to be empirically tested. To address this gap and overcome barriers to delivering targeted psychological interventions for suicide in a psychiatric inpatient setting, the investigators have developed and manualized a brief, transdiagnostic, recovery-oriented, suicide-specific, ACT intervention for Veterans hospitalized due to suicide risk, "ACT for Life". With the support of a Rehabilitation Research and Development (RR\&D) Small Projects in Rehabilitation Research (SPiRE) grant the investigators conducted a randomized controlled acceptability and feasibility trial (N = 70), which demonstrated the acceptability of ACT for Life to Veterans hospitalized due to suicide risk. Data also support the feasibility of the proposed design for a full-scale randomized controlled trial evaluating the efficacy of ACT for Life for maximizing functioning after a suicidal crisis and preventing future suicidal behavior. Using a multisite, two arm, randomized controlled design (ACT for Life + Treatment as Usual [ACT] vs. Present Centered Therapy + Treatment as Usual [PCT]) with 278 participants, and assessments at pre-treatment, pre-inpatient-discharge, and one-, three-, six-, and 12-months post-inpatient-discharge, the investigators will:

Primary Aim: Determine the efficacy of ACT for Life for preventing suicidal behavior and maximizing functional recovery. Primary Hypothesis 1 is that ACT participants will be significantly less likely to engage in suicidal behavior (i.e., suicide or actual, aborted, or interrupted suicide attempts as assessed by the Columbia-Suicide Severity Rating Scale and medical record review) compared to PCT participants during the 12-months following psychiatric hospitalization. Primary Hypothesis 2 is that ACT participants will report significantly greater improvements in functioning on the Outcome Questionnaire 45.2 (OQ-45) compared to PCT participants at one-month post-discharge from psychiatric hospitalization.

Secondary Aims will examine onset and maintenance of treatment gains. Secondary Aim 1: Determine the efficacy of ACT for Life for preventing suicidal behavior at three- and six -months following discharge from psychiatric inpatient care. Secondary Hypotheses 1a and 1b are that ACT participants will be significantly less likely to have engaged in suicidal behavior compared to PCT participants at (a) three- and (b) six-months following discharge from psychiatric inpatient care. Secondary Aim 2: Determine the efficacy of ACT for Life for improving functioning at three-, six-, and 12-months following discharge from psychiatric inpatient care. Secondary Hypothesis 2a, 2b, and 2c are that compared to PCT participants, ACT participants will report significantly greater improvements in functioning relative to pre-treatment on the OQ-45 (a) three-, (b) six-, and (c) 12-months following discharge from psychiatric inpatient care.

Exploratory Aim: Examine candidate ACT for Life treatment mechanisms. Exploratory Hypotheses 1 and 2 are that ACT participants will show (1) greater increases from pre-treatment in psychological flexibility than PCT participants and that (2) compared to PCT participants, a greater proportion of ACT participants will engage in outpatient mental health treatment in the month following discharge from inpatient care.

The proposed RCT of ACT for Life has the potential to fill VHA's critical need for evidence-based psychotherapies that can be delivered during a typical inpatient stay, are recovery oriented, and prevent future suicidal behavior.

Conditions
Suicide
Being tested
ACT for Life, Present Centered Therapy
Keywords
Suicide, Inpatient, Veteran, Acceptance and Commitment Therapy, Present Centered Therapy
Medical subject headings
Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT for LifeBehavioural

    ACT for Life is a brief recovery oriented individual inpatient Acceptance and Commitment Therapy treatment protocol consisting of four modules typically administered in three to six inpatient sessions and one to four outpatient sessions in the 30 days following discharge from inpatient care. The immediate goals of ACT for Life are to increase the participant's psychological flexibility and readiness to cope effectively with future suicidal crises.

  • Present Centered TherapyBehavioural

    PCT is an evidence-based treatment for PTSD but its principles can be applied to psychotherapy for a wide range of difficulties. The standard PCT manual was originally adapted for suicide prevention by Craig Bryan and his colleagues. Our study team made additional minor revisions to prepare the manual for use as an active control condition in the current efficacy trial. PCT includes two initial sessions focused on discussion of current symptoms, psychoeducation, and the rationale for PCT. Current life problems become the focus of the remaining sessions. PCT is expected to consist of three to six, 60-90-minute inpatient sessions and one to four outpatient sessions in the 30 days following discharge. Discontinuation will occur when the participant attends an individual outpatient mental health appointment or 30 days after discharge, whichever occurs first. PCT participants will receive caring communications from their therapist for 12-months following inpatient discharge.

Study groups in NCT04829682
Study groupRoleWhat they receive
ACT for LifeExperimentalACT for Life + Treatment as Usual
Receives: Behavioral: ACT for Life
Present Centered TherapyActive comparatorPresent Centered Therapy + Treatment as Usual
Receives: Behavioral: Present Centered Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Suicide Attempts Since Hospital Discharge Columbia-Suicide Severity Rating Scale and Medical Record Review

    The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-administered interview that assesses for suicidal ideation and behavior based on established definitions. The C-SSRS assesses intensity of suicidal ideation, as well as actual suicide attempts, interrupted suicide attempts, and aborted suicide attempts. A combination of C-SSRS reported suicide attempts and national VHA Joint Legacy Viewer medical record review will be used to determine if participants die by suicide or engage in a suicide attempt (actual, interrupted, or aborted) during the follow-up period.

    Measured: 3-, 6-, and 12-months post-discharge from psychiatric inpatient unit

  2. Change from Baseline on Outcome Questionnaire - 45.2

    The Outcome Questionnaire-45.2 (OQ-45) assesses functioning within the last week across three psychosocial domains which include symptom distress (e.g., "I feel nervous"), interpersonal relationships (e.g., "I have frequent arguments"), and social role functioning (e.g., "I find my work/school satisfying"). Sum total scores range from 0 to 180 with higher scores indicating greater symptom distress and functional impairment.

    Measured: Baseline, 1-, 3-, 6-, and 12-months post-discharge from the psychiatric inpatient unit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2021
  2. Study start1 Oct 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to ACT for Life or Present Centered Therapy. Additionally all participants will continue to receive treatment as usual.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
278 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04829682
Sponsor's protocol ID
D3547-R
Other IDs
RX003547
Status last verified
Apr 2026
First submitted
31 Mar 2021
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A final Limited Data Set will be made available, in accordance with VA policy and regulations and per compliance with current IRB and VA R\&D approvals in place for this project. A study-specific DUA will be required. Data requests must be made in writing. Requests for access to data obtained from this project will be considered and responded to. Data will be provided electronically, only with a DUA in place, and per VA regulations for transferring data.

Questions about this trial

What is this clinical trial studying?

A study testing ACT for Life and Present Centered Therapy in people with Suicide, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Suicide Attempts Since Hospital Discharge Columbia-Suicide Severity Rating Scale and Medical Record Review (time frame: 3-, 6-, and 12-months post-discharge from psychiatric inpatient unit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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