Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Suicide
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Everyone except for the biostatistician will be blind to condition until randomization at the end of the pre-treatment assessment session. Outcome assessors will remain blind to condition for the duration of the study.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 89 years
Gender
Both males and females

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 t...

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.

Tracking Information

NCT #
NCT04829682
Collaborators
Not Provided
Investigators
Principal Investigator: Sean Michael Barnes, PhD Rocky Mountain Regional VA Medical Center, Aurora, CO