Testing the Efficacy of ACT for Life

NCT04829682 | Enrolling By Invitation

• 2 other identifiers: D3547-RRX003547
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Suicide

Keywords

Suicide; Inpatient; Veteran; Acceptance and Commitment Therapy; Present Centered Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Other Outcomes (4)

• Change from Baseline on Multidimensional Psychological Flexibility Inventory

  Baseline, Pre-discharge (within 4 days of hospital discharge), and 1-, 3-, 6-, and 12-months post-discharge from psychiatric inpatient unit

• Change from Baseline on Cognitive Fusion Questionnaire - Suicidal Ideation

  Baseline, pre-discharge (within 4 days of hospital discharge), and 1-, 3-, 6-, and 12-months post-discharge from psychiatric inpatient unit

• Change from Baseline on Valued Living Questionnaire

  Baseline, pre-discharge (within 4 days of hospital discharge), and 1-, 3-, 6-, and 12-months post-discharge from psychiatric inpatient unit

Study Arms (2)

ACT for Life

EXPERIMENTAL

ACT for Life + Treatment as Usual

Behavioral: ACT for Life

Present Centered Therapy

ACTIVE COMPARATOR

Present Centered Therapy + Treatment as Usual

Behavioral: Present Centered Therapy

Interventions

ACT for Life BEHAVIORAL

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.

ACT for Life

Present Centered Therapy BEHAVIORAL

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.

Present Centered Therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

Battle Creek VA Medical Center, Battle Creek, MI

Battle Creek, Michigan, 49037, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Sean Michael Barnes, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to ACT for Life or Present Centered Therapy. Additionally all participants will continue to receive treatment as usual.

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: October 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After conclusion of the study and dissemination of primary and exploratory results and/or in accordance with VA policy and regulations

Locations

US (2)