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ACT for Life: a Brief Intervention for Maximizing Recovery After Suicidal Crises

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ClinicalTrials.gov Identifier: NCT02751983
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
An estimated 20 Veterans kill themselves every day. Suicide prevention literature and public health policy both call for treatment targeting high-risk populations, such as Veterans hospitalized due to suicidal intent and/or attempts. Psychiatric hospitalization is a critical opportunity to provide treatment to reduce the risk of suicide and lay the groundwork for functional recovery. Yet, there are no interventions specifically for suicide prevention that meet Veterans Health Affairs' quality recommendations requiring the provision of evidence-based, recovery-oriented psychotherapy, which are also feasible to use during a typical inpatient stay. The proposed study seeks to take a first step toward filling this gap. In consultation with experts in the field, the authors have developed a protocol applying a recovery-oriented, evidence-based treatment approach to Veteran inpatient care. The proposed pilot study will provide critical information to inform final revisions of the treatment manual and research design for a future study evaluating the efficacy of the intervention.

Condition or disease Intervention/treatment Phase
Suicide Psychiatric Rehabilitation Behavioral: ACT for Life Other: Treatment as usual Not Applicable

Detailed Description:

Psychiatric hospitalization presents a critical opportunity for delivering targeted treatment to reduce suicide risk and promote functional recovery. Yet, there are no suicide-specific empirically-supported interventions that can be feasibly delivered during a typical Veterans Health Affairs (VHA) inpatient stay. Although VHA now requires the provision of evidence-based, recovery-oriented inpatient psychotherapy, extant empirically-supported interventions for patients at high risk of suicide were developed for use in outpatient settings and are too time- and resource-intensive to implement as intended in inpatient psychiatric settings, where shorter lengths of stay are expected. Furthermore, these interventions focus nearly entirely on preventing suicidal behavior without also targeting functional recovery. Similarly, inpatient psychiatric treatment has traditionally focused on medical management of acute illness, not on improving patient functioning. Preventing suicide during a crisis is only a short-term solution if the investigators fail to assist patients in understanding how they can rebuild a life they deem worth living. Given that approximately 50% of inpatients do not engage in recommended outpatient mental health care and are at the highest risk of death by suicide, it is vital that inpatient care promote functional recovery. The ideal brief intervention for Veterans at risk for suicide needs to reduce risk of suicidal behavior while simultaneously fostering recovery.

Acceptance and Commitment Therapy (ACT) is a recovery-oriented, psychosocial treatment approach ideally suited for utilization among Veterans hospitalized for suicide risk. ACT teaches psychological skills to handle painful thoughts, emotions, and sensations, but rather than focusing on symptom reduction, ACT directly targets functional recovery by assisting patients in identifying and engaging in value-consistent behaviors despite the potential for distress. There are no brief, ACT-based, transdiagnostic treatment protocols designed to address suicide risk. In order to fill this gap, the investigators consulted with leading experts in ACT to develop and manualize "ACT for Life", a brief, transdiagnostic, recovery-oriented intervention for Veterans hospitalized due to suicide risk. The ACT for Life manual details the application of ACT to recovery from suicidal crises and consists of three modules, [designed to be utilized in three to four 60-minute individual sessions.] This two arm, randomized, controlled pilot study will provide critical information to inform final revisions to the treatment manual and research design for a future efficacy study of ACT for Life. Veterans who enroll in the study will be randomized to: (a) treatment as usual or (b) treatment as usual plus ACT. The specific aims of this study are to: (1) Determine the acceptability of ACT for Life. (2) Determine the feasibility of the study design and research procedures. (3) Characterize participants' psychosocial functioning and self-directed violence using candidate outcome measures for a future efficacy trial. All participants will complete a baseline assessment, and follow-up assessments one and three months after hospital discharge. Participants in the ACT group will also complete a post-treatment assessment on acceptability of the intervention.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ACT for Life: a Brief Intervention for Maximizing Recovery After Suicidal Crises
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : August 9, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Treatment as usual plus ACT
Participants in this condition will be enrolled in the ACT for Life intervention and still able to engage in treatment as usual.
Behavioral: ACT for Life
A novel protocol detailing the application of Acceptance and Commitment Therapy (ACT) to recovery from suicidal crises. Consists of three modules designed to be delivered in three to four 60-minute individual talk therapy sessions. Nearly all of the metaphors and experiential exercises are adaptations of core ACT techniques included in various empirically-supported applications of ACT to other health conditions. Additionally, the adjunctive intervention is designed to augment safety planning (a hierarchical list of strategies to recognize and cope with a suicidal crisis).

Other: Treatment as usual
All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge. This typically consists of both group and individual therapy and medication management.

Active Comparator: Treatment as usual
Participants in this condition will not be enrolled in ACT for Life, but will continue to participate in treatment as usual (e.g., inpatient and outpatient mental health care).
Other: Treatment as usual
All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge. This typically consists of both group and individual therapy and medication management.




Primary Outcome Measures :
  1. Client Satisfaction Questionnaire [ Time Frame: Post-treatment (0-7 days after treatment completion) ]
    Self-report measure that will be used to assess participants' satisfaction with ACT for Life.

  2. Narrative Evaluation of Intervention Interview [ Time Frame: Post-treatment (0-7 days after treatment completion) ]
    Semi-structured interview assessing each participants' perspective of the impact of the intervention, helpful and unhelpful components, and comparison to other interventions. Will be used to assess acceptability and inform revisions to the treatment manual.

  3. Reasons for Termination (Client and Therapist Versions) [ Time Frame: Post-treatment (0-7 days after treatment termination) ]
    Self-report scale which assesses the impact of 19 common reasons why patients terminate therapy. Will be used to assess treatment acceptability.


Secondary Outcome Measures :
  1. Valued Living Questionnaire (used to assess change) [ Time Frame: Pre-treatment, and one- and three-month follow-ups ]
    Self-report measure that assesses participants' life values as well as the perceived consistency with which they have been living according to their values. Will be examined as a candidate outcome measure for a future efficacy trial.

  2. Inventory of Psychosocial Functioning (used to assess change) [ Time Frame: Pre-treatment, and one- and three-month follow-ups ]
    Self-report measure that assesses impairment within the last 30 days across a spectrum of psychosocial domains. Will be examined as a candidate outcome measure for a future efficacy trial.

  3. PROMIS Global Short Form v1.1 (used to assess change) [ Time Frame: Pre-treatment, and one- and three-month follow-ups ]
    Self-report measure assessing multiple domains of health. The scale yields two subscales: Global Physical Health and Global Mental Health. Will be examined as a candidate outcome measure for a future efficacy trial.

  4. PROMIS Short Form v2.0- Satisfaction with Social Roles and Activities 8a (used to assess change) [ Time Frame: Pre-treatment, and one- and three-month follow-ups ]
    Self-report measure that assesses satisfaction with respondents' ability to perform various social activities. Will be examined as a candidate outcome measure for a future efficacy trial.

  5. Columbia Suicide-Severity Rating Scale (used to assess change) [ Time Frame: Pre-treatment, and one- and three-month follow-ups ]
    Clinician-administered interview that assesses suicidal ideation and behavior. Will be examined as a candidate outcome measure for a future efficacy trial.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible for Veterans Health Administration care
  • Age 18-89
  • Currently hospitalized due to suicide risk
  • Willing to be randomized and participate in the two conditions

Exclusion Criteria:

  • Inability to provide informed consent
  • Inability to complete study measures, e.g.:

    • due to significant acute intoxication/withdrawal symptoms
    • mania
    • psychosis
    • aggression
    • catatonia
    • cognitive impairment
  • membership in vulnerable population, e.g.:

    • prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751983


Locations
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United States, Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Sean Michael Barnes, PhD Rocky Mountain Regional VA Medical Center, Aurora, CO

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02751983     History of Changes
Other Study ID Numbers: D2048-P
I21RX002048-01 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Suicide
Psychiatric Rehabilitation
Acceptance and Commitment Therapy
Brief Psychotherapy
Inpatients

Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms