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

Primary Purpose

Suicide, Psychiatric Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT for Life
Treatment as usual
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Suicide, Psychiatric Rehabilitation, Acceptance and Commitment Therapy, Brief Psychotherapy, Inpatients

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment as usual plus ACT

Treatment as usual

Arm Description

Participants in this condition will be enrolled in the ACT for Life intervention and still able to engage in 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).

Outcomes

Primary Outcome Measures

Client Satisfaction Questionnaire - 8
Self-report measure that will be used to assess participants' satisfaction with ACT for Life. Scale scores range from 8 to 32 with higher scores indicating greater satisfaction. For the purposes of the current study scores greater than or equal to 24 were considered acceptable. The number of participants scoring ≥ 24 is reported below.
Narrative Evaluation of Intervention Interview
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. Qualitative Thematic Analysis was conducted. There are no objective data to report from this interview. Please contact the PI for reference to a manuscript with the qualitative results.
Reasons for Termination (Client and Therapist Versions)
Self-report scale which assesses the impact of 19 common reasons why patients terminate therapy. Will be used to assess treatment acceptability. These participants reported reasons for termination of ACT, but this did not produce quantitative data.

Secondary Outcome Measures

Outcome Questionnaire 45.2 (OQ-45)
The Outcome Questionnaire 45.2 is a 45-item self-report scale that assesses symptom distress, interpersonal relationships, and social role (functioning in the workplace, school, and home) for the past week. The OQ-45 total score ranges from 0-180 with higher scores indicating greater distress and impairment. Scores of 63 or more generally indicate symptoms of clinical significance and changes of 14 points or more are typically considered a "reliable change."
Valued Living Questionnaire (Used to Assess Change)
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. The reported "composite score" accounts for both importance and consistency (mean of the products of importance and consistency scores within each domain) to quantify the extent to which one is contacting values in everyday life. Scores can range from 1 to 100 with higher scores indicating greater contact with values in everyday life, which is generally considered desirable and a sign of good functioning.
Inventory of Psychosocial Functioning (Used to Assess Change)
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. Response options range from 0 = never to 6 = always. The measure yields a mean score for the total scale. Higher scores indicate less functional impairment. The total scale score is reported.
PROMIS Global Short Form v1.1 (Used to Assess Change)
Self-report measure assessing multiple domains of health. The scale yields two subscales: Global Physical Health and Global Mental Health. Global Mental Health will be examined as a candidate outcome measure for a future efficacy trial. The Global Mental Health sum score can range from 4 to 20, with higher scores indicating greater mental health.
PROMIS Short Form v2.0- Satisfaction With Social Roles and Activities 8a (Used to Assess Change)
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. Scale scores range from 8 to 40 with higher scores indicating greater satisfaction with ability to perform social activities.
Columbia Suicide-Severity Rating Scale (Used to Assess Change)
Clinician-administered interview that assesses suicidal ideation and behavior. Will be examined as a candidate outcome measure for a future efficacy trial. Suicidal ideation intensity scores can range from 0 to 25 with higher scores indicating a greater intensity of suicidal ideation. Suicidal ideation intensity scale scores are reported.

Full Information

First Posted
April 21, 2016
Last Updated
October 22, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02751983
Brief Title
ACT for Life: a Brief Intervention for Maximizing Recovery After Suicidal Crises
Official Title
ACT for Life: a Brief Intervention for Maximizing Recovery After Suicidal Crises
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
August 9, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Psychiatric Rehabilitation
Keywords
Suicide, Psychiatric Rehabilitation, Acceptance and Commitment Therapy, Brief Psychotherapy, Inpatients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual plus ACT
Arm Type
Experimental
Arm Description
Participants in this condition will be enrolled in the ACT for Life intervention and still able to engage in treatment as usual.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
ACT for Life
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
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 Measure Information:
Title
Client Satisfaction Questionnaire - 8
Description
Self-report measure that will be used to assess participants' satisfaction with ACT for Life. Scale scores range from 8 to 32 with higher scores indicating greater satisfaction. For the purposes of the current study scores greater than or equal to 24 were considered acceptable. The number of participants scoring ≥ 24 is reported below.
Time Frame
Post-treatment (0-7 days after treatment completion)
Title
Narrative Evaluation of Intervention Interview
Description
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. Qualitative Thematic Analysis was conducted. There are no objective data to report from this interview. Please contact the PI for reference to a manuscript with the qualitative results.
Time Frame
Post-treatment (0-7 days after treatment completion)
Title
Reasons for Termination (Client and Therapist Versions)
Description
Self-report scale which assesses the impact of 19 common reasons why patients terminate therapy. Will be used to assess treatment acceptability. These participants reported reasons for termination of ACT, but this did not produce quantitative data.
Time Frame
Post-treatment (0-7 days after treatment termination)
Secondary Outcome Measure Information:
Title
Outcome Questionnaire 45.2 (OQ-45)
Description
The Outcome Questionnaire 45.2 is a 45-item self-report scale that assesses symptom distress, interpersonal relationships, and social role (functioning in the workplace, school, and home) for the past week. The OQ-45 total score ranges from 0-180 with higher scores indicating greater distress and impairment. Scores of 63 or more generally indicate symptoms of clinical significance and changes of 14 points or more are typically considered a "reliable change."
Time Frame
Pre-treatment, One-Month Follow-Up, Three-Month Follow-Up
Title
Valued Living Questionnaire (Used to Assess Change)
Description
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. The reported "composite score" accounts for both importance and consistency (mean of the products of importance and consistency scores within each domain) to quantify the extent to which one is contacting values in everyday life. Scores can range from 1 to 100 with higher scores indicating greater contact with values in everyday life, which is generally considered desirable and a sign of good functioning.
Time Frame
Pre-treatment, and one- and three-month follow-ups
Title
Inventory of Psychosocial Functioning (Used to Assess Change)
Description
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. Response options range from 0 = never to 6 = always. The measure yields a mean score for the total scale. Higher scores indicate less functional impairment. The total scale score is reported.
Time Frame
Pre-treatment, and one- and three-month follow-ups
Title
PROMIS Global Short Form v1.1 (Used to Assess Change)
Description
Self-report measure assessing multiple domains of health. The scale yields two subscales: Global Physical Health and Global Mental Health. Global Mental Health will be examined as a candidate outcome measure for a future efficacy trial. The Global Mental Health sum score can range from 4 to 20, with higher scores indicating greater mental health.
Time Frame
Pre-treatment, and one- and three-month follow-ups
Title
PROMIS Short Form v2.0- Satisfaction With Social Roles and Activities 8a (Used to Assess Change)
Description
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. Scale scores range from 8 to 40 with higher scores indicating greater satisfaction with ability to perform social activities.
Time Frame
Pre-treatment, and one- and three-month follow-ups
Title
Columbia Suicide-Severity Rating Scale (Used to Assess Change)
Description
Clinician-administered interview that assesses suicidal ideation and behavior. Will be examined as a candidate outcome measure for a future efficacy trial. Suicidal ideation intensity scores can range from 0 to 25 with higher scores indicating a greater intensity of suicidal ideation. Suicidal ideation intensity scale scores are reported.
Time Frame
Pre-treatment, and one- and three-month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Michael Barnes, PhD
Organizational Affiliation
Rocky Mountain Regional VA Medical Center, Aurora, CO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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