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

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751983
• Other study ID #: D2048-P
• Secondary ID: I21RX002048-01
• Status: Completed
• Phase: N/A
• Start date: November 15, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2018
• Est. primary completion date: August 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychiatric Rehabilitation
• Suicide

Intervention

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.

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post-treatment (0-7 days after treatment completion)
Primary	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.	Post-treatment (0-7 days after treatment completion)
Primary	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.	Post-treatment (0-7 days after treatment termination)
Secondary	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."	Pre-treatment, One-Month Follow-Up, Three-Month Follow-Up
Secondary	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.	Pre-treatment, and one- and three-month follow-ups
Secondary	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.	Pre-treatment, and one- and three-month follow-ups
Secondary	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.	Pre-treatment, and one- and three-month follow-ups
Secondary	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.	Pre-treatment, and one- and three-month follow-ups
Secondary	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.	Pre-treatment, and one- and three-month follow-ups