Clinical trial NCT02751983: 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
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Psychiatric Rehabilitation
Keywords: Suicide
Psychiatric Rehabilitation
Acceptance and Commitment Therapy
Brief Psychotherapy
Inpatients
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-04-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Client Satisfaction Questionnaire - 8
timeFrame: Post-treatment (0-7 days after treatment completion)
measure: Narrative Evaluation of Intervention Interview
timeFrame: Post-treatment (0-7 days after treatment completion)
measure: Reasons for Termination (Client and Therapist Versions)
timeFrame: Post-treatment (0-7 days after treatment termination)
Secondary outcomes:
measure: Outcome Questionnaire 45.2 (OQ-45)
timeFrame: Pre-treatment, One-Month Follow-Up, Three-Month Follow-Up
measure: Valued Living Questionnaire (Used to Assess Change)
timeFrame: Pre-treatment, and one- and three-month follow-ups
measure: Inventory of Psychosocial Functioning (Used to Assess Change)
timeFrame: Pre-treatment, and one- and three-month follow-ups
measure: PROMIS Global Short Form v1.1 (Used to Assess Change)
timeFrame: Pre-treatment, and one- and three-month follow-ups
measure: PROMIS Short Form v2.0- Satisfaction With Social Roles and Activities 8a (Used to Assess Change)
timeFrame: Pre-treatment, and one- and three-month follow-ups
measure: Columbia Suicide-Severity Rating Scale (Used to Assess Change)
timeFrame: Pre-treatment, and one- and three-month follow-ups
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Sean Michael Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References: