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Clinical Trials/NCT01359761
NCT01359761
Unknown
Not Applicable

Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

Henry M. Jackson Foundation for the Advancement of Military Medicine4 sites in 1 country218 target enrollmentJune 24, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide, Attempted
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Enrollment
218
Locations
4
Primary Endpoint
Repeat Suicide Attempts
Last Updated
6 years ago

Overview

Brief Summary

This study will implement and empirically evaluate the efficacy of a cognitive behavioral intervention program, titled, Post Admission Cognitive Therapy(PACT), for military service members and beneficiaries [with Veterans expected to be added] admitted for inpatient care due to severe suicide ideation and/or a recent suicide attempt.

Detailed Description

Background: Suicide remains a serious national public health problem and has become a leading cause of death in the United States military. To date, there is no evidence-based civilian or military inpatient interventions aimed at the reduction of suicide behavior. Our proposal addresses this important gap and aims to evaluate an innovative suicide intervention, Post Admission Cognitive Therapy (PACT). Left untreated, severe suicide ideation and/or suicide attempts that require psychiatric hospitalization may place an individual at a lifetime risk for increased psychopathology, subsequent suicide behavior, and death. Objective: The broad objective is to implement and empirically evaluate the efficacy of a cognitive behavioral intervention program, titled Post Admission Cognitive Therapy (PACT), for military service members and beneficiaries \[with Veterans expected to be added\] admitted for inpatient care due to severe suicide ideation (with lifetime history of suicide attempt) and/or a recent suicide attempt. Specific Aims: To evaluate the efficacy of PACT plus Enhanced Usual Care (EUC) versus EUC for the prevention of suicide in psychiatrically hospitalized military personnel and beneficiaries \[with Veterans expected to be added\] at follow-up (1, 3, 6, and 12-month) on (1) incidence of repeat suicide attempt(s) and number of days until a repeat suicide attempt (primary outcomes), and (2) psychiatric symptoms (depression, trauma, sleep, suicide ideation), repeat number of psychiatric hospitalization(s), hope for one's future, and acceptability of treatment (as measured by time to linkage to specialty care, attitudes toward seeking help for mental health issues, and subsequent mental health service utilization) (secondary outcomes). The investigators expect that adults in the PACT+EUC (experimental) condition compared to those in the EUC (control) condition will show favorable outcomes on both primary and secondary measures. Study Design: The research design is a multi-site, single-blind, randomized controlled trial (RCT). A total of 218 individuals who are over the age of 18, able to communicate in English and willing to provide informed consent will be recruited from the inpatient psychiatric units at the Walter Reed National Military Medical Center and the Fort Belvoir Community Hospital \[Washington DC VA expected to be added as third site\]. Participants will be randomized into one of two conditions: (1) \[Post Admission Cognitive Therapy (PACT) + Enhanced Usual Care (EUC)\] or (2) Enhanced Usual Care (EUC). Individuals randomized into PACT+EUC will participate in the study assessments, receive six 60-90 minute individual face-to-face PACT psychotherapy sessions provided during their inpatient stay, up to a maximum of four 30-minute phone PACT booster sessions during the 3 months post hospital discharge, and case management services for 12 months. Individuals randomized into the control condition (EUC) will not receive the study intervention; they will receive the usual care provided in the inpatient setting, participate in study assessments, and receive case management services for 12 months. Patients in both conditions will be assessed on the dependent measures at baseline and at 1-, 3-, 6-, and 12-month follow-up intervals. Relevance: Delivering a brief and possibly potent psychotherapeutic intervention during a psychiatric inpatient hospitalization followed by an aftercare component aims to directly target individuals at high risk for future suicide behavior, specifically psychiatrically hospitalized adults. The development and empirical validation of an inpatient cognitive behavioral treatment is a significant endeavor in our national as well as Department of Defense (DoD) suicide prevention efforts. If Post Admission Cognitive Therapy is found to be efficacious, the intervention can be subsequently disseminated to inpatient settings as the standard of care for military personnel and beneficiaries as well as Veterans admitted for suicide-related events.

Registry
clinicaltrials.gov
Start Date
June 24, 2013
End Date
January 31, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Responsible Party
Principal Investigator
Principal Investigator

Marjan Holloway

Principal Investigator

Henry M. Jackson Foundation for the Advancement of Military Medicine

Eligibility Criteria

Inclusion Criteria

  • Reason for Admission: Suicide-Related Event
  • Baseline Completed within Preferably 48-72 Hours of Admission
  • Over the Age of 18
  • Provides Informed Consent

Exclusion Criteria

  • Medical Incapacity to Participate
  • Serious Cognitive Impairment
  • Expected Discharge within 72 Hours of Admission

Outcomes

Primary Outcomes

Repeat Suicide Attempts

Time Frame: 1, 3, 6, and 12 months

Repeat suicide attempts will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) which documents the number of subsequent suicide attempts; medical records will also be checked.

Secondary Outcomes

  • Depression(1, 3, 6, and 12 months)
  • Hopelessness(1, 3, 6, and 12 months)
  • Suicide Ideation(1, 3, 6, and 12 months)
  • Post-Traumatic Stress Symptoms(1, 3, 6, and 12 months)
  • Acceptability of Treatment(1, 3, 6, and 12 months)
  • Repeat Psychiatric Hospitalizations(1, 3, 6, and 12 months)

Study Sites (4)

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