Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor:
Collaborators:
Duke University
University of Michigan
University of Pennsylvania
Walter Reed National Military Medical Center
Fort Belvoir Community Hospital
Information provided by (Responsible Party):
Marjan Holloway, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT01359761
First received: May 17, 2011
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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 admitted for inpatient care due to severe suicide ideation and/or a recent suicide attempt.


Condition Intervention
Suicide, Attempted
Suicidal Ideation Active
Behavioral: Post Admission Cognitive Therapy (PACT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:

Primary Outcome Measures:
  • Repeat Suicide Attempts [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: Yes ]
    Repeat suicide attempts will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS), which assesses for number of subsequent suicide attempts.


Secondary Outcome Measures:
  • Depression [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    The Beck Depression Inventory-II (BDI-II) will be used to assess for symptoms of depression.

  • Hopelessness [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    The Beck Hopelessness Scale (BHS) will be used to assess for levels of hopelessness.

  • Suicide Ideation [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    The Scale for Suicide Ideation (SSI) will be administered to assess for suicide-related thoughts (ideation), as well as the frequency, intensity, and specificity of these thoughts.

  • Post-Traumatic Stress Symptoms [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    The Clinician Assessment of PTSD Scale (CAPS) and the PTSD Checklist (PCL) will be administered to assess for post-traumatic stress symptoms.

  • Acceptability of Treatment [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Acceptability of treatment will be assessed by using Barriers to Care Items.

  • Repeat Psychiatric Hospitalizations [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Subsequent psychiatric hospitalizations will be assessed for using the Cornell Services Index (CSI), as well as by accessing the Defense Medical Surveillance System (DMSS), which contains electronic medical records of all military personnel (permission to access participants' DMSS records is given at time of consent).


Estimated Enrollment: 218
Study Start Date: November 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post Admission Cognitive Therapy (PACT)
Six (6) 60-90 Minutes Post Admission Cognitive Therapy Individual Sessions; Up to Two (2) Inpatient Booster Sessions; Up to Four (4) Telephone Booster Sessions Following Psychiatric Discharge; 12-Months Case Management
Behavioral: Post Admission Cognitive Therapy (PACT)
Six (60-90 minutes) individual psychotherapy sessions administered over preferably 3 days of inpatient stay, up to 2 booster sessions during hospitalization, and 4 telephone booster sessions within 3-months post discharge
Other Names:
  • Cognitive Therapy
  • Cognitive Behavior Therapy
No Intervention: Enhanced Usual Care (EUC)
Treatment As Usual and Study Assessment Services; 12-Months Case Management

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 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 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 Army Medical Center and the Naval Medical Center Portsmouth. 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 young, psychiatrically hospitalized adults under the direct stress of a military career. 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 admitted for suicide-related events.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suicide Ideation + Prior Attempt OR Recent Suicide Attempt
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359761

Contacts
Contact: Marjan G Holloway, Ph.D. 301-295-3271 marjan.holloway@usuhs.edu
Contact: Laura Neely, Psy.D. 301-295-4158 laura.neely.ctr@usuhs.edu

Locations
United States, Maryland
Walter Reed National Military Medical Center Not yet recruiting
Bethesda, Maryland, United States, 20815
Uniformed Services University of the Health Sciences Not yet recruiting
Bethesda, Maryland, United States, 20814
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27708
United States, Virginia
Fort Belvoir Community Hospital Not yet recruiting
Fort Belvoir, Virginia, United States, 22060
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Duke University
University of Michigan
University of Pennsylvania
Walter Reed National Military Medical Center
Fort Belvoir Community Hospital
Investigators
Principal Investigator: Marjan G Holloway, Ph.D. Uniformed Services University of the Health Sciences
  More Information

No publications provided

Responsible Party: Marjan Holloway, Principal Investigator, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT01359761     History of Changes
Other Study ID Numbers: W81XWH-11-2-0106
Study First Received: May 17, 2011
Last Updated: October 25, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
Suicide
Cognitive Therapy
Inpatient
Military

Additional relevant MeSH terms:
Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014