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Pilot Trial of Inpatient Cognitive Therapy for the Prevention of Suicide in Military Personnel (CDMRP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor:
Collaborator:
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
Marjan Holloway, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT01356186
First received: May 17, 2011
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

The broad objective of this research is to effectively utilize a unique window of opportunity during the hospitalization period following a recent suicide attempt to deliver a brief and targeted intervention for traumatized individuals.


Condition Intervention Phase
Suicide, Attempted
Behavioral: Post Admission Cognitive Therapy (PACT)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of Inpatient Cognitive Therapy for the Prevention of Suicide in Military Personnel With Acute Stress Disorder of Post Traumatic Stress Disorder

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, 2, and 3 months ] [ Designated as safety issue: Yes ]
    The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess for subsequent suicide attempts.


Secondary Outcome Measures:
  • Depression [ Time Frame: 1, 2, and 3 months ] [ Designated as safety issue: No ]
    Depressive symptoms will be measured using the Beck Depression Inventory-II (BDI-II).

  • Hopelessness [ Time Frame: 1, 2, and 3 months ] [ Designated as safety issue: No ]
    Levels of hopelessness will be assessed using the Beck Hopelessness Scale (BHS).

  • Suicide Ideation [ Time Frame: 1, 2, and 3 months ] [ Designated as safety issue: No ]
    The Scale for Suicide Ideation (SSI) will be used to assess for suicide-related thoughts (ideations), as well as intensity, frequency, and specificity of any such thoughts.

  • Post-Traumatic Stress Symptoms [ Time Frame: 1, 2, and 3 months ] [ Designated as safety issue: No ]
    The Clinician Assessments of PTSD Scale (CAPS) and the PTSD Checklist (PCL) will be used to assess for post-traumatic stress symptoms.


Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Post Admission Cognitive Therapy (PACT)
Six (6) 60-90 Minutes Sessions of Post Admission Cognitive Therapy Delivered Preferably Over 3 Consecutive Days of Inpatient Stay
Behavioral: Post Admission Cognitive Therapy (PACT)
Individual psychotherapy; 6 sessions; 60-90 minutes in duration; administered over preferably 3 days of psychiatric hospitalization
Other Names:
  • Cognitive Therapy
  • Cognitive Behavior Therapy
No Intervention: Enhanced Usual Care (EUC)
Treatment As Usual and Study Assessment Services

Detailed Description:

Participation in military operations, especially in times of war, places personnel and their family members at increased risk for mental health problems. In 2003, among the 1.4 million active duty United States service members, mental disorders remained the leading cause of hospitalization for men and the second leading cause of hospitalization for women. Posttraumatic stress disorder (PTSD) and suicide behavior among military personnel are the leading causes of psychiatric hospitalization. Both are considered significant public health problems. Existing literature provides strong support for the relationship between PTSD and suicide ideation, attempts, and deaths. PTSD, in fact, shows the strongest association with suicide behavior of any of the anxiety disorders and has equal or greater odds ratio than mood disorders for resulting in impulsive suicide attempts. However, to date, no evidence-based interventions have been developed for individuals with PTSD who attempt suicide. Therefore, the investigators aim to develop, implement, and evaluate an inpatient based cognitive behavioral care plan for service members and beneficiaries, with symptoms of either Acute Stress Disorder (ASD) or PTSD, who are admitted for hospitalization following a recent suicide attempt.

The investigators will randomize 50 traumatized patients hospitalized at the Walter Reed Army Medical Center for a recent suicide attempt to one of two conditions: (1) Post-Admission Cognitive Therapy + Enhanced Usual Care (PACT+EUC) or (2) Enhanced Usual Care (EUC). Individuals who are over the age of 18, able to communicate in English and willing to provide informed consent will be recruited. The PACT+EUC condition will consist of six 1-hr individual cognitive therapy sessions administered over 3 days over the course of the patient's hospital stay. The EUC condition will consist of the usual care patients receive at an inpatient facility during their hospitalization in addition to assessment services provided by independent evaluators who work directly with our research team. The primary outcome variable is the number of subsequent suicide attempts. The investigators expect that patients in the control condition will reattempt suicide at an earlier date and at a higher frequency as compared to patients enrolled in the intervention condition. Secondary outcome measures include the severity of depression, hopelessness, suicide ideation, and post traumatic symptoms. Patients in both conditions will be assessed on the dependent measures at baseline and at 1-, 2-, and 3- month follow-up intervals. Data analyses will provide estimates of the level of improvement demonstrated by the intervention condition, PACT relative to the control condition, EUC over time.

The development and subsequent dissemination of innovative inpatient focused interventions for traumatized individuals with suicide attempt behavior will significantly contribute to our national and military suicide prevention objectives. The research aims to effectively utilize a unique window of opportunity during the hospitalization period following a recent suicide attempt to deliver a brief and targeted intervention to military personnel and family members diagnosed with a trauma-related condition. If our designed intervention demonstrates to be clinically feasible, acceptable, and associated with preliminary evidence of improvement in symptoms relative to the control condition, a larger randomized controlled trial will be proposed to definitively determine the efficacy of the intervention. Without adequate treatment, PTSD and suicide behavior may result in costly utilization of social services, human suffering, and eventual death. The Department of Veterans Affairs reports that veterans as compared to the general US population are at greater risk for suicide by almost 23%. The study targets at-risk individuals immediately following psychiatric hospitalization to minimize the likelihood of future complications as seen previously with Vietnam veterans. The projected time to achieve a consumer-related outcome would be 3-5 years.

  Eligibility

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

Inclusion Criteria

  1. Suicide Attempt (Recent or Lifetime) Psychiatric Admission
  2. History of Trauma
  3. Baseline Completed within 48 Hours of Admission
  4. Over the Age of 18
  5. Provides Informed Consent

Exclusion Criteria

  1. Self-Inflicted Harm with No Intent or Desire to Die
  2. Medical Incapacity to Participate
  3. Current State of Active Psychosis
  4. 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: NCT01356186

Contacts
Contact: Marjan 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
Uniformed Services University of the Health Sciences Recruiting
Bethesda, Maryland, United States, 20814
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20814
Contact: Marjan Holloway, Ph.D.    301-295-3271    marjan.holloway@usuhs.edu   
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Congressionally Directed Medical Research Programs
Investigators
Principal Investigator: Marjan Holloway, Ph.D. Uniformed Services University of the Health Sciences
  More Information

No publications provided

Responsible Party: Marjan Holloway, Associate Professor, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT01356186     History of Changes
Other Study ID Numbers: W81XWH-08-2-1072
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:
Stress Disorders, Post-Traumatic
Suicide
Suicide, Attempted
Anxiety Disorders
Behavioral Symptoms
Mental Disorders
Self-Injurious Behavior
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on November 20, 2014