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

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01356186
Collaborator
Congressionally Directed Medical Research Programs (U.S. Fed)
36
Enrollment
2
Locations
2
Arms
125
Duration (Months)
18
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or DiseaseIntervention/TreatmentPhase
  • Behavioral: Post Admission Cognitive Therapy (PACT)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

ArmIntervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. Repeat Suicide Attempts [1, 2, and 3 months]

      The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess for subsequent suicide attempts.

    Secondary Outcome Measures

    1. Depression [1, 2, and 3 months]

      Depressive symptoms will be measured using the Beck Depression Inventory-II (BDI-II).

    2. Hopelessness [1, 2, and 3 months]

      Levels of hopelessness will be assessed using the Beck Hopelessness Scale (BHS).

    3. Suicide Ideation [1, 2, and 3 months]

      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.

    4. Post-Traumatic Stress Symptoms [1, 2, and 3 months]

      The Clinician Assessments of PTSD Scale (CAPS) and the PTSD Checklist (PCL) will be used to assess for post-traumatic stress symptoms.

    5. Reliable Change Index [1, 2, and 3 months]

      This is a statistical strategy to examine meaningful clinical change over time for one participant at a time.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    SiteCityStateCountryPostal Code
    1Uniformed Services University of the Health SciencesBethesdaMarylandUnited States20814
    2Walter Reed National Military Medical CenterBethesdaMarylandUnited States20814

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Marjan Holloway, Associate Professor, Henry M. Jackson Foundation for the Advancement of Military Medicine
    ClinicalTrials.gov Identifier:
    NCT01356186
    Other Study ID Numbers:
    • W81XWH-08-2-1072
    First Posted:
    May 19, 2011
    Last Update Posted:
    Feb 20, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Marjan Holloway, Associate Professor, Henry M. Jackson Foundation for the Advancement of Military Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 20, 2020