Pilot Trial of Inpatient Cognitive Therapy for the Prevention of Suicide in Military Personnel (CDMRP)
|ClinicalTrials.gov Identifier: NCT01356186|
Recruitment Status : Active, not recruiting
First Posted : May 19, 2011
Last Update Posted : April 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Suicide, Attempted||Behavioral: Post Admission Cognitive Therapy (PACT)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||July 2008|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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
No Intervention: Enhanced Usual Care (EUC)
Treatment As Usual and Study Assessment Services
- Repeat Suicide Attempts [ Time Frame: 1, 2, and 3 months ]The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess for subsequent suicide attempts.
- Depression [ Time Frame: 1, 2, and 3 months ]Depressive symptoms will be measured using the Beck Depression Inventory-II (BDI-II).
- Hopelessness [ Time Frame: 1, 2, and 3 months ]Levels of hopelessness will be assessed using the Beck Hopelessness Scale (BHS).
- Suicide Ideation [ Time Frame: 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.
- Post-Traumatic Stress Symptoms [ Time Frame: 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.
- Reliable Change Index [ Time Frame: 1, 2, and 3 months ]This is a statistical strategy to examine meaningful clinical change over time for one participant at a time.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356186
|United States, Maryland|
|Uniformed Services University of the Health Sciences|
|Bethesda, Maryland, United States, 20814|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20814|
|Principal Investigator:||Marjan Holloway, Ph.D.||Uniformed Services University of the Health Sciences|