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

Primary Purpose

Suicide, Attempted

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Post Admission Cognitive Therapy (PACT)
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted focused on measuring Suicide, Cognitive Therapy, Inpatient, Military

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uniformed Services University of the Health Sciences
  • Walter Reed National Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Post Admission Cognitive Therapy (PACT)

Enhanced Usual Care (EUC)

Arm Description

Six (6) 60-90 Minutes Sessions of Post Admission Cognitive Therapy Delivered Preferably Over 3 Consecutive Days of Inpatient Stay

Treatment As Usual and Study Assessment Services

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Depression
Depressive symptoms will be measured using the Beck Depression Inventory-II (BDI-II).
Hopelessness
Levels of hopelessness will be assessed using the Beck Hopelessness Scale (BHS).
Suicide Ideation
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
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
This is a statistical strategy to examine meaningful clinical change over time for one participant at a time.

Full Information

First Posted
May 17, 2011
Last Updated
February 18, 2020
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Congressionally Directed Medical Research Programs
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1. Study Identification

Unique Protocol Identification Number
NCT01356186
Brief Title
Pilot Trial of Inpatient Cognitive Therapy for the Prevention of Suicide in Military Personnel
Acronym
CDMRP
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 Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Congressionally Directed Medical Research Programs

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
Keywords
Suicide, Cognitive Therapy, Inpatient, Military

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post Admission Cognitive Therapy (PACT)
Arm Type
Experimental
Arm Description
Six (6) 60-90 Minutes Sessions of Post Admission Cognitive Therapy Delivered Preferably Over 3 Consecutive Days of Inpatient Stay
Arm Title
Enhanced Usual Care (EUC)
Arm Type
No Intervention
Arm Description
Treatment As Usual and Study Assessment Services
Intervention Type
Behavioral
Intervention Name(s)
Post Admission Cognitive Therapy (PACT)
Other Intervention Name(s)
Cognitive Therapy, Cognitive Behavior Therapy
Intervention Description
Individual psychotherapy; 6 sessions; 60-90 minutes in duration; administered over preferably 3 days of psychiatric hospitalization
Primary Outcome Measure Information:
Title
Repeat Suicide Attempts
Description
The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess for subsequent suicide attempts.
Time Frame
1, 2, and 3 months
Secondary Outcome Measure Information:
Title
Depression
Description
Depressive symptoms will be measured using the Beck Depression Inventory-II (BDI-II).
Time Frame
1, 2, and 3 months
Title
Hopelessness
Description
Levels of hopelessness will be assessed using the Beck Hopelessness Scale (BHS).
Time Frame
1, 2, and 3 months
Title
Suicide Ideation
Description
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.
Time Frame
1, 2, and 3 months
Title
Post-Traumatic Stress Symptoms
Description
The Clinician Assessments of PTSD Scale (CAPS) and the PTSD Checklist (PCL) will be used to assess for post-traumatic stress symptoms.
Time Frame
1, 2, and 3 months
Title
Reliable Change Index
Description
This is a statistical strategy to examine meaningful clinical change over time for one participant at a time.
Time Frame
1, 2, and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Suicide Attempt (Recent or Lifetime) Psychiatric Admission History of Trauma Baseline Completed within 48 Hours of Admission Over the Age of 18 Provides Informed Consent Exclusion Criteria Self-Inflicted Harm with No Intent or Desire to Die Medical Incapacity to Participate Current State of Active Psychosis Expected Discharge within 72 Hours of Admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjan Holloway, Ph.D.
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniformed Services University of the Health Sciences
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Ghahramanlou-Holloway M, Cox D, & Greene F. Post-admission cognitive therapy: A brief intervention for psychiatric inpatients admitted after a suicide attempt. Cognitive and Behavioral Practice 19: 233-244, 2012.
Results Reference
background
Citation
Neely L, Irwin K, Carreno Ponce JT, Perera K, Grammer G, & Ghahramanlou-Holloway M. Post Admission Cognitive Therapy (PACT) for the prevention of suicide in military personnel with histories of trauma: Treatment development and case example. Clinical Case Studies, 12(6), 457-473, 2013.
Results Reference
background
PubMed Identifier
30080085
Citation
LaCroix JM, Perera KU, Neely LL, Grammer G, Weaver J, Ghahramanlou-Holloway M. Pilot trial of post-admission cognitive therapy: Inpatient program for suicide prevention. Psychol Serv. 2018 Aug;15(3):279-288. doi: 10.1037/ser0000224.
Results Reference
result
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
PubMed Identifier
29747068
Citation
LaCroix JM, Colborn VA, Hassen HO, Perera KU, Weaver J, Soumoff A, Novak LA, Ghahramanlou-Holloway M. Intimate partner relationship stress and suicidality in a psychiatrically hospitalized military sample. Compr Psychiatry. 2018 Jul;84:106-111. doi: 10.1016/j.comppsych.2018.04.006. Epub 2018 Apr 21.
Results Reference
derived

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

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