Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors
Primary Purpose
Suicide, Attempted, Suicidal Ideation Active
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Post Admission Cognitive Therapy (PACT)
Sponsored by
About this trial
This is an interventional treatment trial for Suicide, Attempted focused on measuring Suicide, Cognitive Therapy, Inpatient, Military
Eligibility Criteria
Inclusion Criteria:
- Reason for Admission: Suicide-Related Event
- 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
Sites / Locations
- Uniformed Services University of the Health Sciences
- Walter Reed National Military Medical Center
- Duke University
- Fort Belvoir Community Hospital
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 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
Treatment As Usual and Study Assessment Services; 12-Months Case Management
Outcomes
Primary Outcome Measures
Repeat Suicide Attempts
Repeat suicide attempts will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) which documents the number of subsequent suicide attempts; medical records will also be checked.
Secondary Outcome Measures
Depression
The Beck Depression Inventory-II (BDI-II) will be used to assess for symptoms of depression.
Hopelessness
The Beck Hopelessness Scale (BHS) will be used to assess for levels of hopelessness.
Suicide Ideation
The Scale for Suicide Ideation (SSI) and the Columbia Suicide Severity Rating Scale (C-SSRS) 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
The MINI Neuropsychiatric Interview and the PTSD Checklist (PCL) will be administered to assess for post-traumatic stress symptoms.
Acceptability of Treatment
Acceptability of treatment will be assessed by using Barriers to Care Items.
Repeat Psychiatric Hospitalizations
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).
Full Information
NCT ID
NCT01359761
First Posted
May 17, 2011
Last Updated
February 18, 2020
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
US Department of Veterans Affairs, Duke University, University of Michigan, University of Pennsylvania, Walter Reed National Military Medical Center, Fort Belvoir Community Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01359761
Brief Title
Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors
Official Title
Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors: A Multi-Site Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 24, 2013 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)
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
US Department of Veterans Affairs, Duke University, University of Michigan, University of Pennsylvania, Walter Reed National Military Medical Center, Fort Belvoir Community Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 and beneficiaries [with Veterans expected to be added] admitted for inpatient care due to severe suicide ideation and/or a recent suicide attempt.
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 and beneficiaries [with Veterans expected to be added] 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 and beneficiaries [with Veterans expected to be added] 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 National Military Medical Center and the Fort Belvoir Community Hospital [Washington DC VA expected to be added as third site]. 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 psychiatrically hospitalized adults. 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 as well as Veterans admitted for suicide-related events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicidal Ideation Active
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
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Post Admission Cognitive Therapy (PACT)
Arm Type
Experimental
Arm Description
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
Arm Title
Enhanced Usual Care (EUC)
Arm Type
No Intervention
Arm Description
Treatment As Usual and Study Assessment Services; 12-Months Case Management
Intervention Type
Behavioral
Intervention Name(s)
Post Admission Cognitive Therapy (PACT)
Other Intervention Name(s)
Cognitive Therapy, Cognitive Behavior Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Repeat Suicide Attempts
Description
Repeat suicide attempts will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) which documents the number of subsequent suicide attempts; medical records will also be checked.
Time Frame
1, 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Depression
Description
The Beck Depression Inventory-II (BDI-II) will be used to assess for symptoms of depression.
Time Frame
1, 3, 6, and 12 months
Title
Hopelessness
Description
The Beck Hopelessness Scale (BHS) will be used to assess for levels of hopelessness.
Time Frame
1, 3, 6, and 12 months
Title
Suicide Ideation
Description
The Scale for Suicide Ideation (SSI) and the Columbia Suicide Severity Rating Scale (C-SSRS) will be administered to assess for suicide-related thoughts (ideation), as well as the frequency, intensity, and specificity of these thoughts.
Time Frame
1, 3, 6, and 12 months
Title
Post-Traumatic Stress Symptoms
Description
The MINI Neuropsychiatric Interview and the PTSD Checklist (PCL) will be administered to assess for post-traumatic stress symptoms.
Time Frame
1, 3, 6, and 12 months
Title
Acceptability of Treatment
Description
Acceptability of treatment will be assessed by using Barriers to Care Items.
Time Frame
1, 3, 6, and 12 months
Title
Repeat Psychiatric Hospitalizations
Description
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).
Time Frame
1, 3, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Reason for Admission: Suicide-Related Event
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjan G 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
20815
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Ghahramanlou-Holloway M, Neely L, Tucker J. A cognitive-behavioral strategy for preventing suicide. Current Psychiatry 13(8): 18-25, 2014.
Results Reference
background
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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Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors
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