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Inpatient Post Admission Cognitive Therapy (PACT) for the Prevention of Suicide Attempts

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:

  • Recent Suicide Attempt
  • Baseline Completed Preferably 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

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
Columbia Suicide Severity Rating Scale; Hospital Records

Secondary Outcome Measures

Depression
Beck Depression Inventory
Hopelessness
Beck Hopelessness Scale
Suicide Ideation
Scale for Suicide Ideation and Columbia Suicide Severity Rating Scale
Post-Traumatic Stress Symptoms
Various measures on trauma
Reliable Change Index
Clinical change that can be considered as meaningful

Full Information

First Posted
April 21, 2011
Last Updated
February 18, 2020
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT01340859
Brief Title
Inpatient Post Admission Cognitive Therapy (PACT) for the Prevention of Suicide Attempts
Official Title
Inpatient Post Admission Cognitive Therapy (PACT) for the Prevention of Suicide Attempts: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2011 (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
National Alliance for Research on Schizophrenia and Depression

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 suicidal individuals.
Detailed Description
Suicide remains a serious public health problem as the 4th leading cause of death among individuals 15-44 years old and the 2nd leading cause of death in the military. Developing effective interventions for suicide behavior has been a stated goal of the National Strategy for Suicide Prevention. To date, only a limited number of controlled studies have examined the efficacy of psychosocial interventions in reducing suicide behavior. Preliminary findings from the University of Pennsylvania (Brown et al., 2005) indicate that outpatient cognitive therapy reduces the likelihood of repeat suicide attempts by approximately 50%. Yet the efficacy of this promising new intervention has not been tested in other medical settings or in other specific at risk groups. We propose an adaptation of Beck and colleagues cognitive therapy suicide protocol for implementation, feasibility, and pilot testing at an inpatient psychiatry setting for specific delivery to military service members and their family members with a recent suicide attempt. Suicide attempt behavior is one of the most powerful risk factors for repeat suicide behavior as well as eventual death by suicide. Delivering a brief and possibly potent psychotherapeutic intervention during a patient's inpatient hospitalization aims to directly target individuals at high risk for future suicide behavior, i.e., young adult, mostly males with a recent suicide attempt, under direct stress of a military career. We expect that the adapted intervention, titled Post Admission Cognitive Therapy (PACT), will show promise in reducing the likelihood of post-hospitalization suicide attempt behavior as well as psychological risk factors associated with suicide such as depression, hopelessness, suicide ideation, and posttraumatic symptoms. Our proposed design is a randomized controlled pilot trial with blinded outcome assessments. Specific Aims: (1) To develop and evaluate a new manual of Post-Admission Cognitive Therapy (PACT) as a targeted inpatient treatment for individuals admitted for a recent suicide attempt to a military hospital. (2) To assess the feasibility of the study's assessment procedures by monitoring the completion rate of outcome measures during face-to-face as well as follow-up phone and web-based administrations. (3) To evaluate the degree of change and variability of response to Post-Admission Cognitive Therapy in comparison to Enhanced Usual Care at post-intervention and follow-up (1-, 2-, and 3-Month) on subsequent suicide attempt behavior (primary outcome) as well as on levels of depression, hopelessness, and suicide ideation (secondary outcomes). (4) To examine in a preliminary manner whether improvements on primary and secondary outcome measures are associated with enhanced problem solving abilities which is viewed as a potential mechanism of change in cognitive therapy for the reduction of suicide behavior. Study Design: We plan to randomize 24 patients hospitalized at the Walter Reed National Military 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 60-90 minute individual cognitive therapy sessions administered preferably over 3 days. 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. We 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, and suicide ideation. 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 statistical power of PACT relative to EUC over time via the usage of repeated observation data. Our preliminary effect size estimates will be used for future sample size calculations to conduct a larger randomized controlled trial to definitively determine the efficacy of PACT.

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
24 (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; 60-90 minutes sessions; 6 sessions over preferably 3 days of inpatient stay
Primary Outcome Measure Information:
Title
Repeat Suicide Attempts
Description
Columbia Suicide Severity Rating Scale; Hospital Records
Time Frame
1, 2, and 3 months
Secondary Outcome Measure Information:
Title
Depression
Description
Beck Depression Inventory
Time Frame
1, 2, and 3 months
Title
Hopelessness
Description
Beck Hopelessness Scale
Time Frame
1, 2, and 3 months
Title
Suicide Ideation
Description
Scale for Suicide Ideation and Columbia Suicide Severity Rating Scale
Time Frame
1, 2, and 3 months
Title
Post-Traumatic Stress Symptoms
Description
Various measures on trauma
Time Frame
1, 2, and 3 months
Title
Reliable Change Index
Description
Clinical change that can be considered as meaningful
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: Recent Suicide Attempt Baseline Completed Preferably 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 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

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
PubMed Identifier
24387921
Citation
Kochanski-Ruscio KM, Carreno-Ponce JT, DeYoung K, Grammer G, Ghahramanlou-Holloway M. Diagnostic and psychosocial differences in psychiatrically hospitalized military service members with single versus multiple suicide attempts. Compr Psychiatry. 2014 Apr;55(3):450-6. doi: 10.1016/j.comppsych.2013.10.012. Epub 2013 Nov 4.
Results Reference
background
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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Inpatient Post Admission Cognitive Therapy (PACT) for the Prevention of Suicide Attempts

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