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

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01340859
Collaborator
National Alliance for Research on Schizophrenia and Depression (Other)
24
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92
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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 suicidal individuals.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Post Admission Cognitive Therapy (PACT)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Inpatient Post Admission Cognitive Therapy (PACT) for the Prevention of Suicide Attempts: A Pilot Study
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/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; 60-90 minutes sessions; 6 sessions over preferably 3 days of inpatient stay
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]

      Columbia Suicide Severity Rating Scale; Hospital Records

    Secondary Outcome Measures

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

      Beck Depression Inventory

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

      Beck Hopelessness Scale

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

      Scale for Suicide Ideation and Columbia Suicide Severity Rating Scale

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

      Various measures on trauma

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

      Clinical change that can be considered as meaningful

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uniformed Services University of the Health Sciences Bethesda Maryland United States 20814
    2 Walter Reed National Military Medical Center Bethesda Maryland United States 20815

    Sponsors and Collaborators

    • Henry M. Jackson Foundation for the Advancement of Military Medicine
    • National Alliance for Research on Schizophrenia and Depression

    Investigators

    • Principal Investigator: Marjan G 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:
    NCT01340859
    Other Study ID Numbers:
    • G172JF
    First Posted:
    Apr 25, 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