Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors
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|ClinicalTrials.gov Identifier: NCT01359761|
Recruitment Status : Recruiting
First Posted : May 25, 2011
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Suicide, Attempted Suicidal Ideation Active||Behavioral: Post Admission Cognitive Therapy (PACT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors: A Multi-Site Randomized Controlled Trial|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
Experimental: Post Admission Cognitive Therapy (PACT)
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
Behavioral: Post Admission Cognitive Therapy (PACT)
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
No Intervention: Enhanced Usual Care (EUC)
Treatment As Usual and Study Assessment Services; 12-Months Case Management
- Repeat Suicide Attempts [ Time Frame: 1, 3, 6, and 12 months ]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.
- Depression [ Time Frame: 1, 3, 6, and 12 months ]The Beck Depression Inventory-II (BDI-II) will be used to assess for symptoms of depression.
- Hopelessness [ Time Frame: 1, 3, 6, and 12 months ]The Beck Hopelessness Scale (BHS) will be used to assess for levels of hopelessness.
- Suicide Ideation [ Time Frame: 1, 3, 6, and 12 months ]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 [ Time Frame: 1, 3, 6, and 12 months ]The MINI Neuropsychiatric Interview and the PTSD Checklist (PCL) will be administered to assess for post-traumatic stress symptoms.
- Acceptability of Treatment [ Time Frame: 1, 3, 6, and 12 months ]Acceptability of treatment will be assessed by using Barriers to Care Items.
- Repeat Psychiatric Hospitalizations [ Time Frame: 1, 3, 6, and 12 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359761
|Contact: Marjan G Holloway, Ph.D.||email@example.com|
|Contact: Jessica LaCroix, Ph.D.||firstname.lastname@example.org|
|United States, Maryland|
|Uniformed Services University of the Health Sciences||Active, not recruiting|
|Bethesda, Maryland, United States, 20814|
|Walter Reed National Military Medical Center||Recruiting|
|Bethesda, Maryland, United States, 20815|
|Contact: Russel Carr, M.D. 301-319-4376 email@example.com|
|United States, North Carolina|
|Duke University||Active, not recruiting|
|Durham, North Carolina, United States, 27708|
|United States, Virginia|
|Fort Belvoir Community Hospital||Recruiting|
|Fort Belvoir, Virginia, United States, 22060|
|Principal Investigator:||Marjan G Holloway, Ph.D.||Uniformed Services University of the Health Sciences|