An interventional study of Post Admission Cognitive Therapy (PACT) in Suicide, Attempted and Suicidal Ideation Active, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. Status unknown at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine · Not applicable, Interventional, and Treatment
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.
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.
701 studies on the registry are indexed under Suicide; 183 are open to participants now.
This study's enrollment of 218 is above the median of 104 across 560 interventional studies indexed under Suicide.
Browse Suicide studies →Henry M. Jackson Foundation for the Advancement of Military Medicine is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Treatment As Usual and Study Assessment Services; 12-Months Case Management
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
Also known as: Cognitive Therapy, Cognitive Behavior Therapy
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.
Time frame: 1, 3, 6, and 12 months
Depression
The Beck Depression Inventory-II (BDI-II) will be used to assess for symptoms of depression.
Time frame: 1, 3, 6, and 12 months
Hopelessness
The Beck Hopelessness Scale (BHS) will be used to assess for levels of hopelessness.
Time frame: 1, 3, 6, and 12 months
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.
Time frame: 1, 3, 6, and 12 months
Post-Traumatic Stress Symptoms
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
Acceptability of Treatment
Acceptability of treatment will be assessed by using Barriers to Care Items.
Time frame: 1, 3, 6, and 12 months
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).
Time frame: 1, 3, 6, and 12 months
Plan to share: No
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Henry M. Jackson Foundation for the Advancement of Military Medicine