Clinical trial NCT01359761: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide, Attempted
Suicidal Ideation Active
Keywords: Suicide
Cognitive Therapy
Inpatient
Military
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
name: Duke University
name: University of Michigan
name: University of Pennsylvania
name: Walter Reed National Military Medical Center
name: Fort Belvoir Community Hospital
First posted: 2011-05-25
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Repeat Suicide Attempts
timeFrame: 1, 3, 6, and 12 months
Secondary outcomes:
measure: Depression
timeFrame: 1, 3, 6, and 12 months
measure: Hopelessness
timeFrame: 1, 3, 6, and 12 months
measure: Suicide Ideation
timeFrame: 1, 3, 6, and 12 months
measure: Post-Traumatic Stress Symptoms
timeFrame: 1, 3, 6, and 12 months
measure: Acceptability of Treatment
timeFrame: 1, 3, 6, and 12 months
measure: Repeat Psychiatric Hospitalizations
timeFrame: 1, 3, 6, and 12 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of the Health Sciences
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Marjan G Holloway, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghahramanlou-Holloway M, Neely L, Tucker J. A cognitive-behavioral strategy for preventing suicide. Current Psychiatry 13(8): 18-25, 2014.
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.
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.