NCT01359761

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 24, 2013

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

7.6 years

First QC Date

May 17, 2011

Last Update Submit

February 18, 2020

Conditions

Suicide, AttemptedSuicidal Ideation Active

Keywords

SuicideCognitive TherapyInpatientMilitary

Outcome Measures

Primary Outcomes (1)

  • 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.

    1, 3, 6, and 12 months

Secondary Outcomes (6)

  • Depression

    1, 3, 6, and 12 months

  • Hopelessness

    1, 3, 6, and 12 months

  • Suicide Ideation

    1, 3, 6, and 12 months

  • Post-Traumatic Stress Symptoms

    1, 3, 6, and 12 months

  • Acceptability of Treatment

    1, 3, 6, and 12 months

  • +1 more secondary outcomes

Study Arms (2)

Post Admission Cognitive Therapy (PACT)

EXPERIMENTAL

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)

Enhanced Usual Care (EUC)

NO INTERVENTION

Treatment As Usual and Study Assessment Services; 12-Months Case Management

Interventions

Post Admission Cognitive Therapy (PACT)BEHAVIORAL

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
Post Admission Cognitive Therapy (PACT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Reason for Admission: Suicide-Related Event
  • Baseline Completed within Preferably 48-72 Hours of Admission
  • Over the Age of 18
  • Provides Informed Consent

You may not qualify if:

  • Medical Incapacity to Participate
  • Serious Cognitive Impairment
  • Expected Discharge within 72 Hours of Admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20815, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, 22060, United States

Location

Related Publications (3)

  • Ghahramanlou-Holloway M, Neely L, Tucker J. A cognitive-behavioral strategy for preventing suicide. Current Psychiatry 13(8): 18-25, 2014.

    BACKGROUND

  • 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.

    PMID: 33884617DERIVED

  • 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.

    PMID: 29747068DERIVED

MeSH Terms

Conditions

Suicide, AttemptedSuicide

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marjan G Holloway, Ph.D.

    Uniformed Services University of the Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 25, 2011

Study Start

June 24, 2013

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)