NCT01356186

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 traumatized individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

10.4 years

First QC Date

May 17, 2011

Last Update Submit

February 18, 2020

Conditions

Suicide, Attempted

Keywords

SuicideCognitive TherapyInpatientMilitary

Outcome Measures

Primary Outcomes (1)

  • Repeat Suicide Attempts

    The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess for subsequent suicide attempts.

    1, 2, and 3 months

Secondary Outcomes (5)

  • Depression

    1, 2, and 3 months

  • Hopelessness

    1, 2, and 3 months

  • Suicide Ideation

    1, 2, and 3 months

  • Post-Traumatic Stress Symptoms

    1, 2, and 3 months

  • Reliable Change Index

    1, 2, and 3 months

Study Arms (2)

Post Admission Cognitive Therapy (PACT)

EXPERIMENTAL

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)

Enhanced Usual Care (EUC)

NO INTERVENTION

Treatment As Usual and Study Assessment Services

Interventions

Post Admission Cognitive Therapy (PACT)BEHAVIORAL

Individual psychotherapy; 6 sessions; 60-90 minutes in duration; administered over preferably 3 days of psychiatric hospitalization

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:

  • Suicide Attempt (Recent or Lifetime) Psychiatric Admission
  • History of Trauma
  • Baseline Completed within 48 Hours of Admission
  • Over the Age of 18
  • Provides Informed Consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Related Publications (5)

  • Ghahramanlou-Holloway M, Cox D, & Greene F. Post-admission cognitive therapy: A brief intervention for psychiatric inpatients admitted after a suicide attempt. Cognitive and Behavioral Practice 19: 233-244, 2012.

    BACKGROUND

  • Neely L, Irwin K, Carreno Ponce JT, Perera K, Grammer G, & Ghahramanlou-Holloway M. Post Admission Cognitive Therapy (PACT) for the prevention of suicide in military personnel with histories of trauma: Treatment development and case example. Clinical Case Studies, 12(6), 457-473, 2013.

    BACKGROUND

  • LaCroix JM, Perera KU, Neely LL, Grammer G, Weaver J, Ghahramanlou-Holloway M. Pilot trial of post-admission cognitive therapy: Inpatient program for suicide prevention. Psychol Serv. 2018 Aug;15(3):279-288. doi: 10.1037/ser0000224.

    PMID: 30080085RESULT

  • 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 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
Associate Professor

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 19, 2011

Study Start

July 1, 2008

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)