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Suicide, AttemptedNCT01340859

Inpatient Post Admission Cognitive Therapy (PACT) for the Prevention of Suicide Attempts

A study testing Post Admission Cognitive Therapy (PACT) in people with Suicide, Attempted, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 suicidal individuals. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicide, Attempted
What is being tested?
Post Admission Cognitive Therapy (PACT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
Apr 2011to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recent Suicide Attempt
  • Baseline Completed Preferably within 48 Hours of Admission
  • Over the Age of 18
  • Provides Informed Consent

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Uniformed Services University of the Health Sciences

    Bethesda, Maryland, 20814

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20815

Other trials in United States

About this study

Official title: Inpatient Post Admission Cognitive Therapy (PACT) for the Prevention of Suicide Attempts: A Pilot Study

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 suicidal individuals.

Read the detailed description

Suicide remains a serious public health problem as the 4th leading cause of death among individuals 15-44 years old and the 2nd leading cause of death in the military. Developing effective interventions for suicide behavior has been a stated goal of the National Strategy for Suicide Prevention. To date, only a limited number of controlled studies have examined the efficacy of psychosocial interventions in reducing suicide behavior. Preliminary findings from the University of Pennsylvania (Brown et al., 2005) indicate that outpatient cognitive therapy reduces the likelihood of repeat suicide attempts by approximately 50%. Yet the efficacy of this promising new intervention has not been tested in other medical settings or in other specific at risk groups.

We propose an adaptation of Beck and colleagues cognitive therapy suicide protocol for implementation, feasibility, and pilot testing at an inpatient psychiatry setting for specific delivery to military service members and their family members with a recent suicide attempt. Suicide attempt behavior is one of the most powerful risk factors for repeat suicide behavior as well as eventual death by suicide. Delivering a brief and possibly potent psychotherapeutic intervention during a patient's inpatient hospitalization aims to directly target individuals at high risk for future suicide behavior, i.e., young adult, mostly males with a recent suicide attempt, under direct stress of a military career. We expect that the adapted intervention, titled Post Admission Cognitive Therapy (PACT), will show promise in reducing the likelihood of post-hospitalization suicide attempt behavior as well as psychological risk factors associated with suicide such as depression, hopelessness, suicide ideation, and posttraumatic symptoms. Our proposed design is a randomized controlled pilot trial with blinded outcome assessments.

Specific Aims: (1) To develop and evaluate a new manual of Post-Admission Cognitive Therapy (PACT) as a targeted inpatient treatment for individuals admitted for a recent suicide attempt to a military hospital. (2) To assess the feasibility of the study's assessment procedures by monitoring the completion rate of outcome measures during face-to-face as well as follow-up phone and web-based administrations. (3) To evaluate the degree of change and variability of response to Post-Admission Cognitive Therapy in comparison to Enhanced Usual Care at post-intervention and follow-up (1-, 2-, and 3-Month) on subsequent suicide attempt behavior (primary outcome) as well as on levels of depression, hopelessness, and suicide ideation (secondary outcomes). (4) To examine in a preliminary manner whether improvements on primary and secondary outcome measures are associated with enhanced problem solving abilities which is viewed as a potential mechanism of change in cognitive therapy for the reduction of suicide behavior.

Study Design: We plan to randomize 24 patients hospitalized at the Walter Reed National Military Medical Center for a recent suicide attempt to one of two conditions: (1) Post-Admission Cognitive Therapy + Enhanced Usual Care (PACT+EUC) or (2) Enhanced Usual Care (EUC). Individuals who are over the age of 18, able to communicate in English and willing to provide informed consent will be recruited. The PACT+EUC condition will consist of six 60-90 minute individual cognitive therapy sessions administered preferably over 3 days. The EUC condition will consist of the usual care patients receive at an inpatient facility during their hospitalization in addition to assessment services provided by independent evaluators who work directly with our research team. The primary outcome variable is the number of subsequent suicide attempts. We expect that patients in the control condition will reattempt suicide at an earlier date and at a higher frequency as compared to patients enrolled in the intervention condition. Secondary outcome measures include the severity of depression, hopelessness, and suicide ideation. Patients in both conditions will be assessed on the dependent measures at baseline and at 1-, 2-, and 3- month follow-up intervals. Data analyses will provide estimates of the statistical power of PACT relative to EUC over time via the usage of repeated observation data. Our preliminary effect size estimates will be used for future sample size calculations to conduct a larger randomized controlled trial to definitively determine the efficacy of PACT.

Being tested
Post Admission Cognitive Therapy (PACT)
Keywords
Suicide, Cognitive Therapy, Inpatient, Military
Medical subject headings
Suicide, Attempted, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Post Admission Cognitive Therapy (PACT)Behavioural

    Also called Cognitive Therapy, Cognitive Behavior Therapy

    Individual psychotherapy; 60-90 minutes sessions; 6 sessions over preferably 3 days of inpatient stay

Study groups in NCT01340859
Study groupRoleWhat they receive
Post Admission Cognitive Therapy (PACT)ExperimentalSix (6) 60-90 Minutes Sessions of Post Admission Cognitive Therapy Delivered Preferably Over 3 Consecutive Days of Inpatient Stay
Receives: Behavioral: Post Admission Cognitive Therapy (PACT)
Enhanced Usual Care (EUC)No interventionTreatment As Usual and Study Assessment Services

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Repeat Suicide Attempts

    Columbia Suicide Severity Rating Scale; Hospital Records

    Measured: 1, 2, and 3 months

Secondary outcomes (5)
  1. Depression

    Beck Depression Inventory

    Measured: 1, 2, and 3 months

  2. Hopelessness

    Beck Hopelessness Scale

    Measured: 1, 2, and 3 months

  3. Suicide Ideation

    Scale for Suicide Ideation and Columbia Suicide Severity Rating Scale

    Measured: 1, 2, and 3 months

  4. Post-Traumatic Stress Symptoms

    Various measures on trauma

    Measured: 1, 2, and 3 months

  5. Reliable Change Index

    Clinical change that can be considered as meaningful

    Measured: 1, 2, and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01340859
Sponsor's protocol ID
G172JF
Status last verified
Feb 2020
First submitted
21 Apr 2011
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

  • Kochanski-Ruscio KM, Carreno-Ponce JT, DeYoung K, Grammer G, Ghahramanlou-Holloway M. Diagnostic and psychosocial differences in psychiatrically hospitalized military service members with single versus multiple suicide attempts. Compr Psychiatry. 2014 Apr;55(3):450-6. doi: 10.1016/j.comppsych.2013.10.012. Epub 2013 Nov 4.

    PubMed 24387921
  • 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.

    PubMed 29747068

Questions about this trial

What is this clinical trial studying?

A study testing Post Admission Cognitive Therapy (PACT) in people with Suicide, Attempted, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Repeat Suicide Attempts (time frame: 1, 2, and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01340859, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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