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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Suicide, Attempted
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Post Admission Cognitive Therapy (PACT) |
| Enhanced Usual Care (EUC) | No intervention | Treatment As Usual and Study Assessment Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat Suicide Attempts
Columbia Suicide Severity Rating Scale; Hospital Records
Measured: 1, 2, and 3 months
Secondary outcomes (5)
Depression
Beck Depression Inventory
Measured: 1, 2, and 3 months
Hopelessness
Beck Hopelessness Scale
Measured: 1, 2, and 3 months
Suicide Ideation
Scale for Suicide Ideation and Columbia Suicide Severity Rating Scale
Measured: 1, 2, and 3 months
Post-Traumatic Stress Symptoms
Various measures on trauma
Measured: 1, 2, and 3 months
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.
- First posted25 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Principal investigator, Marjan Holloway, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Investigators
- Marjan G Holloway, Ph.D., Principal investigator, Uniformed Services University of the Health Sciences
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 24387921LaCroix 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Post Admission Cognitive Therapy (PACT) for the Prevention of Suicide Attempts: A Pilot Study
- ClinicalTrials.gov ID
- NCT01340859
- Acronym / sponsor ID
- G172JF
- Conditions
- Suicide, Attempted
- Keywords
- Suicide, Cognitive Therapy, Inpatient, Military
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Apr 2011
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post Admission Cognitive Therapy (PACT) | Experimental | Behavioral: Post Admission Cognitive Therapy (PACT)Six (6) 60-90 Minutes Sessions of Post Admission Cognitive Therapy Delivered Preferably Over 3 Consecutive Days of Inpatient Stay |
| Enhanced Usual Care (EUC) | No intervention | –Treatment As Usual and Study Assessment Services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recent Suicide Attempt
- Baseline Completed Preferably within 48 Hours of Admission
- Over the Age of 18
- Provides Informed Consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post Admission Cognitive Therapy (PACT)Also: Cognitive Therapy, Cognitive Behavior TherapyIndividual psychotherapy; 60-90 minutes sessions; 6 sessions over preferably 3 days of inpatient stay | Behavioural | Post Admission Cognitive Therapy (PACT) |
Primary outcome
Repeat Suicide Attempts
Time frame: 1, 2, and 3 months
Columbia Suicide Severity Rating Scale; Hospital Records
5 secondary outcomes
Depression
Time frame: 1, 2, and 3 months
Hopelessness
Time frame: 1, 2, and 3 months
Suicide Ideation
Time frame: 1, 2, and 3 months
Post-Traumatic Stress Symptoms
Time frame: 1, 2, and 3 months
Reliable Change Index
Time frame: 1, 2, and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- BackgroundGhahramanlou-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: PubMed 24387921Kochanski-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.
- Derived from this study: PubMed 29747068LaCroix 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjan G Holloway, Ph.D. principal investigator
Uniformed Services University of the Health Sciences
2 sites in 1 country: see every site and its status.
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.