Suicide, AttemptedNCT01359761
Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors
A study testing Post Admission Cognitive Therapy (PACT) in people with Suicide, Attempted and Suicidal Ideation Active, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation Active
- 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
- 218 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Jun 2013to 31 Jan 2021
- 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
- Reason for Admission: Suicide-Related Event
- Baseline Completed within Preferably 48-72 Hours of Admission
- Over the Age of 18
- Provides Informed Consent
Who cannot join
- Medical Incapacity to Participate
- Serious Cognitive Impairment
- Expected Discharge within 72 Hours of Admission
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Uniformed Services University of the Health Sciences
Bethesda, Maryland, 20814
Walter Reed National Military Medical Center
Bethesda, Maryland, 20815
Duke University
Durham, North Carolina, 27708
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
About this study
Official title: Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors: A Multi-Site Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Suicide, Attempted, Suicidal Ideation Active
- 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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Post Admission Cognitive Therapy (PACT) |
| Enhanced Usual Care (EUC) | No intervention | Treatment As Usual and Study Assessment Services; 12-Months Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 3, 6, and 12 months
Secondary outcomes (6)
Depression
The Beck Depression Inventory-II (BDI-II) will be used to assess for symptoms of depression.
Measured: 1, 3, 6, and 12 months
Hopelessness
The Beck Hopelessness Scale (BHS) will be used to assess for levels of hopelessness.
Measured: 1, 3, 6, and 12 months
Suicide Ideation
The Scale for Suicide Ideation (SSI) and the Columbia Suicide Severity Rating Scale (C-SSRS) will be administered to assess for suicide-related thoughts (ideation), as well as the frequency, intensity, and specificity of these thoughts.
Measured: 1, 3, 6, and 12 months
Post-Traumatic Stress Symptoms
The MINI Neuropsychiatric Interview and the PTSD Checklist (PCL) will be administered to assess for post-traumatic stress symptoms.
Measured: 1, 3, 6, and 12 months
Acceptability of Treatment
Acceptability of treatment will be assessed by using Barriers to Care Items.
Measured: 1, 3, 6, and 12 months
Repeat Psychiatric Hospitalizations
Subsequent psychiatric hospitalizations will be assessed for using the Cornell Services Index (CSI), as well as by accessing the Defense Medical Surveillance System (DMSS), which contains electronic medical records of all military personnel (permission to access participants' DMSS records is given at time of consent).
Measured: 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study start24 Jun 2013
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2021 (estimated)
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
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs, Duke University, University of Michigan, University of Pennsylvania, Walter Reed National Military Medical Center, Fort Belvoir Community Hospital
- 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
- NCT01359761
- Sponsor's protocol ID
- W81XWH-11-2-0106
- Status last verified
- Feb 2020
- First submitted
- 17 May 2011
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ghahramanlou-Holloway M, Neely L, Tucker J. A cognitive-behavioral strategy for preventing suicide. Current Psychiatry 13(8): 18-25, 2014.
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.
PubMed 33884617LaCroix 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 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel With Suicidal Behaviors: A Multi-Site Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01359761
- Acronym / sponsor ID
- W81XWH-11-2-0106
- Conditions
- Suicide, Attempted, Suicidal Ideation Active
- Keywords
- Suicide, Cognitive Therapy, Inpatient, Military
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs, Duke University, University of Michigan, University of Pennsylvania, Walter Reed National Military Medical Center, Fort Belvoir Community Hospital
- Study start
- 24 Jun 2013 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 25 May 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.
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.
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 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 |
| Enhanced Usual Care (EUC) | No intervention | –Treatment As Usual and Study Assessment Services; 12-Months Case Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Reason for Admission: Suicide-Related Event
- Baseline Completed within Preferably 48-72 Hours of Admission
- Over the Age of 18
- Provides Informed Consent
Key exclusion criteria (3 listed)
- Medical Incapacity to Participate
- Serious Cognitive Impairment
- 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 TherapySix (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 | Behavioural | Post Admission Cognitive Therapy (PACT) |
Primary outcome
Repeat Suicide Attempts
Time frame: 1, 3, 6, and 12 months
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.
6 secondary outcomes
Depression
Time frame: 1, 3, 6, and 12 months
Hopelessness
Time frame: 1, 3, 6, and 12 months
Suicide Ideation
Time frame: 1, 3, 6, and 12 months
Post-Traumatic Stress Symptoms
Time frame: 1, 3, 6, and 12 months
Acceptability of Treatment
Time frame: 1, 3, 6, and 12 months
Repeat Psychiatric Hospitalizations
Time frame: 1, 3, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- BackgroundGhahramanlou-Holloway M, Neely L, Tucker J. A cognitive-behavioral strategy for preventing suicide. Current Psychiatry 13(8): 18-25, 2014.
- Derived from this study: PubMed 33884617Witt 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.
- 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
4 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 and Suicidal Ideation Active, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 4 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 3 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: status not confirmed, as of the sponsor's last update on 19 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 4 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?
Results are not available in the source record.
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, 3, 6, and 12 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 NCT01359761, 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 19 Feb 2020.