Suicide, AttemptedNCT04168645
Inpatient Cognitive-Behavioral Therapy to Reduce Suicide Risk Post-Discharge
A study testing Cognitive Behavioral Therapy in people with Suicide, Attempted, run by Hartford Hospital at 1 site in United States.
Trial summary
The goal of this randomized-controlled trial is to determine whether adding brief cognitive-behavioral therapy for suicide prevention (BCBT) to inpatient treatment improves suicide-related outcomes after the person leaves the hospital. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2020to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any Gender
- Age 18-65 inclusive
- Fluent in English (speaking, reading, and writing)
- Having made a suicide attempt within one week preceding admission or suicidal ideation and plan on admissions along with suicide attempt within previous two years. Admission will be defined as admission to either the medical floor (in cases where medical stabilization is required prior to transfer to psychiatric inpatient facility) or to psychiatric inpatient facility (in cases where medical stabilization is not required). A suicide attempt will be defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether explicit or implicit, of intent to die.
Who cannot join
- Age <18 or ≥66 years old
- History of schizophrenia or schizoaffective disorder
- History of intellectual disability or organic brain illness
- Active mania or other psychiatric or medical condition that would preclude informed consent or participation in the trial, in the investigator's opinion
- ECT included on patient's inpatient treatment plan. Patients who are referred for ECT after starting the study will be withdrawn from the study.
- Discharge expected within four business days of attending approval.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Living/Hartford Hospital
Hartford, Connecticut, 06106
About this study
The goal of this randomized-controlled trial is to determine whether adding brief cognitive-behavioral therapy for suicide prevention (BCBT) to inpatient treatment improves suicide-related outcomes after the person leaves the hospital. The study will also determine whether being diagnosed with a substance use disorder impacts these outcomes. Participants will either receive treatment as usual or treatment as usual plus up to four sessions of BCBT during their inpatient stay. They will complete monthly follow-up assessments for six months after leaving the hospital.
Read the detailed description
Although inpatient treatment provides immediate stabilization and crisis management for suicidal patients, the risk of suicide post-discharge is substantial, with approximately one third of all suicides by individuals with mental disorders occurring in the 90 days following hospitalization. These data highlight the importance of establishing an empirically-supported inpatient treatment for suicide prevention. Cognitive behavioral therapy (CBT) is a strong candidate, given that CBT reduces risk in suicidal outpatients. In addition, an open trial was completed that 1) adapted the strongest outpatient CBT protocol for an inpatient setting, 2) demonstrated high levels of feasibility and acceptability, and 3) obtained preliminary estimates of efficacy. The objective here is to conduct a largescale randomized controlled trial (RCT) comparing brief cognitive-behavioral therapy for suicide prevention (BCBT) (n = 100) to treatment as usual (TAU, n = 100) to firmly establish efficacy and collect pilot data on treatment implementation metrics. This study aims to determine the efficacy of inpatient BCBT on suicidal behavior, suicidal ideation/intent, and readmission post-treatment and over a 6-month follow-up period. The central hypothesis, based on strong outpatient data, is that inpatient BCBT will reduce suicidal behavior, suicidal ideation/intent, and inpatient readmission over 6 months post-discharge, compared to TAU. Participants will be recruited after inpatient admission following a suicide attempt or with suicidal ideation and plan with suicide attempt within the previous two years. Participants assigned to the BCBT condition will receive four BCBT sessions in addition to treatment as usual. Assessments will occur at intake, discharge, and monthly for six months post-discharge. The proposed study will inform best practices treatment for hospitalized suicidal patients by establishing for the first time, and ultimately disseminating, an empirically-validated inpatient treatment for suicide prevention.
- Conditions
- Suicide, Attempted
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Up to 4 sessions of BCBT (depending on length of stay) will be provided. The first session lasts 1.5 hours and subsequent sessions are 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Presence of SUD with BCBT | Experimental | Patients diagnosed with SUD who are randomly assigned to receive BCBT will participate in all aspects of their prescribed treatment plan (i.e., TAU) and will receive up to 4 sessions of CBT (depending on length of stay), lasting 1.5 hours for the first session and 1 hour for the remaining sessions. Receives: Behavioral: Cognitive Behavioral Therapy |
| Presence of SUD with TAU | No intervention | Patients diagnosed with SUD who are randomly assigned to receive TAU will participate in all aspects of the prescribed treatment plan given by the inpatient unit. |
| Absence of SUD with BCBT | Experimental | Patients without SUD who are randomly assigned to receive BCBT will participate in all aspects of their prescribed treatment plan (i.e., TAU) and will receive up to 4 sessions of BCBT (depending on length of stay), lasting 1.5 hours for the first session and 1 hour for the remaining sessions. Receives: Behavioral: Cognitive Behavioral Therapy |
| Absence of SUD with TAU | No intervention | Patients without SUD who are randomly assigned to receive TAU will participate in all aspects of the prescribed treatment plan given by the inpatient unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia Suicide Severity Rating Scale Number of Participants Reporting Presence of Suicidal Behaviors
Suicidal behavior will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS), a widely used suicide assessment measure. Several suicidal behaviors are assessed on the C-SSRS including the presence or absence of each of the following: suicide attempt, interrupted attempt, aborted attempt, and preparatory acts or behaviors. Scores reflect the number of participants with the presence of the suicide behavior.
Measured: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
Columbia Suicide Severity Rating Scale Number of Suicidal Behaviors
Suicidal behavior will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS), a widely used suicide assessment measure. Several suicidal behaviors are assessed on the C-SSRS including the presence or absence of each of the following: suicide attempt, interrupted attempt, aborted attempt, and preparatory acts or behaviors. Scores on this scale reflect the median number of each behavior.
Measured: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
The Number of Participants Reporting Columbia Suicide Severity Rating Scale Suicidal Ideation Categories as Most Severe
The number of participants endorsing each category as the highest (most severe) suicidal ideation category on the Columbia Suicide Severity Rating Scale (C-SSRS) ranging from 1-5, with 5 being the most severe type of suicidal ideation.
Measured: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
Columbia Suicide Severity Rating Scale Suicidal Ideation Intensity Scale Total Score
The Columbia Suicide Severity Rating Scale (C-SSRS) intensity subscale is the sum of 5 questions (frequency, duration, controllability, deterrents, and reasons for ideation) rated from 1-5, with 5 representing more severe intensity. Zero is entered if no suicidal ideation is reported. Total scores range from 0 to 25 with higher scores indicating more intense suicidal ideation.
Measured: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
Number of Participants With Readmissions
Readmission is determined using the participant's electronic medical record along with a self-report measure.
Measured: Assessed on a monthly basis for 6 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start20 Jan 2020
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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
- Model description
- Participants will be randomly assigned (using a computer-generated randomization schedule) to either BCBT or TAU using stratified block randomization on Substance Use Disorder (SUD). We expect, based on pilot data analyses, that approximately two-thirds of patients in each group will be diagnosed with SUD.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, David Tolin, Hartford Hospital
- Investigators
- David F Tolin, Ph.D., Principal investigator, Institute of Living/Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168645
- Sponsor's protocol ID
- HHC-2019-0163
- Status last verified
- Mar 2025
- First submitted
- 9 Nov 2019
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diefenbach GJ, Lord KA, Stubbing J, Rudd MD, Levy HC, Worden B, Sain KS, Bimstein JG, Rice TB, Everhardt K, Gueorguieva R, Tolin DF. Brief Cognitive Behavioral Therapy for Suicidal Inpatients: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Dec 1;81(12):1177-1186. doi: 10.1001/jamapsychiatry.2024.2349.
PubMed 39259550Stubbing J, Tolin DF, Sain KS, Everhardt K, Rudd MD, Diefenbach GJ. Borderline Personality Traits Do Not Moderate the Relationship Between Depression, Beliefs, and Suicidal Thoughts and Behaviors. Arch Suicide Res. 2025 Jan-Mar;29(1):223-237. doi: 10.1080/13811118.2024.2345168. Epub 2024 Apr 29.
PubMed 38683542Diefenbach GJ, Stubbing J, Rice TB, Lord KA, Rudd MD, Tolin DF. Uncovering the role of substance use in suicide attempts using a mixed-methods approach. Suicide Life Threat Behav. 2024 Feb;54(1):70-82. doi: 10.1111/sltb.13019. Epub 2023 Nov 21.
PubMed 37987548Witt 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 33884617
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Cognitive-Behavioral Therapy to Reduce Suicide Risk Post-Discharge
- ClinicalTrials.gov ID
- NCT04168645
- Acronym / sponsor ID
- HHC-2019-0163
- Conditions
- Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized-controlled trial is to determine whether adding brief cognitive-behavioral therapy for suicide prevention (BCBT) to inpatient treatment improves suicide-related outcomes after the person leaves the hospital. The study will also determine whether being diagnosed with a substance use disorder impacts these outcomes. Participants will either receive treatment as usual or treatment as usual plus up to four sessions of BCBT during their inpatient stay. They will complete monthly follow-up assessments for six months after leaving the hospital.
Detailed description
Although inpatient treatment provides immediate stabilization and crisis management for suicidal patients, the risk of suicide post-discharge is substantial, with approximately one third of all suicides by individuals with mental disorders occurring in the 90 days following hospitalization. These data highlight the importance of establishing an empirically-supported inpatient treatment for suicide prevention. Cognitive behavioral therapy (CBT) is a strong candidate, given that CBT reduces risk in suicidal outpatients. In addition, an open trial was completed that 1) adapted the strongest outpatient CBT protocol for an inpatient setting, 2) demonstrated high levels of feasibility and acceptability, and 3) obtained preliminary estimates of efficacy. The objective here is to conduct a largescale randomized controlled trial (RCT) comparing brief cognitive-behavioral therapy for suicide prevention (BCBT) (n = 100) to treatment as usual (TAU, n = 100) to firmly establish efficacy and collect pilot data on treatment implementation metrics. This study aims to determine the efficacy of inpatient BCBT on suicidal behavior, suicidal ideation/intent, and readmission post-treatment and over a 6-month follow-up period. The central hypothesis, based on strong outpatient data, is that inpatient BCBT will reduce suicidal behavior, suicidal ideation/intent, and inpatient readmission over 6 months post-discharge, compared to TAU. Participants will be recruited after inpatient admission following a suicide attempt or with suicidal ideation and plan with suicide attempt within the previous two years. Participants assigned to the BCBT condition will receive four BCBT sessions in addition to treatment as usual. Assessments will occur at intake, discharge, and monthly for six months post-discharge. The proposed study will inform best practices treatment for hospitalized suicidal patients by establishing for the first time, and ultimately disseminating, an empirically-validated inpatient treatment for suicide prevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned (using a computer-generated randomization schedule) to either BCBT or TAU using stratified block randomization on Substance Use Disorder (SUD). We expect, based on pilot data analyses, that approximately two-thirds of patients in each group will be diagnosed with SUD.
| Arm | Type | Receives |
|---|---|---|
| Presence of SUD with BCBT | Experimental | Behavioral: Cognitive Behavioral TherapyPatients diagnosed with SUD who are randomly assigned to receive BCBT will participate in all aspects of their prescribed treatment plan (i.e., TAU) and will receive up to 4 sessions of CBT (depending on length of stay), lasting 1.5 hours for the first session and 1 hour for the remaining sessions. |
| Presence of SUD with TAU | No intervention | –Patients diagnosed with SUD who are randomly assigned to receive TAU will participate in all aspects of the prescribed treatment plan given by the inpatient unit. |
| Absence of SUD with BCBT | Experimental | Behavioral: Cognitive Behavioral TherapyPatients without SUD who are randomly assigned to receive BCBT will participate in all aspects of their prescribed treatment plan (i.e., TAU) and will receive up to 4 sessions of BCBT (depending on length of stay), lasting 1.5 hours for the first session and 1 hour for the remaining sessions. |
| Absence of SUD with TAU | No intervention | –Patients without SUD who are randomly assigned to receive TAU will participate in all aspects of the prescribed treatment plan given by the inpatient unit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any Gender
- Age 18-65 inclusive
- Fluent in English (speaking, reading, and writing)
- Having made a suicide attempt within one week preceding admission or suicidal ideation and plan on admissions along with suicide attempt within previous two years. Admission will be defined as admission to either the medical floor (in cases where medical stabilization is required prior to transfer to psychiatric inpatient facility) or to psychiatric inpatient facility (in cases where medical stabilization is not required). A suicide attempt will be defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether explicit or implicit, of intent to die.
Key exclusion criteria (6 listed)
- Age <18 or ≥66 years old
- History of schizophrenia or schizoaffective disorder
- History of intellectual disability or organic brain illness
- Active mania or other psychiatric or medical condition that would preclude informed consent or participation in the trial, in the investigator's opinion
- ECT included on patient's inpatient treatment plan. Patients who are referred for ECT after starting the study will be withdrawn from the study.
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 |
|---|---|---|
| Cognitive Behavioral TherapyUp to 4 sessions of BCBT (depending on length of stay) will be provided. The first session lasts 1.5 hours and subsequent sessions are 1 hour. | Behavioural | Absence of SUD with BCBT, Presence of SUD with BCBT |
Primary outcome
Columbia Suicide Severity Rating Scale Number of Participants Reporting Presence of Suicidal Behaviors
Time frame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
Suicidal behavior will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS), a widely used suicide assessment measure. Several suicidal behaviors are assessed on the C-SSRS including the presence or absence of each of the following: suicide attempt, interrupted attempt, aborted attempt, and preparatory acts or behaviors. Scores reflect the number of participants with the presence of the suicide behavior.
Columbia Suicide Severity Rating Scale Number of Suicidal Behaviors
Time frame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
Suicidal behavior will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS), a widely used suicide assessment measure. Several suicidal behaviors are assessed on the C-SSRS including the presence or absence of each of the following: suicide attempt, interrupted attempt, aborted attempt, and preparatory acts or behaviors. Scores on this scale reflect the median number of each behavior.
The Number of Participants Reporting Columbia Suicide Severity Rating Scale Suicidal Ideation Categories as Most Severe
Time frame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
The number of participants endorsing each category as the highest (most severe) suicidal ideation category on the Columbia Suicide Severity Rating Scale (C-SSRS) ranging from 1-5, with 5 being the most severe type of suicidal ideation.
Columbia Suicide Severity Rating Scale Suicidal Ideation Intensity Scale Total Score
Time frame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.
The Columbia Suicide Severity Rating Scale (C-SSRS) intensity subscale is the sum of 5 questions (frequency, duration, controllability, deterrents, and reasons for ideation) rated from 1-5, with 5 representing more severe intensity. Zero is entered if no suicidal ideation is reported. Total scores range from 0 to 25 with higher scores indicating more intense suicidal ideation.
Number of Participants With Readmissions
Time frame: Assessed on a monthly basis for 6 months follow-up.
Readmission is determined using the participant's electronic medical record along with a self-report measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39259550Diefenbach GJ, Lord KA, Stubbing J, Rudd MD, Levy HC, Worden B, Sain KS, Bimstein JG, Rice TB, Everhardt K, Gueorguieva R, Tolin DF. Brief Cognitive Behavioral Therapy for Suicidal Inpatients: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Dec 1;81(12):1177-1186. doi: 10.1001/jamapsychiatry.2024.2349.
- Derived from this study: PubMed 38683542Stubbing J, Tolin DF, Sain KS, Everhardt K, Rudd MD, Diefenbach GJ. Borderline Personality Traits Do Not Moderate the Relationship Between Depression, Beliefs, and Suicidal Thoughts and Behaviors. Arch Suicide Res. 2025 Jan-Mar;29(1):223-237. doi: 10.1080/13811118.2024.2345168. Epub 2024 Apr 29.
- Derived from this study: PubMed 37987548Diefenbach GJ, Stubbing J, Rice TB, Lord KA, Rudd MD, Tolin DF. Uncovering the role of substance use in suicide attempts using a mixed-methods approach. Suicide Life Threat Behav. 2024 Feb;54(1):70-82. doi: 10.1111/sltb.13019. Epub 2023 Nov 21.
- 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.
- 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.
David F Tolin, Ph.D. principal investigator
Institute of Living/Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Suicide, Attempted, run by Hartford Hospital at 1 site 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 6 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 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Columbia Suicide Severity Rating Scale Number of Participants Reporting Presence of Suicidal Behaviors (time frame: Assessed at completion of inpatient treatment (average of 12 days), and on a monthly basis for 6 months follow-up.). The study lists 5 primary outcomes in all. 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 NCT04168645, which also lists 4 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 16 Apr 2025.