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.

Completed

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

Official record

Search all trials

Trial summary

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 Patients who are referred for ECT after starting the study will be withdrawn from the study.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

Other trials in United States

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 groups in NCT04168645
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.

20 Jan 202015 Aug 2023

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)

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 39259550
Stubbing 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 38683542
Diefenbach 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 37987548
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 33884617

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Not yet recruiting
THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers
Suicide

All Suicide, Attempted trials

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.

Detailed description

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

Results posted to the registry on 16 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Presence of SUD With BCBT	62	30
Presence of SUD With TAU	65	33
Absence of SUD With BCBT	41	23
Absence of SUD With TAU	45	28

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.. Count of participants. Unit: Participants

Measure	Presence of SUD With BCBT n = 53	Presence of SUD With TAU n = 57	Absence of SUD With BCBT n = 38	Absence of SUD With TAU n = 41
Actual Suicide Attempt at Post-treatment	1	1	0	0
Actual Suicide Attempt at Follow-up 1	1	4	0	2
Actual Suicide Attempt at Follow-up 2	3	4	0	3
Actual Suicide Attempt at Follow-up 3	1	4	0	2
Actual Suicide Attempt at Follow-up 4	0	2	0	3
Actual Suicide Attempt at Follow-up 5	2	3	2	1
Actual Suicide Attempt at Follow-up 6	1	2	0	0
Interrupted Suicide Attempt at Post-treatment	0	0	0	1

Population analysed: Data were missing due to attrition.

Primary outcome: 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.. Median (Standard Deviation). Unit: Number of Events

Measure	Presence of SUD With BCBT n = 53	Presence of SUD With TAU n = 57	Absence of SUD With BCBT n = 39	Absence of SUD With TAU n = 41
Actual Suicide Attempt at Post-treatment	0.00 (0.14)	0.00 (0.13)	0.00 (0.00)	0.00 (0.00)
Actual Suicide Attempt at Follow-up 1	0.00 (0.15)	0.00 (0.28)	0.00 (0.00)	0.00 (0.36)
Actual Suicide Attempt at Follow-up 2	0.00 (0.26)	0.00 (0.80)	0.00 (0.00)	0.00 (0.40)
Actual Suicide Attempt at Follow-up 3	0.00 (0.16)	0.00 (1.69)	0.00 (0.00)	0.00 (0.25)
Actual Suicide Attempt at Follow-up 4	0.00 (0.00)	0.00 (0.22)	0.00 (0.00)	0.00 (0.29)
Actual Suicide Attempt at Follow-up 5	0.00 (0.38)	0.00 (0.48)	0.00 (0.83)	0.00 (0.18)
Actual Suicide Attempt at Follow-up 6	0.00 (0.18)	0.00 (0.38)	0.00 (0.00)	0.00 (0.00)
Interrupted Suicide Attempt at Post-treatment	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.00 (0.16)

Population analysed: Data were missing due to attrition.

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Presence of SUD With BCBT n = 53	Presence of SUD With TAU n = 56	Absence of SUD With BCBT n = 38	Absence of SUD With TAU n = 41
Most Severe Ideation at Post-treatment: None	31	21	20	15
Most Severe Ideation at Post-treatment: Wish to be Dead	7	16	8	4
Most Severe Ideation at Post-treatment: Non-Specific Active Suicidal Thoughts	2	3	3	1
Most Severe Ideation at Post-treatment: Active Suicidal Ideation with Any Methods	5	5	2	9
Most Severe Ideation at Post-treatment: Active Suicidal Ideation with Some Intent to Act	1	3	0	2
Most Severe Ideation at Post-treatment: Active Suicidal Ideation with Specific Plan	7	8	5	10
Most Severe Ideation at Follow-up 1: None	32	23	16	12
Most Severe Ideation at Follow-up 1: Wish to be Dead	3	11	8	11

Population analysed: Data were missing due to attrition.

Primary outcome: 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.. Mean (Standard Deviation). Unit: score on a scale

Measure	Presence of SUD With BCBT n = 52	Presence of SUD With TAU n = 56	Absence of SUD With BCBT n = 38	Absence of SUD With TAU n = 41
Intensity of Suicidal Ideation at Post-treatment	6.04 (7.60)	9.68 (7.94)	6.84 (7.69)	10.29 (8.32)
Intensity of Suicidal Ideation at Follow-up 1	4.76 (7.55)	7.79 (7.97)	7.24 (7.11)	9.42 (7.07)
Intensity of Suicidal Ideation at Follow-up 2	4.48 (6.84)	6.60 (7.45)	8.23 (8.71)	7.86 (8.67)
Intensity of Suicidal Ideation at Follow-up 3	4.47 (6.78)	6.76 (8.17)	6.59 (7.78)	6.81 (8.17)
Intensity of Suicidal Ideation at Follow-up 4	2.35 (5.69)	6.41 (7.30)	7.19 (8.33)	8.74 (8.37)
Intensity of Suicidal Ideation at Follow-up 5	3.88 (6.68)	5.68 (7.72)	7.54 (8.28)	7.87 (7.95)
Intensity of Suicide Ideation at Follow-up 6	2.83 (6.40)	6.12 (7.29)	6.91 (8.48)	6.21 (7.15)

Population analysed: Data were missing due to attrition.

Adverse events

Time frame: Adverse events were assessed from the moment participants provided informed consent to the end of the 6-month follow-up period (approximately 7 months, dependent on length of inpatient stay).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Presence of SUD With BCBT	23 of 62 (37.1%)	47 of 62 (75.8%)	1 of 62
Presence of SUD With TAU	26 of 65 (40%)	50 of 65 (76.9%)	1 of 65
Absence of SUD With BCBT	8 of 41 (19.5%)	26 of 41 (63.4%)	0 of 41
Absence of SUD With TAU	16 of 45 (35.6%)	31 of 45 (68.9%)	0 of 45

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.