Ignite Creation Date:
2024-05-06 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03442699
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2018-01-30
Brief Title:
An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients
Sponsor:
Hartford Hospital
Organization:
Hartford Hospital
Study Overview
Official Title:
An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Suicide is a major public health problem Although inpatient treatment provides immediate stabilization and crisis management the risk of suicide post-discharge is substantial Approximately one third of all suicides by individuals with mental disorders occur in the 90 days following hospitalization Cognitive behavioral therapy CBT has been shown to reduce both suicidal ideation and behavior in outpatients However to date the efficacy of inpatient CBT for suicide prevention is not clear This study aims to 1 develop and implement a brief CBT treatment for suicide prevention for inpatients 2 conduct a brief feasibility test and collect initial pilot data on efficacy and 3 collect preliminary data on the effects of CBT on implicit cognitive suicide associations In Phase 1 the investigators will work with an expert in CBT for suicide prevention to modify his treatment protocol for use with inpatients and meet with this expert for a 2-day protocol training In Phase 2 the investigators will conduct an initial feasibility trial with 5-10 inpatients recruited from the Institute of Living inpatient units Participants will be recruited within 24 hrs of admission or later and will provide written informed consent prior to any study procedures Enrolled participants will undergo a clinical assessment by an independent evaluator IE that will include diagnosticsymptom assessments assessment of suicide risk using the Columbia-Suicide Rating Scale and an implicit association test IAT Participants will receive up to 10 daily sessions of CBT depending on length of stay lasting 1 hour following the manualized protocol developed in Phase 1 Participants will then meet with the IE again for reassessment after the 10th session or within 24 hr prior to discharge whichever comes first After discharge participants will have a telephone interview at 1 month 2 month and 3 month follow-up The IE will administer the C-SSRS during these calls The proposed study will yield feasibility and initial efficacy data that will be used to inform a grant proposal to the American Foundation for Suicide Prevention That proposal will fund a randomized controlled trial of CBT vs treatment as usual Concurrently the investigators will develop an in-house program to train other staff in the protocol and will submit a second grant to investigate the efficacy of the training program as well as the efficacy of CBT by those clinicians
Detailed Description:
Rationale Suicide is a major public health problem suicidal ideation affects 14 of the adult US population and as many as 5 have a lifetime history of suicide attempts1 Among individuals with depressive disorders there is an 11 mortality rate from suicide2 Although inpatient treatment provides immediate stabilization and crisis management the risk of suicide post-discharge is substantial Approximately one third of all suicides by individuals with mental disorders occur in the 90 days following hospitalization3 A review of nearly 2 million adult psychiatric inpatients found that the suicide rate in the 90 days after discharge for patients diagnosed with depressive disorders was 2351 per 100000 person-years markedly higher than that in the US general population 142 per 100000 person-years4
Cognitive behavioral therapy CBT has been shown to reduce both suicidal ideation and behavior5-8 Though specific protocols vary typical interventions include problem-solving training9 cognitive restructuring10 and training in emotion regulation skills11 To date most of the existing research on CBT has been in outpatient samples and the efficacy of inpatient CBT for suicide prevention is not clear
Project Aims The aims of the proposed project are to
1 develop and implement a brief CBT for suicide prevention on the adult inpatient units
2 conduct a brief feasibility test and collect initial pilot data on efficacy and
3 collect preliminary data on the effects of CBT on implicit cognitive suicide associations
Method The investigators selected Rudd et als12 CBT protocol for the proposed project This protocol was tested in a randomized controlled trial RCT of outpatients and resulted in a significant reduction in suicide attempts over a 24-month follow-up assessment hazard ratio 038 those receiving CBT were 60 less likely to make a suicide attempt than were those receiving treatment as usual13 Of the 6 RCTs that measured suicidal behavior this was the strongest behavioral effect documented7
There will be two phases involved in this project which are described below
In Phase 1 of the project the investigators will work with Dr Rudd to modify his treatment protocol for use in an inpatient setting and attend a two-day training in the protocol from Dr Rudd
In Phase 2 of the project the investigators will conduct an initial feasibility trial with 5-10 inpatients
Participants The investigators will recruit 5-10 consecutive adult inpatients dependent on flow within the 6-month treatment window from the Donnelly units
Procedures It is anticipated that the treatment component of the study will take place over a period of six months
Participants will be recruited by a member of the research staff on the day following their inpatient admission or later for example in the case of a Saturday admission Patients who meet all of the inclusion criteria and none of the exclusion criteria and agree to participate will provide written informed consent prior to any study procedures Informed consent will be documented using the Documentation of Informed Consent Form For patients who are admitted to the hospital involuntarily documentation of competency to provide consent will be completed as well Only those involuntarily committed patients who have been found competent to provide informed consent for research will be consented Patients who decline participation will not be approached again Patients who agree to participation will undergo the informed consent process This process will involve providing the patient with the informed consent and HIPAA authorization forms to read The study staff member obtaining consent will highlight the voluntary nature of the research and emphasize that the patients decision whether or not to participate will not impact his usual care treatment plan however patients will also be informed that the information discussed with the study clinician is shared with the inpatient treatment team and thus may be used by them when making decisions about discharge planning Patients will be informed that they may keep the forms to review with others if they wish to do so before signing In addition all questions the patient has about study participation will be answered prior to obtaining written consent
Enrolled participants will undergo a clinical assessment by an independent evaluator IE who will administer the DIAMOND C-SSRS SIGH-D and IAT
Participants will receive up to 10 daily sessions of CBT depending on length of stay lasting 15 hours for the first session and 1 hour for the remaining sessions following the manualized protocol developed in Phase 1 The CBT protocol is designed to be delivered in two phases In phase I the therapist conducts a detailed assessment of the patients most recent suicidal episode or suicide attempt identifies patient-specific factors that contribute to and maintain suicidal behaviors provides a cognitive behavioral conceptualization collaboratively develops a crisis response plan The crisis response plan is reviewed and updated in each session by adding new skills andor removing skills determined to be ineffective impractical or too challenging In phase II the therapist teaches the patient new coping skills inclusion emotion regulation strategies eg relaxation mindfulness and cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior eg hopelessness perceived burdensomeness guilt and shame During the first session of CBT participants are provided with a small pocket-sized notebook called a smart book in which they are directed to record a lesson learned at the conclusion of each session Lessons learned include new skills learned or knowledge gained by participants during each session Participants are encouraged to use the smart book in the future as a memory aid for managing emotional distress and solving problems
Participants will then meet with the IE again for the C-SSRS SIGH-D IAT and CSQ after the 10th session or within 24 hrs prior to discharge whichever comes first After discharge participants will have a telephone interview at 1 month 2 month and 3 month follow-up The IE will administer the C-SSRS during these calls
Cognitive behavioral therapy CBT has been shown to reduce both suicidal ideation and behavior5-8 Though specific protocols vary typical interventions include problem-solving training9 cognitive restructuring10 and training in emotion regulation skills11 To date most of the existing research on CBT has been in outpatient samples and the efficacy of inpatient CBT for suicide prevention is not clear
Project Aims The aims of the proposed project are to
1 develop and implement a brief CBT for suicide prevention on the adult inpatient units
2 conduct a brief feasibility test and collect initial pilot data on efficacy and
3 collect preliminary data on the effects of CBT on implicit cognitive suicide associations
Method The investigators selected Rudd et als12 CBT protocol for the proposed project This protocol was tested in a randomized controlled trial RCT of outpatients and resulted in a significant reduction in suicide attempts over a 24-month follow-up assessment hazard ratio 038 those receiving CBT were 60 less likely to make a suicide attempt than were those receiving treatment as usual13 Of the 6 RCTs that measured suicidal behavior this was the strongest behavioral effect documented7
There will be two phases involved in this project which are described below
In Phase 1 of the project the investigators will work with Dr Rudd to modify his treatment protocol for use in an inpatient setting and attend a two-day training in the protocol from Dr Rudd
In Phase 2 of the project the investigators will conduct an initial feasibility trial with 5-10 inpatients
Participants The investigators will recruit 5-10 consecutive adult inpatients dependent on flow within the 6-month treatment window from the Donnelly units
Procedures It is anticipated that the treatment component of the study will take place over a period of six months
Participants will be recruited by a member of the research staff on the day following their inpatient admission or later for example in the case of a Saturday admission Patients who meet all of the inclusion criteria and none of the exclusion criteria and agree to participate will provide written informed consent prior to any study procedures Informed consent will be documented using the Documentation of Informed Consent Form For patients who are admitted to the hospital involuntarily documentation of competency to provide consent will be completed as well Only those involuntarily committed patients who have been found competent to provide informed consent for research will be consented Patients who decline participation will not be approached again Patients who agree to participation will undergo the informed consent process This process will involve providing the patient with the informed consent and HIPAA authorization forms to read The study staff member obtaining consent will highlight the voluntary nature of the research and emphasize that the patients decision whether or not to participate will not impact his usual care treatment plan however patients will also be informed that the information discussed with the study clinician is shared with the inpatient treatment team and thus may be used by them when making decisions about discharge planning Patients will be informed that they may keep the forms to review with others if they wish to do so before signing In addition all questions the patient has about study participation will be answered prior to obtaining written consent
Enrolled participants will undergo a clinical assessment by an independent evaluator IE who will administer the DIAMOND C-SSRS SIGH-D and IAT
Participants will receive up to 10 daily sessions of CBT depending on length of stay lasting 15 hours for the first session and 1 hour for the remaining sessions following the manualized protocol developed in Phase 1 The CBT protocol is designed to be delivered in two phases In phase I the therapist conducts a detailed assessment of the patients most recent suicidal episode or suicide attempt identifies patient-specific factors that contribute to and maintain suicidal behaviors provides a cognitive behavioral conceptualization collaboratively develops a crisis response plan The crisis response plan is reviewed and updated in each session by adding new skills andor removing skills determined to be ineffective impractical or too challenging In phase II the therapist teaches the patient new coping skills inclusion emotion regulation strategies eg relaxation mindfulness and cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior eg hopelessness perceived burdensomeness guilt and shame During the first session of CBT participants are provided with a small pocket-sized notebook called a smart book in which they are directed to record a lesson learned at the conclusion of each session Lessons learned include new skills learned or knowledge gained by participants during each session Participants are encouraged to use the smart book in the future as a memory aid for managing emotional distress and solving problems
Participants will then meet with the IE again for the C-SSRS SIGH-D IAT and CSQ after the 10th session or within 24 hrs prior to discharge whichever comes first After discharge participants will have a telephone interview at 1 month 2 month and 3 month follow-up The IE will administer the C-SSRS during these calls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None