An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients
NCT ID: NCT03442699
Last Updated: 2020-01-02
Study Results
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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
8 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-02-01
Study Completion Date
2018-11-01
Brief Summary
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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 diagnostic/symptom 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.
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Detailed Description
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Rationale. Suicide is a major public health problem: suicidal ideation affects 14% of the adult U.S. population, and as many as 5% have a lifetime history of suicide attempts.1 Among individuals with depressive disorders, there is an 11% mortality rate from suicide.2 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.3 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 235.1 per 100,000 person-years, markedly higher than that in the US general population (14.2 per 100,000 person-years).4
Cognitive behavioral therapy (CBT) has been shown to reduce both suicidal ideation and behavior.5-8 Though specific protocols vary, typical interventions include problem-solving training,9 cognitive restructuring,10 and training in emotion regulation skills.11 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 al.'s12 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 = 0.38); those receiving CBT were 60% less likely to make a suicide attempt than were those receiving treatment as usual.13 Of the 6 RCTs that measured suicidal behavior, this was the strongest behavioral effect documented.7
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 patient's 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 1.5 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 patient's 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 and/or 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 (e.g., relaxation, mindfulness) and cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior (e.g., 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 behavior.5-8 Though specific protocols vary, typical interventions include problem-solving training,9 cognitive restructuring,10 and training in emotion regulation skills.11 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 al.'s12 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 = 0.38); those receiving CBT were 60% less likely to make a suicide attempt than were those receiving treatment as usual.13 Of the 6 RCTs that measured suicidal behavior, this was the strongest behavioral effect documented.7
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 patient's 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 1.5 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 patient's 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 and/or 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 (e.g., relaxation, mindfulness) and cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior (e.g., 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.
Conditions
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Suicide, Attempted
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Participants will receive up to 10 daily sessions of CBT (depending on length of stay), for about an hour each day. During this time the therapist will work with participants to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Cognitive Behavioral Therapy
Participants will receive up to 10 daily sessions of cognitive behavioral therapy (depending on length of stay), for about an hour each day. During this time the therapist will work to develop a crisis response plan and build coping skills to prevent future suicidal thoughts and behaviors.
Group Type
EXPERIMENTAL
Cognitive Behavioral Therapy
Intervention Type
BEHAVIORAL
Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
Interventions
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Cognitive Behavioral Therapy
Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* males and females
* age 18-65 inclusive
* fluent in English (speaking, reading, and writing)
* having made a suicide attempt within one week preceding admission. Admission will be defined as admission to either Hartford Hospital medical floor (in cases where medical stabilization is required prior to transfer to IOL) or to IOL (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.
* age 18-65 inclusive
* fluent in English (speaking, reading, and writing)
* having made a suicide attempt within one week preceding admission. Admission will be defined as admission to either Hartford Hospital medical floor (in cases where medical stabilization is required prior to transfer to IOL) or to IOL (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.
Exclusion Criteria
* age \<18 or ≥66 years old
* history of schizophrenia spectrum disorder
* history of mental retardation or organic brain illness
* current substance use disorder
* 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.
* history of schizophrenia spectrum disorder
* history of mental retardation or organic brain illness
* current substance use disorder
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hartford Hospital
OTHER
Sponsor Role
lead
Responsible Party
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David Tolin
Director, Anxiety Disorders Center
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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David F Tolin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Institute of Living/Hartford Hospital
Locations
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Institute of Living
Hartford, Connecticut, United States
Site Status
Countries
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United States
References
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Kessler RC, Borges G, Walters EE. Prevalence of and risk factors for lifetime suicide attempts in the National Comorbidity Survey. Arch Gen Psychiatry. 1999 Jul;56(7):617-26. doi: 10.1001/archpsyc.56.7.617.
Reference Type
BACKGROUND
Wulsin LR, Vaillant GE, Wells VE. A systematic review of the mortality of depression. Psychosom Med. 1999 Jan-Feb;61(1):6-17. doi: 10.1097/00006842-199901000-00003.
Reference Type
BACKGROUND
Huisman A, Kerkhof AJ, Robben PB. Suicides in users of mental health care services: treatment characteristics and hindsight reflections. Suicide Life Threat Behav. 2011 Feb;41(1):41-9. doi: 10.1111/j.1943-278X.2010.00015.x.
Reference Type
BACKGROUND
Olfson M, Wall M, Wang S, Crystal S, Liu SM, Gerhard T, Blanco C. Short-term Suicide Risk After Psychiatric Hospital Discharge. JAMA Psychiatry. 2016 Nov 1;73(11):1119-1126. doi: 10.1001/jamapsychiatry.2016.2035.
Reference Type
BACKGROUND
Tarrier N, Taylor K, Gooding P. Cognitive-behavioral interventions to reduce suicide behavior: a systematic review and meta-analysis. Behav Modif. 2008 Jan;32(1):77-108. doi: 10.1177/0145445507304728.
Reference Type
BACKGROUND
Mann JJ, Apter A, Bertolote J, Beautrais A, Currier D, Haas A, Hegerl U, Lonnqvist J, Malone K, Marusic A, Mehlum L, Patton G, Phillips M, Rutz W, Rihmer Z, Schmidtke A, Shaffer D, Silverman M, Takahashi Y, Varnik A, Wasserman D, Yip P, Hendin H. Suicide prevention strategies: a systematic review. JAMA. 2005 Oct 26;294(16):2064-74. doi: 10.1001/jama.294.16.2064.
Reference Type
BACKGROUND
Mewton L, Andrews G. Cognitive behavioral therapy for suicidal behaviors: improving patient outcomes. Psychol Res Behav Manag. 2016 Mar 3;9:21-9. doi: 10.2147/PRBM.S84589. eCollection 2016.
Reference Type
BACKGROUND
Hepp U, Wittmann L, Schnyder U, Michel K. Psychological and psychosocial interventions after attempted suicide: an overview of treatment studies. Crisis. 2004;25(3):108-17. doi: 10.1027/0227-5910.25.3.108.
Reference Type
BACKGROUND
Salkovskis PM, Atha C, Storer D. Cognitive-behavioural problem solving in the treatment of patients who repeatedly attempt suicide. A controlled trial. Br J Psychiatry. 1990 Dec;157:871-6. doi: 10.1192/bjp.157.6.871.
Reference Type
BACKGROUND
Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.
Reference Type
BACKGROUND
Linehan MM, Armstrong HE, Suarez A, Allmon D, Heard HL. Cognitive-behavioral treatment of chronically parasuicidal borderline patients. Arch Gen Psychiatry. 1991 Dec;48(12):1060-4. doi: 10.1001/archpsyc.1991.01810360024003.
Reference Type
BACKGROUND
Rudd MD, Joiner TE, Rajab MH. Treating suicidal behavior: An effective, time-limited approach. New York: Guilford Press; 2001.
Reference Type
BACKGROUND
Rudd MD, Bryan CJ, Wertenberger EG, Peterson AL, Young-McCaughan S, Mintz J, Williams SR, Arne KA, Breitbach J, Delano K, Wilkinson E, Bruce TO. Brief cognitive-behavioral therapy effects on post-treatment suicide attempts in a military sample: results of a randomized clinical trial with 2-year follow-up. Am J Psychiatry. 2015 May;172(5):441-9. doi: 10.1176/appi.ajp.2014.14070843. Epub 2015 Feb 13.
Reference Type
BACKGROUND
Tolin DF, Gilliam C, Wootton BM, Bowe W, Bragdon LB, Davis E, Hannan SE, Steinman SA, Worden B, Hallion LS. Psychometric Properties of a Structured Diagnostic Interview for DSM-5 Anxiety, Mood, and Obsessive-Compulsive and Related Disorders. Assessment. 2018 Jan;25(1):3-13. doi: 10.1177/1073191116638410. Epub 2016 Mar 17.
Reference Type
BACKGROUND
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
Reference Type
BACKGROUND
Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988 Aug;45(8):742-7. doi: 10.1001/archpsyc.1988.01800320058007.
Reference Type
BACKGROUND
Borkovec TD, Nau SD. Credibility of analogue therapy rationales. J. Behav. Ther. Exp. Psychiatry. 1972;3:257-260
Reference Type
BACKGROUND
Nock MK, Park JM, Finn CT, Deliberto TL, Dour HJ, Banaji MR. Measuring the suicidal mind: implicit cognition predicts suicidal behavior. Psychol Sci. 2010 Apr;21(4):511-7. doi: 10.1177/0956797610364762. Epub 2010 Mar 9.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HHC-2017-0218
Identifier Type: -
Identifier Source: org_study_id
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