Clinical trial NCT03442699: An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients
Official title: An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Keywords: cognitive behavioral therapy
suicidal ideology
suicidal behavior
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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 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.

Detailed description: 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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Suicidal Ideation Intensity as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Intensity Subscale.
timeFrame: Pre-treatment, after treatment which was an average of 16 days, and through follow up, an average of 3 months post-treatment
Secondary outcomes:
measure: Structured Interview Guide for the Hamilton Rating Scale for Depression (SIGH-D)
timeFrame: Pre-treatment through post-treatment up to 24 days, 16 days on average
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living
state: Connecticut
Study officials:
affiliation: Institute of Living/Hartford Hospital
name: David F Tolin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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