An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients

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.

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.