An Initial Feasibility Study of Brief Cognitive Behavioral Therapy for Suicidal Inpatients
Condition: Suicide, Attempted
MeSH terms: Suicide; Suicide, Attempted
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
Intervention model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive behavioral therapy; suicidal ideology; suicidal behavior