CAMS-G Group Therapy for Suicidal Veterans
Condition: Suicide and Self-harm
MeSH terms: Suicide; Self-Injurious Behavior
Study type: Interventional

Summary: 
      The primary aim of this pilot study is to determine the feasibility and acceptability of
      CAMS-G. Our aim is to determine if CAMS-G is an effective treatment and whether it has the
      potential to be tested in a large-scale setting.
    

Detailed description: 
      A total of 60 patients from either the Robley Rex VAMC inpatient psychiatry unit or
      outpatient clinics will be enrolled in the study. If the Veteran is referred from inpatient
      psychiatry, study staff will meet with the Veteran to determine eligibility and consent the
      Veterans on the inpatient unit prior to discharge. A phone interview will be scheduled to
      complete the baseline interview after the Veteran has been discharged from the inpatient
      psychiatry unit. Outpatient referrals will be handled similarly. Whenever possible, to reduce
      participant burden, the study team will meet Veterans at a community based outpatient clinic
      (CBOC) to consent outpatients either immediately prior to or after a scheduled appointment. A
      phone interview will be scheduled to complete the baseline prior to the start of their group.
      Patients will then be randomized to either (a) an experimental group receiving CAMS-G or (b)
      a group receiving care as usual. All study participants will then complete telephone
      follow-up assessments at 1-, 3-, and 6-month time points administered by members of the
      research team. Dr. Gutierrez and his study team will rate the CAMS-G sessions for adherence
      to the treatment manual. Individual Veterans remain in the CAMS-G sessions until their
      suicidal crisis is resolved. The baseline assessment battery will take approximately 60
      minutes and the 1-, 3-, and 6-month assessment batteries will take approximately 45 minutes.

      The Client Satisfaction Questionnaire will be administered at three- and six-month follow-up
      for each study participant. This will allow reflection on the acceptability and perceived
      utility of CAMS-G. Notes will be kept on patients who decided to drop out of the intervention
      and/or the study. The outcome of this aim is evidence that the final CAMS-G manual and study
      procedures that would be used in an efficacy trial are acceptable to participants. The
      investigators will examine the mean and standard deviation for the total score and individual
      items to determine if study participants report acceptable ratings of satisfaction. The
      investigators will review the responses to open ended questions regarding what Veterans
      perceived as being helpful about their group experience and what they could do in the future
      if they become suicidal.

      The investigators will tabulate average scores and standard deviations for the overall rating
      and each individual item on the CAMS-G Rating Scale to determine whether the facilitators
      maintained fidelity to the treatment manual over the course of the study.

      The investigators will tally the different services received by study participants in order
      to accurately describe what care as usual consisted of for all study participants, regardless
      of their assigned treatment condition. This will also the investigators to control for any
      major differences in care as usual between treatment conditions, for example more individual
      psychotherapy for one condition, when examining between group differences on outcomes of
      interest.

      At the termination of data collection, the investigators will complete a data cleansing
      process. Descriptive statistics for demographic and clinical variables will be tabulated. All
      scales will be scored and subscales described. This process will include examining the data
      for missing values, appropriate ranges, and outliers, with transformations to skewed data
      applied as needed. Although the randomization design should ensure balance between the two
      groups, it is essential to control for any known confounders in the design and analysis to
      prevent a biased assessment of the suicide assessment effect. Any baseline demographic or
      clinical variables found to be statistically significant in the analysis and significantly
      associated with the outcomes of interest will be included as covariates in all analytic
      models.

      Dropouts and missing data. The investigators will use an intent-to-treat sample to complete
      our analyses. That is, all participants who provide consent, are randomized to a treatment
      condition, and attend at least one group therapy session will be included in the analyses
      regardless of whether they drop out or complete a full course of group therapy. To understand
      whether treatment drops were completely random, random, or informative, the investigators
      will analyze our missing data and adjust our interpretation of the results accordingly. The
      investigators will use generalized linear mixed models (GLMM) to measure differences at 1-,
      3-, and 6-months follow-up between veterans in the CAMS-G treatment condition and those in
      the control treatment condition on constructs of Hopelessness, Thwarted Belongingness,
      Perceived Burdensomeness, Overall Symptom Distress, and Reasons for Living. The investigators
      will use Poisson or similar variant of generlized linear mixed modeling (GLMM) for skewed and
      count data to measure differences at 1-, 3-, and 6-months follow-up between Veterans in the
      CAMS-G treatment condition and those in the control treatment condition on severity of
      suicidal ideation and incidence of self-directed violence.
    

Intervention name(s): CAMS-G
Intervention type(s): Behavioral
Intervention description(s): Group-based suicide-specific intervention based upon the Collaborative Assessment and Management of Suicidality.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be assigned in even numbers to CAMS-G or care as usual.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment