Development of a Recovery Oriented Treatment for Post-Acute Suicidal Episode (PASE) Veterans

Research Design and Methods

Phase 1

CI-CT has not, to date, been used for the PASE Veteran population. To optimize CI-CT's effectiveness for a PASE population and continue to align it as closely as possible with a recovery orientation, a dynamic adaptation approach will be used to run multiple treatment development trials of the group therapy to continue to improve CI-CT prior to running a pilot RCT. In this first phase the treatment materials will be used to run 3 one-arm treatment development trials of CI-CT (each with an n of 4-6 Veterans) to test and improve the therapy protocol. One goal of these trials is to identify CI-CT features or materials that appear functional in theory but do not execute as expected in a clinical setting. Following each treatment development trial, the feedback of the members of the group about the treatment as well as the assessment materials will be used to assess acceptability and feasibility. Upon completion of the trials, through consultation with the SAB and CAB, these results will be used to update treatment materials, instruments used for assessment, and delivery form. The experience of running these treatment development trials will also be used to develop a CI-CT adherence measure which will then be tested during the pilot RCT.

Veteran Participants

To have a final sample of 15 Veterans, 19 Veterans will be recruited (estimating 20% attrition) with a recent (within 1 year) acute suicidal episode, for participation in treatment development trials of CI-CT. The 20% estimate attrition rate is based on the initial CI-CT pilot data. As suggested by the aforementioned Post-Acute focus, treatment will be limited to PASE Veterans after the first week following their suicidal episode and without current acute suicidality (see assessment strategy below). This clinical decision was based on; (1) Veteran feedback from the initial pilot of CI-CT asking for screening to be used to limit the group to those ready to work on recovery, (2) empirical evidence suggesting that the first week after a suicidal episode is a period of distinctly high suicide risk with men 175, and women 583, times more likely than matched controls to die by suicide (N \> 20,000 suicide attempters). During this 'acute suicidality' period, treatments exist for Veterans that are more focused on their immediate safety needs while CI-CT focuses on the recovery of Veterans following this 'acute' period. Furthermore, participants will be screened for current acute suicidal symptoms using two validated measures of suicidal symptoms the Suicide Behavior Questionnaire - Revised (SBQ-R) and the Beck Suicide Intent Scale (BSI). Due to the historical nature of some of these measures' items, as have other studies, the SBQ-R item 4 will be used, focusing on self-perception of likelihood of future suicide, with scores above 3 (i.e. at least 'likely') considered current acute suicidality. For the BSI, a cut off score \>21 (i.e. 1SD from the mean BSI score) will be used among suicide attempt survivors (Mean=16, SD=5.7).

Recruitment, Screening and Enrollment Procedures

Investigators at the VISN 2 MIRECC maintain close collaborative relationships with mental health providers across the JJPVA. The standard operating procedure is to notify JJPVA mental health leadership when recruitment is being conducted for a study. Presentations will be made about ongoing studies at clinical team meetings and flyers will be sent to individual clinicians to facilitate recruitment. Potential participants identified through these avenues will be approached in-person at scheduled appointments. After initial contact, potential participants will subsequently be contacted by phone. Flyers will also be posted in waiting room areas. These recruitment procedures have yielded substantial success; investigators at this MIRECC have completed large clinical trials of Veterans with suicidal behavior with sample sizes of over 100 participants. Participants who meet eligibility will be scheduled for a consent and screening visit. Research staff will obtain informed consent using IRB approved procedures including assessment of the prospective participant's capacity to fully understand study procedures and related risks and benefits. Veterans who complete informed consent will be screened for eligibility criteria including a thorough medical record review, confirmation of clinical stability from a VA mental health provider, and confirmation of medical stability from a medical provider and completion of suicide symptoms assessments. If participants discontinue the study or are excluded before the first intervention session, a new participant will be recruited to maximize sample size. Detailed records recruitment process will be kept for reporting in a CONSORT chart.

Subject Characterization

1. Demographics: Data will be collected via the electronic health record: age, ethnicity, psychiatric treatment history including recent psychiatric admission, medications and medical history, years of education, marital status, housing, disability/employment status, history of childhood trauma, and "high-risk" list status. 2. Clinical Characteristics - Lifetime suicide attempts: Columbia Suicide History Form (CSHF) records lifetime suicide attempts and methods, including lethality, precipitant, and surrounding circumstances. The scale has inter-rater reliability of 0.97 and been used extensively in prospective suicide studies. 3. Diagnosis: mental health diagnosis will be determined via a structured clinical interview - the Mini-International Neuropsychiatric Interview (MINI).

Treatment

The trial will use the CI-CT intervention of the proposed project. CI-CT is planned to be a weekly, 90-minute, 12-session group treatment and to be run by two clinicians using the final version manual and workbook. The study will include 3 cycles of the CI-CT intervention with a projected average of 5 Veterans/group. The groups will be led by YS (co-PI) and a co-therapist (a TBD MIRECC staff interventionist who will be trained by YS to deliver CI-CT). YS will be a co-group facilitator to aid in the further tailoring and development of CI-CT following each of these developmental trials. The treatment is adjunctive, and Veterans will continue with their psychiatrist, case manager and services by the suicide prevention coordinator if needed.

CI-CT Training and Fidelity

CI-CT training will include one full-day training with the PI, weekly supervision with therapists, audiotaping and review of sessions for fidelity to the CI-CT manual. An adherence scale will be developed during this phase to assess core features of its structure, contents and treatment principles along with general clinical competence (e.g., building rapport, crisis management, etc.). The adherence scale will have three sections addressing different areas of adherence; 1) general CI-CT requirements, 2) session specific requirements, and 3) general group psychotherapy requirements. Clinicians will be required to maintain an average score of 4 on each session, rated on a 5-point Likert scale (where 0 = unacceptable and 5 = excellent) to demonstrate adequate adherence. If ratings fall below this criterion, supervision will be increased and adherence will be closely monitored until adequate adherence is regained.

Management of Disruptive Participants

Significant disruptive behavior by Veterans is rare but possible, therefore plan will be developed to manage or discontinue disruptive Veterans including a guide for clinicians to decide whether a Veteran should be immediately discontinued (e.g., for making threats) or if redirecting the Veteran is likely to help the Veteran participate in an appropriate manner.

Developmental Trial Assessments and Assessment Strategy

There will be four assessment time points: (TP-1) baseline, (TP-2) post-intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention; to track Veterans until the end of the 1-year PASE period. Veterans will receive compensation for assessment completion but not for intervention attendance to minimize potential impact of compensation on treatment engagement.

Measurement of Feasibility and Acceptability of CI-CT

To examine Feasibility, the following will be tracked: 1) ease of implementation by recording the number of hours CI-CT clinicians spend in preparation, delivery of the intervention, and supervision. While the target is 60 hours/12 session cycle, beginning cycles are anticipated to take longer while the intervention is still being learned; 2) recruitment by measuring rates of successful referral to CI-CT and 3) attendance/retention, by tracking the number of sessions and specific sessions each Veteran attends. Based on rates in studies conducted by Dr. Sokol's primary mentor, the predetermined criteria for retention will be "adequate" if 70% of participants attend at least 9 of the 12 sessions, and "inadequate" otherwise. A similar strategy will be used for recruitment rates, with "adequate" feasibility if at least 65% of Veterans approached for participation in the study agree. To examine Acceptability, participants and CI-CT therapists will complete a brief survey after each session, and upon completion of the intervention. The Client Satisfaction Questionnaire (CSQ-8) will also be used to measure client satisfaction with the treatment (post-intervention). The CSQ-8 is an 8-item widely used measure in mental health studies containing items about quality and helpfulness, and provides a single score. Homework adherence will also be monitored.

Preliminary Efficacy Outcomes

Key outcomes of interest include: personal recovery and suicidal ideation. Secondary outcomes include recovery related constructs including quality of life, life satisfaction, hopelessness, disability, future self-continuity, and suicide related constructs including isolation and burdensomeness. Two primary outcomes were chosen, with recovery as a primary outcome, in addition to suicide ideation (of paramount import in all suicide treatments), in line with the significance given to personal recovery in this treatment.

Primary Outcome Measures

Personal recovery will be measured using the widely used Recovery Assessment Scale (RAS; Corrigan et al., 2004): The RAS is a 41-item self-report measure using a 5-point Likert scale. Sample items include: 'I have a desire to succeed.' and 'I have goals in life that I want to reach.' Factor analysis identified five factors: personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by symptoms. Narrative reviews of recovery measures have been highly favorable toward the RAS which has been described as the most acceptable and valid measure of personal recovery available. A review study found that across 28 studies, means ranged between 3.14 and 4.12, Cronbach's alphas from .76 and .97 and test-retest reliability from .65 to .88. The RAS has been widely used in VA and non-VA clinical trial studies with diverse populations, a range of mental illnesses and has demonstrated sensitivity to change over time. Suicidal ideation will be assessed using the Columbia Suicide Severity Rating Scale (CSSRS) a widely used semi-structured interview in VA clinical studies measuring suicide ideation and behavior has demonstrated sensitivity to change. The first subscale, (severity scale) is a 6-point ordinal scale, ranging from 1 (wish to be dead) to 5 (suicidal intent with plan). The second subscale, (intensity scale) is comprised of five items (i.e., frequency, duration, controllability, deterrents, reasons for ideation), rated on an ordinal scale (total scores ranging from 2 to 25). The behavior scale is a 5-point scale assessing interrupted, aborted, and actual suicide attempts; preparatory behavior for a suicide attempt; and non-suicidal self-injurious behavior.

Exploratory/Secondary Outcome Measures

Quality

• Change in WHOQOL-BREF [Time frame: four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention]
• Change in Satisfaction With Life Scale [Time frame: four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention]
• Change in Beck Hopelessness Scale [Time frame: four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention]
• Change in WHODAS 2.0 [Time frame: four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention]
• Change in Future Self Continuity Questionnaire [Time frame: four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention]
• Change in Lubben Social Network Scale-Revised [Time frame: four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention]
• Change in Interpersonal Needs Questionnaire [Time frame: four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention]