BACKGROUND/RATIONALE:
Suicide is one of the leading causes of death for military personnel, and for the first time in recorded history, the rates of military suicides are exceeding civilian rates. Despite the public and patient health costs associated with suicidal ideation and behavior, existing efforts have not appreciably reduced the rates of suicidal behavior in the military. Consequently, finding novel, efficacious, and acceptable methods to reduce suicide behaviors is of great military health relevance. The Veteran's Coping Long Term with Active Suicide Program (CLASP-VA) is a unique suicide reduction program that combines individual therapy, case management, and family interventions with the implementation of both individual and telephone-based therapeutic strategies adapted from innovative newer cognitive-behavioral and family approaches. It is one of the few programs that directly targets high-risk patients at the time of hospital discharge, and is also one of the few empirically-developed and promising interventions (e.g., strong pilot data) for individuals hospitalized for suicide behavior.

OBJECTIVE(S):
The primary objective of this study is to test the efficacy of CLASP-VA in a sample of veterans at risk for suicide behavior. CLASP will be compared to an enhanced monitoring control condition to examine the program's efficacy in reducing suicide and rehospitalization. Efficacy will be determined by several primary outcomes including: number of attempts, number of re-hospitalizations, severity, and chronicity of suicidal ideation. A secondary objective is to identify the types of patients who will receive the most benefit from the CLASP-VA intervention.

METHODS:
CLASP-VA is a 6-month, telephone-based, adjunctive program designed for patients at risk for suicide. The intervention, modified specifically for VA patients and health care system, combines aspects of problem-solving therapy, case management, family support, and assessment.

A goal of 200 inpatients from the Providence Veterans Affairs Medical Center will be randomly assigned to either CLASP-VA or an enhanced monitoring control condition. Inclusion criteria are: 1) suicide attempt or suicidal ideation with any methods, plan, and/or intent to make a suicide attempt within 1 week of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS; 2) 18 or older; 3) have a telephone; and 4) ability to speak, read, and understand spoken English sufficiently well to complete the procedures of the study. Exclusion criteria are: 1) diagnosis of primary psychotic disorder based on chart review (e.g. Schizophrenia or Schizoaffective disorder); 2) diagnosis of borderline personality disorder (based on screening with MSI-BPD, and SCID -II); or 3) cognitive impairment (MMSE < 20). We will also enroll patients' significant others/family members for those assigned to CLASP intervention; n=100).

Participants will be assessed on all outcomes at baseline, 3, 6, 9, & 12-month follow-up. Primary outcome is suicide attempts. Secondary outcomes are re-hospitalization due to suicide risk and suicidal ideation. Tertiary outcomes include treatment engagement, psychiatric symptoms, and psychosocial functioning.

FINDINGS/RESULTS:
Study Recruitment
105 Veterans and 10 significant others were enrolled in the study. Chi-squares and t-tests revealed no significant baseline differences between CLASP and control arm participants on demographic variables, suicide history, #of previous attempts, or lifetime most severe suicidal ideation. Significant differences were found on baseline depression scores (QIDS) t(96) = with participants in the intervention group reporting higher depression.

Sample Characteristics:
The randomized sample was largely male (92%) and Caucasian (88%), with a mean age of 47 (SD=14.4). Only 23% of the Veterans were married and 48% were separated or divorced. Most participants (81%) had some post high-school education, although more than half (57%) were unemployed. Almost half the sample (46%) had made no suicide attempts prior to hospitalization, 24% had 1 prior suicide attempt, and 30% had a history of multiple suicide attempts. Eighty-six percent of the sample were recruited for hospitalization due to suicidal ideation and 14% were hospitalized following a suicide attempt.

The two study conditions were very similar in demographic characteristics. T-tests revealed no significant difference between the conditions in demographics, # of past suicide attempts, intake reason, or current suicide ideation severity. Participants randomized to the CLASP intervention reported higher levels of baseline depression (M=18.45, SD=4.79) compared to the control condition (M=16, SD=5.43) participants as indicated by baseline QIDS scores t(96)=2.36, p<.05 and had higher levels of lifetime suicidal ideation as measured by the C-SSRS: 2 (1, 80) = 4.095, p=0.043

Retention
Assessments were performed at baseline, and at 3, 6, 9, 12 month follow up. Eighty percent of participants completed 3 month assessments, 70% completed 6 month assessments, 61% and 68% completed.

64% of CLASP participants completed all three in-person sessions however, only 8% completed all 11 intervention calls. Mean number of intervention calls completed was 4.18 (SD=3.93). Only 10/53 CLASP participants identified significant others to participate with them. Of those significant others, average significant other phone calls completed was 6.5.

Primary outcome: No differences were found between the intervention group and control group in # of suicide attempts at 3-month post-hospitalization, 6-months, 9-months, or 12 months.

Secondary outcome: No differences were found between conditions on either suicide ideation severity or re-hospitalization rates during the 12-month follow up period.

Tertiary outcomes: Project team is still analyzing the results to examine tertiary outcomes such as treatment engagement, psychiatric symptoms, and psychosocial functioning. These results are in preparation for an upcoming manuscript.

Summary and conclusions:
Primary and secondary hypotheses were not supported however data analysis on ongoing to examine potential covariates and to examine differences between time to first suicide behavior using weekly longitudinal suicide ideation and behavior data (LIFE). There were no significant differences between CLASP and SAFE participants on either suicide attempts, suicide ideation severity, or rehospitalization rates. Results in our Veteran sample contradict results in civilian populations where CLASP was found to be reduce suicide behaviors.

One potential reason for reduced efficacy of CLASP in our Veteran sample, is the presence of an SPC program within the VA. Unlike in civilian hospitals, patients in the VA who are identified as high-risk receive extensive case management and additional treatment. CLASP is an intervention that combines case management and therapy during the transition period, however, VA patients already receive significantly more services than civilian patients. As such, CLASP may not be providing a large amount of additional services above and beyond what Veterans already receive as VA treatment as usual.

The project team is continuing to examine data in greater detail to look at the types of patients that may benefit from CLASP.





IMPACT:
The goal of the proposed study is to test the efficacy of a suicide prevention program. The project team is still conducting ongoing analyses for more fine grained examination of results and these results will be submitted for publication when concluded.

Results did not support efficacy of CLASP over VA treatment as usual. No differences were found in number of suicide attempts, suicide ideation severity or psychiatric re-hospitalization across the 12-month post-hospital discharge.

Data analysis is ongoing. from follow up assessments is currently ongoing thus actual impact can not be assessed in full.

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External Links for this Project

NIH Reporter

Grant Number: I01HX001275-01
Link: https://reporter.nih.gov/project-details/8593995

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PUBLICATIONS:

Center Products

1. Primack JM. Mobile App for the Prevention of Suicide. Providence, RI: The Center of Innovation in Long Term Services and Supports (LTSS COIN); 2017 Oct 1. [view]

Conference Presentations

1. Primack JM, Miller IW, Doyle RL. Connecting Research to Practice in Multifaceted Ways With Male Veterans: the Veterans Coping Long Term with Active Suicide Program. Paper presented at: American Psychological Association Annual Convention; 2014 Aug 7; Washington, DC. [view]
2. Doyle RL, Miller IW, Primack JM. High Risk Suicidal Veterans: Characterizing an Inpatient Psychiatric Sample. Poster session presented at: VA HSR&D / QUERI National Meeting; 2015 Jul 9; Philadelphia, PA. [view]

DRA: Mental, Cognitive and Behavioral Disorders
DRE: Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: none
MeSH Terms: none