Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for Suicide Risk
Phase: NA
Conditions: Suicide, Attempted, Suicidal Ideation
Sponsor: Ohio State University

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for 
Suicide Risk 
 
NCT Number: 2020B0414-B 
 
Date: 5/18/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for 
Suicide Risk 
 
1. Objectives 
The aim of the current project is to compare the use and preliminary effectiveness of a self-
administered version of the Crisis Response Plan (CRP) in decreasing suicidal/death ideation and 
distress and increasing positive affect when compared to a clinician-administered version of the 
protocol in a sample of 150 military Veterans experiencing current death or suicidal ideation. As the 
aim of examining the effectiveness self- and clinician-administered versions of the CRP is 
exploratory, no hypotheses are proposed. However, the results of this research will inform best 
practices for administration of the CRP in future research and clinical contexts. 
 
2. Background and Rationale 
 
In response to enhanced detection of suicide risk, there is a need to identify psychotherapeutic 
interventions targeting suicide risk among military veterans who may be unable or unwilling to seek 
follow-up mental health services. Indeed, reasons for refusal to seek mental health services among 
veterans include public and self-stigma (Held & Owens, 2013), adherence to masculine norms (Burns 
& Mahalik, 2011). However, Wilson et al. (2008) observed that the majority of Army soliders who were 
unwilling to speak to a clinician about mental health care have were willing to utilize technology-based 
approaches to mental health care. 
  
 
2.1 Crisis Response Planning for Suicide Risk. Crisis Response Planning (CRP) is a brief, 
psychotherapeutic intervention with demonstrated efficacy in increasing positive affect, decreasing 
negative affect and psychiatric hospitalizations, and reducing suicide attempts by 76% in military 
personnel when compared to contracts to safety (Bryan et al., 2017, 2018).  Give the efficacy and 
flexibility of the intervention, CRP has been successfully implemented as part of interventions 
targeting PTSD and suicide risk (Bryan and Rudd, 2018; Rozek & Bryan, 2020). This proposed 
research is aimed at examining the efficacy of the intervention in reducing suicidal ideation, 
distress, and negative affect and increasing positive affect when compared to a self-
administered version. 
CRP is focused on creating personalized set of steps for individuals to follow in case of a crisis 
and includes individuals’ personal warning signs of distress, behavioral coping strategies, reasons for 
living, social supports to contact, and contact information for professional services, including 
emergency services. Personalization of the CRP is encouraged, and individuals are instructed to 
handwrite each step of the CRP on an index card. Additionally, clinicians instruct patients to review 
the CRP periodically in order to mentally rehearse each step and change the contact of the CRP as 
needed (e.g., after using the CRP, a behavioral coping strategy was found to be unhelpful or 
iatrogenic). 
 
 
3. Procedures 
 
3.1. Research Design. A two-arm randomized controlled simulation design will be employed 
in both parts of this proposed research. Participants will be randomized using stratified blocks of 6 or 
8 participants, per recommendations by Krenan et al. (1999), based on gender and suicide attempt 
history (no history of suicide attempts, history of one suicide attempt, or history of multiple suicide 
attempts).  
 
3.2. Sample. A sample of 150 Veterans will be included in the study and randomized to study 
conditions (75 in the clinician-administered CRP condition and 75 in the self-administered CRP 
condition). Results of a priori power analyses conducted using G*Power software (Faul et al., 2007) 

indicate that a total sample of 150 will results in a highly-powered study (𝛽 =.98-.99) to detect 
medium-sized effects in all regression-based analyses, assuming moderate correlations amongst the 
seven daily measurements for this proposed study. Therefore, although we anticipate low attrition 
from this study, the proposed sample size is sufficiently powered for the proposed analyses, even 
when conservatively assuming a 20% attrition rate observed in longitudinal efficacy trials of the CRP 
(Bryan et al., 2017). Online recruitment methods for the study are include wed-based survey and 
research recruitment systems (e.g., SurveyMonkey), listservs and forums, and social media sites 
(e.g., Facebook, Twitter, Reddit). Additionally, we are requesting use of ResearchMatch (RM), which  
is an NIH sponsored national registry for research volunteers. ResearchMatch (RM) and OSU have 
had a fully executed agreement since August 2009. The IRB of record for ResearchMatch is 
Vanderbilt University. The Principal Investigator will be authorized to recruit study participants.  
 
We will enroll any prospective Veteran meeting inclusion criteria (18 years of age or older, US military 
veteran, death or suicidal ideation/suicide attempt within the past month) in the proposed study. 
Exclusion criteria include: non-Veteran status, acute intoxication or active psychosis precluding 
provision of informed consent, an inability to communicate and comprehend English, residence 
outside the United States, and lack of past-month death/suicide ideation or attempt. Participants 
recruited through web-based survey and research and recruitment systems will provide consent for 
study personnel to initiate contact through email or phone call, while those recruited through other 
online methods (e.g., listservs, forums) will be provided contact information for study personnel in 
order to inquire about the study or schedule participation.  
 
3.3 Measurement/Instrumentation. The following self-report measures will be administered through 
Qualtrics online survey software during baseline procedures as part of the proposed research: 
 
Visual Analog Scale - Participants will be instructed to reflect on their urges for suicide using the 
Suicide Visual Analog Scale (S-VAS; Bryan, 2019) The S-VAS assesses “urge to kill myself” using a 
horizontal line with anchors on the left reflecting “none” (score: 0) and on the right reflecting “extreme” 
(score: 100). The S-VAS is initially presented with the indicator on the “none” position, and non-
movement of the indicator is followed by a prompt to remind the participant to move the indicator, if 
relevant, to ensure response accuracy 
 
The Patient Health Questionnaire Depression Scale (PHQ-2; Arrol et al., 2010). The PHQ-2 is a 
2-item measure of depression symptom severity adapted from the 9-item version of the PHQ 
(Kroenke & Spitzer, 2002). Item responses are scores on a Likert scale ranging from 0 to 3, with 
higher scores indicating greater symptom severity. This version of the PHQ was chosen in lieu of the 
PHQ-9 in order to omit an item about suicide risk contained on the PHQ-9 and decrease participant 
burden.  
 
Positive and Negative Affect Schedule – Short Form (PANAS-SF; Mackinnon et al.,1999) is a 20-
item validated self-report measure of state positive and negative affect. In the current study, the 
PANAS-SF will assess past-day positive and negative affective states.  
 
 
3.3.1 Daily surveys. Prior to completing the CRP and once daily for seven days following completion 
of the CRP, participants in both conditions will be emailed a secure link to a Qualtrics survey including 
the following questionnaires: 
 
Visual Analog Scale – See above.  
Patient Health Questionnaire – 2. See above 
Positive and Negative Affect Schedule – Short Form. See above.   
Crisis Response Plan Use – In order to assess whether CRP use after completion impacts suicide 
urges and affect, participants will be instructed to “Please list all dates and times that you used part or 

all of the Crisis Response Plan that you completed since you last completed this survey. (or since you 
completed your Crisis Response Plan if this is the first survey you will complete)” You may provide us 
with your best estimates of dates and times.” 
 
3.4. Informed Consent and Confirmation of Eligibility 
Informed consent will be obtained through Qualtrics survey software from each participant prior to 
initiation of study tasks. Study personnel will obtain informed consent from participants and answer 
questions about the study or informed consent process prior to beginning study activities.  Following 
informed consent, participants will complete a demographics questionnaire through Qualtrics that also 
includes items assessing history of suicide attempts from the Self-Injurious Thoughts and behaviors 
Interview (Nock, Holmberg, Photos, & Michel, 2007) for study eligibility determination and 
randomization purposes as well as the Suicide Visual Analog Scale (Bryan, 2019). Regardless of 
eligibility, all participants will be provided with contact information for crisis resources including the 
National Suicide Prevention Lifeline and Veterans Crisis Line.  
3.5. Randomization to Study Conditions.  
REDCap, a secure online survey and data management system maintained by The Ohio State 
University, will be utilized to randomize participants to study conditions in both components of the 
study immediately after obtaining demographic information (man, woman, other) and information 
about suicide attempt history (no suicide attempts, one suicide attempt, more than one suicide 
attempt) obtained from the SITBI). Participants will be randomized using stratified blocks of 6 or 8 
participants, per recommendations by Krenan et al. (1999). After randomization, each participant will 
complete the remainder of the research study, but will be presented with one of the following pages 
containing instructions for completing the CRP: 
 
Self-Administered CRP: In this condition, participants will be presented with instructions for 
completing and printing off the CRP. They will be directed to type in their responses onto the 
Qualtrics page and upload a picture of their CRP. 
Clinician-Administered CRP: In this condition, study personnel will guide participants through the 
CRP protocol, outlined by Bryan and Rudd (2018). Participants will be directed to a Qualtrics page 
instructing them to collaborate with study personnel to develop a personalized CRP. Study personnel 
will take a screenshot picture of the CRP and upload it to Qualtrics. 
 
3.6. Additional incentives following completion of the first portion of the study.  
Following the study session, all participants will receive payment in the form of $50 for participation. 
Additional incentives will be described to participants at the beginning of the study as part of the 
informed consent process, and administered no later than two weeks following completion of the 
study protocol: 
 
 
3.4. Detailed Study Procedures. One hundred and fifty adult military Veteran participants 
residing in the United States will complete study components during the baseline study session: 
consenting, demographics survey and self-reported history of suicide attempts, randomization to 
study conditions, and the CRP. Consenting procedures will always be completed first, and 
demographic and suicide attempt history data will always be collected second for randomization to 
conditions of the study through REDCap online software. We estimate that the total participation time 
will be approximately 1 hour. Participants will be active in the study for eight days. In order to protect 
participant confidentiality, password-protected Zoom or phone-based sessions will be conducted 
during the baseline session and to administer the CRP to individuals in the clinician-administered 
CRP condition. All data will be collected through the Qualtrics, and non-PHI demographic information 
will be entered into REDCap system for randomization purposes. ID numbers will be linked to all data 
collected in the study, including identifying information collected in a separate data set as part of 
safety procedures, which will be deleted at the conclusion of the study. All deidentified data will be 
downloaded and deleted from Qualtrics servers at the conclusion of the study and stored on the 

password protected OneDrive server hosted by OSU indefinitely for the proposed analyses and 
secondary analysis. Additionally, in order to protect participant privacy during the study, all study 
personnel will conduct study procedures from a private location, using a secure Internet connection 
and instruct all participants to do the same, if possible, and outline the risks of loss of privacy or 
confidentiality if the participant is unable to so. 
3.7. Internal Validity.  A number of measures will be implemented to mitigate threats to internal 
and external validity. Specifically, the randomization procedures employed in the proposed research 
study (See Section 4.1.2) were selected to account for the potential influences of gender and suicide 
attempt status on study findings. Further, all study personnel administering the CRP will be trained to 
administer the protocol to maintain an average fidelity rating of 85%. A random selection of CRP 
sessions recorded using Zoom teleconferencing software, will be reviewed by the Principal 
Investigator and other trained members of the research team in order to assess fidelity to 
administering the protocol. If a personnel’s average fidelity rating drops below 85%, they will be 
temporarily prohibited from administering further CRP sessions until remedial training has been 
completed and they obtain fidelity ratings of at least 85% for three consecutive practice 
administrations of the CRP. 
 
3.8 Data Analysis. A linear mixed effects regression analysis with repeated measurements will be 
conducted to examine differences in suicide risk between Veterans in the clinician-administered and 
self-administered CRP conditions. Condition will be entered as the independent variable and outcome 
measures at baseline and each follow-up assessment will be entered as outcomes. These analytic 
procedures are consistent with previous trials examining the efficacy of the CRP (Bryan et al.,2017; 
Bryan et al., 2018). 
 
3.9. Safety Procedures. The intervention under study includes two iterations of Crisis Response 
Planning, an intervention with demonstrated efficacy in reducing suicidal ideation and distress.  
Therefore, we anticipate that both versions of the CRP will demonstrate similar effects in this 
proposed study. Additionally, the use of crisis response plans, safety plans, and regular follow-up 
assessments are widely-used strategies that have been associated with decreased suicide risk 
and are all included in the proposed research. During enrollment in the study, all participants, 
regardless of agreement to participate in both portions of the study, will provide their contact 
information (home address, telephone number, email address) and a telephone number for an 
alternate person that study personnel may contact in case of imminent suicide risk. Home addresses 
may be used to contact the participant’s local emergency services in case of imminent suicide risk. If 
a subject reports suicidal ideation, or a research staff member becomes aware that the subject is at 
imminent risk to harm himself/herself, the following questions will be asked to clarify the nature of risk 
(and to identify those at imminent risk requiring consideration for hospitalization): (1) Do you have a 
plan for killing yourself and do you intend to act on the plan?; (2) Do you have a desire to kill yourself 
that you believe you might act on?; (3) Have you already taken steps to act on your plan? If so, what 
steps have you taken? Both iterations of the CRP, which is a recommended and empirically-
supported strategy for reducing suicide risk, will include contact information for professional resources 
and crisis services, the National Suicide Prevention Lifeline phone number, and other local behavioral 
health clinics and emergency departments. These procedures have been used successfully by our 
research team in dozens of studies with acutely suicidal individuals, to include multiple clinical trials. 
All participants will be provided with contact information to use in case of crisis (National Suicide 
Prevention Lifeline, emergency services), regardless of whether individuals choose to participate in 
developing the CRP.