ACT for Life: a Brief Intervention for Maximizing Recovery After Suicidal Crises
Phase: NA
Conditions: Suicide, Psychiatric Rehabilitation
Sponsor: VA Office of Research and Development

 
 
 
 
 
ACT for Life: a Brief Intervention for Maximizing Recovery After Suicidal Crises 
NCT02751983 
 
Protocol and Statistical Analysis Plan 
October 22, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
For questions concerning this protocol or for information about the resulting publication please 
e-mail Sean Barnes at Sean.Barnes2@va.gov. A manuscript based on this work is currently 
under review. The protocol reflects the most recent IRB approved protocol and has been edited 
to focus on aspects of the protocol directly relevant to NCT02751983  
 

The following pilot study aims are designed to determine the feasibility of a future randomized 
clinical trial to evaluate the efficacy of a novel application of Acceptance and Commitment 
Therapy (ACT) in a larger sample of Veterans hospitalized due to suicide risk. By design, the 
proposed study is not powered to determine the efficacy of the intervention. That objective will 
be addressed in a subsequent trial. However, each aim is a necessary precursor to an 
anticipated efficacy study.1 As recommended by Thabane et al.,2 a priori criteria for feasibility 
outcomes have been specified. Using a two arm, randomized controlled design, we will: 
 
Aim 1: Determine the acceptability of ACT for Life. Acceptability refers to the suitability of the 
intervention from the perspective of the clinical population of interest.3 To determine if 
participants find the intervention to be acceptable, defined as ≥ 70% of participants scoring ≥ 
24 on the Client Satisfaction Questionnaire (CSQ),4 we will examine the percentage of 
participants obtaining CSQ scores ≥ 24. Responses on the Narrative Evaluation of Intervention 
Interview (NEII),5 a qualitative interview, and Reasons for Termination6 scale will be used to 
identify potential areas for modification to the intervention. 
 
Aim 2: Determine the feasibility of the study design and research procedures. This will be 
accomplished by examining the following outcomes: a) number of patients approached who are 
eligible for the study and the number who enroll in the study. Feasibility is defined as ≥ 50% 
eligible and (of these) ≥ 30% willing to participate in the proposed time frame. b) providers’ 
adherence to the treatment protocol (i.e., clinicians’ ability to deliver the intervention as 
intended in a routine inpatient setting) will be examined using the treatment fidelity checklist, 
with ≤ 15% of deviations for each clinician across participants considered acceptable fidelity. c) 
participant completion of intervention modules will be measured by examining the percentage 
of patients randomized to ACT who complete the treatment per protocol. This is crucial to 
ensuring that patients receive an adequate dose of the intervention. A minimum of 70% 
completing the entire intervention will be considered feasible. d) percentage of participants lost 
to follow up (LTFU) across both groups. This will be measured by examining the percentage of 
participants across both groups who fail to complete the three-month follow-up visit, with ≤ 
30% LTFU in each group considered feasible. This will inform the target sample size and 
retention strategies for the subsequent study. 
 
Aim 3: Characterize participants’ functional outcomes and self-directed violence at baseline, 
one-month and three-months post-discharge. This aim will provide variability estimates on: (a) 
progress towards living consistently with self-defined values (assessed by the Valued Living 
Questionnaire7) and engagement in a range of functional behaviors, (assessed by the Inventory 
of Psychosocial Functioning, Outcome Questionnaire 45.2, and select PROMIS modules8), (b) 
objective treatment engagement based on medical record review, and (d) self-directed violence 

as assessed by the Columbia-Suicide Severity Rating Scale9 and medical record review. 
Variability estimates can then be used to inform selection of outcome measure(s) and the 
sample size for a subsequent efficacy trial. 
 
A.  Outcome Measure(s):   
Aim One Measures: Acceptability. The Client Satisfaction Questionnaire (CSQ-8)4 is a self-
report measure that will be used to assess patients’ satisfaction with ACT for Life. (Duration: 5 
minutes; Administration: Post-Treatment). The Narrative Evaluation of Intervention Interview 
(NEII)5 is a 16-item semi-structured interview assessing each participants’ perspective of the 
impact of the intervention, helpful and unhelpful components, and comparison to other 
interventions. This yields rich information regarding how the intervention can be modified to 
better meet patients’ needs (Duration: 15 minutes; Administration: Post-Treatment). 
Participants who withdraw from treatment, but agree to remain in the study will also complete 
the Reasons for Termination (Client and Therapist versions; RT-C/RT-T)6 scale, which assess 
the impact of 19 common reasons why patients terminate therapy. Study clinicians will also 
complete the RT-T (Duration: 5 minutes; Administration: Following withdrawal from treatment). 
 
Aim Two Measures: Feasibility. A treatment fidelity checklist was developed for the current 
study to monitor clinician adherence to the treatment manual after each recorded session. 
(Audio recorders will be FIPS compliant.)  It was modeled off of fidelity checklists included in 
trials of other cognitive behavioral therapies and incorporates treatment competency items 
from an ACT fidelity measure used in the ACT for Depressed Veterans roll out. (Please note that 
this checklist is for internal use only/is not given to participants and therefore is not included in 
the measures submitted with this application.) 
 
Aim Three Measures: Characterize Treatment Outcomes. The following measures will be 
included as candidate outcome measures for a future efficacy trial, and be administered at 
baseline, one-month, and three-month assessment sessions. The Valued Living Questionnaire 
(VLQ)7 is a self-report measure that assesses participants’ life values as well as the perceived 
consistency with which they have been living according to their values. Participants rate the 
importance of ten domains of living (e.g., friendship). Then participants rate how consistently 
they have lived with the valued behavioral pattern within each domain over the past week. 
(Duration: 10 minutes). The Inventory of Psychosocial Functioning (IPF)10,11 assesses 
impairment within the last 30 days across a spectrum of psychosocial domains (e.g., work, 
socializing etc.). The 80-item self-report measure was developed and validated in a sample of 
Veterans. The scale does not require respondents to make attributions regarding the cause of 
impairments and is therefore ideal for transdiagnostic assessment of functioning (Duration: 15 

minutes). The Outcome Questionnaire-45.2 (OQ-45) is a 45-item self-report scale that assesses 
symptom distress, interpersonal relationships, and social role (functioning in the workplace, 
school, and home) for the past week.  It was designed for repeated measurement of client 
progress in therapy (Duration: 5 minutes). The PROMIS Global Short Form v1.112 is a ten-item 
self-report measure assessing multiple domains of health. The scale yields two subscales: 
Global Physical Health and Global Mental Health (Duration: 5 minutes). The PROMIS Short 
Form v2.0- Satisfaction with Social Roles and Activities 8a13 is an eight-item self-report 
measure that assesses satisfaction with respondents’ ability to perform various social activities 
(Duration: 5 minutes). The Columbia Suicide-Severity Rating Scale (C-SSRS)9 is a clinician-
administered interview that assesses suicidal ideation and attempts. The C-SSRS assesses 
severity of suicidal ideation and behavior (Duration: 15 minutes).  
 
B. Description of Population to be Enrolled:   
 
Participants will consist of all eligible and willing Veterans who meet the following eligibility 
criteria 
Inclusion Criteria: 1) Eligible for VHA care [Medical Record Review], 2) Age 18-89 [Medical 
Record Review], 3) Currently hospitalized due to suicide risk [Medical Record Review], and 4) 
Willing to be randomized and participate in the two conditions (i.e., treatment and control) 
[Asked by study team member during recruitment. Reiterated during the consent process].  
Exclusion Criteria: 1) Inability to provide informed consent [Pre-consent Questions], 2) Inability 
to complete study measures (e.g., due to significant acute intoxication/withdrawal symptoms, 
mania, psychosis, aggression, catatonia, cognitive impairment) [Medical Record Review, 
Consultation with treatment team, Experimenter or Study Therapist Observation], or 3) 
membership in vulnerable population [e.g., pregnant women, prisoners, etc. see p.4 of 
Application for protocol review; Medical Record Review, Consultation with treatment team, 
Pre-consent Questions, Experimenter or Study Therapist Observation]. 
 
C. Study Design and Research Methods   
 
Design: We are proposing a two arm, randomized, controlled pilot study to assess the feasibility 
of a future randomized clinical trial evaluating the efficacy of ACT for Life. Veterans 
psychiatrically hospitalized at the Denver VA Medical Center (Denver VAMC) who are eligible 
and interested in participating in the study will be randomized to: (1) enhanced care as usual (E-
CARE) or (2) E-CARE plus ACT for Life (referred to as the ACT group). 
 

Description of Treatment Conditions. Enhanced Care as Usual (E-CARE). Group therapy and 
medication management are the primary treatment modalities. About 25% of patients also 
receive individual psychotherapy. We are referring to this group as “enhanced” treatment as 
usual because, in addition to standard care, all participants will complete the assessment 
sessions and the VLQ, which will cause participants to reflect on their values and the 
consistency of their behavior with their values. The assessment alone has the potential to 
beneficially impact the participants.14 ACT for Life. Act for Life is a 3-6 session individual therapy 
applying Acceptance and Commitment Therapy to promote functional recovery from suicidal 
crises and prevent future suicidal behavior. (Please contact the study PI, Sean Barnes, at 
Sean.Barnes2@va.gov for reference to a manuscript describing the treatment protocol in more 
detail.)  
 
Measures: 
The following measures were selected based on their content validity and other psychometric 
properties. Descriptive Measure.  The Rocky Mountain MIRECC Demographics Form will be 
used to assess demographic variables such as age, sex, and ethnicity, as well as variables 
related to education, employment, housing, and military history (Duration: 5 minutes; 
Administration: Baseline assessment).  
 
Safety Monitoring Measure. The University of Washington Risk Assessment Protocol 
(UWRAP)15 is a structured clinical interview that evaluates participants’ acute emotional state 
prior to the study and capacity to complete the study procedures. At the end of the study, the 
UWRAP debriefing protocol will be initiated. Members of the research team will evaluate 
responses and access additional assistance as necessary (Duration: 10 minutes; Administration: 
All Assessments). 
 
Aim One Measures: Acceptability. The Client Satisfaction Questionnaire (CSQ-8)4 is a self-
report measure that will be used to assess patients’ satisfaction with ACT for Life. (Duration: 5 
minutes; Administration: Post-Treatment). The Narrative Evaluation of Intervention Interview 
(NEII)5 is a 16-item semi-structured interview assessing each participants’ perspective of the 
impact of the intervention, helpful and unhelpful components, and comparison to other 
interventions. This yields rich information regarding how the intervention can be modified to 
better meet patients’ needs (Duration: 15 minutes; Administration: Post-Treatment). 
Participants who withdraw from treatment, but agree to remain in the study will also complete 
the Reasons for Termination (Client and Therapist versions; RT-C/RT-T)6 scale, which assess 
the impact of 19 common reasons why patients terminate therapy. Study clinicians will also 
complete the RT-T (Duration: 5 minutes; Administration: Following withdrawal from treatment). 

 
Aim Two Measures: Feasibility. A treatment fidelity checklist was developed for the 
current study to monitor clinician adherence to the treatment manual after each recorded 
session. [(Audio recorders will be FIPS compliant.)]  It was modeled off of fidelity checklists 
included in trials of other cognitive behavioral therapies and incorporates treatment 
competency items from an ACT fidelity measure used in the ACT for Depressed Veterans roll 
out.  
 
Aim Three Measures: Characterize Treatment Outcomes. The following measures will be 
included as candidate outcome measures for a future efficacy trial, and be administered at 
baseline, one-month, and three-month assessment sessions. The Valued Living Questionnaire 
(VLQ)7 is a self-report measure that assesses participants’ life values as well as the perceived 
consistency with which they have been living 
according to their values. Participants rate the 
importance of ten domains of living (e.g., 
friendship). Then participants rate how 
consistently they have lived with the valued 
behavioral pattern within each domain over 
the past week. (Duration: 10 minutes). The 
Inventory of Psychosocial Functioning 
(IPF)10,11 assesses impairment within the last 
30 days across a spectrum of psychosocial 
domains (e.g., work, socializing etc.). The 80-
item self-report measure was developed and 
validated in a sample of Veterans. The scale 
does not require respondents to make 
attributions regarding the cause of 
impairments and is therefore ideal for 
transdiagnostic assessment of functioning 
(Duration: 15 minutes). ). The Outcome 
Questionnaire-45.2 (OQ-45) is a 45-item self-
report scale that assesses symptom distress, 
interpersonal relationships, and social role 
(functioning in the workplace, school, and 
home) for the past week.  It was designed for 
repeated measurement of client progress in 
therapy (Duration: 5 minutes).  The PROMIS 
Global Short Form v1.112 is a ten-item self-report measure assessing multiple domains of 
health. The scale yields two subscales: Global Physical Health and Global Mental Health 

(Duration: 5 minutes). The PROMIS Short Form v2.0- Satisfaction with Social Roles and 
Activities 8a13 is an eight-item self-report measure that assesses satisfaction with respondents’ 
ability to perform various social activities (Duration: 5 minutes). The Columbia Suicide-Severity 
Rating Scale (C-SSRS)9 is a clinician-administered interview that assesses suicidal ideation and 
attempts. The C-SSRS assesses severity of suicidal ideation and behavior (Duration: 15 minutes).  
Procedures:  
Recruitment and Preliminary Screening. Participants will be recruited from the Denver VA 
Medical Center’s psychiatric inpatient unit. Potential participants will be told about the study by 
a member of their treatment team. The PI and Co-Is are treatment providers on the inpatient 
unit and will have a treatment relationship with potential participants. They will work in 
conjunction with the other inpatient treatment providers to identify potentially eligible 
participants. A waiver of consent and HIPAA are being requested so that the study team can 
review medical records of potential participants to determine whether they are likely to be 
eligible for the study. Apart from gauging Veterans’ interest in participation, it will be possible 
to assess all inclusion and exclusion criteria based on chart review and verbal consultation with 
other treatment team members. If it is determined, in consultation with other treatment 
providers, that a Veteran is likely to be eligible for study participation, the PI or a Co-I will tell 
them about the study and see if they are interested in participating. If the Veteran is interested 
in participating, they will be scheduled for their baseline assessment session.    
 
Baseline Assessment Session and Randomization. After passing the consent questions and 
providing documented consent (see Informed Consent section below for more details), 
participants will complete the safety measure (UWRAP), demographics form, and then 
candidate outcome measures (VLQ, IPF, OQ-45, PROMIS, C-SSRS). The study assessor and 
participants will be blind to condition. At the end of the session, participants will be randomized 
to ACT or E-CARE. Group assignment will be predetermined by the study statistician using block 
randomization (random block sizes), and concealed in a sealed envelope. The baseline 
assessment session is expected to last roughly one and  a half hours. Participants will be 
compensated $20. Treatment Participation. Participants randomized to ACT will complete ACT 
for Life while hospitalized. Depending on participants’ anticipated length of stay and clinical 
needs they will receive approximately three hours of treatment delivered in about three to four 
sessions. No compensation will be provided for treatment participation. Post-treatment 
Assessment Session. A study assessor will meet with participants in the ACT condition and 
administer the UWRAP and treatment acceptability measures (CSQ-8, NEII, and RT-C if 
appropriate). The post-treatment assessment session is expected to last roughly 30 minutes. 
Participants will be compensated $10. One-Month and Three-Month Follow-ups. A different 
assessor, still blind to condition, will administer the one- and three-month follow-up measures 
(UWRAP, VLQ, IPF, OQ-45, PROMIS, C-SSRS). These assessment session are expected to last 
roughly one hour each. Participants will be compensated $20 for each assessment. [This was 

later increased to $50 per session.] If participation in post-treatment or follow-up sessions is 
limited by lack of funds to travel to the Denver VAMC, participants may be provided with 
additional mileage reimbursement at the government rate or funds to pay for public 
transportation. 
 
Enrollment: 
Informed Consent. Participation will be voluntary, and potential participants will have ample 
time to review the informed consent with trained staff and to ask questions about the study. 
Authorization to collect protected health information (PHI) will also be obtained (HIPAA 
authorization). Research staff will assess patients’ ability to provide informed consent, based on 
whether they can adequately respond to the following questions about the study: 
 
1) What are you being asked to do? 
2) Finish this sentence - The purpose of this study is to find out…  
3) True or False: After beginning this study, you can decide not to 
continue at any time, without penalty. 
4) What should you do if you have questions about this study?  
5) Who should you call if you feel you have been harmed in this study? 
6) What are the risks of participating in this study?  
7) What are the benefits of participating in this study? 
 
Veterans who cannot adequately answer these questions will be excluded from participating. 
Veterans who provide informed consent and HIPAA authorization will receive signed and dated 
copies of the informed consent and HIPAA forms. 
 
Adverse Events 
Significant adverse events are not expected. For the purposes of this study, adverse events are 
defined as any newly identified medical diagnoses noted by medical personnel, or symptoms 
reported by the participant, which are directly related to participation in the study and occur 
during the administration of testing/treatment or appear shortly thereafter. Participants will be 
instructed to contact the principal investigator if they believe they have potentially experienced 
an adverse event. Any adverse event will be reported to COMIRB by the PI in keeping with 
COMIRB regulations 
Data Analysis Plan 
Analyses will be descriptive in nature, although variability and precision estimates (95% 
confidence intervals [CIs]) will be provided for acceptability and feasibility summary statistics. 
Results will be presented across participants and individually for each group. Sample Size. 

Arean and Kraemer recommend 20-30 participants per condition for a “dress rehearsal for the 
clinical trial” (p. 95).16 We will enroll 35 participants per condition to account for attrition.  
 
Aim 1: Acceptability. To examine whether participants find ACT for Life acceptable (i.e., ≥ 70% 
of participants with CSQ ≥ 24), we will compute the proportion of participants who found the 
intervention acceptable. If fewer than 70% of participants find it acceptable, we will turn to the 
qualitative data collected with the NEII and RT-T/C to determine areas for improvement. To 
examine acceptability qualitatively, we will employ qualitative  description and analyze NEII 
responses using qualitative content analysis.17,18 
 
Aim 2: Feasibility. a) Participant recruitment rates. Recruitment rates will be monitored to 
determine the feasibility of recruiting enough participants for a future efficacy trial. The 
proportion of eligible patients will be reported as the number of patients who meet criteria for 
inclusion in the study out of all of the patients who are admitted to the unit during the study 
period. This proportion will be compared to the a priori ≥ 50% eligible criterion for feasibility. 
Similarly, the proportion of eligible and willing patients out of all eligible patients will be 
compared to the a priori feasibility criterion of ≥ 30% of eligible patients willing to participate. 
b) Treatment Fidelity. To examine whether ACT for Life can be delivered as intended (≤ 15% of 
deviations for each clinician across participants on the treatment fidelity checklist), the 
proportion of sessions in which each clinician achieved acceptable fidelity out of all of the 
clinician’s sessions will be reported for all clinicians. If treatment fidelity is less than desired, 
qualitative review of the fidelity checklists will be used to identify areas of difficulty and inform 
clinician training procedures and revisions to the treatment manual. c) Participant completion 
of intervention. The proportion of participants randomized to the ACT condition who 
completed all three modules of the intervention out of all participants randomized to the ACT 
condition will be computed and compared to the a priori ≥ 70% criterion. If fewer than 70% of 
participants were able to complete the intervention, the clinicians will identify barriers (e.g., 
too much treatment content, participant fatigue, early hospital discharge, etc.) and review 
reasons for any instances of treatment discontinuation (assessed by RT-C/T). These factors will 
inform revisions to the treatment manual and implementation procedures. d) Participant 
completion of study procedures. The proportion of participants not completing the three-
month follow-up (i.e., participants LTFU) across both groups relative to all participants enrolled 
in the study will be calculated and compared to the a priori ≤ 30% LTFU feasibility criterion. If 
greater than 30% of participants are LTFU, the study team will review known causes of attrition 
(e.g., participant relocation, unable to contact, etc.) and integrate additional participant 
retention measures for future studies (e.g., increased compensation, more frequent reminders, 
travel assistance) and adjust target enrollment numbers to ensure adequate power to test the 
efficacy of the intervention. 
 

Aim 3: Characterize functional outcomes and self-harm behaviors. We will provide descriptive 
statistics, including estimates of variability, for each of the candidate outcome measure at 
baseline and one-month and three-month follow-up assessments. Statistics will be reported 
across participants and separately for each group. (a) Valued Living. “Progress living 
consistently with self-defined values” will be operationalized as change in each participant’s 
VLQ consistency score between the baseline and follow-up assessment. (b) Engagement in 
Functional Behaviors. Progress in functional engagement will be reported as the change in IPF, 
OQ-45, and PROMIS measures between baseline and follow-up assessment. (c) Objective 
treatment engagement. Engagement in outpatient mental health treatment will be determined 
using medical record review and reported categorically as the proportion of participants having 
attended at least one individual mental health appointment, out of all participants. (d) Suicide 
attempts. Suicide attempts will be reported based on a combination of self-report (C-SSRS) and 
medical record review. When both sources of data are available they will be compared for 
consistency, any discrepancies will be clarified. If one source of data is missing, the other will be 
used to determine whether any suicide attempts occurred during the follow-up period. The 
proportion of participants who attempted suicide will be reported. Descriptive data on suicidal 
ideation and planning will also be reported. Finally, the magnitude of missing data will be 
calculated for all outcome measures to help inform selection of outcome(s) for an efficacy trial.  
 
 

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