Pilot Test of a Self-Management Program for Completers of Trauma-Focused Therapy
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sponsor: VA Office of Research and Development

PROTOCOL: #4735-B Pilot Test of a Self-Management Program for Completers of Trauma-Focused 
Therapy 
VERSION DATE: 4/9/2019 
Principal Investigator: Shannon Kehle-Forbes, PhD, LP 
NCT03225859 
Page | 1  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
2 | P a g e  
 
 
 
 2. Specific Aims. Annually, the Veterans Health Administration (VHA) provides care for over 610,000 
Veterans with PTSD.1 Left untreated, PTSD is often chronic and is associated with depression and other 
comorbidities, functional impairments, poor quality of life, and suicidality.2-5 Fortunately, the two evidence-
based trauma-focused therapies (TFTs), prolonged exposure and cognitive processing therapy, significantly 
reduce the suffering associated with PTSD for a majority of Veterans.6-9 In addition to improvements in PTSD 
symptomology, Veterans who participate in a TFT report improvements in quality of life as well as social and 
role functioning.6;10 Given their positive impact on the lives of Veterans, TFTs have been widely disseminated 
throughout VHA and an estimated 16,000 Veterans completed a TFT in the past year.11  
Despite their effectiveness, our pilot data suggest that over 90% of Veterans who complete TFTs continue to 
perceive a need for mental health treatment; Veterans attended only slightly fewer mental health appointments 
in the six months following TFT completion than in the six months prior to initiation. The VA / Department of 
Defense (DoD) PTSD Clinical Practice Guidelines recommend that Veterans who demonstrate a full remission 
of symptoms and improvement in functioning following TFT should discontinue psychotherapy, and those who 
experience a partial response should decrease the frequency and intensity of care.12 However, the guidelines 
do not provide recommendations for how to effectively reduce care such that treatment gains are maintained, 
and no evidence-based strategies for reducing the intensity of psychotherapy exist. Further, the goals of post-
TFT mental health care have not been elucidated and, prior to our pilot data collection, Veterans’ perceived 
needs for this care had not been assessed. In order to better understand Veterans’ post-TFT treatment needs, 
we conducted qualitative interviews with recent TFT completers. Full and partial TFT responders reported that 
they wanted to continue to engage in mental health services in order to practice and apply skills learned during 
therapy with the goal of maintaining or building upon treatment gains. Veterans expressed low self-efficacy for 
being able to meet these goals without the support of their therapists and feared relapse without ongoing 
mental health services. 
These expressed treatment needs are particularly well-suited to a therapist-assisted self-management 
approach. Self-management protocols emphasize patients’ (rather than the providers’) roles in managing 
symptoms and have been shown to increase perceptions of self-efficacy.13 A secondary benefit of self-
management is a reduced dependence on the mental health system and, in turn, increased community 
engagement.14 This is consistent with recovery-oriented mental health care which encourages patients to “live 
beyond their illness” through engaging in meaningful activities and exemplifies RR&D’s focus on functional 
outcomes and societal engagement.14 The existing literature on self-management interventions for PTSD has 
demonstrated that such approaches are acceptable, safe, and effective; however, they have exclusively been 
used as stand-alone treatments or as the first step up in a stepped-care model.15;16 We propose the first 
examination of a self-management intervention designed to be used to step down from an intensive course of 
psychotherapy for PTSD. 
The overall objective of this study is to complete stages 1A and 1B of the Stage Model of Treatment 
Development for a therapist-assisted self-management program for Veterans who have recently completed a 
course of TFT for PTSD.17 Specifically, we will achieve the following aims: 
1. Refine a self-management treatment protocol through eliciting feedback from experienced TFT providers on 
a draft of the self-management program. 
2. Conduct a pilot open trial to assess the (a) acceptability of the self-management program components, 
structure, and materials and (b) feasibility of the self-management program (retention and intervention fidelity) 
and the study approach (screening, recruitment, assessment process). 
3. Explore the effects of the program on select outcomes including Veterans’ confidence in managing their 
PTSD (self-efficacy) and the downstream effects of improved self-management on functioning, quality of life, 
community engagement, and mental health symptoms. 
 
To achieve Aim 1, we will conduct semi-structured individual interviews with a sample of TFT providers (n = 
10-12), during which participants will be asked to provide feedback on the planned components and structure 
of the self-management program. To achieve Aims 2 and 3, we will enroll twelve Veterans in a non-
randomized, open-trial pilot test of the intervention at the Minneapolis VA Healthcare Systems (VAHCS). 

 
3 | P a g e  
 
Enrolled Veterans will complete survey batteries immediately post-TFT, and survey batteries and qualitative 
interviews two weeks after the final self-management program therapist contact. Findings from this project will 
strongly position us to apply for Merit funding to conduct a randomized clinical trial (Stage 2 of the Stage Model 
of Treatment Development) of this innovative self-management program designed to enable Veterans to take 
primary ownership of their PTSD-related symptoms and functioning following a successful course of TFT. 
2A. Background. 
2A1. Background & Rationale for the Proposed Study. Posttraumatic stress disorder (PTSD) is a prevalent 
and debilitating condition. Estimates of the lifetime prevalence of PTSD among Veterans who served in a 
combat zone range between 13% and 17%.18;19 Left untreated, PTSD fails to remit in one-third of cases and 
chronic PTSD is associated with diminished functioning, lower levels of social support, poor quality of life, poor 
physical health, and increased suicidality.2;4;5;20;21 Fortunately, efficacious treatments for PTSD exist. Trauma-
focused therapies (TFTs; prolonged exposure [PE] and cognitive processing therapy [CPT]) have larger 
evidence bases than any other treatments for PTSD and have been found to be effective across a wide range 
of Veteran populations.6;8;22-24 Further, gains achieved in TFTs have been shown to persist for up to ten years 
post-treatment.25 In addition to symptom reduction, completion of TFTs have been shown to have a positive 
impact on physical health, social and work functioning, quality of life, and life outlook.6;10;26 Given these 
benefits, VHA has mandated that TFTs be made available to all Veterans with PTSD.27 In order to achieve this 
goal, VHA launched the Mental Health Dissemination Initiative which was designed to create a nationwide 
workforce trained to deliver TFTs.11 This implementation has led to an ever-increasing number of Veterans with 
PTSD completing TFTs and experiencing reductions in symptoms and improvements in functioning. 7;28 
Despite the significant improvements that result from TFTs, Veterans who complete the treatments 
continue to seek mental health care. Although completion yields a modest reduction in mental health service 
use in the year following completion as compared to the year prior to initiation, our pilot data demonstrate that 
Veterans attend an average of one mental health appointment every other week in the six months after TFT 
completion (see 2A.3.1 for description of prior work).29;30 Further, among a small sample (N = 23) of Veterans 
who completed TFTs, the vast majority of whom perceived improvements resulting from therapy, 88% reported 
additional mental health needs.26 Prior to our pilot data collection, Veterans’ reasons for continuing to engage 
in mental health care following completion of TFTs that yielded improvements in symptoms and functioning 
were unknown. Despite the documented stability of gains achieved during TFTs, our data demonstrate that the 
primary post-TFT mental health treatment need among completers who experienced at least a partial 
improvement in PTSD symptoms is support for additional practice and reinforcement of skills learned in TFT. 
Veterans expressed low self-efficacy for maintaining or building upon their existing gains and believed 
continued contact with their TFT therapist would increase their likelihood of success (see section 2A. 3.2). 
These treatment needs are particularly well-suited to a therapist-assisted self-management approach. 
Self-management (SM) protocols teach patients to be responsible for the day-to-day management of their 
symptoms, thereby emphasizing patients’ (rather than providers’) roles in wellness.13 This occurs through 
promoting the daily application of illness management skills, encouraging the maintenance and/or development 
of meaningful activities, and managing emotions that arise during the SM process.13;31 Participation in SM 
programs has been shown to increase patients’ self-efficacy in managing their illnesses in a variety of settings 
and contexts and studies have demonstrated the mediating role of increased self-efficacy on positive 
outcomes.13;32;33 Further, SM is consistent with a recovery-oriented mental health orientation, which also 
emphasizes the role of patients in managing their own health and encourages patients to “live beyond their 
illness” through engaging in meaningful activities.14 Thus, a second potential benefit of a SM approach is 
increased community engagement, which could result either directly from SM activities that encourage 
participation in meaningful activities or indirectly through reduced dependence on mental health services.14 
Finally, a SM approach is highly consistent with TFT protocols; continued and increasingly generalized 
application of TFT skills following treatment completion is an explicit goal of both PE and CPT. 34;35 While SM 
programs for PTSD with the goals of increasing knowledge, teaching general coping skills, and facilitating 
treatment seeking have been designed and evaluated, they were developed as stand-alone treatments or as 
the first step up in a stepped-care model.15;16;36;36-38 In contrast, a post-TFT SM program would be a direct 
extension of what was learned in therapy; with the support and guidance of their TFT providers, Veterans 
would continue to manage trauma-related symptoms through the application of TFT skills and extend this new 
knowledge base to cope with additional stressors. 

 
4 | P a g e  
 
2A.2. Significance of the Proposed Work. Using data from the Mental Health Evidence-Based Psychology 
Dashboard, we estimate that more than 17,000 Veterans completed TFTs during the past year. A significant 
majority of these Veterans continue to seek mental health treatment; however, therapists are providing these 
services without the benefit of evidence regarding effective post-TFT care. The VA / Department of Defense 
(DoD) PTSD Clinical Practice Guidelines recommend that Veterans who demonstrate a full remission of 
symptoms and improvement in functioning following TFT should discontinue psychotherapy, and those who 
experience a partial response should decrease the frequency and intensity of care.12 However, the guidelines 
do not provide recommendations for how to effectively reduce care (e.g. step-down) in a manner that is 
acceptable to Veterans and maintains treatment gains, as no evidence-based strategies for reducing the 
intensity of psychotherapy for PTSD exist. This project has the potential to improve the health and well-being of 
Veterans with PTSD and move the field forward by refining and evaluating the first intervention designed to 
help Veterans step-down from active to maintenance mental health services following a successful course of 
psychotherapy. Finally, the project will advance RR&Ds missions of evaluating interventions designed to 
maximize psychological recovery and prioritize functional outcomes and societal engagement. 
 
2A.3. Prior Work.  
2A.3.1. Post-TFT Mental 
Health Service Use among 
Completers in a National VHA 
Sample. Participation in TFTs 
is monitored via templated 
progress notes which are 
available as health factor data 
within the Corporate Data 
Warehouse (CDW). Using 
these template data, we 
sought to quantify 
engagement in mental health services following TFT completion. We identified Veterans who completed TFTs 
between November 2014 and March 2015 (n = 2,183). For those Veterans, we extracted the number and type 
of mental health encounters in the six months following TFT completion and six months prior to the estimated 
TFT initiation date from VHA administrative data sources. While there was a modest reduction in pre- to post-
TFT mental health service use, the data clearly demonstrate that Veterans continue to engage in mental health 
treatment following TFT completion (Table 1). Since these data don’t elucidate the target of these services 
(e.g., why Veterans continue to engage in care), we conducted interviews with TFT completers in order to 
understand Veterans’ perceived post-TFT mental health treatment needs. 
 
2A.3.1. Veterans’ Post-TFT Mental Health Needs. As part of a funded project examining dropout from TFTs 
(PI: Kehle-Forbes; IIR14-030), we conducted interviews with 58 (including 20 women and 25 Operation 
Enduring Freedom [OEF] / Operation Iraqi Freedom [OIF]) Veterans who had recently completed TFT. We 
asked: “What (if anything) did you feel like you needed from treatment after PE/CPT?” A large majority 
reported additional mental health needs. Preliminary thematic analyses revealed that most Veterans with low 
to moderate post-TFT PTSD Checklist (PCL) scores expressed (a) concerns about maintaining gains or (b) 
hope for further improvement with sustained practice.39 Veterans reported needing the following from post-TFT 
treatment: (a) additional practice and reinforcement of TFT skills, (b) support from their TFT therapist in 
continuing to implement the newly learned skills, and (c) additional coping skills. Preliminary analyses suggest 
that these themes did not differ by gender or service era; further, completers of PE and CPT did not differ in 
their post-TFT treatment needs. In summary, Veterans’ report of low-self efficacy and perceived treatment 
needs led us to hypothesize that a therapist-assisted SM program would be an effective post-TFT intervention. 
 
2A.4. Research Design & Method. We will complete stages 1A (therapy manual refinement and creation of 
training materials; Aim 1) and 1B (pilot testing of the intervention; Aims 2 & 3) of the Stage Model of Treatment 
Development.17 To achieve Aim 1, we will conduct semi-structured individual interviews with a sample of TFT 
providers during which participants will be asked to provide feedback on a draft of the SM intervention (data 

 
5 | P a g e  
 
regarding Veterans’ perceptions of post-TFT care needs were gathered as part of our prior work, see Section 
2A.3.1). For Aim 2, we will enroll twelve Veterans in a non-randomized, open-trial pilot test of the intervention 
at the Minneapolis VAHCS and the Northwest Metro VA Clinic (Ramsey, MN). We will assess the programs’ 
acceptability, the dimensions of feasibility delineated by Leon and colleagues, Veterans’ self-efficacy in 
managing PTSD symptoms (the primary mechanism through which the SM program is expected to improve 
outcomes), and a range of Veteran-centered outcomes expected to be impacted by the program.40 Following 
this work, we will be well positioned to apply for Merit funding for Stage 2 of the treatment development 
process (randomized trial testing the program’s efficacy).17 
 
2A.4.1. Aim 1 Methodology (Refine a self-management treatment protocol).  
Sample Identification & Recruitment. Participants will be ten to twelve TFT providers at the Minneapolis 
VAHCS. To be eligible, providers must be staff providers who have delivered TFT to a minimum of four 
Veterans during the prior twelve months. Eligible providers will be identified via administrative data. To do so, 
we will first identify patients who received at least one session of TFT during the past year. Specifically, we will 
identify all Veterans at the Minneapolis VAHCS with Current Procedure Terminology codes indicative of an 
individual psychotherapy session (90832, 90834, 90837, 90845, 90847) for full or subthreshold PTSD (ICD-10: 
F43.10 - 43.12; F43.8, F43.9) during the prior 12 months. We will then search those records for the presence  
of health factor data generated from TFT templated notes (participation in TFT is indicated via templated 
progress notes available as health factor data in the CDW). For each identified TFT session, we will identify the 
primary provider. Providers who delivered at least one session of TFT to at least four unique Veterans and who 
are verified as being staff providers (via a crosscheck with a list of current staff provided by the Minneapolis 
VAHCS’s PTSD Clinical Team program manager) will be invited to participate via an e-mail from the principal 
investigator. Data maintained by the Evidence-Based Psychotherapy Coordinator indicates that there are 
currently 50 unique TFT providers at the Minneapolis VAHCS; given our success enrolling TFT providers into 
qualitative studies (59% enrollment rate in IIR14-030) we are confident we will be able to reach our recruitment 
target of five to six providers per month over a two-month period. 
Sampling Strategy. In qualitative methodology, there is no equivalent to a power calculation to 
determine the sample size needed to address the research question. Instead, qualitative methodologists agree 
that the objective is to conduct enough interviews to reach “saturation.”41 It has been demonstrated that a 
sample size of six results in the identification of over 90% of high-frequency themes and a sample size of 
twelve results in the identification of 90% of all themes in a homogeneous population.42 Our goal for this aim is 
to identify high-frequency themes. Since our sample of providers will be heterogeneous (e.g. will contain both 
PE and CPT providers), we will initially conduct ten provider interviews, using purposeful sampling to 
guarantee the sample contains at least four providers who deliver each TFT. If after the completion of ten 
interviews, analysis suggests that the major themes differ by treatment (which is not expected based on our 
prior work with Veterans), we will conduct two additional interviews (for a total of 6 PE and 6 CPT providers). 
Data Collection. Prior to the interview, participants will be e-mailed the draft SM program to review so 
that they have familiarity with the program at the time of the interview. Interviews will be conducted in person 
by Dr. Kehle-Forbes and will be audio-recorded and transcribed verbatim. A semi-structured interview guide 
will be used; interview guides systematize the interview (e.g., ensure that the same topics are explored within 
each interview), while also allowing for the emergence of new themes and the development of rapport. 43 
Interview domains of inquiry will be conceptually informed by the “appropriateness” domain of Levesque et al.’s 
Patient-Centered Access to Health Care framework, which posits that fit between services and patient needs, 
the timeliness of the intervention, the technical (e.g., intervention components and materials) and interpersonal 
(e.g., therapeutic contact) aspects of a treatment, and its effectiveness all impact a patients’ likelihood of 
engaging in and adequately benefiting from a service.44 As such, providers will be asked if the proposed goals 
and format (frequency and type of therapist involvement) of the program fit Veterans’ post-TFT needs, what 
existing components may be unnecessary, what content is missing, what they like and what they think could be 
improved for each existing program component, what strategies and materials they currently use to help 
patients meet similar goals, and perceived training needs (see draft interview guide in the Appendix). 
Self-Management Intervention. The SM program is cognitive-behavioral (CB) in its theoretical 
orientation and is conceptually rooted in the Supportive Accountability model of self-management and 
Bandura’s CB theory of self-efficacy45;46. It is also grounded in evidence regarding the characteristics of 

 
6 | P a g e  
 
effective SM programs. Effective SM interventions must 1) facilitate problem solving, 2) guide decision making 
(help patients identify normal fluctuations in symptoms and those that require provider involvement), 3) 
encourage the use of existing resources (e.g., other SM or community resources), 4) promote an ongoing 
relationship with providers, 5) support action (e.g. goal setting), and 6) be tailored to the patient. 13 The program 
is designed to be used by completers of both PE and CPT. While the two TFTs are comprised of different 
components, 
both are rooted 
in CB theories of 
behavior change 
and teach CB 
strategies. Thus, 
this SM program 
which applies 
CB principles to 
increase self-
efficacy for 
managing PTSD 
symptoms is 
consistent with 
both 
approaches, 
even though 
some of the 
specific skills or 
strategies for 
which self-
efficacy is being 
developed will 
differ. Our 
confidence in the 
utility of 
developing one 
program for both 
TFTs is bolstered by our prior work examining post-TFT treatment needs (Section 2A.3.1). The overall 
objectives of the therapist-assisted self-management program are to increase Veterans’ self-efficacy for 
managing their PTSD, enable the maintenance or building upon gains made in TFT (e.g. formalize the 
expectation for continued practice of TFT skills and provide structure for the ongoing use of skills), and 
encourage engagement in meaningful activities. The program’s components, the element of effective SM 
programs 
addressed by each 
component, and the 
specific goals 
associated with the 
components are 
outlined in Table 2 
(strategies that will 
be employed within 
each component 
are expanded upon 
in the detailed 
outline of the 
intervention 
included in the Appendix). TFT therapists will assist Veterans with tailoring their plan to reflect their goals, 

 
7 | P a g e  
 
strengths, and the TFT completed (PE and CPT modules will be available for components that require TFT-
specific content; e.g. continued practice of TFT skills). The draft program proposes four planned therapist 
contacts over the ten weeks following TFT completion (Table 3). Specifically, TFT therapists will meet with 
Veterans in person or through V-tel at the conclusion of TFT (SM intervention introduced during an expanded 
final TFT session), by phone for a brief check in two weeks after TFT completion, in person or through V-tel 
approximately four weeks after TFT completion, and by phone ten weeks after TFT completion. Therapists will 
also be available for additional contact as needed by Veterans; however, as Veterans gradually develop 
greater self-efficacy in managing their PTSD symptoms, their need for therapist contact should decrease. 
Intervention development and refinement is ongoing and will continue until immediately prior to the Aim 2 
therapist training. 
Data Analysis and Intervention Refinement. We will utilize an efficient, rapid turn-around analytic 
approach well-suited to short-term projects, interviews that use targeted guides, and projects that lend 
themselves to straightforward explanatory analyses.47 This process improves on past rapid procedures through 
its systematic, rigorous approach, and is less time and resource intensive than traditional analytic techniques. 47 
This approach uses data reduction, rather than coding, as the first step of analysis. Following transcription of 
the first three interviews, Dr. Kehle-Forbes (with feedback from co-investigators) will develop a draft template 
that will be used to summarize each transcript. The template will include sections for each main topic of inquiry, 
unexpected findings, and exemplary quotes. After fielding the template and making any necessary revisions, 
Dr. Kehle-Forbes and the project coordinator (trained by Dr. Kehle-Forbes) will carry out the data reduction 
process. After all transcripts have been summarized, the project coordinator will transfer the summary points to 
a data matrix that organizes the summary points for each main topic of inquiry. Finally, following a meeting 
during which each investigator will provide their impression of the matrix contents, Dr. Kehle-Forbes will create 
a memo summarizing the findings and noting key themes. The findings will be used to refine the draft 
intervention prior to the start of Aim 2. Some examples include (a) a program component may be added to 
address a post-TFT treatment need frequently cited by providers as missing from draft program (if addressable 
within a self-management framework), (b) providers’ existing strategies and materials used to address program 
components may be adapted for use with providers’ permission, (c) the timing or amount of therapist contact 
may be modified, or (d) the number of components with TFT-specific modules may be expanded. 
 
2A.4.2. Aim 2 (Conduct a pilot open trial to assess the (a) acceptability of the SM program and (b) feasibility of 
SM program and the study approach) and Aim 3 (Explore the effects of the SM program) methodology.  
Sample Identification and Recruitment. Participants will be twelve Veterans at the Minneapolis VAHCS or 
Northwest Metro VA Clinic who experienced a clinically-significant improvement in PTSD symptomology (e.g., 
a decrease of at least 10 points on the PCL) following a course of individually-delivered TFT with a provider 
trained to deliver the SM intervention (study therapist). While the Stage Model of Treatment Development does 
not recommend a sample size for stage 1B activities, published accounts of psychotherapy treatment 
development frequently report on samples of ten to twelve participants.48-51 Potential participants will be 
identified via referrals from study therapists; study therapists will refer their own patients to whom they 
will then deliver the intervention. To facilitate this process, we will identify potential participants via 
administrative data and notify study therapists that they are treating a Veteran who may be eligible for 
the study. We will first identify potential participants using the method described in Aim 1 Sample 
Identification (identification of Veterans who received an individual psychotherapy session for full or 
subthreshold PTSD and who have health factor data indicative of TFT delivery by one of the study 
therapists). Veterans who have attended at least six PE or eight CPT sessions (e.g., those nearing 
treatment completion as Veterans will be enrolled in the study immediately prior to treatment 
completion) will be selected for manual chart review, which will be used to confirm TFT delivery and 
verify additional inclusion criteria. Study therapists will introduce potential participants to the study; 
with the Veterans’ permission, study staff will then contact him/her to describe the project in greater 
detail and ensure eligibility. Participants will complete informed consent with study staff one to three 
weeks before their final TFT session. If unable to complete during that timeframe, then informed 
consent will be completed immediately prior to their final TFT session. In some instances, Veterans 
may be mailed consent form and HIPAA to be returned to staff prior to first self-management 

 
8 | P a g e  
 
intervention session. Study staff will set a time to review the consent and HIPAA over the phone 
before the Veteran is asked to sign, date, and return the forms. Using data drawn from the Mental 
Health Evidence-Based Psychology Dashboard and published rates of treatment completion and 
response, we conservatively estimate that 64 Veterans will be eligible to participate during the seven-
month recruitment period.7;52 We are confident in our ability to meet our recruitment target of 1-2 
Veterans per month for seven months. To ensure the representativeness of our sample, we will seek 
to enroll at least two women and four OEF/OIF Veterans. 
 
Therapist Training, Consultation, & Fidelity Assessment. The intervention will be delivered by existing 
trauma-focused therapists at the Minneapolis VAHCS (see Dr. Meyers’s letter of support). Study therapists will 
complete a two-hour in-person training with Drs. Polusny and Galovski and will be provided with the finalized 
SM program manual. In order to ensure fidelity and skillful delivery of the protocol, Drs. Polusny and Galovski 
will lead a monthly group consultation for study therapists and be available as needed for additional 
consultation. All SM sessions will be audio-recorded. Drs. Kehle-Forbes and Possemato will develop a fidelity 
checklist for the program and apply that checklist to one randomly-selected SM session for each participant. 
 
Data Collection. Data will be collected via a survey assessment, semi-structured qualitative interview, 
and administrative data. The outcomes of interest for Aims 2 & 3, the source from which the data will be drawn, 
and the specific survey measure (as applicable) are presented in Table 4. Participants will complete a survey 
assessment immediately before their final TFT session (baseline) and two weeks after their final SM program 
contact (follow-up; three months after final TFT session, see Table 3). The baseline survey will be administered 
in person; the follow-up survey will be administered via mail using a modified Dillman protocol frequently used 
by Drs. Kehle-Forbes and Polusny.53 Participants who complete and return a survey will receive $20 as 
compensation. Veterans will also complete a 45-60 minute semi-structured interview two weeks after the final 
SM therapist contact (follow-up). The interviews will follow the methodology described in Aim 1, with the 
exception that interviews will be conducted via telephone. As with Aim 1, the interviews will be conceptually 
informed by the “appropriateness” domain of Levesque et al.’s Patient-Centered Access to Health Care  
 

 
9 | P a g e  
 
 
framework.44 The interviews will assess Veterans’ (1) attitudes regarding the components (e.g. intervention 
targets), structure (e.g. level of therapist contact), and materials (e.g. handouts) of the intervention, (2) 
suggestions for improving the acceptability and efficacy of the SM program,(3) engagement with the SM 
program and materials (including retention), and perceived barriers/facilitators to engaging with the program, 
(4) perceptions of the impact of the program on the intervention targets (e.g. self-efficacy, outcomes associated 
with improved self-management) and exploration of unexpected domains impacted by the program, and (5) the 
completeness and time burden of the survey battery. Veterans will be paid $25 for completing the interview. 
We will also extract the following administrative data: (1) the number of SM sessions attended by each Veteran 
(from electronic medical record; retention), (2) SM program fidelity ratings (see Fidelity Assessment above), (3) 
the number of “as-needed” contacts between Veterans and study therapists (from the electronic medical 
record; intervention fidelity), (4) the number of participants screened each month (screening), and (5) the 
number of eligible Veterans who declined participation (recruitment). 
Data Analysis. To assess the acceptability of the treatment program, we will calculate the percentage of 
participants who report neutral or better treatment credibility and expectancy on the Credibility-Expectancy 
scale and examine the distribution of scores on the Client Satisfaction Scale. We will triangulate these 
quantitative data with qualitative themes related to acceptability (qualitative data will be analyzed using the 
same methodology as described in Aim 1 Data Analysis); specifically, we will create a matrix with themes that 
emerge from the interviews regarding the programs’ acceptability stratified by Veterans’ quantitative Credibility-
Expectancy and Satisfaction scores. Qualitative themes regarding the feasibility domain of program retention 
will be triangulated with administrative data regarding session attendance; a matrix presenting themes 
associated with high, medium, and low attendance (tertiles) will be produced by Dr. Kehle-Forbes. Descriptive 
statistics and graphical representations depicting intervention fidelity, screening, and retention will be 
generated. To assess the feasibility of the assessment approach, we will calculate rates of survey non-
response and item missingness. We will also create a matrix summarizing themes related to the assessment 
process. Finally, we will calculate and graphically display the direction and magnitude of change from baseline 

 
10 | P a g e  
 
to follow-up for self-efficacy and outcomes associated with improved SM; we will also calculate the percentage 
of participants who improved, worsened, and experienced no change for each of these measures. These 
quantitative data will be triangulated with qualitative themes regarding self-efficacy and other program-related 
outcomes; themes and exemplary quotations will be presented in a matrix stratified by self-reported change 
(improved, worsened, no change) on the survey measures. We will also calculate descriptive statistics and pre-
to-post treatment effect sizes for the sample. 
2A.4.3. Limitations. The primary limitation is the project’s focus on individually-delivered TFT given that 
a significant minority of CPT is delivered in groups. Once the efficacy of the SM intervention is established for 
individually-delivered TFT, we plan to modify and evaluate the protocol for use with completers of group TFT. A 
second limitation is our reliance on the templated TFT progress notes for sample identification. The 
implementation of the templated notes has been variable; as such, our sample identification procedures will not 
identify all Veterans who completed a TFT. Because generalizability is not a goal of a pilot examination, we 
chose not to employ a more time and labor intensive method that would identify all TFT completers. Finally, 
provider and system factors not addressed by the SM intervention may impact Veterans’ perceived need for 
post-TFT care. Assessing those contextual variables is beyond the scope of this project; we plan to 
qualitatively explore such factors as part of our Stage 2 evaluation. 
 
2A.5. Project Management. Study activities are detailed in Table 5. Dr. Kehle-Forbes will be responsible for 
the overall conduct and integrity of the project, conduct Veteran and provider interviews, participate in data 
analysis, conduct fidelity ratings, and have primary responsibility for intervention refinement. Drs. Polusny and 
Galovski will develop the therapist training and provide supervision to study therapists. Dr. Possemato will 
participate in developing the therapist training and conduct fidelity ratings. All investigators will participate in 
data interpretation, intervention refinement, and dissemination activities. 
 
 
HUMAN SUBJECTS  
For Aims 1 and 2, we will obtain approval from the Minneapolis VA Health Care System’s (VAHCS) Institutional 
Review Board (IRB) for all research activities involving human subjects. We will also seek union approval prior 
to recruiting providers for Aim 1 activities. With the exception of the providers being interviewed as part of Aim 
1, the project will not involve any other non-Veteran participants.  
 
1. Human Subjects Involvement and Characteristics  
 
Aim 1. We aim to enroll 10-12 trauma-focused therapy (TFT) providers at the Minneapolis VAHCS. Providers 
will be asked to complete a 45-60-minute semi-structured interview during which they will provide their opinion 
on a draft version of a self-management intervention for Veterans who have completed TFTs. The interviews 
will be recorded and transcribed. We will use VHA administrative data to identify potential participants. 

 
11 | P a g e  
 
Providers will be eligible to participate in the interviews if (a) they provided a TFT to at least four Veterans 
during the past twelve months and (b) are staff providers (e.g. not trainees). 
 
Aim 2. We will enroll 12 Veterans that seek care at either the Minneapolis VAHCS or Northwest Metro VA 
Clinic (Ramsey, MN), to participate in the post-TFT therapist-assisted self-management intervention. Veterans 
will be asked to participate in the self-management intervention, complete a brief survey at baseline 
(immediately prior to the first self-management session) and follow-up (12 weeks later), and participate in a 45-
minute semi-structured interview at the follow-up time point. While follow-up procedures are planned to be 
completed 12 weeks after a participant’s first self-management session, there can be unforeseen scheduling 
and logistical conflicts that may push this timeline back. Provider and veteran can handle these circumstances 
on an individual basis and adjust the timeline as seen fit. Follow-up procedures should be completed with the 
goal of 12 weeks after the first self-management session but can be completed up to 16 weeks after the first 
self-management session if unable to stick to the original outlined study schedule. Veterans will be eligible to 
participate if they (a) are about to complete a course of individually-delivered TFT (enrollment will occur one to 
three weeks prior the final session or immediately before the final session) with a provider trained to deliver the 
self-management intervention, (b) experienced a clinically meaningful reduction in PTSD symptomology (PCL 
decrease of at least 10 points) from pre-TFT to the time of the enrollment, (c) at the time of enrollment are not 
planning to initiate another active course of psychotherapy for PTSD in the following three months, (d) are 
willing to participate in a self-management intervention, and (e) can provide informed consent. Veterans will be 
excluded if they have suicidal or homicidal ideation that in the opinion of their TFT therapist needs to be the 
focus of treatment. We will use a combination of provider referrals and administrative data to identify potential 
participants. We will also access VHA administrative data for surveyed Veterans in order to collect contact 
information, demographic characteristics, and mental health service utilization information. 
 
2. Data Sources 
 
The proposed project will use information that we gather through individual TFT provider interviews, Veteran 
surveys, individual Veteran interviews, audio recordings of the self-management sessions, and VHA 
administrative data. VHA administrative data will also be extracted to identify potential Veteran participants. 
The data will be gathered solely for research purposes. 
 
3. Potential Risks 
 
For both Aim 1 and Aim 2, the proposed research poses “minimal risk” to subjects as the risks are no greater 
than what are encountered in routine clinical care. 
 
Aim 1 Risks: The primary risk to provider study participants is the potential loss of privacy and confidentiality; 
during the interviews, participants will be asked to provide their opinion on the self-management intervention, 
not their own personal experiences, so the consequences of a breach of privacy and/or confidentiality are 
believed to be negligible. There are no anticipated economic, physical, or social risks in this study. 
 
Aim 2 Risks: The primary risk is the potential loss of privacy and confidentiality. The other potential risk 
associated is psychosocial stress resulting from either participation in the assessments or the intervention. The 
questionnaires and interviews will ask about current mental symptoms and functioning; the questions are 
consistent with those included in routine clinical care, and participants can refuse to answer any question(s). 
The self-management intervention may cause individuals to experience some psychological or social 
discomfort; however, we believe the intervention is likely to increase their well-being given that they are 
continuing to implement skills that they have already found to be helpful. The potential economic risks include 
potential loss of wages and transportation costs associated with traveling to and participating in the research 
intervention. There are no anticipated physical or social risks in this study. 
 
Adequacy of Protection from Risks 
1. Recruitment and Informed Consent 

 
12 | P a g e  
 
Provider Aim 1 Interview Recruitment & Consent: Eligible providers will be invited to participate in a 45 to 60-
minute semi-structured interview via an e-mail from the principal investigator and will be able to either opt out 
of the study or to schedule an interview via e-mail. If providers do not respond to the initial e-mail, they will 
receive an additional e-mail and a follow-up phone call. If we fail to reach or receive a contact back from a 
provider after those contacts, we will assume they are not interested in participating in the study. We anticipate 
this activity will be IRB exempt and therefore will not include informed consent. 
 
Veteran Aim 2 Recruitment & Consent: Veterans who meet eligibility criteria will be introduced to the study by 
their TFT provider. If participants agree to be contacted by the project, we will call participants to invite them to 
participate in the study. Veterans will receive three phone calls; if we fail to reach or receive a contact back 
from a Veteran after those contacts, we will assume they are not interested in participating in the study. Once 
we make contact with a Veteran, project staff will describe the purpose of the study and the risks and benefits 
associated with participating. Study staff will also administer a PTSD Checklist via the telephone to verify study 
eligibility. Veterans who are interested in participating in the study will meet in-person at the Minneapolis VA 
Medical Center or Northwest Metro VA Clinic with study staff one to three weeks before their final TFT session. 
If unable to complete during that timeframe, then informed consent will be completed immediately prior to their 
final TFT. If travel is burdensome or Veteran is unable to meet in person, then the Veteran can be mailed a 
consent form and HIPAA to be returned to staff prior to beginning the self-management intervention sessions.  
 
2. Protection Against Risk 
For both Aim 1 and Aim 2, the proposed research poses “minimal risk” to subjects as the risks are no greater 
than are encountered in routine clinical care. The potential risks to study participants include loss of privacy 
and confidentiality, psychosocial stress (any research project with direct contact with human subjects contains 
some risk of deleterious effects due to psychosocial stress), and loss of wages / transportation costs 
associated with study participation. There are no known physical or social risks of participating in the study. 
CCDOR has well-established methods to limit the risk of loss of confidentiality and protect the privacy of 
research participants. 
 
The following procedures will be employed to ensure privacy and confidentiality: 
 
Interviews & Session Audio-recordings: 
1. Participants will be assigned a pseudonym identifier to be used instead of actual names in the audit trail, 
interview transcripts, and interview labels. 
2. The only copy of the key linking actual names to pseudonyms will be kept in a password protected file, 
stored on a secure server. 
3. Other individuals referred to by participants during the interviews will not be referenced by name in the study 
materials but only by salient but non-identifiable characteristics. 
4. All electronic recordings, interview transcripts, and analytic notes will be stored in VA servers. 
5. Handwritten notes will be stored in a locked cabinet in Dr. Kehle-Forbes’s VA office. 
6. At the conclusion of the study, data will be destroyed in accordance with VA policy. 
 
Survey Data: 
1. Veteran contact information will be stored in a SQL server database. A study identification number (StID) will 
be pre-printed onto the survey so Veterans’’ identifying information remains private while maintaining the ability 
to link the survey back to an individual. 
2. The data analyst will construct SAS datasets for analyses. All PHI will be removed from the SAS files, and a 
StID will serve as the only key to the initial data files. The programmer will have the only access to a crosswalk 
file linking StIDs with securely stored initial data files. Once the period for the required data maintenance has 
expired, all data will be destroyed under the supervision of the PI. 
3. Our DART request will include permission to transfer necessary data to a local server to facilitate subject 
recruitment for Aim 1. We will create a separate workspace on a local server accessible only to the project 
programmers/data managers to process CDW abstracted data necessary for identification and recruitment of 
eligible subjects. The CCDOR Core Data Group works with OIT staff to maintain permission, data storage, and 

 
13 | P a g e  
 
server applications. All individuals with server access privileges have clearance to work with PHI. Backups are 
written to secured tapes and data stored in password protected project folders. 
 
The CCDOR Statistical and Data Management (SDM) team maintain several secure servers accessible only 
SDM team members who have been screened and obtained proper security clearance. One common-access 
server contains individual project data. Access to that data is granted only through authorization by the 
principal investigator. Other VA investigators have used these procedures in previous studies and they have 
proved both feasible to execute and acceptable to multiple IRBs. 
The second possible risk is distress among participants. While this risk is unlikely, we will take several steps to 
minimize this risk. Participants will be informed that participation is voluntary, that they may choose not to 
answer any questions and that they may discontinue their participation at any time. Further, we will provide 
participants with the Principal Investigator’s (PI’s) phone number so that participants can contact Dr. Kehle-
Forbes with any questions or concerns. The PI is a licensed clinical psychologist with extensive experience 
working with Veterans with PTSD. Finally, if any study activities cause psychological distress or a psychiatric 
emergency emerges among participants, Dr. Polusny will assess risk and provide appropriate referrals. All 
surveys will be screened upon receipt by study staff. If a psychiatric emergency is reported on surveys (i.e., 
expression of risk for suicide or homicide), Dr. Kehle-Forbes or Polusny will contact the disclosing participant 
by phone, assess risk and safety, and provide the participant with appropriate referrals. We will utilize access 
to local and national mental health resources available through the VA, including the suicide prevention hotline, 
risk assessments through Mental Health during regular business hours (Psychiatry Urgent Care), or the 
facility’s Emergency Room during off hours. 
 
The final risk is economic. Participants may choose to take time off work or may incur transportation costs as a 
result of participating in this study. Every effort will be taken to schedule assessments and therapy sessions at 
times convenient to participants. 
 
All collaborators will have completed appropriate human subjects trainings in the areas of research ethics and 
protection of human subjects. 
 
Potential Benefits of the Proposed Research to the Subject and Others 
There are no direct benefits to participation, although Veterans will receive $20 for completing the Aim 2 
baseline surveys; $20 for completing the Aim 2 follow-up surveys; and $25 for completing the Aim 2 semi-
structured interviews. Thus, Aim 2 Veteran participants can receive up to $65 for participation. Some 
participants may find it interesting to share their opinions. The knowledge to be gained during the course of this 
study may positively impact Veterans with PTSD’s health and well-being. 
 
Importance of Knowledge to be Gained 
Most Veterans who complete trauma-focused therapies (TFTs) for PTSD continue to seek mental health 
treatment; however, therapists are providing these services without the benefit of evidence regarding effective 
post-TFT care. The VA / Department of Defense (DoD) PTSD Clinical Practice Guidelines recommend that 
Veterans who demonstrate a full remission of symptoms and improvement in functioning following TFT should 
discontinue psychotherapy, and those who experience a partial response should decrease the frequency and 
intensity of care (e.g. step-down). However, the guidelines do not provide recommendations for how to 
effectively reduce care in a manner that is acceptable to Veterans and maintains treatment gains. This project 
has the potential to improve the health and well-being of Veterans with PTSD and move the field forward by 
refining and evaluating the first intervention designed to help Veterans step-down from active to maintenance 
mental health services following a successful course of psychotherapy. Further, the project will advance 
RR&Ds missions of evaluating interventions designed to maximize psychological recovery and prioritizing 
functional outcomes and societal engagement. 
 
Data and Safety Monitoring Plan 
Privacy protections: All study data will be stored on CCDOR’s secure data servers. CCDOR protects data 
collected for the purpose of conducting research projects at a level higher than that provided for clinical 

 
14 | P a g e  
 
encounters. We use “stand-alone,” secure data servers that are accessible only to designated, security-
cleared, and trained personnel and data are de-identified as quickly as is feasible. Details about CCDOR’s 
specific data privacy assurance procedures to be employed for this study are provided below. 
 
Maintaining Secure Servers: CCDOR maintains three secure computer servers that are protected under the 
Minneapolis VAMC Windows 2000 network. All individuals with administrative access privileges to the Center’s 
servers, including IRM personnel and the CCDOR SDM Team, have been screened and assigned a security 
clearance putting them in trusted positions of the hospital with clearances to work with patient level data. 
These individuals and their access to the CCDOR servers is ultimately monitored and controlled by Sean 
Nugent, Senior Program Analyst for the CCDOR Statistical & Data Management Team. IRM’s access to the 
data is strictly limited to backing up server data, which prevents catastrophic loss of data. Backups are written 
to tapes that are stored in a secure location accessible only to IRM personnel. CCDOR’s Statistical & Data 
Management Team members maintain permissions, data storage, and all server applications. 
 
Organization and Access to Research Data: With the exception of one server, named the “CCDOR Server,” 
only the CCDOR Statistical & Data Management Team has access to remaining Center servers. Data on the 
“CCDOR Server” are organized by projects within folders designated by each investigator. Only members of a 
given project have access to a specific project folder on the “CCDOR Server.” Even then, access to project 
data is obtained through Windows authentication (i.e., PIV card). It is virtually impossible for any person 
without a login name and password to the VAHCS hospital’s domain network to access data on the Center’s 
servers. Thus, all data housed on the “CCDOR Server” is extremely secure, and access by unauthorized 
persons highly unlikely. 
 
Securing Confidential Research Data: Primary data (e.g. interviews transcripts and survey responses) are 
identified only by participant number. The original data sources (e.g. digital recordings and paper notes) will 
either be kept in locked cabinets within a locked room or stored in a secure folder stored on the CCDOR 
server. Only individuals with a need to access the data, as vetted by the project’s Principal Investigator are 
granted access. Even then, only the absolute minimum number of data elements is released. This protects the 
integrity of the data as well as its confidentiality. 
 
Inclusion of Women and Minorities 
Women and minorities will be represented in our study sample; all Veterans who complete TFT at the 
Minneapolis VAHCS who meet our inclusion criteria are eligible to participate. We will purposively sample 
women Veterans, with the goal of recruiting at least two women for Aim 2 activities. We will not purposively 
sample for race / ethnicity, but we anticipate that our sample will reflect the demographics of the population; 
given the demographic makeup of the Minneapolis VAHCS (82% White, 10% African American or Black; 3% 
Hispanic in the outpatient PTSD treatment program), we anticipate the majority of our sample will be White. 
 
Inclusion of Children 
All study subjects are expected to be 18 years of age or older.