Adaptive Disclosure: A Combat-Specific PTSD Treatment
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sponsor: Veterans Medical Research Foundation

 
 
 
                                          Protocol Proposal Page #  
COVER SHEET ........................................................ 1 
TABLE OF CONTENTS .................................................. 2 
I. PROJECT SUMMARY ................................................. 3 
A. Abstract 
3 
B. Key words 
3 
C. Abbreviations used 
3 
D. Key personnel 
4 
E. Human use assurance statement 
6 
F. Sub-investigators 
7 
G. Budget summary 
8 
H. Detailed budget list 
8 
II. PROJECT DESCRIPTION ............................................ 8 
A. Background & Significance 
8 
B. Specific Objectives 
10 
C. Previous Work By You Related To Proposal 
10 
D. Research Design 
11 
 
1. General Approach 
11 
 
2. Methods 
11 
 
3. Retrovirology Research 
15 
 
4. Investigational Drugs/Devices/Biologics Research 
15 
 
5. Statistical Analysis 
16 
 
6. Military Relevance/Operational Use 
18 
E. APPLICATION TO USE HUMAN SUBJECTS 
19 
 
1. Subject Population With Inclusion/Exclusion Criteria 
19 
 
2. Protected Population 
21 
 
3. Subject Recruiting/Consent Process 
21 
 
4. Experimental Procedure(s) 
22 
 
5. Research Material Collected 
22 
 
6. Protection of Patient Privacy 
22 
 
7. Risks 
23 
 
8. Radiation or Laser Exposure 
23 
 
9. Justification of Risks 
23 
 
10. Minimization of Risks 
23 
 
11. Medical Monitor 
25 
 III.  DATA COLLECTION SHEET AND QUESTIONNAIRE .................... 26 
  
IV.  CONSENT FORM, INFORMATION SHEET, OR WAIVER               26 
   V.  BIBLIOGRAPHY ............................................... 27 
  VI.  CURRICULUM VITAE ........................................... 31 
 VII.  DECLARATION OF CONFLICT OF INTEREST ........................ 32 
VIII.  SPECIAL INFORMATION AND SUPPLEMENTARY DOCUMENTATION ........ 33 
  IX.  APPENDIX ................................................... 34 
A. Review Signatures 
34 
 B. Department Support Statement ............................... 35 
 C. Committee Minutes .......................................... 36              
 
 
 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
Updated February 2016March 2018 
 
                                                       
 
 
2 
I. PROJECT SUMMARY 
 
    A. ABSTRACT: 
 
Many Marines and Sailors return from deployment with mental health 
problems related to their experiences. One such problem is 
posttraumatic stress disorder (PTSD), which involves symptoms such as 
persistent unwanted memories of traumatic events, avoidance of 
reminders of the events, excessive watchfulness, jumpiness and 
irritability. Current therapies for PTSD focus chiefly on fear related 
to life-threat and were developed chiefly on civilians.  We developed 
and piloted tested a psychological treatment for PTSD specifically for 
service members who suffer not only life-threat, but also traumatic 
loss and inner conflicts from morally challenging experiences.  This 
intervention, Adaptive Disclosure (AD) is an eight-session PTSD 
treatment that helps Marines to identify unhelpful beliefs about a 
traumatic event and find ways to move forward. Preliminary clinical 
data suggests that AD is acceptable to Marines, feasible to implement, 
and safe and that it reduces PTSD and depression. The primary 
objective of this randomized controlled non-inferiority trial is to 
determine whether or not AD is as least as effective as Cognitive 
Processing Therapy, cognitive only version (CPT-C), which is an 
empirically validated and commonly used PTSD treatment. 
We plan to recruit 266 Marines for this project. They will be randomly assigned 
to AD or CPT-C and followed during and after treatment. The groups will be 
compared on measures of mental health (particularly PTSD and depression), work-
related functioning, trauma-related beliefs, coping and attitudes about mental 
health care. 
 
  B. KEY WORDS: 
PTSD, psychotherapy, clinical trial 
 
   C. ABBREVIATIONS USED: 
 
AD Adaptive Disclosure 
AE: adverse event 
AHLTA: Armed Forces Health Longitudinal Technology Application 
AUDIT: Alcohol Use Disorders Identification Test 
AUDIT-C: Alcohol Use Disorders Identification Test-consumption items 
CAPS: Clinician Administered PTSD Scale 
CFR: Code of Federal Regulations 
CONSORT: Consolidated Standards of Reporting Trials Statement 
COSI: Combat and Operational Stress Injury 
CPT: Cognitive Processing Therapy 
DSMB: Data Safety Monitoring Board 
DSM-IV: Diagnostic and Statistical Manual of Mental Disorders, Fourth 
Edition 
EMDR: Eye Movement Desensitization and Reprocessing 
HRPO: Human Research Protections Office 
IPG-13: Inventory of Prolonged Grief 
IRB: Institutional Review Board 
NHCP: Naval Hospital Camp Pendleton 
NMCSD: Naval Medical Center San Diego 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
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OEF: Operation Enduring Freedom 
OIF:  Operation Iraqi Freedom 
OND: Operation New Dawn 
ORP: Office of Research Protections 
PCL-M: PTSD Checklist, Military Version 
PE: Prolonged Exposure 
PHQ-9: Patient Health Questionnaire 
PTCI: Posttraumatic Cognitions Inventory 
PTSD: post-traumatic stress disorder 
RSES: Response to Stressful Experiences Scale 
SAE: serious adverse event 
TAU: treatment as usual 
VA: United States Department of Veterans Affairs 
WHI: Work History Inventory 
 
 
 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
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4 
D.  KEY PERSONNEL [The names listed here must be identical to those names listed in 
Section E.] 
 
 
 
• 
Name, Degree & Grade/Rank 
• 
Phone #  
• 
Cell # 
• 
E-mail address: 
• 
PI, AI, PI(A)*or RM 
• 
Projected Rotation Date 
(PRD) 
• 
% of time devoted to 
this effort 
• 
Organization (e.g. NMCSD) 
• 
Department  
• 
Status (Trainee, Resident, Staff, 
Fellow, DoD Contractor) 
(1) Nancy Lovell, PhD 
760.719.3312 
nancy.b.lovell.civ@mail.mil 
 
NHCP site PI, PRD 
N/A, 5% 
 
NHCP, Mental Health, Staff 
(GS employee) 
(2) Ariel Lang, PhD 
858-246-0631 
ajlang@ucsd.edu 
 
Overall PI 
University of California, 
San Diego / Veterans Medical 
Research Foundation 
(3)  
 
 
(4)  
 
 
(5)  
 
 
(6)  
 
 
(7)  
 
 
(8)  
 
 
 
 
 
 
 
PI = Principal Investigator 
 
* PI (A) = The local Principal Investigator for Administrative purposes (use only if PI is deployed or on extended TAD) 
 
AI = Associate Investigator (please see NMCSD Guidebook for information on requirements of adding associate investigators) 
RM = Research Monitor (formerly referred to as Medical Monitor) 
 
 
 
 
 
 
NOTE:  PLEASE COMPLETE 
This is the  
 
Original or 
X Updated (check one) key personnel listing. 
 
Date Effective:  
 
January 2018 
 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
Updated February 2016March 2018 
 
                                                       
 
 
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D.  KEY PERSONNEL [The names listed here must be identical to those names listed in 
Section E.] 
 
 
 
• 
Name, Degree & Grade/Rank 
• 
Phone #  
• 
Cell # 
• 
E-mail address: 
• 
PI, AI, PI(A)*or RM 
• 
Projected Rotation Date 
(PRD) 
• 
% of time devoted to 
this effort 
• 
Organization (e.g. NMCSD) 
• 
Department  
• 
Status (Trainee, Resident, Staff, 
Fellow, DoD Contractor) 
(1) Ariel Lang, PhD 
858-246-0631 
ajlang@ucsd.edu 
 
Overall PI 
University of California, 
San Diego / Veterans Medical 
Research Foundation 
(2) Shiva Ghaed 
619-524-4051 
Shiva.g.Ghaed2.civ@mail.mil 
NMCSD site PI, PRD 
N/A, 5% 
NMCSD, Mental Health, Staff 
(GS employee) 
(3)  
 
 
(4)  
 
 
(5)  
 
 
(5) Amy Lansing, PhD 
858-246-0631 
alansing@ucsd.edu 
 
AI at NHCP, NMCSD 
University of California, 
San Diego / Veterans Medical 
Research Foundation 
(6) Selena Baca 
858-642-2965 
Selena.baca@va.gov 
AI at NMCSD 
Veterans Medical Research 
Foundation 
(7)  
(8)  
 
 
 
 
 
PI = Principal Investigator 
 
* PI (A) = The local Principal Investigator for Administrative purposes (use only if PI is deployed or on extended TAD) 
 
AI = Associate Investigator (please see NMCSD Guidebook for information on requirements of adding associate investigators) 
RM = Research Monitor (formerly referred to as Medical Monitor) 
 
 
 
 
 
 
 
 
 
 
 
E.  HUMAN USE ASSURANCE STATEMENT 
 
We, the Principal Investigator and Associate Investigators on the above 
NOTE:  PLEASE COMPLETE 
This is the  
 
Original or 
X Updated (check one) key personnel listing. 
 
Date Effective:  
 
January 2018 
 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
Updated February 2016March 2018 
 
                                                       
 
 
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noted research project, have read and understand the provisions of 32 CFR 
Part 219 (Protection of Human Subjects), the Belmont Report, "Ethical 
Principles and Guidelines for the Protection of Human Subjects of 
Research," and NAVMEDCEN SDIEGOINST 6500.9, Human Clinical Investigation 
Program, Institutional Review Board, and the Protection of Human 
Subjects.  The DOD Multiple Project Assurance Number for this facility is 
DOD40005.  We agree to abide by all applicable laws and regulations and 
agree that in all cases the most restrictive regulation related to a 
given aspect of research involving protection of research volunteers will 
be followed during the conduct of this research project.  In the event 
that we have a question regarding our obligations during the conduct of 
this Navy sponsored project, we have ready access to each of these 
regulations, as either a personal copy or available on file from the 
Chairman, Institutional Review Board.  We understand that the immediate 
resource for clarification of any issues related to the protection of 
research volunteers is the Chairman of that committee.  We understand 
that failure to comply with reporting and/or review requirements will 
require suspension or termination of the project. 
 
 
 
PRINT  
NAME, RANK / DEGREE 
POSITION OR 
ROLE 
(PI, AI, MM) 
 
SIGNATURE 
 
DATE 
Nancy Lovell, PhD 
Local PI NHCP 
On file 
 
Ariel Lang, PhD 
Overall PI 
On file 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amy Lansing, PhD 
AI 
On file 
 
 
 
 
 
Shiva Ghaed, PhD 
Local PI NMCSD 
On file  
 
Selena Baca 
AI 
See attached 
 
Genelle Weits 
RM 
On file 
 
Maureen Hallett 
AI 
On file 
 
 
 
 
 
 
 
 
 
 
 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
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F.  SUB-INVESTIGATORS 
 
Sub-investigators are individuals who will be trained in the specifics 
of the protocol and on how to perform the informed consent process 
from prospective subjects.  This does not require the submission of a 
curriculum vitae or listing them as investigators on the Human Use 
Assurance Statement.  However, the Principal Investigator will be 
responsible for providing training to all Sub-Investigators and 
documenting such by listing the names below.  Prior approval must be 
obtained from the IRB, before Sub-Investigators can be utilized.  
Approval can be requested by completing this form and including it 
with the protocol submission.  If approved, the information must be 
updated at the time of continuing review. 
 
1. Will anyone other than the Key Personnel be performing the 
consent process?  (Check one.) 
x Yes 
 
No 
 
 
 
If Yes, provide justification: All work including the consent process 
will be performed by VMRF, UCSD and BVARI personnel, who are supported 
by the extramural award. Personnel will be hired in order to minimize 
the impact of the study on NHCP and NMCSD mental health clinics.  
 
Category (Residents, Staff, Civilian): 
 
Civilian 
 
2. Provide Names and SSNs for all Sub-Investigators in the table 
below.  
 
The following individuals will be sub-investigators on this study.  All 
have/will participate(d) in, and satisfactorily complete(d), training 
in the specifics of this protocol, as well as how to appropriately 
obtain informed consent form prospective subjects. 
 
PRINTED NAME 
Last 4 SSN 
 
PRINTED NAME 
Last 4 SSN 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
Updated February 2016March 2018 
 
                                                       
 
 
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G. BUDGET 
 
Budget Summary or Payment Schedule:  Not applicable.  The project is 
funded by DoD grant entitled “Adaptive Disclosure: A Combat-Specific 
PTSD Treatment,” awarded to Ariel Lang, PhD, MPH (Initiating PI, 
VMRF), Brett Litz, PhD (Partnering PI, BVARI), Amy Lansing, PhD 
(Partnering PI, UCSD). 
 
H. DETAILED BUDGET LIST 
 
This study is funded by the Congressionally Directed Medical Research 
Program, with execution of funding through the Veterans Medical 
Research Foundation. Naval Hospital Camp Pendleton and Naval Medical 
Center San Diego will not receive direct funding for the execution of 
this work; support at NHCP and NMCSD will be defined in the pending 
Cooperative Research and Development Agreement (which will be 
submitted to the IRB when finalized). 
 
II. PROJECT DESCRIPTION 
 
     A. BACKGROUND AND SIGNIFICANCE: 
 
        As of spring 2009, more than 1.8 million U.S. troops have 
served in the wars in Afghanistan and Iraq, with 37% having deployed at 
least twice. Findings from epidemiologic studies of infantry troops in 
the early stages of the wars suggest that 10-18% of combat troops 
experience deployment-related psychological health problems, such as 
posttraumatic stress disorder (PTSD; e.g., Hoge et al., 2004; see Litz 
& Schlenger, 2009; Smith, et al., 2008). Rates of PTSD continue to 
increase as the wars continue (e.g., Milliken, Achterlonie, & Hoge, 
2007). The negative public health impact of PTSD related to combat and 
operational trauma is heightened by its frequent co-occurrence with 
substance abuse (Jacobson et al., 2008), physical health problems 
(Hoge, Terhakopian, Castro, Messer, & Engel, 2007), and functional 
disability (Hoge, Auchterlonie, & Milliken, 2006). Thus, effective 
treatment of PTSD is an important priority for our military personnel 
and veterans. Further, the reach of effective PTSD treatment extends 
well beyond the individual to family members and friends, to the 
employer and colleagues at work, and to the society. 
     The primary evidence-based treatments for PTSD have limitations in 
the military population. Strategies such as Prolonged Exposure (PE) and 
Cognitive-Processing Therapy (CPT) have been shown to be effective, but 
they were developed and tested primarily on civilian women with sexual 
assault and are not specifically tailored to address the unique 
challenges of service members exposed to sustained combat and 
operational stress, trauma, loss, and other war-related adversities and 
conflicts. Consistent with this, effect sizes in PTSD treatment trials 
with Veterans are consistently smaller than those generated in civilian 
trials (e.g., Monson et al., 2006; Rauch et al., 2009; Ready et al., 
2008; Schnurr et al., 2007). PE and CPT also are lengthy and require 
extensive homework, which may not fit the high operation and training 
tempo of the active-duty garrison-life. 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
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     AD was developed to address this need. It is an eight-session 
fully manualized intervention designed specifically for active duty 
Marines and Sailors with PTSD stemming from a variety of traumatic 
deployment experiences (fear-based trauma, traumatic loss, and moral 
injury). The first session is devoted to assessment, psychoeducation, 
using motivational interviewing strategies to help the service member 
clarify what they would like to see happen, and providing a road-map 
about how AD can be used in service of those goals. The middle six 
sessions are devoted to (1) processing the most difficult, pressing, or 
emblematic combat and operational experience, (2) unearthing the 
service member’s evolved understanding of the experience as they move 
forward in their military careers and beyond, and (3) providing 
experiential opportunities for the service member to consider 
alternative, more helpful ways of thinking about the experience, and 
(4) identifying a path towards healing and recovery. The last session 
is devoted to articulating lessons learned, getting and giving 
feedback, wrapping up, and planning for future challenges. AD is based 
on the idea that trauma-related symptoms are sustained because of 
avoidance and maladaptive beliefs about traumatic experience and the 
post-traumatic experience (e.g., Ehlers & Clark, 2000; Resick & 
Schnicke, 1992). Having service members disclose and form a narrative 
of a traumatic event (such as is used in PE) serves two purposes. 
First, the narrative provides an experience to disconfirm the common 
fears that fully remembering and disclosing the event may lead to 
“going crazy,” losing control, or being judged or rejected. By 
providing a positive and/or useful experience with disclosure, patients 
may be more likely to disclose difficult deployment experiences with 
natural support networks (family, friends, fellow service members) or, 
if need be, with formal support services in the military and VA, thus 
avoiding the negative repercussions of avoidance and withdrawal. 
Second, the trauma narrative is used to elicit emotions and beliefs 
that are linked to combat and operational trauma in order to unearth 
tacit or previously unacknowledged maladaptive interpretations. Once 
such beliefs are recognized, the therapist helps the individual to see 
the ways in which these beliefs might be extreme and unhelpful and to 
encourage the consideration of alternative, more useful and adaptive 
appraisals moving forward. This may be accomplished through cognitive 
therapy strategies or through experiential techniques. AD also includes 
behavioral strategies, often assigned as homework, which may include 
exposure to avoided stimuli to address hypervigilance, activities to 
honor the departed to address grief, and ways of “making amends” for 
guilt/shame. 
     Finally, because of its brevity, the goal of AD is to plant 
restorative and healing seeds. We assume that for service members who 
have been exposed to multiple deployments with multiple injurious war-
zone experiences, AD is the start of a healing and recovery process 
that the service member will need to embrace, own, and carry-forward to 
be truly effective. In other words, our goal is to provide an 
opportunity for a course-correction, to help service members get clear 
about where they are and how they would like to be moving forward. AD 
provides a sober but hopeful, evocative and emotion-focused opportunity 
for service members to realize how they have changed as a result of 
combat and operational experiences and to think about who they want to 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
Updated February 2016March 2018 
 
                                                       
 
 
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be moving forward (and how to get there). In AD, we reduce PTSD symptom 
burden and improve functioning because the service member: (a) becomes 
more accepting and less self-condemning; (b) begins to make choices in 
service of wellness and self-care; (c) shares and discloses with 
trusted others; (d) reclaims competence and confidence in military and 
social roles; and (e) is better prepared to seek support and care if 
they need it over time. 
 
     B. SPECIFIC OBJECTIVES: 
 
     The primary objective of this randomized controlled non-
inferiority trial is to determine whether or not Adaptive Disclosure 
(AD), a new combat-specific psychotherapy for PTSD, is as least as 
effective as Cognitive Processing Therapy, cognitive only version (CPT-
C), in terms of its impact on deployment-related psychological health 
problems (specifically PTSD and depression) and functioning. 
 
Primary Specific Aim 1: To determine whether or not AD is as least as 
effective as CPT-C in terms of change in psychological health problems 
over the treatment period. 
Primary Specific Aim 2: To determine whether or not AD is at least as 
effective as CPT-C in terms of change in military-relevant functioning 
over the treatment period. 
 
The project has several secondary objectives. First, because AD was 
developed to be consonant with the Marine Corps culture, we aim to test 
whether AD will be better accepted by Marines than CPT-C. Second, we 
will examine whether AD will be superior to CPT-C in terms of changing 
constructs that are uniquely targeted by AD, namely traumatic grief and 
moral injury. Third, we examine whether AD will be superior to CPT-C in 
terms of increasing resilience and posttraumatic growth. Finally, we 
will examine trauma-related cognition as a mediator of symptom and 
functioning changes. 
 
Secondary Specific Aim 1: To compare the acceptability of AD and CPT-C. 
Secondary Specific Aim 2: To compare the degree of change in grief and 
moral injury in the two treatments. 
Secondary Specific Aim 3: To compare the degree of change in resilience 
and posttraumatic growth in the two treatments. 
Secondary Specific Aim 4: To examine posttraumatic cognition as a 
mediator of treatment-related changes. 
Secondary Specific Aim 5: To complete a qualitative analysis of 
reactions to Adaptive Disclosure at the end of treatment 
 
     C. PREVIOUS WORK BY YOU RELATED TO PROPOSAL: 
 
     Fifty-six Marines have enrolled in an earlier 6-session version of 
Adaptive Disclosure through a clinical demonstration project at Camp 
Pendleton. Complete treatment data is available for 26 of these 
individuals. Responses to our satisfaction measure suggest that AD is 
well received. Out of 20 respondents: 20 agreed or strongly agreed that 
the intervention was helpful, 20 agreed or strongly agreed that they 
would recommend the intervention to other Marines, 17 agreed or 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
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strongly agreed that they would use an intervention like this following 
future deployments (2 felt neutral), 17 agreed or strongly agreed that 
the intervention was tailored to their individual needs (3 felt 
neutral), 16 agreed or strongly agreed that the intervention helped 
them feel more in control (4 felt neutral), and 16 agreed or strongly 
agreed that the intervention helped resolve emotional difficulties they 
had been experiencing (2 felt neutral, 2 disagreed). Nine agreed or 
strongly agreed that the intervention was long enough to make a 
significant improvement on their life (5 felt neutral), but 4 
disagreed, 1 disagreed strongly. This feedback was part of the reason 
for extending the current version of the intervention to 8 sessions. 
There were no serious adverse events. No Marine decompensated or needed 
emergency care. There were no clinically significant exacerbations in 
PTSD, depression or drinking behavior between the beginning and end of 
treatment. 
     Based on data from first 36 individuals who completed treatment, 
AD appears to significantly and positively impact mental health 
symptoms. The average score on the PTSD Checklist – Military Version 
(PCL-M) dropped from 62.3 at pre-treatment to 50.2 after six sessions 
[effect size (Cohen’s d) = 0.80, 90% CI 0.53-1.07]. The average score 
on the Patient Health Questionnaire – 9 (PHQ-9), our measure of 
depression severity, dropped from 14.6 at pre-treatment to 11.4 at 
post-treatment [effect size (Cohen’s d) = 0.6, 90% CI 0.35-0.85]. The 
total score on the Posttraumatic Cognitions Inventory (PTCI) reduced 
from 11.2 to 9.3 [effect size (Cohen’s d) = 0.45, 90% CI 0.19-0.71], 
with the most pronounced differences on the scales assessing negative 
cognitions about the self and world. Finally, the total score on the 
Response to Stressful Experiences Scale (RSES), a measure of resiliency 
after stressful events, increased from 9.7 to 10.9, suggesting improved 
ability to cope with stress in an adaptive way. 
 
 
D. RESEARCH DESIGN 
 
1. General Approach: 
   This project is a randomized noninferiority trial comparing AD to 
CPT-C. 
 
2. Methods: 
Potential participants will be referred by Naval Hospital Camp 
Pendleton and Naval Medical Center San Diego mental health providers 
(refer to Recruitment of Subjects). A partial HIPAA waiver is being 
requested so that providers can give names and contact information to 
study personnel to facilitate scheduling. Individuals who are referred 
will be contacted by telephone by study personnel, who will explain the 
project and offer an initial appointment. If the individual is willing 
to be evaluated for the study, the staff member will set a time for the 
initial evaluation, in which consent will be obtained and inclusionary 
and exclusionary criteria will be assessed. For eligible individuals 
who choose to participate, the baseline self-report measures will be 
completed in this visit as well. During the visit (or within the next 
week if necessary), the individual will be introduced by telephone 
(Boston VA), or in person (San Diego VA), to an assessor who will 
complete a clinician-rated assessment of their PTSD symptoms [using the 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
Updated February 2016March 2018 
 
                                                       
 
 
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CAPS, see Assessment]. This interview will be completed by telephone or 
in person to provide an independent clinical assessment by a mental 
health professional who can remain blind to treatment condition; the 
CAPS retains good psychometric properties when administered in this way 
(Aziz & Kenford, 2004). 
Once eligibility is established, participants will be randomly 
assigned to one of two treatment conditions: AD or CPT-C. The Boston 
site will provide randomization materials ahead of time so that staff 
biases cannot influence group assignment. The participant will begin 
treatment with a study therapist immediately. The therapist will 
contact the participant by phone, email or text message to arrange 
appointments, but no clinical information will be sent by email or 
text. He/she will receive 720 minutes of individual psychotherapy 
delivered as 8 weekly 90-minute sessions of AD or 12 60-minute sessions 
of CPT-C over 8 weeks (ideally scheduled twice a week for the first 4 
weeks and once a week for the second 4 weeks nut some variation is 
permitted); sessions may extend over an additional 2 weeks if needed. A 
brief symptom assessment will be used weekly during treatment. The full 
assessment battery will be repeated at the end of treatment and 3 and 6 
months after treatment (see Assessment). We will contact the 
participant by telephone, email or text to arrange these appointments. 
An effort will be made to retain subjects in the study. Therapists 
will call patients after missed sessions to explore the reasons for 
nonattendance and encourage continuation. In the event that a patient 
does discontinue the treatment (either by dropping out being 
discontinued for clinical reasons), we will attempt to perform a full 
assessment within one week of exit from the trial. Following the 
protocol recommended by the CONSORT statement (Moher, et al., 2001), we 
will keep track of: how many people are referred to the study; how many 
of those participate in screening for the study; how many of those 
screened meet inclusion criteria and how many are excluded by exclusion 
criteria; how many are invited to participate in the study; and of 
those who we invite to participate, how many actually enroll. This 
information will provide an empirical basis for assessing pre-inclusion 
attrition rates and identifying any potential enrollment bias. In 
addition to assessing possible differential refusal and the impact it 
might have on generalizability of findings, we will record the reasons 
patients are excluded from or refuse to participate in the study. This 
will permit us to examine potential differences in rates and reasons 
for study refusal or exclusion. 
 
Assessment 
Initial eligibility will be determined by use PCL-M (total 
score > 34; Weathers, Litz, Huska, & Keane, 1991) immediately 
after consent. In addition, sections A, B, C, K and I of the Mini 
International Neuropsychiatric Interview (MINI; Sheehan et al 
1998) and a brief neuropsychological battery will be administered 
to assess for exclusionary criteria, and the potential 
participant will be queried about homicidality and current mental 
health utilization. The Boston or San Diego site then will 
determine final eligibility by telephone or in-person, using the 
Clinician Administered PTSD Scale (CAPS; Blake et al., 1990). 

Adaptive Disclosure: A Combat-Specific PTSD Treatment  NHCP PI: Lovell, Nancy; NMCSD PI: Ghaed, Shiva   CIP# NHCP.2010.0177        
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Should the Boston site interview someone who is off site, a 
prepared sheet of contact information with Dr. Ghaeds’ and other 
designated NMC staff members phone numbers to intervene in case 
of emergency, will be in possession by the the San Diego 
assessor.Once determined to be eligible, participants will complete the 
full assessment battery, which will be repeated at the end of the 
initial treatment period, 3 months after the end of treatment and 6 
months after the end of treatment except as indicated below. 
Assessments may be completed within 2 weeks of these time points. The 
full battery, the entirely to which is administered to both 
experimental groups, will consist of the following measures. All 
instruments are well-established and frequently used. 
 
Descriptives and Covariates 
Demographic information will be collected, including age, gender, 
race/ethnicity, marital status, education, branch of service, rank, 
military occupational specialty (MOS), length of service, deployment 
history and items which are in standard use in the NHCP Mental Health 
Clinic to help us to characterize the individual’s baseline level of 
impairment. (Administered at baseline) 
The INTRuST TBI Screening Instrument is a 3-item tool to identify 
probable exposure to head injury, modified to include age at which 
endorsed events occurred. 
The Alcohol Use Disorders Identification Test (AUDIT; Saunders, 
Aasland, Babor, de la Fuente, & Grant, 1988) is a brief self-report 
measure of problematic alcohol use. 
A short neuropsychological battery will be administered to assess 
cognitive processes that may have been impacted by head injury or 
psychopathology. These measures include: WAIS-IV Digit Span (~5-10 
minutes), California Verbal Learning Test - 2 (CVLT-2; 15 minutes 
total), DKEFS Trails (~6 minutes), WAIS-IV Letter-Number Span (~5 
minutes). (Administered at screening) 
The mental health service history – Interview supplement will be 
used to detail mental health treatment received prior to study entry 
(at baseline) and since the last assessment. 
 
Primary Aims 
Psychological Health 
The CAPS is the primary outcome measure. This 45–60 minute 
interview yields PTSD diagnostic status as well as a continuous total 
severity score. The scale also assesses social and occupational 
functioning, guilt, and the validity of symptom reports. A question 
will be added in the format of the interview to ask about shame. It 
will be administered by telephone or in person by a trained clinician 
in Boston or San Diego, who is blind to treatment status at the 
beginning and end of the intervention. (Administered before and after 
treatment) 
The PTSD Checklist, Military Version (PCL-M; Weathers, Litz, Huska, 
& Keane, 1994) is a 17-item self-report measure of DSM-IV PTSD 
symptoms. 
The nine depression items from the Patient Health Questionnaire 
(PHQ-9; Spitzer, Kroenke & Williams, 1999) make up a brief self-report 
measure of the severity of depressive symptoms. 

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The Buss-Perry Aggression Questionnaire (Buss & Perry, 1992) is a 
27-item questionnaire assessing physical and verbal aggression, anger 
and hostility. 
Military-Relevant Functioning 
The brief version of the Inventory of Functional Impairment (IFI; 
Marx) is 14-item self-report measure of multiple dimensions of 
functional impairment in active duty service members and veterans. The 
measure will be supplemented with additional questions about military-
specific work functioning. 
The SF-12 is an abbreviated version of the Short Form 36 Health 
Survey (SF-36), which is a measure of health-related quality of life. 
The Physical and Mental Component Summary scales (PCS and MCS) from the 
SF-12 are virtually identical to those derived from the SF-36, and the 
SF-12 has good validity for detecting ill health (Jenkinson et al., 
1997). 
 
Secondary Aims 
Acceptability 
Credibility measure adapted from Borkovec & Nau, 1972. 
(Administered after session 1.) 
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 
1994), an 8-item measure of satisfaction with services received. 
(Administered after the final therapy session) 
The Working Alliance Inventory (WAI; Busseri & Tyler, 2003), a 12-
item measure of rapport/alliance with the therapist.  (Administered at 
the treatment mid-point). 
AD-Specific Constructs 
The Inventory of Prolonged Grief (IPG-13; Prigerson et al., in 
press) is a 13-item measure of bereavement-related distress. 
The Moral Injury Events Scale (MIES; Nash et al., in submission) 
is a 9-item measure of perceived transgressions by the self or others 
and perceived betrayal. 
The short form of the Posttraumatic Growth Inventory (PTGI-SF; Cann 
et al., 2010) is a 10-item measure of five domains of posttraumatic 
growth. 
Mechanism 
The Posttraumatic Cognitions Inventory (PTCI; Foa, Ehlers, Clark, 
Tolin, Orsillo, 1999) will be used to assess changes in trauma related 
cognitions. The PTCI assesses 3 broad categories of posttraumatic 
beliefs known to be associated with poorer posttraumatic adjustment – 
negative beliefs about self, negative beliefs about the world, and 
self-blame. 
 
Before treatment sessions 2-8, both conditions will also complete 
an abbreviated assessment battery [PCL-M, PHQ-9 and AUDIT-C (consisting 
of the first 3 items of the AUDIT)] to monitor weekly symptom changes.  
Assessor Training and Adherence: Dr. Gray will train the assessors 
prior to beginning enrollment unless they can demonstrate prior 
appropriate training. Training will include reading and viewing 
training materials, observation of CAPS administration, and supervised 
administration of at least three CAPS. Each assessor will be considered 
trained on CAPS when he or she “matches” Dr. Gray on three interviews. 
To establish matching, Dr. Gray will co-rate an interview conducted by 

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the assessor. A match occurs when the assessor and Dr. Gray agree on 
the diagnosis and are within 2 points of severity (frequency + 
intensity) on all of the symptom clusters (PTSD criteria B, C, and D). 
If the assessor does not match on three interviews after five attempts, 
Dr. Gray will determine whether additional training is necessary or if 
the assessor needs to be replaced. 
Dr. Lansing will train the personnel who will be administering the 
neuropsychological battery. Training will include didactics about the 
administration and scoring of the instruments, observation of 
administration and scoring, observed administration and scoring, and 
periodic monitoring. 
 
Intervention 
 
 
Both AD and CPT-C are manualized interventions. Weekly feedback 
about progress in treatment will be provided to the patient’s mental 
health clinic provider, but details of the approach being used will be 
excluded so that providers remain blind to the randomization. The blind 
can be broken if necessary for crisis management. Providers will 
receive a summary of progress after the post-treatment assessment has 
been completed. AD is outlined in the table below. 
 
Adaptive Disclosure: Treatment Outline 
 Session 1:  Assessment and Introduction to AD 
Welcome, introductions 
Assess current functioning, desired change (hopeful and/or realistic?), how 
we can help, what Marine was like before deployment, how Marine is now 
Discuss change due to trauma and reclaiming old self 
Introduce “adaptive disclosure” 
Psychoeducation: Combat and Operational Stress Injury (COSI) 
Give instructions for impact statement 
 
Sessions 2-7: Exposure-Based Activation, Identification and Processing 
of Deployment-Related Difficulties 
Review week and impact statement 
Trauma narrative 
Process appraisals and meaning and implications of event. Go to Supplements 
as appropriate. 
Review session and grounding/relaxation (if needed) 
 
Grief Supplement 
Moral Injury 
Supplement 
 
3a.  Education about 
grief 
3b.  “Empty Chair” 
for grief 
3c.  Discuss ways to 
honor the dead 
3a.  Education about 
moral injury 
3b.  “Empty Chair” 
for moral injury 
3c.  Discuss ways to 
make amends or move 
on 
 
 
Session 8: Wrap-up and Planning for the Long Haul 
Review progress 
Identify/discuss areas to continue to work on, including triggers, self-

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care, social reattachment/reengagement 
Wrap-up 
 
Therapist Training and Adherence: Therapists will have a doctoral 
degree in clinical psychology and some experience treating PTSD, 
preferably with active duty military or Veterans. There will be a 
primary AD therapist who delivers only AD and a primary CPT-C therapist 
who delivers only that approach. One additional staff position is 
available for treatment delivery; if a single full-time clinician is 
hired, it will be necessary for this person to delivery both 
approaches. Therapists will be trained in San Diego by Drs. Litz, Nash 
and Rodgers. Training will involve review of the AD or CPT manual and 
supporting materials, intensive supervision of the first two cases and 
weekly group supervision. 
All sessions will be audiotaped and reviewed to ensure sustained 
fidelity to the treatment approach (provided that the participant 
consents). Dr. Litz will review AD cases and Dr. Rodgers will review 
CPT-C cases for adherence. They will review audio recordings of 100% of 
the first 2 cases, 50% of the subsequent 3 cases, and 25% of the next 5 
and 10% thereafter. Drs. Litz and Rodgers can at their discretion 
increase the proportion reviewed for difficult patients or therapists 
needing additional monitoring. Therapists will be provided with prompt 
feedback about their performance. All recordings will be transported to 
the VMRF facility and stored in a locked cabinet in an office in the 
VMRF building. Selected sessions will be transported to Dr. Litz via 
Federal Express or another carrier that allows for tracking. All 
recordings will be destroyed when the participant completes or drops 
out of treatment. 
 
3. Retrovirology Research: N/A 
 
4. Investigational Drugs/Devices/Biologics Research: N/A 
 
5. Statistical Analysis: 
 
Statistical Plan 
Data analysis will be completed by the Boston site and will involve 
the following 
 
Data screening and missing data: Given the assumptions underlying some 
of the analyses described below, tests of normality will be conducted 
and transformation applied where appropriate. In addition, outliers 
will be identified, and corrective action (deletion, adjustment, or 
retention) will be taken depending on the source of the deviation, as 
per Tabachnick and Fidell (1996). Missing data will not be imputed; 
instead, the maximum likelihood estimation in Mplus will be used to 
estimate the models. This method derives the parameter estimates from 
the data that is available. 
 
Pre-treatment equivalence: In order to determine pretreatment 
equivalence, a one-way ANOVA (with treatment condition as the between 
subjects factor) will be conducted on the primary outcome measure, the 
CAPS (indexed as symptom severity, defined as the mean of the sum of 

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the 17 Frequency and Intensity Ratings). For descriptive purposes, 
this analysis will also be conducted on the other outcome and 
moderator variables. In addition, t-tests and chi-square analyses will 
be conducted on demographic variables to determine equivalence across 
groups. Similar analyses will be conducted to compare dropouts and 
completers on pre-treatment and demographic variables in order to 
determine if these groups differ on relevant variables. 
 
Primary Outcome Analysis: We will calculate the mean difference in 
CAPS scores by subtracting the average change in scores for CPT from 
the average change in scores for AD. Then, we will create a 95% 
confidence interval around that difference. If the interval is above a 
non-inferiority margin of -10 points, we will reject the null 
hypothesis (that CPT is superior) and accept the research hypothesis 
(that AD is non-inferior). The non-inferiority margin is based on a 
calculation of a reliable difference in CAPS scores (Monson et al., 
2006).  We will follow a similar procedure for the other primary 
outcome measures (i.e., the PCL-M, the PHQ-9, the IFI, and the SF-12). 
 
Analyses of Clinical Significance: Clinically significant change will 
be calculated by the Jacobson-Truax (Jacobson & Truax, 1991) method, 
as recommended in recent reviews of clinical change indices (e.g., 
Bauer, Lambert, & Neilson, 2004). This method suggests a two-step 
criterion. First, a reasonable cutoff between the 
patient/dysfunctional and non-patient/functional populations is 
established. Jacobson and Traux’s suggested cutoff A, defined as the 
point 2 SDs beyond the range of the pre-therapy mean for the CAPS 
(i.e., cutoff A = Mclinical - 2 SDclinical), will be used. Second, a 
reliable change index (RC) for each participant will be calculated to 
ensure that changes are not due to an artifact of measurement error. 
The RC is computed according to the following formula: RC = (x2 – 
x1)/Sdiff where x1 represents the participant’s pretreatment CAPS 
total score, x2 represents the participant’s posttreatment or follow-
up CAPS total score, and Sdiff is the standard error of difference 
between the two test scores. Sdiff will be calculated from the 
internal consistency of the CAPS at each time point, as suggested by 
Martinovich, Saunders, and Howard (1996). An RC larger than 1.96 
reflects real change (Jacobson & Truax, 1991). Based on the two-step 
criterion, individuals will be classified as recovered (passed both 
cutoff A and RC criteria), improved (pass RC criterion but not cutoff 
A), unchanged (did not pass RC criteria), or deteriorated (passed RC 
criterion but symptom scores increased). 
We will also calculate three other indices of change based on the 
percentage of PTSD cases in each group, the number of treatment 
responders, and the number of participants who exhibit high-end state 
functioning (see Ehlers et al., 2003). Participants will be considered 
responders on a measure if they demonstrate at least a 20% improvement 
from pre-therapy levels (e.g., Ladouceur et al., 2000), and 
participants exhibiting high end-stage functioning will be defined as 
those with total CAPS scores at or below 30 and PHQ-9 scores at or 
below 5. Chi-square analyses between treatment conditions will be 
conducted to compare the proportion within each condition meeting PTSD 

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diagnosis, responder status, and high end-state functioning at post-
treatment and follow-up assessment. 
 
Secondary inferential analyses: The longitudinal nature of the design 
will produce a multilevel or nested data structure (Raudenbush & Bryk, 
2001; Kenny, Kashy, & Bolger, 1998). The lower level, or level-1 data, 
will consist of the repeated measures that will be collected for each 
individual at multiple time points (e.g., pre, post, follow-up, and 
session-by-session outcome data). The level-1 data is nested within 
upper level, level-2, or person-level variables (e.g., individual 
difference variables including treatment group membership, minority 
status, posttraumatic cognitions, etc.). This data structure is 
appropriate for contemporary growth curve modeling techniques (see 
Collins & Sayer, 2001; Singer & Willett, 2003). With these techniques 
(e.g., growth-curve analysis), we will be able to estimate initial 
status and change over time in the outcome variables (i.e., level-1 or 
within-subjects component of the analyses), and examine how these 
coefficients vary as a function of individual difference variables 
(the level-2 or between-participants component of the analyses; e.g., 
gender). In terms of measurement of specific aims: 
 
Primary Specific Aim 1: To determine whether or not AD is as least as 
effective as CPT-C in terms of change in psychological health problems 
over the treatment period. 
As mentioned above, we will chiefly be interested in the results of 
the non-inferiority tests. These results will show whether or not AD 
is as least as effective as CPT-C, in terms of its impact on 
deployment-related psychological health problems (specifically PTSD 
and depression).  
 
Primary Specific Aim 2: To determine whether or not AD is as least as 
effective as CPT-C in terms of change in military-relevant functioning 
over the treatment period. 
 
The results will also show whether or not AD is as least as effective 
as CPT-C, in terms of its impact on functioning. 
 
 
Secondary Specific Aim 1: To compare the acceptability of AD and CPT-
C. 
    We will use an independent sample t test to compare the 
acceptability of the two treatments. 
 
Secondary Specific Aim 2: To compare the degree of change in grief and 
moral injury in the two treatments. 
    We will use a mixed model repeated measures ANOVA to determine 
whether the groups differ in terms of change in grief and moral injury 
over time. A mixed model analysis is advantageous because it uses all 
of the available data; no adjustment is needed for missing data. Also, 
a mixed model analysis does not require sphericity or compound 
symmetry. 
 
Secondary Specific Aim 3: To compare the degree of change in 
resilience and posttraumatic growth in the two treatments. 

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    Analyses for this aim are similar to those described in Secondary 
Specific Aim 2. 
 
Secondary Specific Aim 4: To examine posttraumatic cognition as a 
mediator of treatment-related changes. 
We will use two methods to evaluate whether PTCI mediates the 
relationship between treatment and PTSD symptom severity.  The first 
method is the casual step approach (Baron & Kenny, 1986).  With this 
method, we hope to show that treatment predicts PTCI scores and PTCI 
scores predict PTSD symptom severity.  Also, we hope to show that the 
relationship between treatment and PTSD symptom severity score is 
reduced with the introduction of PTCI scores.  Because this method 
infers an indirect effect but does not test for it specifically, we 
will also employ a bootstrapping procedure. Mplus will be used to 
generate 5000 samples of the data set in order to produce 5000 
estimates of path coefficients between treatment and PTCI scores and 
between PTCI scores and symptom severity scores. Multiplication of 
these two path coefficients will produce a sampling distribution of 
the indirect effect. Thus, there is no need to make an assumption 
about the shape of the sampling distribution (and the standard error 
of the indirect effect; Hayes, 2009), unlike the Sobel test (Sobel, 
1982, 1986). 
 
Secondary Specific Aim 5: To complete a qualitative analysis of 
reactions to Adaptive Disclosure at the end of treatment 
 
As part of the treatment protocol, the therapist queries 
participants about their subjective impressions of the intervention 
and what changes, if any, they attribute to it. We will use 
qualitative methodology to code these responses so that we may 
describe subjective reactions. 
 
6. Military Relevance / Operational Use, if any: 
 
As of spring 2009, more than 1.8 million U.S. troops have served 
in the wars in Afghanistan and Iraq, with 37% having deployed at least 
twice. Findings from epidemiologic studies in the early stages of the 
wars suggest that 10-18% of combat troops experience deployment-
related psychological health problems, such as posttraumatic stress 
disorder, and rates of PTSD continue to increase as the wars continue. 
PTSD itself is impairing, but the burden of the disorder is heightened 
by its frequent co-occurrence with other mental and physical health 
problems.  
The impact of PTSD does not stop with the affected service 
member.  Forty four percent of active duty military in the USA have 
children under the age of eighteen. PTSD symptoms have a substantial 
impact on spousal well-being and the overall functioning of the 
family, leading to problems such as poor parenting, family violence, 
divorce, sexual problems, aggression, caregiver burden and child 
behavioral problems. PTSD also impacts the communities in which the 
service member lives. PTSD is associated with work impairment, 
including increased unemployment, missed work and work inefficiencies, 
homelessness, increased medical costs for treatment of PTSD and 
secondary problems. Thus, advancing research and clinical care for 

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PTSD has the potential to have a cascading positive affect beyond the 
service member to their family and communities.  
This study has the potential to impact research on the treatment 
of PTSD in service members because it is based on a sophisticated and 
dimensional understanding of the phenomenology and unique impact of 
combat and operational trauma, loss, and inner conflict in active duty 
service members across the deployment cycle.  We anticipate that our 
results will foster more innovative, military-culture sensitive, and 
ecologically valid treatments for mental health problems related to 
combat and operational trauma, traumatic loss, and various sources of 
lasting inner conflict, utilizing evidence-informed and theory-driven 
cognitive-behavioral strategies.   
The results of this study also have the potential to greatly 
impact patient care for service members.  At present, the DoD and the 
VA are participating in large scale roll outs of cognitive-behavioral 
therapies.  Yet, in our opinion, because these approaches have not 
been tested specifically on active-duty service members (or new 
veterans), their acceptance and feasibility with patients and care 
providers, and their efficacy all remain empirical questions. In 
contrast, AD was developed from clinical experience and observations 
about the psychological, biological, spiritual, and social challenges 
that stem a wide variety of combat and operational experiences (such 
as grief, guilt and moral injury).  In our experience thus far, 
clinicians in our early demonstration project setting (Marine Corps 
Base Camp Pendleton) have requested training in AD and greatly 
appreciate our manual, which has extensive information not only about 
the how-to’s but also the justification for the approach in terms of 
the phenomenology and unique clinical presentations of service members 
with combat and operational trauma.  Thus, AD holds the promise of not 
only helping warriors to find better ways of healing and recovering 
from their experiences but provides a model of care that can build 
confidence and self-efficacy among caregivers.  Because it is brief 
and culturally sensitive, AD may also be more attractive to service 
members, their leaders, and care-providers.  
 
E. APPLICATION TO USE HUMAN SUBJECTS 
 
  
1. Subject Population: 
 
Participants will be 266 active duty Marine Corps or Navy 
personnel. They will be referred to the study by their mental health 
provider (see Recruitment). Participating individuals must: (1) have 
experienced at least one traumatic event as defined by DSM-IV during 
deployment during OIF, Operation New Dawn (OND), and/or OEF; (2) have 
current PTSD or subsyndromal PTSD with clinically significant 
distress/impairment and be able to recount the event that led to the 
PTSD symptoms; and (3) have received an initial mental evaluation from 
a military provider. 
 
The sample size of 266 was established based on the following sample 
size calculation. We used the Study Size program, Version 2.0.4 
(Olofsson, 2001-2007) and a standard deviation of 25, based on Monson 
et al. (2008). If the true difference between AD and CPT is 0 points, 

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then we need 99.1 participants per group, or roughly 200 participants, 
to ensure that power=.80. Estimating an attrition rate of 
approximately 25%, we anticipate a need to recruit 266 (200/.75) 
participants to achieve an adequate sample. 
 
    
 Subject Inclusion Criteria: 
1. Age 18 or older 
2. Current PTSD as diagnosed by the CAPS or subsyndromal PTSD (at 
least meeting criteria A and B) with distress and/or functional 
impairment as determined by the CAPS and review by study senior 
clinicians. Co-occurring disorders such as depression, anxiety, 
or treated substance abuse or dependence problems are permitted. 
3. Individuals expected to deploy two or more months from the time 
of referral and/or assessment are eligible. Anyone deploying 
sooner than that would be unable to complete the entire 
intervention and thus are ineligible. Potential enrollees need 
not be presently deployable. 
4. Prospective enrollees must be willing to commit to all treatment 
sessions and to complete assessment materials. 
 
      Subject Exclusion Criteria: 
1. Serious suicidality or homicidality that has required urgent or 
emergent evaluation or treatment within the past three months. 
2. A known, untreated substance abuse or dependence problem. 
Inclusion is possible if there is evidence that the individual 
has been afforded and is complying with treatment for the 
substance problem. Inclusion is possible if the treating 
clinician and study supervisor concur that participation is not 
contraindicated. 
3. Serious Axis I mental disorders (those that are normally 
incompatible with active military service), such as psychotic 
disorders or bipolar type I, are not eligible. 
4. Cognitive impairment that would interfere with one’s ability to 
complete the intervention. If a potential participant performs 
below the mildly impaired range on the neuropsychological 
battery, the study neuropsychologist (Dr. Lansing) will review 
the case and make a clinical judgment based on review of testing 
and, in some cases, additional evaluation as to ability to 
participate. 
5. Concurrent enrollment in any cognitive-behavioral treatment, 
group therapy, or any other treatment that involves systematic 
disclosure of troubling deployment-related memories. Participants 
can continue current pharmacological treatment, marital 
counseling, or any supportive therapy. 
6. People will be excluded if they received CPT in the past, unless 
a clinician believes that additional CPT could be clinically 
useful because of the amount of time that has passed, the number 
of sessions received or another circumstance. 
 
We expect sample demographics to approximately represent the 
demographic composition of the Marines at Camp Pendleton, which is 
94% male, mostly Caucasian (66% white, 15% Hispanic, 8% black) and 

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relatively young (48% age 22-30, 38% age 17-21, 11% age 31-40) 
(Marine Corps demographics, December 2008). 
 
 
   
2. Protected Population (i.e., children, women of childbearing   
 
age, and 3rd party subjects): 
 
 
Women of childbearing age are eligible for participation as 
there is no risk based on this psychotherapeutic intervention to 
potential offspring. 
 
Prisoners are eligible for participation provided that (a) consent was 
provided prior to incarceration, (b) continued participation is in the best 
interest of the participant based on the judgment of the PI and IRB Chair, 
(c) privacy can be provided for study activities, and (d) the participant 
demonstrates continued understanding of the voluntary nature of his/her 
participation and his/her rights as a research subject. 
    
3. Method of Subject Indentification and Recruitment: 
This project will rely on referrals from Naval Hospital Camp 
Pendleton and Naval Medical Center San Diego mental health providers. 
We will meet regularly with clinic leadership to maintain support for 
the project. Mental health providers educated about the study in the 
following ways: (a)provide materials describing the nature of the 
intervention and the target population, (b) attend weekly staff 
meetings, (c) give talks to describe the interventions in staff grand 
rounds, and (d) provide feedback to staff about referred patients. If 
a mental health provider identifies a patient who may be eligible, 
he/she will briefly explain the nature of the study and ask for oral 
permission (based on the requested partial HIPAA waiver)to give the 
patient’s name and phone number to study staff, who will then call the 
patient to explain the study in more detail and, if the patient is 
willing, to schedule a screening visit. 
 
 
      a.  Consent Process: 
This study will be conducted in compliance with Title 45 Part 46 
of the CFR pertaining to informed consent. At the first visit, prior 
to initiation of any study procedures, subjects will give their 
written consent to participate in the study after having been informed 
about the nature and purpose of the study, participation/termination 
conditions, risks, and potential benefits. 
Informed consent is a process that is initiated prior to the 
individual’s agreeing to participate in the study and continuing 
throughout the individual’s study participation. Extensive discussion 
of risks and possible benefits of this therapy will be provided to the 
participants. Consent forms describing in detail the intervention, 
study procedures and risks are given to the participant and written 
documentation of informed consent is required prior to starting the 
intervention. Upon reviewing the document, the investigator will 
explain the research study to the participant and answer any questions 
that may arise. The participants will sign the informed consent 
document prior to any procedures being done specifically for the 
study. The participants will have sufficient opportunity to discuss 
the study and process the information in the consent process prior to 
agreeing to participate. The participants may withdraw consent at any 

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time throughout the course of the study. A copy of the informed 
consent document will be given to the participants for their records. 
The rights and welfare of the participants will be protected by 
emphasizing to them that the quality of their medical care will not be 
adversely affected if they decline to participate in this study. 
The informed consent form for the Naval Medical Center San Diego 
Clinical Investigation Department has been used for this study because 
all subjects will be recruited and all activities will take place at 
Naval Hospital Camp Pendleton or Naval Medical Center San Diego. A VA 
HIPAA Authorization will be required because the grant supporting this 
project was awarded to the Veterans Medical Research Foundation. In 
addition, the Boston VA will obtain a verbal consent to conduct their 
portion of the assessment interview. 
 
   4. Experimental Procedure(s): 
 
AD is an experimental psychotherapy. CPT is a well established 
psychotherapy for PTSD, but its use in active duty Marines and Sailors 
remains experimental. 
 
   5. Research Material Collected: 
 
Research materials consist of assessments, questionnaires and 
audio recordings of therapy sessions. 
 
   6. Protection of Patient Privacy: 
 
Patient confidentiality will be maintained through the assignment 
of patient identification numbers. These numbers will be used in 
keeping of all research records. The key linking identification 
numbers to identifying information will be kept in a locked cabinet 
separate from other study data. All hard copy research materials will 
be securely transported by authorized study personnel from Naval 
Hospital Camp Pendleton and Naval Medical Center San Diego to the VMRF 
building. Hard copies of the data will be kept in locked file cabinets 
in a locked office with keys available only to research personnel 
participating directly in this protocol. Hard copies of the data with 
all HIPAA identifiers removed will be faxed securely from VA to VA, or 
transported using Federal Express oranother service that adequately 
tracks shipments to the Boston site for data entry and analysis. 
Electronic data will be managed with all current security provisions. 
Patients will be informed during the consent process about the limits 
of confidentiality. 
 
  
7. Risks: 
 
The risks or discomforts which are possibly related to 
participation in this study are as follows: the interview questions, 
questionnaires, and discussions during psychotherapy may produce 
discomfort or anxiety from the discussion of personal or emotional 
topics.  
Individuals who are part of a vulnerable population may feel 
additional pressure to comply with study procedures based on their 
status. 

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 8. Radiation or Laser Exposure: N/A 
 
 9. Justification of Risks: 
 
Preliminary evidence suggests that AD may be useful for reducing 
distress in this sample, and CPT-C is an empirically supported PTSD 
treatment. Some patients may also feel that they are making a useful 
contribution by furthering our understanding of how to treat other 
Marines with deployment-related symptoms. 
There is benefit to the Marine Corps and to society in evaluating 
the efficacy of this intervention, which has the potential to be a 
better PTSD intervention for military trauma. 
We believe that the benefits from this study outweigh its risks. 
 
  10. Minimization of Risks: 
 
The therapists will have 24-hour access (via cell phone or pager) 
to Dr. Lovell and Dr. Lang or a designated clinical supervisor in case 
of any clinical emergencies. Any potential serious adverse events will 
be immediately reported to the principal investigators. All serious 
(i.e., severe and undesirable event with significant symptoms or more 
serious), unexpected (i.e., not anticipated based on the literature 
and as discussed in the MSP and/or consent forms) adverse events 
(AEs), regardless of their relationship to study treatment or 
procedure (causality), and those SAEs judged to be associated with the 
study treatment or procedure must be reported to the DSMB, IRBs and 
the Army’s Human Research Protections Office (HRPO). All life-
threatening SAEs or lethal reactions must be reported regardless of 
attribution. 
Subjects will be informed about all potential study risks during 
the informed consent process. They will be informed that they can 
refuse to answer any question or terminate their assessments at any 
time if they so desire. The assessors and therapists will be 
specifically trained to respond effectively to subjects who experience 
anxiety and/or other distress during assessments or treatment and will 
be under the supervision of senior clinicians. 
The risk associated with treatment-related discomfort is 
mitigated because patients can titrate the way in which they talk 
about the trauma and the activities in which they engage. Therapists 
will be carefully trained to encourage full engagement in imaginal 
exposure but to allow the patient to set limits where needed. Subjects 
can contact their therapist at any time if they are not able to cope 
with their anxiety independently. The therapist’s contact information 
will be provided in the initial therapy session. Subjects will also 
have 24-hour access to mental health services at Naval Hospital Camp 
Pendleton and Naval Medical Center San Diego. 
There may be a concern that study participation would delay 
subjects from seeking other forms of treatment for their symptoms. 
First, pros and cons of available treatment options will be reviewed 
during the initial evaluation, so potential participants will have 
chosen to participate will full knowledge of their other options. 
Second, there is reason to believe that AD will be a potent 
intervention for these conditions based on preliminary data and the 
efficacy of CPT-C has been established for PTSD. Third, if at any time 

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the therapist and supervisors judges that a subject requires a 
different approach or higher intensity care, the subject will be 
provided with referrals for outpatient or inpatient care, as 
appropriate. 
Consistent with consent being a process, individuals who are part 
of a vulnerable population will be reminded that the terms of the 
consent form are unchanged based on their new status and that 
participation/non-participation has no bearing on legal proceedings. 
For prisoners, an individual will be identified in the detention 
facility in the event that safety monitoring becomes indicated. 
A Data Safety Monitoring Board (DSMB) will be created as an 
independent body charged with ensuring that the safety of study 
subjects is protected and that the scientific goals of the study are 
being met. To support those purposes, the DSMB will review the initial 
protocol and any proposed amendments, perform expedited monitoring of 
all serious adverse events, perform ongoing monitoring of drop-outs 
and non-serious adverse events, determine whether study procedures 
should be changed or the study should be halted for reasons related to 
the safety of study subjects, and perform periodic review of the 
completeness and validity of data to be used for analysis of safety 
and efficacy. The DSMB will also ensure subject privacy and research 
data confidentiality. A statistical penalty will not be assessed for 
the ongoing unblinded review of safety by the DSMB. Unblinded data 
will not be released to the investigators unless necessary for safety 
reasons. 
 
 

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11. Medical Monitor (signature form attached separately) 
 
III. DATA COLLECTION SHEET(S) AND QUESTIONNAIRES:  
 
Included in this submission are data collection sheets and 
questionnaires for the proposed study. 
 
 
IV.  CONSENT FORM, INFORMATION SHEET, OR WAIVER 
 
Included in this submission is a 1st party consent with HIPAA Patient 
Authorization form. 

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Bauer, S., Lambert, M., & Neilson, S. L. (2004). Clinical significance 
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Hoge, C. W., Auchterlonie, J. L., & Milliken, C. S. (2006). Mental 
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Schnurr, P., Friedman, M. & Southwick, S. (2008). The Response to 
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and reserve component soldier returning from the Iraq War. 
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Monson, C. M., Schnurr, P. P., Resick, P. A., Friedman, M. J., Young-
Xu, Y., & Stevens, S. P. (2006). Cognitive processing therapy for 

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veterans with military-related posttraumatic stress disorder. 
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Marwit S, Wortman C, Goodkin K, Neimeyer R, Bonanno G, Block S, 
Kissane D, Boelen P, Maercker A, Litz B, Johnson J, First M, 
Maciejewski P. (in press). Field trial of consensus criteria for 
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Bass. 

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Sobel, M. E. (1986). Some new results indirect effects and their 
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PTSD Checklist. Boston, MA: National Center for PTSD. 
  

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IX. APPENDIX 
 
A. REVIEW SIGNATURES 
 
The proposed research involves reviews and/or approvals by the 
committees and organizations noted below. 
 
 
YES 
NO 
 
APPROVAL DATES: 
INITIAL 
PENDING 
APPROVED 
 
1. HUMAN SUBJECTS 
 
 
IRB 
 
 
 
2. RETROVIRUS 
  
 
MED-O2H 
 
 
 
3. INVESTIGATIONAL AGENT 
  
 
FDA 
 
 
 
4. RADIATION/LASER 
  
 
RSC/LUC 
 
 
 
5. COLLABORATION 
 
 
CRADA/MOU  
 
 
(CID will complete approval dates.) 
 
The following signatures indicate the documentation has been 
reviewed and has been completed appropriately according to the 
best knowledge of the signees. 
 
 
CID Program Administrator  
 
 
 
 
 (Signature) 
Date 
 
 
 
  
 
 

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B.  DEPARTMENT SUPPORT STATEMENT 
 
• There is no support anticipated to be required from, or impact on, 
any other department at Naval Hospital Camp Pendleton and Naval 
Medical Center San Diego. 
 
• Any support from VMRF/UCSD to NHCP and NMCSD will be outlined in 
the pending CRADA. 
 
 
 
 

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C. INSERT: COMMITTEE MINUTES signed by Chairman, IRB, and Commander 
 

SUPPLEMENT: Power Calculation and Data Analysis Plan 
 
Sample size. Our initial sample size was planned for 266. Due to unanticipated and 
uncontrollable delays, we established an interim analysis plan with our DSMB to determine 
whether additional accrual would likely change the results. On this basis, the study was halted 
prior to achieving the intended sample size.  
Data analysis plan: Non-inferiority. To assess NI, we examined the predicted difference 
in mean change between AD and CPT-C. If the 95% confidence interval (CI) around the estimate 
does not contain the NI margin, we can reject the null hypothesis (that AD is inferior to CPT) 
and accept the research hypothesis (that AD is non-inferior to CPT-C). The NI margin for CAPS-
IV scores was established a priori, based on a calculation of a reliable difference from baseline 
to posttreatment CAPS-IV scores from a previous trial (10 points). The margins for other 
outcomes were generated using the Reliable Change Index (RCI). Although the RCI threshold 
for CAPS-IV in this trial was 22 points; we adhered to the pre-specified 10-point differential as a 
more conservative NI test.   
We conducted linear regression analyses (SAS Software version 9.4) to predict the 
effects of treatment on mean change score (at a one-tailed 0.05 alpha), controlling for the 
influences of baseline scores. We also controlled for time (days) since the start of the trial. 
Although the study was powered for pre- to posttreatment change, we conducted exploratory 
analyses of the available follow-up data. 
Because a significant proportion of participants did not complete the posttreatment 
evaluation, we performed a series of sensitivity analyses to test the robustness of the results. The 
sensitivity analyses varied slightly for each outcome. For the CAPS-IV, the first analysis 
multiply imputed CAPS-IV scores based on the last recorded PCL-M score of each participant 

that attended at least half of the therapy sessions. The second analysis also used PCL-M scores, 
employing a series of preemptive imputations of all missing within treatment PCL-M scores. In 
the third analysis, multiple imputation was used to simulate posttreatment CAPS-IV scores based 
on a rational set of baseline covariates (age, race, CEQ scores, highest level of education, and 
baseline CAPS-IV scores). The above analyses were contingent upon the Missing-At-Random 
assumption. Because there is no definitive way to determine the cause of missing data, we 
interrogated potential differences between completers and non-completers and found that 
completers in the CPT-C arm had lower mean baseline CAPS-IV scores than non-completers (72 
vs. 81, Cohen’s d = .49). This led us to perform a fourth imputation analysis under the Missing-
Not-At-Random assumption; we imputed conditional posttreatment CAPS-IV scores for the 
CPT-C arm to reflect the higher propensity for dropout given higher baseline scores by 
generating proportionately higher posttreatment scores.  
Data analysis plan: Describing the clinical significance of the results. To benchmark the 
clinical significance of the primary endpoint, consistent with recent PTSD trials of service 
members, we categorized the clinical significance of change scores and end-point state for each 
participant in each arm. Participants that exceeded the RCI threshold (> 22-point change) were 
categorized as “improved.” Participants who exceeded the RCI and whose posttreatment 
endpoint score was two SD below the mean baseline score for the trial were categorized as 
“recovered”. If individuals’ change did not exceed the RCI, they were categorized as “no-
change.” Individuals whose post-test scores were higher than their baseline scores and outside 
the RCI were categorized as “deteriorated.” A second set of benchmarks were created, which we 
labeled intent-to-treat; these were the same as the completers, except that patients who had 
missing posttreatment scores were added to the “no-change” category.