An Adjunctive Family Intervention for Individual PTSD Treatment
Phase: NA
Conditions: Posttraumatic Neuroses
Sponsor: VA Office of Research and Development

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An adjunctive family intervention for individual PTSD treatment 
 
NCT number: 02956434 
 
Document date: 7/2/21 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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(1)  Rationale  
 
 
(a)  Statement of the Problem.  Post-traumatic stress disorder (PTSD) is a significant 
public health problem, with lifetime prevalence rates of 8% (Kessler, Sonnega, Bromet, Hughes, 
& Nelson, 1995). The national burden of the disorder, and particularly its impact on the VA 
system, has increased in magnitude as military personnel return from the recent conflicts in Iraq 
and Afghanistan; rates of PTSD among these veterans are estimated at 13-20% (Kok, Herrell, 
Thomas, & Hoge, 2012). Although trauma-focused cognitive-behavioral treatments have been 
shown to be effective in the treatment of PTSD (Foa, Keane, Friedman, & Cohen, 2009), up to 
two-thirds of Veterans from Iraq and Afghanistan receive less than minimally adequate levels of 
care for PTSD (Lu, Duckart, O’Malley, & Dobscha, 2011; Spoont, Murdoch, Hodges, & Nugent, 
2010). This is in part due to very high levels of treatment dropout, which can reach 36% (Imel, 
Laska, Jakcupcak, & Simpson, 2013). These high dropout rates are consistent across clinical 
trials and civilian studies of PTSD treatment (Edlund et al., 2002; Imel, Laska, Jakupcak, & 
Simpson, 2013; Swift, Greenberg, Whipple, & Kominiak, 2012; Wang et al., 2005). Premature 
treatment termination is clearly a critical predictor of PTSD treatment failure, and thus bolstering 
engagement/retention is central to improving the effectiveness of evidence-based treatments. 
 
Family members represent one potentially powerful resource that could be harnessed to 
enhance treatment engagement and outcomes. Lack of social support is one of the strongest 
predictors of the development and maintenance of PTSD (Brewin, Andrews, & Valentine, 2000; 
Ozer, Best, Lipsey, & Weiss, 2008), and poor family functioning negatively affects treatment 
outcomes (Evans, Cowlishaw, Forbes, Parslow, & Lewis, 2010; Evans, Cowlishaw, & Hopwood, 
2009; Tarrier, Sommerfield, & Pilgrim, 1999). In the case of Veterans, family involvement in 
mental health services is now a national priority (Department of Veterans Affairs, 2006; New 
Freedom Commission on Mental Health, 2003), and all mental health providers are encouraged 
to involve families in Veterans’ care (Veterans Health Administration, 2008). However, analysis 
of data from the VA’s national records system showed that only 4.2% of Veterans receiving 
mental health care in the VA had any type of family session; this included sessions with or 
without the Veteran present, multi-family groups, or family psychoeducation (Laws & Hoff, 
2015). In 2013 family sessions accounted for <1% of all VA mental health visits (Laws & Hoff, 
2015), despite social support being associated with 15-20% of the variance in PTSD symptoms 
(Brewin et al., 2000; Wright, Kelsall, Sim, Clarke, & Creamer, 2013).  
 
 
(b)  Hypotheses or Key Question.   
Hypothesis 1: Levels of feasibility and acceptability of the family-inclusive treatment among 
Veterans, family members, and VA clinicians will be high. 
 
Hypothesis 2a: Patients whose family members receive family-inclusive treatment will show 
lower levels of PTSD symptoms at post-treatment and greater engagement throughout 
treatment compared to control patients.  
Hypothesis 2b: Family members who receive family-inclusive treatment will show more 
active support for treatment and less accommodation than control family members. 
 
 
(c)  Specific Objectives.  Immediate objectives are to test the feasibility and effectiveness of a 
family-inclusive intervention for Veterans with PTSD. Longer-term objectives are to examine the 
mechanisms of family-inclusive treatment and the factors associated with its successful use in 
VA clinics. 
 
 
(2)  Background and Significance  
 

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(a) Background.   
Family-involved PTSD treatment can enhance Veterans’ sense of support and connection to 
their family members; positive, active encouragement of treatment by family members such as 
verbal support, practical help getting to appointments, and reminders to practice homework 
assignments is likely to reduce Veterans’ levels of perceived criticism. Perceived criticism is 
associated with worse PTSD treatment outcomes (Tarrier et al., 1999), whereas positive family 
encouragement may be a powerful source of motivation for patients and a way for families to 
interact in a positive manner. The sense of the family being on the same “team” against the 
disorder, along with the practical assistance in attending sessions and remembering homework 
assignments, will likely enhance Veterans’ treatment participation. 
 
On the other hand, families may also be inadvertently engaging in behavior that 
undermines the Veterans’ PTSD treatment. One such problematic behavior is symptom 
accommodation, or changes that family members make to their own behavior in order to reduce 
or prevent disorder-related distress in patients. Although often driven by compassion or by 
simple practical concerns (Boeding et al., 2013; Calvocoressi et al., 1995, 1999; Thompson-
Hollands, Kerns, Pincus, & Comer, 2014), accommodation allows patients to avoid their 
emotional experience, and therefore reinforces the disorder pathology. Accommodation has 
been most well-studied in OCD, where it has been found to have strong associations with 
increased symptoms and functional impairment (Amir, Freshman, & Foa, 2000; Calvocoressi et 
al., 1999; Stewart et al., 2008), and both cross-sectional and longitudinal studies have shown 
that higher levels of family accommodation are associated with poorer treatment outcomes 
(Amir et al., 2000; Merlo, Lehmkuhl, Geffken, & Storch, 2009). Although the research literature 
is most robust in patients with OCD, accommodation is a transdiagnostic phenomenon that is 
found across a range of disorders (Lebowitz et al., 2013; Lebowitz, Scharfstein, & Jones, 2014; 
Thompson-Hollands et al., 2014) In PTSD, accommodation may involve family behaviors such 
as a partner avoiding topics of conversation related to the military or combat, or the partner 
doing all of the family’s shopping because the Veteran can’t tolerate crowded stores (Fredman, 
Vorstenbosch, Wagner, Macdonald, & Monson, 2014). Accommodation of PTSD symptoms is 
associated with patients’ PTSD symptoms and relationship distress (Fredman et al., 2014). 
Furthermore, accommodation also conflicts with a fundamental goal of current gold-standard 
treatments for PTSD: patients allowing themselves to experience and accept their emotions 
surrounding the trauma, and the elimination of trauma-related avoidance in their daily lives (Foa, 
Hembree, & Rothbaum, 2007; Resick & Schnicke, 1992). A recent study by Campbell and 
colleagues (Campbell, Renshaw, Kashdan, Curby, & Carter, in press) found evidence of a bi-
directional relationship between PTSD symptoms and accommodation: PTSD symptoms among 
military service members predicted later accommodation by romantic partners, and partners’ 
earlier accommodation behaviors contributed specifically to service members’ later avoidance 
symptoms. Taken together, these results indicate that accommodation is an especially 
important interpersonal variable to target as Veterans begin a course of trauma-focused 
treatment. 
 
Existing Family Treatments: Several family-based interventions for PTSD have been 
developed, but these are quite extensive in terms of both their clinical targets and their number 
of sessions. For example, Cognitive-Behavioral Conjoint Therapy (Monson, Stevens, & Schnurr, 
2005) (CBCT) is a 15-session treatment designed to treat the symptoms of PTSD while also 
improving overall relationship functioning. A family-based intervention for PTSD that was 
specifically developed for use in the VA, REACH (Reaching out to Educate and Assist Caring, 
Healthy families; formerly the S.A.F.E. program) involves attending sessions for up to 9-months 
(Fischer, Sherman, Han, & Owen, 2013; Glynn et al., 1999; Sherman, 2006). These treatments 
are generally effective in reducing PTSD symptoms and improving relationship satisfaction (e.g., 

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Monson et al., 2011, 2012). However, they are costly to the healthcare system, demanding 
many hours of time from highly trained staff. In addition, the lengthy commitments are difficult 
for families, who may need to arrange child/elder care or take time off from work to attend. The 
protocols are also burdensome to clinicians; in addition to the time cost, many clinicians do not 
have expertise in family or couples treatment, which may make them reluctant to take on this 
work. Furthermore, the large number of intervention targets in each of these treatments 
(psychoeducation, problem-solving, communication skills, etc.) makes isolating specific 
mechanisms of change much more complex. There is no currently existing short-term family 
intervention that focuses solely on increasing treatment engagement and reducing avoidance. 
 
The Brief Family Intervention (BFI): The PI has previously developed and tested a brief 
family intervention (BFI) for reducing family accommodation in the context of treatment for OCD 
(Thompson-Hollands, Abramovitch, Tompson, & Barlow, 2015). The intervention is not a stand-
alone treatment, but is rather designed to complement the patient’s course of evidence-based 
treatment. The protocol is delivered to an adult family member individually, without the patient 
present, in two 50-minute sessions scheduled at the beginning of the patient’s individual 
treatment. The goals of the BFI are to increase family members’ active support for treatment 
and to reduce family accommodation of the Veteran’s PTSD symptoms. The approach is highly 
behavioral, focusing on identifying relevant examples and practicing how to complete them. The 
clinician and the family member each play an active role during the sessions, and there is an 
approximately equal amount of time devoted to didactic information and discussions/role-plays. 
The BFI’s strengths in comparison to existing family-based treatments in PTSD include: 
shorter duration, reducing burden to families, clinicians, and the system; individual rather than 
couples’ sessions, negating the need for clinicians to be comfortable with couples or family 
work; and a limited, highly behavioral focus, relying on concepts and strategies which will be 
familiar to any clinician with CBT experience. 
 
 
(b)  Significance.  The proposed study may identify a new, feasible, and effective family-
inclusive treatment to enhance existing PTSD treatments. A substantial number of Veterans 
with PTSD who complete trauma-focused treatment are not completely symptom-free at 
treatment termination, or they drop out of treatment prematurely. The proposed intervention may 
reduce these numbers by enhancing the effect of treatment and encouraging Veterans not to 
drop out. 
 
 
(c)  Relevance to Veterans Health.  
There are large numbers of Veterans who suffer from PTSD, and PTSD in turn affects Veterans’ 
relationships with significant others. Family-inclusive treatment has the potential to enhance 
existing treatments in terms of their effects on PTSD symptoms, while also improving 
relationship functioning. An increase in treatment effectiveness and Veteran quality of life would 
be a substantial benefit. Furthermore, the BFI has the potential to provide these benefits in an 
extremely cost-effective and efficient manner compared to existing family-focused interventions. 
Should the BFI prove to be effective in this population and setting, it would provide a more 
parsimonious way for clinicians and administrators to fulfill the directive to involve families in 
Veterans’ care. 
 
 
 
(3)  Work Accomplished  
 
As noted above in section 2a, Dr. Thompson-Hollands (PI) has already developed and 
tested the BFI, which was originally piloted among a sample of family members of patients with 
obsessive-compulsive disorder (OCD). In that study, a randomized clinical trial with 36 

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participants (18 patient-family member dyads), the BFI was rated by family members as being 
highly satisfactory (mean satisfaction = 6.88 out of 7, SD = .35) and useful (mean = 6.29/7, SD 
= .76) (Thompson-Hollands et al., 2015). Family members who received the BFI demonstrated 
significantly greater decreases in accommodation compared to controls; at the end of the study, 
average accommodation scores in the control group remained at 78% of their baseline levels, 
while scores in the BFI group had dropped to 37% of baseline. Moreover, patients whose family 
member had participated in the BFI had significantly lower levels of OCD symptoms following 
their individual treatment (d = 1.27), and changes in family accommodation significantly 
predicted patients’ later symptom levels. These promising initial efficacy outcomes support the 
use of the BFI in the present effectiveness trial. 
 
Although the BFI has only been previously tested in the context of OCD, the protocol’s 
applicability is not limited to OCD. Accommodation is not a disorder-specific phenomenon; any 
disorder that involves avoidance (essentially all of the so-called “emotional disorders” (Moses & 
Barlow, 2006)) is likely to produce family accommodation in addition to the patient’s own 
attempts to avoid. Indeed, previous work by the PI and others has shown that accommodation 
occurs across a wide range of disorders (Lebowitz et al., 2013; Thompson-Hollands et al., 
2014), including PTSD (Fredman et al., 2014).  
 
 
 
(4)  Work Proposed 
 
 
We expect to begin enrollment in the winter of 2016/2017. A total of 48 Veteran-family 
member participants will be enrolled (24 dyads). We will enroll approximately 2 participants (i.e., 
a dyad of one Veteran and their adult family member) per month, for a recruitment rate of 12 
dyads over the course of a year. Veterans and their family members will participate in the study 
for 16 weeks total. 
 
 
The proposed study will use an effectiveness design to evaluate a brief intervention 
targeting reductions in family accommodation and increases in active family support for 
treatment (the BFI). Veterans with PTSD who are beginning a course of trauma-focused 
treatment and their adult family members (one family member per Veteran) will be recruited at 
VA Boston.   
 
 
All Veterans enrolled in the study will be beginning a course of either Prolonged Exposure 
(PE) or Cognitive Processing Therapy (CPT), which will be delivered as usual by PTSD clinical 
staff. As the BFI is an adjunctive intervention, Veterans’ trauma-focused treatment is considered 
separate from the present study. The Veterans will be seen by regular clinical staff and no 
artificial limits will be imposed upon their treatment, although treatment engagement will be 
tracked (see Assessment section, below). Veterans and their family members will be recruited 
for the present study at the beginning of a course of treatment at the clinic. Phase I will be an 
open pilot trial of 4 dyads. All family members in Phase I will receive the BFI, which will be 
delivered as 2 weekly 50-minute sessions of the BFI, consistent with the application with the BFI 
in previous work (Thompson-Hollands et al., 2015). Phase II will include 20 dyads (N=40) using 
identical recruitment, inclusion/exclusion criteria, and assessment structure; however, in this 
second phase family members will be randomly assigned to receive or not receive the BFI, and 
VABHS clinicians will deliver the BFI sessions (rather than the PI as in Phase I). 
 
Veterans: 
Inclusion criteria.  
(1) has a current diagnosis of PTSD 

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(2) is 18 years of age or older 
(3) has an eligible family member (defined as a spouse/significant other, parent, adult child, 
sibling, etc., 18 years of age or older who currently has substantial daily or weekly contact with 
the Veteran) 
(4) is beginning a course of either CPT or PE at VA Boston.  
 
Exclusion criteria.  
(1) has current diagnoses of unstable bipolar disorder, past or present psychosis, or 
organic mental disorder 
(2) has clear and current suicidal risk (assessed via the MINI-Suicide Module (Sheehan et 
al., 1998), see Assessment section below)  
(3) has current moderate or severe substance use disorder 
(4) is currently participating in family-based therapy/couples-counseling 
 
Family members: 
Inclusion criteria.  
(1) is 18 years of age or older 
(2) is the family member (defined as a spouse/significant other, parent, adult child, sibling, 
etc.) of the Veteran 
(3) currently has substantial daily or weekly contact with the Veteran 
 
Exclusion criteria.  
(1) has a current diagnosis of PTSD 
(2) has current diagnoses of unstable bipolar disorder, past or present psychosis, or 
organic mental disorder 
(2) has clear and current suicidal risk (assessed via the MINI-Suicide Module (Sheehan et 
al., 1998), see Assessment section below)  
(3) has current moderate or severe substance use disorder 
(4) is currently participating in family-based therapy/couples-counseling 
 
 
Recruitment of Veterans and family members will occur through the VABHS outpatient 
mental health clinics (e.g., the PTSD Clinic, the Women’s Clinic, General Mental Health, Center 
for Returning Veterans, etc.). All interested participants will be contacted by the PI for a phone 
screen, where the study and its procedures will be described and a short screen for eligibility will 
be administered. If the initial screening requirements are met, participants will be invited to an 
in-person assessment. During the first appointment, the Veteran and family member will be 
provided with a thorough description of the project and the informed consent form will be 
reviewed and signed. Baseline assessment measures will then be administered (see 
Assessment section). 
 
 
Veterans will proceed with PE or CPT as usual through the clinic, with no restrictions or 
limitations. Should a Veteran choose to discontinue PE or CPT, he or she will continue to be 
enrolled in the proposed study for follow-up assessments, as treatment drop-out is a variable of 
interest. All family members who are to receive the BFI (i.e., all family members in Phase I and 
half of family members in Phase II) will participate in the two BFI sessions, and then move into 
the follow-up portion of the study. 
 
 
BFI: The BFI is a 2-session individual intervention delivered by a clinician to the adult 
family member of a Veteran with PTSD who is beginning a course of CPT or PE treatment. The 
BFI sessions are guided by a manual, which has previously been developed by the PI but will 

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be revised for the purposes of the current study as described earlier to enhance its relevance to 
the families of Veterans with PTSD. The BFI may be completed either in person or remotely via 
telephone. 
 
The protocol begins with a brief assessment of the family member’s current 
accommodation behaviors, as captured by the SORTS interview (Fredman et al., 2014). The 
clinician explores the circumstances in which the family member engages in accommodation 
and helps to determine the primary motivations for that accommodation (e.g., fears that 
upsetting the Veteran will cause emotional damage, or a desire to communicate support to the 
Veteran by “taking care of him” or “not stressing him out”). This discussion helps the clinician to 
begin conceptualizing how best to approach reducing accommodation, as well as providing an 
important view of how PTSD has affected this individual family or relationship. 
 
The family member is next provided with psychoeducation regarding a cognitive-behavioral 
conceptualization of PTSD, with particular attention paid to how avoidance of distress results in 
temporary relief but ultimately reinforces the psychopathology and increases further avoidance 
in the long term. The model of exposure is then explained as a powerful mechanism for testing 
fears and learning to tolerate discomfort. The clinician explicitly addresses issues regarding the 
safety of exposure-based treatment, including whether exposure makes patients “go crazy” and 
why a modest, temporary increase in intrusive thoughts about the trauma early in treatment is a 
positive sign. The clinician also briefly describes the research support for trauma-focused 
treatment, to assure family members that these interventions have been rigorously studied and 
found to be safe and effective. 
 
The clinician then works with family members to brainstorm ideas of how they can support 
the Veteran’s efforts in treatment. Relatives are encouraged to come up with as many 
possibilities as they can, from large (e.g., committing to driving the Veteran to each treatment 
session) to small (e.g., making a note in the calendar to ask the Veteran if he or she needs to 
complete any homework before the next session). In addition to these practical forms of 
support, the family member is also strongly encouraged to provide verbal support to the 
Veteran. This can include praising the Veteran’s efforts in treatment (e.g., consistency in 
attending sessions, challenging him or herself to change unhelpful behaviors) as well as 
reminders that seeking treatment benefits and is appreciated by the family. Family members are 
coached to explicitly note any positive changes they observe in the Veteran as treatment 
progresses; such comments may increase the Veteran’s motivation to continue with treatment, 
and also convey pride, gratitude, and hope on the part of the family member. 
 
Following the overview of the treatment and treatment support, the clinician returns to the 
topic of accommodation. Accommodation is described as an understandable and common 
response from family members, but one which is also a form of avoidance. Personalized 
examples from the SORTS are used to illustrate how accommodation results in short-term relief 
for the patient but ultimately prevents him or her from testing out maladaptive beliefs and 
learning to tolerate discomfort. Family members are encouraged to capitalize on the Veteran’s 
starting treatment by shifting their own behavior to be more consistent with the treatment 
approach. By highlighting the benefits of making these family changes now, while the Veteran is 
making other positive changes to address his or her PTSD, we reduce shame regarding the 
family member’s past accommodation behavior and focus on their potential to work in 
coordination with this new phase of treatment. 
 
All BFI sessions across both Phases will be audiotaped and quality assurance will be 
assessed by an independent study staff member familiar with the BFI.  Family members will be 

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provided with $10 in travel compensation for each BFI session that they attend in person (total 
of $20); sessions conducted remotely will not be eligible for travel compensation. 
 
During the pilot Phase I the PI will serve as the BFI clinician. The PI has considerable 
clinical experience in the treatment of Veterans with PTSD. Additionally, as described above, 
the PI designed the BFI and has successfully tested its efficacy in a study of patients with OCD 
and their family members. Beginning in Phase II the PI will no longer deliver the intervention; 
instead, a minimum of 3 clinicians from the VABHS PTSD clinic will be recruited and trained to 
deliver the BFI. 
 
Comparison condition: Family members in the control or comparison condition of Phase 
II will not receive the BFI or any other study-specific family sessions (aside from the 
assessments described below). In keeping with the effectiveness aims of the present study, 
family members in the comparison condition (and the BFI condition) will not be prohibited from 
receiving any family-inclusive services or sessions that would normally be offered to them in the 
context of usual VA care. 
 
Independent variables: Receiving or not receiving the BFI (for Veterans/family members); 
receiving or not receiving training in the BFI (for clinicians). 
 
Dependent variables: Treatment engagement and PTSD symptoms (for patients); 
accommodation and active treatment support (for family members); qualitative feedback and 
rates of participation (for Veterans, family members, and clinicians). 
 
Assessment:  
Measures and assessment points are shown in Table 1. Qualitative interviews with 
stakeholders (Veterans, family members, and clinicians) will continue throughout both Phases of 
the study, as described below. Clinician-rated assessments of Veterans and family members 
will be completed (in person or via telephone/mail, or a combination of in person and remotely) 
at baseline and weeks 6, 12, and 16; Veterans and family members will be compensated $50 
for each of these 4 assessment visits that they complete (total of $200 for the major 
assessments). Finally, PE and CPT therapists will complete ratings of Veterans’ treatment 
engagement at each session, and will monitor dropout. 

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 Table 1. Assessment Measures and Timepoints 
 
 
 
 
Time of Administration 
 
Baseline 
Weeks 
0-6 
Every 
PE/CPT 
session 
Week 
6 
Week 
12 
Week 
16 
CAPS-5 
Xv 
 
 
Xv 
Xv 
Xv 
SCID-5 
Xv, f 
 
 
 
 
 
Demographics form (Vet/FM) 
Xv, f 
 
 
 
 
 
Demographics form (Clin) 
Xtx 
 
 
 
 
 
Relationship information form (Vet) 
Xv 
 
 
 
 
 
Relationship information form (FM) 
Xf 
 
 
 
 
 
LEC-5 
Xv, f 
 
 
 
 
 
WTAR 
Xv, f 
 
 
 
 
 
MOCA 
Xv, f 
 
 
 
 
 
AUDIT 
Xv, f 
 
 
 
 
 
MINI-Suicide module* 
Xv, f 
 
 
Xv, f 
Xv, f 
Xv, f 
PCS 
Xv, f 
 
 
Xv, f 
Xv, f 
Xv, f 
MSPSS 
Xv, f 
 
 
Xv, f 
Xv, f 
Xv, f 
RDAS 
Xv, f 
 
 
Xv, f 
Xv, f 
Xv, f 
DERS 
Xv, f 
 
 
Xv, f 
Xv, f 
Xv, f 
ODSIS 
Xv, f 
 
 
Xv, f 
Xv, f 
Xv, f 
OASIS 
Xv, f 
 
 
Xv, f 
Xv, f 
Xv, f 
IPF-80 
Xv, f 
 
 
Xv, f 
Xv, f 
Xv, f 
PCL-5 
Xv, f 
 
 
Xv, f 
Xv, f 
Xv, f 
CTS-2SF 
Xv, f 
 
 
Xv, f 
Xv, f 
Xv, f 
PABQ 
Xv 
 
 
Xv 
Xv 
Xv 
PTCI 
Xv 
 
 
Xv 
Xv 
Xv 
Homework Compliance Scale 
 
 
Xtx 
 
 
 
Treatment attendance/dropout 
 
 
Xtx 
 
 
 
SORTS 
Xf 
 
 
Xf 
Xf 
Xf 
Caregiving appraisal scale 
Xf 
 
 
Xf 
Xf 
Xf 
ITC 
 
 
 
Xf 
Xf 
Xf 
TEQ 
 
Administered to family members after BFI 
sessions 1 and 2, respectively 
CSQ 
 
WAI 
 

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Note: Xv = measure completed with/by Veteran; Xtx = measure completed by Veteran’s individual therapist; Xf = 
measure completed with/by family member; *MINI-Suicide module is only administered to family members at 
follow-up if they scored ≥ 1 at baseline 
 
 
Veteran-specific assessments:  
Clinician Administered PTSD Scale for DSM-5  (CAPS-5) (Weathers et al., 2013).  
 
Structured Clinical Interview for DSM-5 – Research Version (SCID-5) (First, Williams, Karg, & Spitzer, 
2015).  
 
Demographics form. This form collects basic demographic information (age, marital status, etc), as well as 
a very brief overview of medical, social, and psychiatric status/history. 
 
Relationship information form 
 
Life Events Checklist for DSM-5 (National Center for PTSD) 
 
Wechsler Test of Adult Reading (WTAR; Wechsler, 2001)  
 
The Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005)  
 
Alcohol Use Disorders Inventory (AUDIT) 
 
MINI-Suicide module (Sheehan et al., 1998) Individuals will be excluded from enrolling in this study if they 
score 17 or higher (high risk) on the MINI suicide module at the initial assessment. 
 
The Revised Dyadic Adjustment Scale (RDAS; Busby, Christensen, Crane, & Larson, 1995) is a 14-item 
scale measuring relationship satisfaction in couples. The scale consists of 3 subscales: dyadic consensus, 
stability, and engagement.  
 
Perceived Criticism Scale (Hooley & Teasdale, 1989) 
 
Multidimensional Scale of Perceived Social Support (Zimet, Powell, Farley, Werkman, & Berkoff, 1990) 
 
Difficulties in Emotion Regulation Scale (Gratz & Roemer, 2004) 
 
The Beck Depression Inventory-II (BDI-II; Beck et al., 1996)  
 
The Beck Anxiety Inventory (BAI; Beck et al., 1988)  
 
The Inventory of Psychosocial Functioning (IPF-80; Bovin et al., 2018) will be used to index objective role 
functioning/impairment in the following domains: romantic relationship, family, parenting, work, friendships and 
socializing, education, and self-care  
 
PTSD Checklist-5 (PCL-5) (Weathers, Litz, Huska, & Keane, 1994)  
 
Revised Conflict Tactics Scale (CTS-2; Straus, Hamby, Boney-McCoy, & Sugarman, 1996)  
 
Posttraumatic Avoidance Behavior Questionnaire (PABQ; van Minnen & Hagenaars, 2010)  
Posttraumatic Cognitions Inventory (PTCI; Foa, Ehlers, Clark, Tolin, & Orsillo, 1999)  

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At each PE or CPT session, the Veteran’s therapist will complete (1) a record of session attendance (or 
dropout, if applicable), along with (2) the Homework Compliance Scale (Leung & Heimberg, 1996) (HCS).  
 
 
Family member-specific assessments:  
Family members will complete/be assessed using the following previously described measures, as 
outlined in Table 1:  
 
SCID-IV 
Demographics form 
Relationship information form 
AUDIT 
LEC-5 
WTAR 
MOCA 
MINI-Suicide module (only administered at follow-up if score was ≥ 1 at baseline, see DSMB section) 
RDAS 
PCS 
MSPSS 
DERS 
BDI-II 
BAI 
IPF-80 
CTS-2-SF 
PCL-5 (family members will rate the PCL-5 based on their perception of the Veteran’s current symptoms) 
 
Family members will also complete the following (timing outlined in Table 1): 
 
Significant Others’ Responses to Trauma Scale (Fredman et al., 2014) (SORTS)  
 
Caregiving Appraisal Scale (Lawton, Moss, Hoffman, & Perkinson, 2000) 
 
Involvement in Therapy Checklist (ITC). This measure consists of a checklist of involvement in the 
Veteran’s treatment since the last assessment (assisting with therapy homework, driving patient to 
appointments, attending therapy sessions with the Veteran, etc.). 
 
Treatment Expectancy Questionnaire (TEQ; Borkovec & Nau, 1972). The TEQ will be administered 
immediately after the first BFI session. Wording was modified slightly to better describe the family program. 
 
 
The therapeutic alliance following the BFI will be assessed using the 12-item therapist and client versions of 
the Working Alliance Inventory (WAI; Horvath & Greenberg, 1989; Tracey & Kokotovic, 1989). Wording was 
modified slightly to better describe the family program. 
 
 
The Client Satisfaction questionnaire (CSQ) will assess family members’ satisfaction with the overall 
program. 
 
 
Clinician-specific assessments:  
Demographics form 
 

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Assessment Quality Assurance. The CAPS-5 and SCID-5 will be administered by assessors who have at least 
MA-level education background. IEs will be trained to reliability by Dr. Sloan as part of the ongoing training 
process in her lab. After achieving gold-standard reliability, assessors will continue to have ongoing 
supervision by Dr. Sloan throughout the course of the study. Reducing assessor drift. All assessments will be 
audio recorded and 15% of randomly selected interviews will be re-rated at regular intervals to establish 
interrater reliability. If reliability falls below criteria, IEs will be retrained. 
 
Data Management.  All study data will be entered into SPSS database, which will be housed on a secure 
network server accessible only by project staff.  SPSS software is provided by the NC-PTSD and the license 
fees are paid by the NC-PTSD. The PI will check all data on the same day as entry to ensure completeness. 
Any incomplete data will be brought to the attention of the assessor and/or therapist and every effort will be 
made to complete ratings. Field parameters will be specified such that suspect or missing values are either 
disallowed or flagged for the immediate attention. Prior to data analysis, all data will be cleaned and rechecked 
for accuracy before conducting data analysis. Three times per year, blinded data will be compiled and 
reviewed by the PI and Co-I’s to ascertain overall completeness and issues requiring clarification, as well as for 
purposes of providing information to the data safety and monitoring board. Files will be destroyed according to 
the VA Record Control Schedule. 
 
 
Power analysis: 
Given the aims and scope outlined here, the present study is considered preliminary. It will provide pilot 
data to assess the feasibility and preliminary effectiveness of the BFI. The use of repeated measures increases 
our ability to detect significant relationships. Our results will inform next steps in the investigation of the 
effectiveness and implementation of the BFI, including a fully powered study examining the BFI in comparison 
to an established family-based treatment in a routine VA clinic. 
 
k.  Human Studies Section   
 
1. Risks to the Subjects 
a. Human subjects involvement, characteristics, and design 
Over the two phases of the study, the participant population is to be composed of 48 Veterans and family 
members. Veterans will be recruited on the basis of the presence of a current diagnosis of PTSD; family 
members will be adult relatives of the Veterans. These individuals will be recruited on a volunteer basis. As 
indicated in the Method section, inclusion criteria for Veterans are: (1) Currently enrolled in the VA Healthcare 
System; (2) meets current criteria for DSM-5 PTSD; (3) 18 years of age or older; (4) has an eligible family 
member who is willing to participate; and (5) beginning a course of Cognitive Processing Therapy (CPT) or 
Prolonged Exposure (PE) at VA Boston. Inclusion criteria for family members are: (1) Spouse/significant other, 
adult child, parent, sibling, or other relative of the Veteran; (2) currently has substantial daily or weekly contact 
with the patient; (3) 18 years of age or older. 
 
Exclusion criteria for Veterans and family members are: (1) Presence of current unstable bipolar disorder, past 
or present psychosis, organic mental disorder, or significant cognitive impairment (standard cut-off score of 
<14 on the Mini Mental Status Examination-Brief Form (Folstein, Folstein, & Fanjiang, 2001)); (2) clear and 
current suicidal risk (assessed via the MINI-Suicide Module (Sheehan et al., 1998)); (3) current moderate or 
severe substance use disorder, and (4) current participation in family-based therapy/couples-counseling. 
 
Only individuals who provide written informed consent will participate. A participant may withdraw his or her 
consent at any time and without prejudice. A clear and detailed explanation will precede all procedures. At the 
beginning of the first session participants will be fully informed about their condition assignment (BFI during 
Phase I; random assignment to BFI or no BFI during Phase II). Participants will also be informed that they are 
free to withdraw from the study at any time without any consequences. It will be clearly explained to all 

BFI-CDA 7/2/21 
 
13 
 
participants that a decision by either the Veteran or the family to withdraw from this study will not affect the 
Veteran’s individual CPT or PE treatment in any way. 
 
At the conclusion of the study, an in-depth debriefing will explain all procedures and hypotheses, and answer 
any remaining questions. The debriefing will be conducted at the final follow-up assessment session. 
Participants will be told the exact nature of the study cannot be revealed to them until completion of the follow-
up visits to reduce any bias in the results. Any participant withdrawing early from the experiment will be 
provided with a debriefing at the time of withdrawal. 
 
This application also involves clinician participants currently working in a VA Boston mental health clinic and 
regularly providing CPT and/or PE (n ≤ 20). This part of the proposed study involves: (1) Conducting qualitative 
interviews with providers regarding family-inclusive PTSD treatment; (2) providing training to providers in the 
delivery of the BFI; (3) collecting recordings of BFI sessions for the purposes of training and measuring fidelity; 
and (4) notes and recordings from supervision. Clinicians administering the BFI in Phase II will be asked to 
complete qualitative interviews at posttreatment and turn in audio recordings of sessions. Data in the form of 
ratings of digital audio recordings of BFI sessions will be collected from the clinicians to monitor their in-session 
use of the BFI and assess modifications/adaptations to the protocol. These digital audio recordings will either 
be hand-delivered to the PI (on the recording device) for her to upload onto a secure research drive, or the 
recordings will be uploaded to a subfolder on the research drive by the clinicians themselves. Each clinician 
will have access to a dedicated subfolder on the PI’s research drive in which to deposit session recordings; 
these personal subfolders will also include any training materials or other relevant study information from the PI 
to the clinician. Clinicians will be therapists who are providers in the VA Boston Healthcare System. Thus they 
will be over 18, as they will need to have completed their training to become therapists. 
 
b. Sources of research materials 
All information pertaining to this project (e.g., screening forms, questionnaire data, recordings of assessment 
sessions and BFI sessions for all participants) will be held in the strictest confidence and will be kept in locked 
files located within the PI’s locked office at the National Center for PTSD (NCPTSD) (or, during construction on 
the 13th floor of Building 1 in JP, in a secure basement storage area appropriate for materials containing PII). 
Data will be available only to individuals directly involved with the project. Under no circumstances will 
individually identifiable data be released to anyone without written consent of the participant. Results will be 
published as group findings only. Experimental results will be discussed with the participant at their request. 
 
Additionally, clinician-related data collection will include surveys and digital audio recordings of BFI sessions 
and interviews. Notes will be taken at meetings with clinicians during training and used for research. Audio 
recordings of BFI sessions will be obtained and will be rated using a standardized rating instrument by an 
adherence rater. Interviews will be reviewed and coded. Veteran symptom inventories and feedback forms will 
be collected for the purposes of the study. All data obtained in the study will be used exclusively for the 
purposes of the proposed research. 
 
c. Potential Risks 
Intervention: Some risks are associated with the administration of psychosocial interventions. The primary risk 
is the evocation of uncomfortable levels of anxiety or other emotions during the sessions. Some participants 
may find sessions or assignments stressful and react to them with anxiety. We have no reason to anticipate 
that these potential negative reactions will be of any greater magnitude than would be experienced in standard 
family-inclusive interventions. 
 
Recording: Some participants may feel uncomfortable about the assessment, intervention, and interview 
sessions being recorded. However, this will be a required procedure. The purpose of the recording will be 
explained, confidentiality will be respected, and both informed consent and authorization for recording will be 
obtained as per requirements put forth by the Healthcare Information Portability and Accountability Act 

BFI-CDA 7/2/21 
 
14 
 
(HIPAA). Recordings will be marked only by subject identification codes and stored on a password-protected 
research drive.  
 
Self-Report Measures and Assessor Ratings: No risks are seen associated with these assessment 
procedures other than discomfort associated with the recording. These will be handled as described above for 
recording of assessment and BFI sessions. 
 
Clinician Data: The major types of risk stemming from study participation include the discomfort of revealing 
personal information and opinions during surveys or interviews, and an unforeseen breach of confidentiality, 
which could affect employment. Every effort will be made to minimize this risk. Providers who participate will 
experience risks associated with the evaluations and monitoring of the effects of training on their ability to use 
the BFI. The major types of risk stemming from study participation include: the discomfort of revealing personal 
information on the surveys or interviews and discomfort at having their in-session behaviors evaluated and 
monitored to assess their ability to adhere to the protocol. 
 
2. Adequacy of Protection Against Risks 
a. Recruitment and consent procedures 
Following the recruitment procedures used in recent clinical trials within BSD, we plan to recruit participants 
from various specialty clinics at VABHS. Patients will be recruited in these clinics by providing clinic staff and 
directors information about the study and placing study advertisements around VABHS. A recent PTSD trial 
using this technique was able to randomize 3 participants per month. Given that the criteria are not very 
stringent for the proposed study, we expect a good flow of recruitment. The study announcements will state 
that the free family intervention is part of a research study that is available to qualified individuals. Interested 
individuals will be instructed to call for further information. 
 
In accordance with HIPAA regulations, written informed consent will be obtained from each participant after a 
thorough explanation of procedures by a project staff person and the opportunity for the participant to ask and 
receive answers to questions. Participants will be informed of the nature of the investigation, the types of 
assessments and treatments involved, alternative treatments, and the potential risks involved in participation 
and will be asked to sign an informed consent statement prior to participating in the proposed study. In 
addition, the participant will receive an explanation of how information related to their case will be handled 
including all parties involved, data management, and plans to publish data in group format without identifying 
information. Participants will also be informed that if suicidal intentions are disclosed confidentiality may be 
broken in order for protective measures to be taken. See Section 5 (Data Safety and Monitoring Plan) for 
specific information on assessment of suicidal information from participants and at what point action(s) would 
be taken. 
 
To prevent clinic staff from feeling pressure to participate, the following measures will be taken: Several clinics 
that commonly treat PTSD (e.g., the PTSD Clinical Team, Women’s Stress Disorders Treatment Team, 
General Mental Health, Center for Returning Veterans) and employ multiple clinicians (more than 5) will be 
contacted at the time of recruitment and informed of the option to participate. It will be made clear that surveys 
and interviews assessing information that is gathered during the study will not be shared with the 
administration (other than in the prepared research report, which will not disclose participant name or 
identifying characteristics). Providers who participate will receive a thorough description of study-related 
procedures, will have the opportunity to ask questions, and will provide informed consent. Providers who 
participate by providing the intervention, and/or completing surveys and interviews all will be asked to provide 
informed consent. Interview, survey responses, and competence and adherence data collected will not be 
made available to employers or become a part of their employment records and will remain confidential. 
 
b. Protection against risk 
 
1. We will carefully screen to identify individuals whose risk for potential adverse outcomes is elevated 
were they to participate in the proposed research. Such individuals will be excluded from the study. As an 

BFI-CDA 7/2/21 
 
15 
 
example, an actively suicidal person would be excluded from study participation and appropriate clinical 
treatment or referrals provided. 
 
2. Clinical staff will be trained to cope with any anxiety/distress experienced by participants during the 
assessments and intervention. Staff will also monitor assessment items that ask about risk of suicide or current 
domestic violence at each timepoint. These items will be reviewed immediately upon completion, and 
participants who endorse elevated risk of suicide or current domestic violence will meet with the PI for further 
assessment. See Section 5b (“Safety monitoring plan”) below for details of the standard procedure for suicidal 
risk. For current domestic violence, the PI (in consultation with a licensed clinical supervisor on site) will assess 
risk and provide the participant with clinical and community referrals as needed. 
 
3. Careful monitoring of participants during study participation will be conducted by the project staff. 
Participants will be monitored for any increase in symptoms as the study progresses. Each participant will see 
the same clinician for each of their treatment or intervention visits (in the case of Veterans, their same usual 
care clinician. In the case of family members, the same BFI clinician), and the same assessor for each 
assessment occasion when appropriate. Following the clinical trial policy of the VA Boston Healthcare System, 
all participants will be given an emergency number to call in case of an emergency. This number will be the 
psychiatry on call system of the VA Boston Healthcare System. 
 
4. Participants will be instructed to contact study personnel at any time (including during the follow-up 
period) in the event of worsening symptoms. Participants whose clinical condition has deteriorated will be 
removed from the study and given appropriate clinical care. See DSMP for details. 
 
5. Veterans will be under treatment with clinicians at the VA Boston Healthcare System, and thus will 
be monitored by their clinicians and will be provided with appropriate referrals as necessary at the end of their 
PTSD treatment. Family members failing to benefit from the study intervention will be provided with appropriate 
clinical care and referrals. The exact nature of these referrals will be determined by the judgment of clinicians 
and supervisor familiar with the specific participant and may include services delivered by the Social Work 
Service of VA Boston or other community resources. 
 
6. As in any type of treatment or clinical research program, participants’ (those receiving interventions 
and all clinician participants) confidentiality must be carefully guarded and respected. All data with identifying 
information will be stored in locked files or password-protected computer servers. Data being analyzed will be 
identified by subject codes, and identifying information will be removed. The identity of participants will not be 
revealed in the presentation or publication of any results from the project. All personnel working on the project 
will be educated about the importance of strictly respecting participants’ rights to confidentiality and will have 
completed several training courses including proper practice in accordance with HIPAA regulations, protection 
of human subjects, and computer security. 
 
3. Potential Benefits of the Proposed Research to the Subjects and Others 
There is no direct benefit to participants who enter this study, although some may experience relief from PTSD 
symptoms, decreased avoidance, decreased conflict, and increased quality of life. 
 
The clinician participants may receive benefit from the training in a new brief family intervention, from access to 
expert consultation on the intervention, and/or by providing feedback about the potential barriers that require 
addressing within the mental health clinics. Providers who participate in the treatment portion of the study will 
receive free training in a new psychotherapy intervention, and this training will also be made available to 
clinicians who would like the training but do not wish to provide the intervention in the context of the study. 
Over the longer term, they may also benefit professionally (e.g., future job opportunities at agencies that value 
family-inclusive approaches to treatment) from the training. Consequently, the potential risks of participation in 
the study are outweighed by the potential benefit to the participants. 
 
4. Importance of the Knowledge to be Gained 
PTSD is a significant public health problem, with national lifetime prevalence rates of 8%(Kessler et al., 1995) 
and estimated rates in Veterans of the current conflicts in Iraq and Afghanistan of 13-20%(Kok et al., 2012). 
Family members may serve as a unique resource that can be harnessed to improve outcomes for PTSD 
treatment; social support is one of the most important predictors of the development and maintenance of 

BFI-CDA 7/2/21 
 
16 
 
PTSD(Ozer et al., 2008), and family members may provide substantial practical and emotional support for 
treatment. However, relatives may also inadvertently behave in ways that contribute to the maintenance of the 
disorder(Erbes et al., 2008). The proposed study will examine a brief family intervention (BFI) delivered in 
conjunction with individually-delivered trauma-focused treatment. 
 
5. Data Safety and Monitoring Plan (DSMP) 
 
a. Data Monitoring Plan. Data will be collected using standardized forms and will only be identified using the 
participants’ ID number (no names or identifying information will be on the forms). A username and password 
is required to gain access to the network server, permission is needed to access the data drive, and a separate 
password is needed to gain access to the database. Data will be stored on a VABHS server 
(VHABOSCLURES1) and is backed up nightly; no data will be stored on a hard drive.  
 
The codes that link the names of participants and their ID numbers will be kept confidential by the PI in a 
secured cabinet located within the PI’s office (JP campus, room 13B-60) (or, during construction on the 13th 
floor of Building 1 in JP, in a secure basement storage area appropriate for materials containing PII). Collected 
data forms will be in a locked file cabinet located in the PI’s office (or, during construction on the 13th floor of 
Building 1 in JP, in a secure basement storage area appropriate for materials containing PII). These data are 
accessible to the PI and personnel working on the project. Data will be entered electronically by trained staff, 
and data entry discrepancies will be corrected by the data entry supervisor based on source documents. The 
quality of the data will be monitored quarterly. Data will be securely transmitted using VA approved methods.   
 
Audio recordings will be captured using Philips recorders with FIPS 140-2 validated encryption. Recordings 
may be obtained while study staff are teleworking; in these cases the recorders will be stored in the home in a 
locked cabinet/drawer that is only accessible to the study staff member. Recorders will be hand-carried to the 
VA as soon as it is feasible and safe to do so, at which point the recordings will be uploaded to the PI’s 
personal research drive behind the VA firewall and deleted from the recording device. 
 
The primary outcomes measures will be CAPS-5 total scores and ratings of homework completion (from the 
Homework Completion Scale), and number of sessions attended/dropout. Data quality will be monitored by 
inspection of the completed forms by the research assistant and any problems detected will be discussed with 
the PI. All assessors will be fully trained on the assessment measures, per the usual training procedures within 
BSD. Adherence to the intervention will be monitored using recordings of sessions and weekly supervision, as 
described previously. If diagnostic and/or intervention drift is observed, staff will be retrained until acceptable 
reliability is reached. 
 
b. Safety Monitoring Plan. In the proposed study we will use the FDA definition of adverse events (AE) and 
serious adverse events (SAE). Any SAE, whether or not related to the study intervention, will be reported 
immediately to the IRB. In the event that a participant either withdraws from the study or the PI decides to 
discontinue a participant due to an SAE, the participant will be monitored by the PI via ongoing status 
assessment until (a) a resolution is reached (e.g., the problem has resolved or stabilized with no further 
change expected), (b) the SAE is determined to be clearly unrelated to the study intervention, or (c) the SAE 
results in death. Outcomes of SAEs will be regularly reported to the IRB. A summary of the SAEs that occurred 
during the previous year will be included in the annual IRB renewal. Suicidal ideation and AEs will be formally 
assessed at baseline and at all other assessment visits (see below for detailed information regarding 
assessment of suicidal ideation). 
 
Participants will be informed that the interim results of the study will not necessarily be revealed to them, even 
if there is a suggestive trend in favor of the treatment, so as to maintain the scientific integrity of the 
study(Slutsky & Lavery, 2004). During the first in person screening, potential participants will undergo a 
comprehensive screening to determine their eligibility for, and safety for, participation in the study. Attention will 

BFI-CDA 7/2/21 
 
17 
 
be paid to current suicidal ideation. Individuals who report imminent risk will be excluded from participation in 
the study and will be provided with appropriate clinical referrals. 
 
b.1. Assessment of suicidal ideation: During the course of the study the clinician-administered MINI 
suicide module will be used to thoroughly assess participant suicidal risk and distress beyond what would be 
expected in treatment for trauma. The MINI suicide module consists of 9 questions related to suicidal ideation 
and behaviors, with possible scores ranging from 0 to 53. Low suicide risk is defined as 0-8 points, moderate 
suicide risk is defined as 9-16 points, and high suicide risk is defined as scoring 17 or greater. The MINI 
suicide module includes clear guidelines for determining suicide risk, and requires approximately 10 minutes to 
administer. Individuals will be excluded from enrolling in our proposed trial if they score 17 or higher on the 
MINI suicide module at the initial assessment. Individuals who are excluded will be provided with appropriate 
clinical referrals. The PI will follow up with each of these individuals within one week to make sure they have 
connected with appropriate clinical care.  
 
Additionally, if at any point during the study (either baseline or follow-up) a participant describes a clear 
intent or inability/unwillingness to develop and follow a Suicide Prevention Safety Plan, which is a VA standard 
of care, then they will be terminated from the study and the crisis will be managed. Specifically, staff will 
immediately locate Dr. Sloan, who is a licensed psychologist, or another licensed psychologist, who will follow 
standard VA suicide prevention and risk management procedures. A licensed clinical psychologist will always 
be on-site when assessments are conducted. The psychologist will intervene by (a) following up with direct 
questions about suicidal behaviors, (b) assessing mental status by asking about psychotic symptoms, mood 
symptoms, and drug and alcohol use, (c) scheduling extra contacts if necessary, emphasizing problem solving, 
(d) helping the participant to generate short-term objectives, and (e) collaboratively developing or refining a 
Safety Plan using the VA’s comprehensive Safety Planning template and manual. The plan will address what 
actions need to be taken in the succeeding days to solve the problems that precipitated suicidal behavior. The 
plan will also address the use of voluntary and involuntary hospitalization, if necessary. In addition to these 
formal assessments, all participants will be given the number of the on-call psychiatry service at VA Boston 
Healthcare System and informed that they should call this number after normal business hours in the event 
that they are feeling suicidal and/or distressed, as well as the National Suicide Prevention hotline number, 
which is a 24-hour service with a specific line dedicated to Veterans. During business hours the participants 
will be instructed to contact the PI. Should a participant call to indicate suicidal risk, then the previously 
described intervention plan will be followed. All Veterans in the study will also be under non-study care through 
the VABHS, and will be monitored as appropriate by their individual clinicians. 
 
Veteran participants will be administered the MINI-Suicide module at baseline and at each follow-up 
assessment. Family members will be administered the MINI-Suicide module at the baseline assessment; those 
family members who score a 0 at baseline on the MINI-Suicide module will not be reassessed at future follow-
up points. However, any family members that score ≥ 1 baseline will continue to have the MINI administered at 
follow-up assessments to monitor risk. If at any point during these follow-up assessments a family member 
indicates that they are experiencing high levels of suicidal thoughts, study staff will proceed with the steps 
outlined above (e.g., further assessment by a licensed psychologist of the intensity of thoughts, assessment of 
any related behaviors, collaborative completion of a Safety Plan, scheduling of additional contacts in the near 
term, and/or potentially a voluntary or involuntary hospitalization, as determined by the licensed psychologist). 
 
In the event that a participant experiences high distress (i.e. exacerbated symptoms) but without any suicidal 
ideation or threat, then the PI will intervene by asking direct questions about the nature and causes of the 
distress, conduct a symptom assessment, and schedule extra contacts (assessments) and/or work closely with 
the patient’s other VA providers if deemed necessary. Veterans’ PTSD care will not be constrained or limited in 
any way by their participation in the study; therefore, their individual clinicians will be free to make any 
appropriate treatment decisions in response to increased distress, including seeking hospitalization or another 
higher level of care, discontinuing PE/CPT and instead conducting supportive or crisis-oriented therapy, etc. 
Any such changes in treatment focus will be monitored and reported to the IRB as appropriate. 

BFI-CDA 7/2/21 
 
18 
 
DATA ANALYSIS.  
Data management: All clinician-administered and self-report questionnaire data will be entered into the 
database by the Research Assistant (RA) on the same day of administration to ensure completeness. All data 
will be cleaned and rechecked for accuracy before being exported into the appropriate program (e.g., SPSS, 
MPlus, and NVivo) for analysis. Data collected via mEMA will be continuously available via the secure cloud-
based storage system and accessible via a unique access site available only to study staff. 
 
Overview of data analysis: Quantitative data analysis will be performed using MPlus and SPSS, and 
NVivo management software will be used for qualitative data. Prior to full data analysis, the balance of 
randomization will be checked and unbalanced factors between groups will be controlled for in subsequent 
analyses. Similarly, all major variables will be assessed for skewness and outliers, and in cases where 
parametric analytic assumptions are violated we will use transformations. Preliminary analyses will consist of 
descriptive statistics by assessment period. All quantitative outcomes will be tested at a two-sided =.05 level. 
 
Data checking: Standard data checking procedures will include checking forms for missing data, double 
entry with discrepancy resolution, daily back-up copies of computer files, and examination of key variables for 
skewness, variability, missing data, and outliers. Data will be transformed to achieve normality if needed. If any 
outcome variable is too zero-inflated to allow for transformation, it will be analyzed with logistic regression or 
generalized estimating equation techniques (appropriate for this small pilot study).  
 
Missing data: We will make every effort to retain participants, but as treatment engagement is a key 
outcome of the present study we will also carefully tabulate and report dropout rates and patterns in the 
present study, including exact timing of dropout. Multilevel regression models will be used to evaluate 
treatment outcomes; this approach is robust to missing data and is considered “state of the art” for use with 
unbalanced data sets due to treatment dropout (Schafer & Graham, 2002). There are also several methods for 
correcting biases due to missing data when using a multilevel regression approach (e.g., pattern-mixture 
modeling). 
 
Power analyses: Determining sample sizes for multilevel models is a complex issue and "rules of thumb" 
are disputed (Maas & Hox, 2005; Mok, 1995). Furthermore, "effective" sample sizes in MLMs (as opposed to 
nominal sample sizes) will vary according to the model's predictors (Bickel, 2007). Given the aims and scope 
of this funding mechanism, the present study is considered preliminary. It will provide pilot data to assess the 
effectiveness of the BFI as well as exploring the proposed mechanisms of action. The use of repeated 
measures increases our ability to detect significant relationships. Our results will inform next steps in the 
investigation of the effectiveness and implementation of the BFI, including a fully powered R01 application to 
examine the BFI in comparison to an established family-based treatment in a routine VA clinic. 
 
Defining key concepts for analyses: 
Treatment dropout: Consistent with past trials of CPT and PE, treatment dropout will be defined by 
ending treatment prior to the allocated treatment period. In the case of CPT full treatment duration is 12 
sessions, while in the case of PE full treatment duration is at least 8 sessions and the concomitant agreement 
of the therapist that an appropriate ending place has been reached. Any Veteran who ends treatment prior to 
these milestones will be considered a dropout. 
 
Feasibility/Acceptability: In the current study, feasibility and acceptability will refer to the evaluation and 
analysis of recruitment, randomization, retention, treatment adherence and fidelity, and use of the BFI with the 
families of Veterans beginning PTSD treatment. These variables help to determine the acceptability of the 
treatment and procedures for future studies. 
 
Aim 1: Collect qualitative and quantitative data on feasibility and acceptability of the BFI in a routine care 
setting. 

BFI-CDA 7/2/21 
 
19 
 
 
Hypothesis 1: Levels of feasibility and acceptability of the BFI among Veterans, family members, and 
clinicians will be high and comparable to levels found in the previous efficacy trial in OCD. 
 
Hypothesis 1 analytic strategy: We will examine the feasibility and acceptability of the BFI by examining 
rates of BFI recruitment and refusal, as well as level of drop-out from the BFI sessions. These data will be 
benchmarked to previous BFI efficacy data. We will also assess the success of the clinician training program 
by reviewing rates of clinician recruitment and attitudes reported on the EBPAS-50.  Furthermore, we will 
conduct detailed in-person, semi-structured exit interviews with Veterans, family members, and clinicians in 
order to collect qualitative data. These data will allow us to contextualize our findings related to the protocol’s fit 
in this novel setting and its acceptability to Veterans, families, and providers. The qualitative interviews will 
provide more nuanced feedback regarding the perceived fit of the BFI, and further identify necessary 
modifications to the protocol (see below for qualitative analytic strategy).  
 
Aim 2: Assess the BFI’s effects on symptoms as well as potential mechanisms of change using multilevel 
modeling. 
 
Hypothesis 2a: Veterans whose family members receive the BFI will show lower levels of PTSD symptoms 
at post-treatment and greater engagement throughout treatment compared to control Veterans.  
 
Hypothesis 2b: Family members who receive the BFI will show more active support for treatment and less 
accommodation than control family members. 
 
   Hypothesis 2c: Family members’ active support for treatment will be positively related to Veterans’ 
treatment engagement, and Veterans’ levels of perceived criticism will be negatively related to their treatment 
engagement 
 
   Hypothesis 2a-2c analytic strategy: Multilevel regression (i.e., hierarchical linear modeling (HLM), growth 
curve analysis, etc.) will be used to evaluate change in continuous outcome variables (Singer & Willett, 2003). 
Multilevel regression is a robust method for analyzing change over time, with excellent options for handling 
missing data, powerful estimation abilities, and flexibility of modeling. This approach will allow for the analysis 
of an intent-to-treat sample in line with CONSORT guidelines (Altman et al., 2001). For our analysis of change 
in the variables of interest we will use a multilevel framework in the Mplus program to model time as a Level 1 
predictor of the outcome variables (baseline and weeks 6, 12, and 16). We will first specify an unconditional 
model to ascertain the shape of the change trajectories (e.g., linear versus quadratic change over Time), and 
will subsequently specify conditional multilevel models to examine treatment effects and the impact of other 
variables as predictors of individual differences in change. We will also calculate the Cohen’s d effect size and 
95% confidence intervals in order to provide a benchmark for future trials. 
 
 
 
 
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