Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure
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|ClinicalTrials.gov Identifier: NCT03056157|
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : January 25, 2021
|First Submitted Date ICMJE||January 31, 2017|
|First Posted Date ICMJE||February 17, 2017|
|Last Update Posted Date||January 25, 2021|
|Actual Study Start Date ICMJE||March 1, 2018|
|Estimated Primary Completion Date||November 30, 2021 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure|
|Official Title ICMJE||Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure|
|Brief Summary||The aim of this study is to determine the efficacy of Adaptive Disclosure for Moral Injury and Loss (AD-MIL), a combat-specific psychotherapy for war-related PTSD stemming from Moral Injury (MI) and traumatic loss (TL) with Iraq and Afghanistan War Veterans with PTSD. AD-MIL will be compared to Present Centered Therapy (PCT). AD-MIL is a modified version of Adaptive Disclosure (AD), which has been modified and extended to solely treat MI and TL by targeting psychological and behavioral obstacles to occupational, relationship, and family functioning, as well as quality of life. PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials. The primary end-point is psychosocial functioning (improvements in social, educational and occupational functions and improvements in quality of life). Secondary end-points include PTSD, depression, and shame and guilt. The investigators will also explore the impact of AD-MIL on anger and aggressive behaviors, suicidal ideation, and alcohol abuse.|
The overarching goal of this study is to conduct a multi-site randomized control trial comparing Adaptive Disclosure-Moral Injury and Loss (AD-MIL), a new combat-specific psychotherapy for war-related PTSD stemming from Moral Injury (MI) and traumatic loss (TL), to Present Centered Therapy (PCT; Frost et al., 2014), in terms of its impact on psychosocial functioning. The investigators have five hypotheses, grouped into (A) functional change and (B) mental health change.
A: Functional and behavioral change hypotheses:
A.1. Immediately post-treatment, 3-, and 6-months post-treatment, Iraq and Afghanistan Veterans with PTSD randomized to AD-MIL will have greater reductions in social, educational, and occupational disability A.2. Immediately post-treatment, 3-, and 6-months post-treatment, Iraq and Afghanistan Veterans with PTSD randomized to AD-MIL will have greater improvements in quality of life.
A.3 COVID-19 aim. In the extended time period for the trial, at the post-treatment and 3-months post-treatment intervals, veterans with PTSD randomized to AD-E will have greater reductions in social, educational and occupational disability
B: Mental health change hypotheses:
B.4. Veterans randomized to AD-MIL will have greater reductions in PTSD symptom severity and a smaller percentage of PTSD cases B.5. Veterans randomized to AD-MIL will have greater reductions in depressive symptoms B.6. Veteran randomized to AD-MIL will have greater reductions in shame and guilt B.7. Veterans randomized to AD-E will have greater reductions in psychological distress
The investigators will also explore the impact of treatment on anger and aggressive behaviors, suicidal ideation, and alcohol abuse.
BACKGROUND Posttraumatic stress disorder (PTSD) is a highly prevalent and disabling condition among war Veterans, posing a significant public health burden. Depending on the degree and type of exposure to warzone stressors, approximately 20% of the 2.5 million service members who served in Iraq and Afghanistan have or will develop clinically significant PTSD. PTSD causes private suffering and has a uniquely damaging ripple effect on family members, friends, co-workers, productivity, and healthcare costs. Veterans with PTSD suffer from a variety of co-morbid mental and physical health conditions and are heavy service-utilizers. They also have extensive functional impairments, such as occupational problems, family and relationship difficulties, aggressive and risky behaviors, and reduced quality of life. Unfortunately, although considerable gains have been made in the VA's dissemination of PTSD treatments that are highly effective with civilian trauma, these therapies have been shown to work considerably less well for war trauma. The investigators have argued that this is partly due to a lack of attention to the military culture and ethos and the unique harms of war trauma, namely, moral injury (MI) and traumatic loss (TL). In addition, VA treatments have failed to demonstrate an impact on functioning and quality of life, problems that are no less impacted by the warzone trauma being targeted in treatment. Instead, symptom change is typically the sole metric of success, and functional deficits are rarely taken into account. The investigators argue that PTSD symptoms should be conceptualized and targeted as part of the fabric of the whole Veteran and his or her context. Consequently, the overarching goal of this proposed study is to fill a substantial care-gap in the VA by creating an evidence-based treatment for war-related PTSD stemming from MI and TL focusing on improving psychosocial functioning. The investigators have modified and extended Adaptive Disclosure to treat MI and TL (AD-MIL) by building in skills training and behavioral contracting to improve functioning, and targeting MI- and TL-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles. If found to be effective, AD-MIL will fill a care-gap in the VA, reduce PTSD patients' suffering, and help Veterans reclaim or establish positive relationships, work roles, and self-care routines.
METHOD Overview CTVHCS is part of a multi-site randomized controlled trial of AD-E, comparing it to PCT (Frost et al., 2014). The VA sites are Boston, Minneapolis, San Francisco and San Diego, and Central Texas. The coordinating/lead site is VA Boston Healthcare System led by the study PI, Brett Litz, PhD. The trial will follow the consensus recommendations for clinical trials in the VA (VAORD, 2008): (1) clearly defined target symptoms: Functional and clinical outcomes will be operationalized; (2) reliable and valid measures: Assessment tools are selected for their content relevance and psychometric properties; (3) use of blind evaluators of outcome: The evaluator will be independent and blind to treatment condition. This assessor will remind participants to help maintain their blind; (4) assessor training: The independent evaluator (IE) will be carefully trained to criteria and monitored on an ongoing basis; (5) manualized, replicable, specific treatment programs; (6) unbiased assignment to treatment arms and (7) treatment adherence: Sessions will be recorded, and a random percentage will be used to assess treatment integrity. Adherence to the therapy manuals will be monitored by senior supervisors. We will follow the CONSORT guidelines for randomization and participant tracking.
Participants For the trial, participants will comprise a sample of 148 veterans (including women and members of diverse ethnic and racial groups) with PTSD as a result of military trauma.
We plan to recruit 50 CTVHCS Veterans total. 25 CTVHCS Veterans will be enrolled at the CTVHCS site; thus, our local intent to treat sample is 25 CTVHCS Veterans. A secondary aim of this proposal is to support recruitment in the trial, and to this end approximately 25 CTVHCS Veterans will be enrolled in the San Francisco site and will be seen by our San Francisco VA study therapist. We will review 400 charts and expect to recruit and enroll approximately 16% of reviewed Veterans, based on experiences at other study sites.
Recruitment Veterans will be recruited and treated at VA sites in Minneapolis, MN, San Diego, CA (Oceanside CBOC), and San Francisco, CA. Co-Investigators (Co-Is) at these study sites have successfully resolved operational obstacles and challenges to implementing clinical trials in their respective settings. Referrals for clinical studies have been nurtured through each Co-I's role as a clinician and PTSD expert. Co-Is will (a) provide materials describing the nature of the study and the target populations sought, distributing said materials via formal (e.g., staff meetings) and informal (e.g., bulletin boards) channels; (b) attend clinical staff meetings; (c) give talks to describe various treatments in staff grand rounds and other contexts (e.g., to trainees); and (d) provide feedback to staff about referred patients.
Assessor Training and Adherence
A co-investigator, Dr. Matt Gray (University of Wyoming) will train the assessors prior to beginning enrollment. Training will include reading and viewing training materials, observation of CAPS administration, and supervised administration of at least three CAPS. Dr. Gray has expertise in the conduct of CAPS assessment and has past experience performing training and fidelity monitoring for use of CAPS assessment in clinical trials. 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 the assessor. A match occurs when the assessor and Dr. Gray agree on the diagnosis and are within 2 points of severity on all of the symptom clusters (PTSD criteria B, C, D, and E). 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.
All assessments will be audiotaped to ensure that a standardized approach is being used across patients (provided that the participant consents). Dr. Gray will review audio recordings of 10% of the assessments, selected randomly. Dr. Gray can at his discretion increase the proportion reviewed for difficult patients or assessors needing additional monitoring. Assessors will be provided with feedback about their performance. All recordings will be stored on a restricted-access directory (i.e., only lab personnel with personal usernames expressly granted access may access the directory containing the folder of recordings, and they must log in with their personal username and password to do so) in a locked office maintained at the Boston VA Healthcare System, Jamaica Plain campus. Selected sessions (recordings and interviewer-scored assessments sheets) will be transported to Dr. Gray via Federal Express or another carrier that allows for tracking.
Random Assignment Veterans will be randomly assigned to PCT or AD-MIL. The Boston site will generate a randomized permuted block scheme to randomly assign patients to blocks by gender and minority status. Block size for gender and minority status will be based on the distribution of these variables at each site. Blocking by gender and minority status will ensure appropriate accrual rates for participants with lower base-rate characteristics. The Boston site will use constrained randomization (i.e., biased coin design) if unexpected imbalance arises in gender and minority distribution across treatment groups.
Treatment Fidelity Monitoring
Two half-time therapists with Ph.D.'s in clinical or counseling psychology and VA internship experiences treating Veterans with PTSD will be trained to deliver AD-MIL or PCT (not both). Training will involve a review of the respective manuals and supporting materials, intensive supervision of two trial cases, weekly group phone supervision (Dr. Litz for AD-MIL; Dr. Bolton for PCT), and weekly one-on-one supervision with Dr. Amidon (for AD-MIL) or Dr. Bolton (for PCT). Dr. Amidon was trained by Dr. Litz to administer AD for the Marine Corps trial and was recently trained to conduct AD-MIL. Dr. Bolton has provided training, supervision, and fidelity monitoring on numerous other treatment outcome studies, including two large randomized trials for Veterans in which PCT was compared to a trauma-focused intervention. Drs. Amidon and Bolton will review recordings of the first 2 trial cases to shape fidelity. All sessions will be audiotaped. Two random session recordings from a random 20% of the cases will be rated to ensure fidelity to each treatment approach. Selected sessions will be transported to Dr. Amidon and Bolton via Federal Express or another carrier that allows for tracking.
ANALYSES Inferential analyses. The longitudinal and clustered nature of the design produces a multilevel or nested data structure. In this study, Veterans and therapists are nested (clustered) within performance sites. The lower level (level-1) data consists of the repeated measures for each individual at each assessment. Level-1 data is nested within upper level (level-2) person-level variables (e.g., treatment arm and study site). In SAS Proc Mixed the two levels merge into one model with random intercept and slopes (aka "growth curve" model) using compound symmetry for variance within site and auto-correlated AR1 structure for the repeated measures. The investigators will conduct a mixed model analysis with random slopes/random intercepts from this multilevel regression framework to estimate initial status and formally compare 3-month changes over time in outcome (i.e., a linear contrast, with the level-1 or the within-subjects component of the analyses). Also, as an exploratory analysis, the investigators will test how coefficients vary as a function of level-2 components, including the longer term 6-month follow-up data. The analyses include continuous and categorical time varying and invariant predictors and covariates, use all the data, and produce more accurate parameter estimates.
Aim I: Randomized controlled trial of AD-MIL, comparing it to PCT:
Hypotheses 1 and 2: Veterans in the AD-MIL arm will have a steeper downward and upward slope in SDS (primary endpoint) and QOLI scores, respectively. Schematically, the following model will be tested:
Level 1: Yij = 0j + 1jdumpost + 2jdum3mosfu + 3jdum6mosfu + rij, Level 2: 0j = 00 + 01T + ui; 1j = 10 + 11T, 2j = 20 + 21T, 3j = 30 + 31T where Yij is the SDS score for subject j at assessment point i. In this model, time is represented by dummy-coded variables. Initially, dummy-coded variables representing the post-treatment (dumpost) and three- (dum3mosfu) and six- (dum6mosfu) month follow-up intervals will be entered into the level-1 component of the model. With this coding scheme, the pre-treatment time point is the reference time point; therefore, 0j = an individual's pre-treatment SDS score, while 1j, 2j, and 3j index the change from pre-treatment to post-treatment, three-month follow-up, and six-month follow-up, respectively. rij represents the level-1 (within-subjects) residual term. At level-2, there is a regression equation for each of the level-1 coefficients, and T is the indicator for treatment condition (AD-MIL or PCT), while uj represents the level-2 residual term. With Time (T) entered as a dummy-coded variable, in each level-2 equation, 0. represents the value of the particular level-1 regression coefficient for the treatment condition coded as 0 (i.e., the reference group), while 1. represents the difference between the two treatment conditions. The primary hypothesis will be evaluated by the level-2 coefficient 11, which represents differences between the two treatment groups from pre- to post-treatment. The investigators hypothesize that the AD-MIL group will show larger treatment gains: H0: 11 = 0 vs. H1: 11 0. The level-2 coefficients 21 and 31 can be evaluated to determine whether the treatment differences remain at follow-up assessments. Different coding schemes can be employed for the time component of the analyses. For example, orthogonal polynomial contrast codes can be used to evaluate linear and quadratic change in SDS scores from pre-treatment to the six-month follow-up assessment point. Identical calculations will be performed with the B-IPF and DRRI-2 Post-Deployment Social Support measure.
Hypotheses 3-5: Veterans in AD-MIL will have: (3) steeper downward PTSD symptom severity slopes (CAPS-5 and PCL-5) and lower incidence of PTSD cases (tested with Chi-square); (4) steeper slopes in depressive symptoms (PHQ-9); and (5) steeper slopes in shame and guilt (PANAS and TRGI). Separate models will be tested for each outcome. These models will be structured the same as the model used to test Hypotheses 1 and 2, with the above continuous measure scores designated as the outcome variables (Yij) in separate analyses. Once again, the level-2 coefficient 11 representing differences between the two treatment groups from pre- to post-treatment will be of primary interest, with the level-2 coefficients 21 and 31 evaluated to determine whether treatment differences remain at follow-up assessments.
Exploratory analyses: Will AD-MIL be associated with steeper downward slopes in anger and aggressive behaviors (STAXI-II, CTS2), suicidal ideation (DSI-SS), and alcohol abuse (QDS) as compared to PCT? The models used to evaluate these questions will be structured the same as the models above. The investigators will be especially circumspect about statistically significant findings for these variables.
Clinical significance: Clinical significance will be calculated by the Jacobson-Truax (1991) method. This method suggests a two-step criterion. First, a reasonable cutoff between the dysfunctional and functional populations is established. Because normative data for Veterans on the SDS and QOLI do not yet exist, Jacobson and Truax's (1991) suggested cutoff A, defined as the point 2 SDs beyond the range of the pre-therapy mean (cutoff A = Mclinical - 2 SDclinical for SDS and + 2 SDclinical for the QOLI) will be used. Next, 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: RC = (x2 - x1)/Sdiff where x1 represents the participant's pre-treatment SDS or QOLI total score, x2 represents the participant's post-treatment or follow-up 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 measure at each time point. An RC larger than 1.96 reflects real change. 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 (passed neither criteria), or deteriorated (passed RC criterion but symptom scores increased) for each follow-up interval. Chi-square analyses will be used to compare proportions per arm at each follow-up.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Study Arms ICMJE||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Estimated Study Completion Date ICMJE||November 30, 2021|
|Estimated Primary Completion Date||November 30, 2021 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT03056157|
|Other Study ID Numbers ICMJE||D2135-I
RX-15-005 ( Other Grant/Funding Number: Office of Research and Development )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||VA Office of Research and Development|
|Study Sponsor ICMJE||VA Office of Research and Development|
|PRS Account||VA Office of Research and Development|
|Verification Date||January 2021|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP