Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03056157
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : March 25, 2019
Sponsor:
Collaborators:
Minneapolis Veterans Affairs Medical Center
San Francisco Veterans Affairs Medical Center
San Diego Veterans Healthcare System
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Moral Injury Traumatic Loss Behavioral: Adaptive Disclosure for Moral Injury and Loss Behavioral: Present Centered Therapy Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adaptive Disclosure for Moral Injury and Loss
Ad-MIL is a 12-session treatment designed to address shame and guilt and to develop compassion for the self and the other. At the outset of AD-MIL, the investigators ask Veterans to enlist a family member or friend to provide support and to reinforce their plan for adaptive, purposeful functioning moving forward. The sessions that follow homework assignments involve a discussion to reinforce positive steps taken and identifying obstacles to completion (e.g., self-defeating beliefs). There is a special emphasis on discussing self-handicapping, namely feeling unworthy of getting better or living a good life. The goal is not only for Veterans to develop a sense of mastery in accomplishing tasks and to experience the benefits of the activities, but also to work on overcoming feelings of unworthiness.
Behavioral: Adaptive Disclosure for Moral Injury and Loss
Ad-MIL is a 12-session treatment designed to address shame and guilt and to develop compassion for the self and the other. At the outset of AD-MIL, the investigators ask Veterans to enlist a family member or friend to provide support and to reinforce their plan for adaptive, purposeful functioning moving forward. The sessions that follow homework assignments involve a discussion to reinforce positive steps taken and identifying obstacles to completion (e.g., self-defeating beliefs). There is a special emphasis on discussing self-handicapping, namely feeling unworthy of getting better or living a good life. The goal is not only for Veterans to develop a sense of mastery in accomplishing tasks and to experience the benefits of the activities, but also to work on overcoming feelings of unworthiness.
Other Name: AD_MIL

Active Comparator: Present Centered Therapy
PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role, but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive responses to these stressors with a problem-focused and problem-solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD.
Behavioral: Present Centered Therapy
Participants randomized to the PCT arm will receive 12 sessions of therapy focused on problems occurring in the present (with no focus on trauma or re-visiting past experiences).
Other Name: PCT




Primary Outcome Measures :
  1. Rate of change in functional impairment from baseline through 6-month follow-up [ Time Frame: Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline ]
    The Sheehan Disability Scale (SDS) will be the investigators' primary functional outcome measure. Respondents indicate the degree to which symptoms disrupted work/school, social life, and family life/responsibilities on an 11-point scale ranging from "Not at all" to "Extremely," and list the number of lost and unproductive work or school days. For this study, the investigators will have participants' index impairment caused by PTSD symptoms in the last month.

  2. Rate of change in psychosocial functional gains made from baseline through 6-month follow-up [ Time Frame: Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline ]
    The Brief Inventory of Psychosocial Functioning (BIPF) will be used to confirm and expand upon the description of the functional gains made from AD-MIL, and allow comparisons with veteran norms or other published trial results. It is a 7-item scale indexing overall level of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living.

  3. Rate of change in PTSD symptom severity and diagnosis from baseline through 6-month follow-up [ Time Frame: Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline ]
    The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) will be used to diagnose PTSD and index PTSD symptom severity.

  4. Rate of change in state anger from baseline through 6-month follow-up [ Time Frame: Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline ]
    The investigators will measure anger with the State-Trait Anger Expression Inventory-2 (STAXI-2) State Anger subscale, which is a 15-item self-report measure of current intensity of anger.

  5. Rate of change in use of aggressive behavior from baseline through 6-month follow-up [ Time Frame: Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline ]
    We will measure aggressive behaviors using the physical assault and psychological aggression subscales of the Revised Conflict Tactics Scale (CTS2).

  6. Rate of change in alcohol use from baseline through 6-month follow-up [ Time Frame: Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline ]
    Alcohol abuse will be evaluated with the Quick Drinking Screen (QDS), a 4-item probe of frequency and quantity of alcohol consumption in the last month. The QDS has very good psychometric characteristics (Sobell et al., 2003).


Secondary Outcome Measures :
  1. Moral Injury Events Scale [ Time Frame: Baseline ]
    The MIES is an 11-item scale that evaluates various military-related potential moral transgressions by self or others.

  2. Rate of change in quality of life from baseline through 6-month follow-up [ Time Frame: Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline ]
    The Quality of Live Inventory will be used to generate an overall score on scores and subscales of achievement, self-expression, relationships, and surroundings calculated based on satisfaction scores weighted by endorsed importance.

  3. Rate of change in social support resources from baseline through 6-month follow-up [ Time Frame: Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline ]
    The Post-Deployment Social Support subscale of Deployment Risk and Resiliency Inventory-2 scale will be used to assess social support resources.

  4. Rate of change in PTSD symptom burden across course of psychotherapy [ Time Frame: Baseline and weekly prior to each of the 12 weekly treatment sessions ]
    The PTSD Checklist for DSM-5 will be used to examine PTSD symptom burden at baseline and prior to each of the 12 weekly treatment session.

  5. Rate of change in shame and guilt from baseline through 6-month follow-up [ Time Frame: Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline ]
    The investigators will use the Positive and Negative Affectivity Schedule (PANAS) to measure shame and guilt, indexed to the last month.

  6. Rate of change in guilt feelings and attitudes about a specific warzone event from baseline through 6-month follow-up [ Time Frame: Assessments will occur at baseline and approximately 3, 6, and 9 months after the first treatment session, or, if no treatment sessions were attended or a participant terminated therapy early, approximately 3, 6, and 9 months after baseline ]
    The Trauma-Related Guilt Inventory (TRGI) will be used to assess guilty feelings and attitudes about a specific warzone event (Kubany et al., 1996). It is scored into three scales (Global Guilt, Distress Scale, and Guilt Cognitions) and 3 subscales (Hindsight-Bias/Responsibility, Wrongdoing, and Lack of Justification).

  7. Rate of change in suicidality across course of psychotherapy [ Time Frame: Baseline and weekly prior to each of the 12 weekly treatment sessions ]
    The Depressive Symptoms Index - Suicidality Subscale (DSI-SS) is a 4-item scale that focuses on ideation, plans, perceived control over ideation, and impulses for suicide. It is being used as a core measure in the Military Suicide Research Consortium. A review of measures of suicidal ideation and behaviors found that the DSI-SS had excellent internal consistency and concurrent validity (Batterham et al., 2014).

  8. The DRRI-2 Combat Experiences and Aftermath of Battle [ Time Frame: Baseline ]
    The DRRI-2 measures combat exposure to potentially traumatic events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • deployed to the Afghanistan and/or Iraq Wars
  • meet the DSM-5 diagnostic criteria for PTSD

Exclusion Criteria:

  • bipolar or psychotic disorders
  • current drug or alcohol dependence (other than caffeine or tobacco dependence)
  • evidence of traumatic brain injury severe enough to influence the ability to understand and respond to study procedures
  • suicidal or homicidal ideation severe enough to warrant immediate attention
  • concurrent enrollment in any cognitive-behavioral treatment or any other treatment that involves systematic disclosure of troubling deployment-related memories

    • participants may continue current pharmacological treatment if stable on medication for at least 6 weeks, marital counseling, or any supportive therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056157


Contacts
Layout table for location contacts
Contact: Brett T Litz, PhD (617) 232-9500 ext 4131 brett.litz@va.gov
Contact: Jessica Carney, BA (857) 364-6190 Jessica.Carney@va.gov

Locations
Layout table for location information
United States, California
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Ariel J Lang, PhD    858-522-8585 ext 5359    ajlang@ucsd.edu   
San Francisco VA Medical Center, San Francisco, CA Recruiting
San Francisco, California, United States, 94121
Contact: Shira Maguen, PhD    415-221-4810 ext 2511    shira.maguen@va.gov   
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Brett T Litz, PhD    617-232-9500 ext 4131    brett.litz@va.gov   
Contact: Jessica Carney, BA    (857) 364-6190    Jessica.Carney@va.gov   
Principal Investigator: Brett T. Litz, PhD         
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: J. Irene Harris, PhD    612-467-1654    jeanette.harris2@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Minneapolis Veterans Affairs Medical Center
San Francisco Veterans Affairs Medical Center
San Diego Veterans Healthcare System
Investigators
Layout table for investigator information
Principal Investigator: Brett T. Litz, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03056157     History of Changes
Other Study ID Numbers: D2135-I
RX-15-005 ( Other Grant/Funding Number: Office of Research and Development )
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Moral Injury
Post-traumatic Stress Disorder
Traumatic Loss
Adaptive Disclosure
Veterans

Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders