Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure

NCT03056157 | Completed Results DMC

• 2 other identifiers: D2135-IRX-15-005
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of this study was 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 to address functioning problems in several large-scale PTSD trials. The primary end-point was psychosocial functioning (improvements in social, educational and occupational functions). Secondary end-points included PTSD, depression, moral emotions (anger, shame, and guilt), alcohol use, self-compassion, and mindful/valued living.

Conditions

Post-traumatic Stress Disorder; Moral Injury; Traumatic Loss

Keywords

Moral Injury; Post-traumatic Stress Disorder; Traumatic Loss; Adaptive Disclosure; Veterans

Outcome Measures

Primary Outcomes (7)

• Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)

  The Sheehan Disability Scale (SDS; Sheehan, 1983; Sheehan et al., 1996) is a composite of three self-rated items regarding 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," with an option for "Not applicable". The possible range of scores is 0 to 30. Higher scores indicate greater disability.

  Assessments occurred at baseline, every treatment session, post treatment, and approximately 3 and 6 months after post treatment.

• Pre-to-Post-Treatment Clinically Significant Change (CSC) in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS)

  The investigators used the Jacobson and Truax methodology to index individual participant clinically significant change in functional impairment, assessed through the Sheehan Disability Scale (SDS). Individuals were classified as experiencing probable recovery if they passed the Criterion Cutoff and the RCI criteria; improved if they passed the RCI criterion, but their post-treatment or follow-up score did not pass the Criterion Cutoff; unchanged if they failed to pass the RCI; or deteriorated if they passed the RCI criterion but symptom scores increased.

  Baseline and post-treatment.

• Change in Psychosocial Functioning Assessed Through the Brief Inventory of Psychosocial Functioning (B-IPF)

  The Brief Inventory of Psychosocial Functioning (B-IPF; Marx, 2013) was used to assess functional gains. 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. The investigators used a prorated total percentage for the dimensional ratings, such that Veterans who were not in romantic relationships, had no children, or were not in employed or in school did not have those domains included in their percentage. Possible scores on the B-IPF range from 0% to 100%, with higher scores indicating more issues in psychosocial functioning.

  Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.

• Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort

  The Sheehan Disability Scale (SDS; Sheehan, 1983; Sheehan et al., 1996) is a composite of three self-rated items regarding 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," with an option for "Not applicable". The investigators used a prorated total mean score for the dimensional ratings such that only social and family ratings will be included for Veterans who were not employed or attending school at the time. The possible range of scores is 0 to 30. Higher scores indicate greater disability.

  Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.

• Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort

  The PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item self-report checklist based on the 20 DSM-5 symptoms post-traumatic stress disorder (PTSD). The PCL-5 has been validated as a means of monitoring symptom change during treatment. The 20 items are scored are scored in the past month on a scale from 0 ("not at all") to 4 ("extremely"), generating a total symptom severity score between 0 and 80, with higher scores indicating greater PTSD symptom severity.

  Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.

• Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) for the COVID-19 Cohort

  The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) is closely modeled on the CAPS-IV, a structured diagnostic interview and gold standard for assessing PTSD. It has excellent psychometric properties and diagnostic efficiency (Weathers et al., 2001). The CAPS-5 uses a single 4-point ordinal rating scale to measure symptom severity. These ratings combine information about symptom frequency and intensity obtained by the interviewer. CAPS-5 scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.

  Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.

• Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort

  The Patient Health Questionnaire (PHQ-9) is widely used and well-validated measure of symptoms of depression (Kroenke et al., 2001). It scores each of the nine DSM criteria for depression on a scale of 0 ("not at all") to 3 ("nearly every day"). The range of possible scores is 0 to 27. A higher score indicates more frequent depression symptoms.

  Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.

Secondary Outcomes (11)

• Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.

• Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  Baseline and post treatment.

• Change in PTSD Caseness Assessed Through PTSD Diagnoses Using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.

• Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)

  Assessments occurred at baseline, every treatment session, and approximately 3 and 6 months after post treatment.

• Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5)

  Baseline and post treatment.

Other Outcomes (8)

• Change in Overall Self-Compassion Assessed Through the Self Compassion Scale (SCS)

  Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.

• Change in State Anger Assessed Through the Dimensions of Anger Reactions (DAR)

  Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.

• Change in Use of Psychologically Aggressive Behavior Assessed Through the Psychological Aggression Subscale of the Revised Conflict Tactics Scale (CTS2)

  Assessments occurred at baseline, post treatment, and approximately 3 and 6 months after post treatment.

Study Arms (2)

Adaptive Disclosure for Moral Injury and Loss

EXPERIMENTAL

AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).

Behavioral: Adaptive Disclosure for Moral Injury and Loss

Present Centered Therapy

ACTIVE COMPARATOR

PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials that focuses on improving day-to-day functioning. 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 functional 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

Interventions

Adaptive Disclosure for Moral Injury and Loss BEHAVIORAL

AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame).

Also known as: AD-MIL

Adaptive Disclosure for Moral Injury and Loss

Present Centered Therapy BEHAVIORAL

Participants randomized to the PCT arm will receive 12 sessions of therapy focused on day-to-day functional problems with no focus on trauma or re-visiting past experiences

Also known as: PCT

Present Centered Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Served in an active-duty role within the military since September 2001 (Veterans may be eligible whether or not they were deployed to a warzone)
• Met the DSM-5 diagnostic criteria for PTSD as a result of military trauma (per Clinician Administered PTSD Scale for DSM-5 \[CAPS-5\]) and reported non-negligible levels of associated functional impairment (Sheehan Disability Scale \[SDS\] score = 10)
• Prospective enrollees must have been willing to commit to 12 consecutive weekly therapy sessions lasting up to 90 minutes in duration and to complete assessment materials.

You may not qualify if:

• Bipolar or psychotic disorders.
• Current drug or alcohol dependence (other than caffeine or tobacco dependence). Prospective enrollees who had maintained sobriety for at least 6 weeks immediately prior to the time of enrollment may have been eligible.
• 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 treatment that involves: (1) systematic disclosure of troubling trauma-related memories or (2) present-focused psychosocial skills training for PTSD or (3) supportive therapy/case management on a \> monthly basis or (4) any individual therapy or (5) newly (\< 6 weeks) prescribed pharmacological treatment.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Minneapolis Veterans Affairs Medical Center: collaborator
• San Francisco Veterans Affairs Medical Center: collaborator
• San Diego Veterans Healthcare System: collaborator
• Central Texas Veterans Health Care System: collaborator

Study Sites (5)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Waco, Texas, 76711, United States

Location

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• Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www. ptsd.va.gov. 2013; 10(4): 206.

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• Litz BT, Yeterian J, Berke D, Lang AJ, Gray MJ, Nienow T, Frankfurt S, Harris JI, Maguen S, Rusowicz-Orazem L. A controlled trial of adaptive disclosure-enhanced to improve functioning and treat posttraumatic stress disorder. J Consult Clin Psychol. 2024 Mar;92(3):150-164. doi: 10.1037/ccp0000873.

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

Therapists delivered both therapies; Did not measure moral injury or prolonged grief as outcomes; Approximately half of participants were not evaluated at the 6-month follow-up interval; Use of retrospective paper and pencil measures of functioning.

Results Point of Contact

• Title: Dr. Brett Litz
• Organization: VA Boston Healthcare System

brett.litz@va.gov, litzb@bu.edu

(617)5849314

Study Officials

• Brett T. Litz, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 17, 2017
• Study Start: January 3, 2018
• Primary Completion: November 30, 2021
• Study Completion: February 28, 2022
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)