N/A
N=174
Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure
Post-traumatic Stress Disorder · Moral Injury · Traumatic Loss
Bottom Line
View on ClinicalTrials.gov: NCT03056157 ↗Enrolled (actual)
174
Serious AEs
1.7%
Results posted
Jul 2024
Primary outcome: Primary: Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) — 20.52; 20.43; 17.39; 18.04 Score on a scale — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adaptive Disclosure for Moral Injury and Loss (Behavioral); Present Centered Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) |
20.52; 20.43; 17.39; 18.04; 16.93; 18.25 | 0.03 sig |
| PRIMARY Pre-to-Post-Treatment Clinically Significant Change (CSC) in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) |
56.86; 35.71; 0; 12.50; 43.14; 48.21 | 0.03 sig |
| PRIMARY Change in Psychosocial Functioning Assessed Through the Brief Inventory of Psychosocial Functioning (B-IPF) |
59.37; 61.06; 52.68; 55.97; 43.47; 52.87 | 0.35 |
| PRIMARY Change in Functional Impairment Assessed Through the Sheehan Disability Scale (SDS) for the COVID-19 Cohort |
21.78; 19.82; 17.22; 18.15; 18.47; 19.50 | 0.75 |
| PRIMARY Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) for the COVID-19 Cohort |
48.53; 50.62; 47.11; 46.48; 41.65; 47.15 | 0.92 |
| PRIMARY Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) for the COVID-19 Cohort |
39.76; 40.86; 24.07; 34.79; 35.50; 28.33 | 0.10 |
| PRIMARY Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) for the COVID-19 Cohort |
17.31; 14.95; 15.07; 16.14; 14.44; 16.02 | 0.76 |
| SECONDARY Change in PTSD Symptom Severity and Diagnosis Assessed Through the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) |
36.08; 35.69; 21.78; 30.74; 24.44; 29.63 | <0.001 sig |
| SECONDARY 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) |
15.25; 3.03; 30.51; 25.76; 52.54; 63.64 | 0.01 sig |
| SECONDARY Change in PTSD Caseness Assessed Through PTSD Diagnoses Using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) |
89; 85; 30; 45; 31; 35 | 0.07 |
| SECONDARY Change in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) |
49.26; 51.66; 45.79; 45.60; 42.49; 44.01 | .003 sig |
| SECONDARY Pre- to Post-Treatment Clinically Significant Change (CSC) in PTSD Symptom Burden Assessed Through the PTSD Checklist for DSM-5 (PCL-5) |
42.86; 25.45; 17.86; 23.64; 37.50; 50.91 | 0.04 sig |
| SECONDARY Change in Symptoms of Depression Assessed Through the Patient Health Questionnaire (PHQ-9) |
16.88; 16.62; 15.92; 15.70; 14.80; 15.81 | 0.14 |
| SECONDARY Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the (Lack of) Justification Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief) |
1.88; 2.00; 1.59; 1.86; 1.70; 2.08 | 0.18 |
| SECONDARY Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Hindsight-Bias Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief) |
1.66; 1.68; 0.93; 1.51; 0.98; 1.31 | <0.001 sig |
| SECONDARY Change in Guilt Cognitions About a Specific Warzone Event Assessed Through the Wrongdoing Subscale of the Brief Trauma Related Guilt Inventory (TRGI-Brief) |
1.71; 1.74; 1.34; 1.65; 1.33; 1.51 | 0.01 sig |
| SECONDARY Change in Shame Tied to a Specific Warzone Event Assessed Through the Internal Shame Subscale of the Trauma-Related Shame Inventory (TRSI) |
12.74; 14.23; 11.71; 12.76; 10.59; 12.00 | 0.45 |
| SECONDARY Change in Psychological Health and Distress Assessed Through the Schwartz Outcome Scale-10 (SOS-10) |
24.94; 25.43; 32.16; 29.53; 32.43; 26.78 | 0.02 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03056157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.