CompletedNot Applicable

Psychosocial Rehabilitation After Moral Injury and Loss With Adaptive Disclosure

United States174 participantsStarted 2018-01-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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

Timeframe: 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)

Timeframe: Baseline and post-treatment.

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

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

Trial details

NCT IDNCT03056157

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2021-11-30

Results submitted2022-12-15

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