Clinical trial NCT01628718: Adaptive Disclosure: A Combat-Specific PTSD Treatment
Official title: Adaptive Disclosure: A Combat-Specific PTSD Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: OEF/OIF
Veterans
Psychotherapy
PTSD
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: United States Naval Medical Center, San Diego
name: University of Wyoming
name: Boston University
name: University of California, San Diego
First posted: 2012-06-27
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this randomized controlled non-inferiority trial is to determine whether or not Adaptive Disclosure (AD), a new combat-specific psychotherapy for Post Traumatic Stress Disorder (PTSD), is as least as effective as Cognitive Processing Therapy, cognitive only version (CPT-C), in terms of its impact on deployment-related psychological health problems (specifically PTSD and depression) and functioning.

Detailed description: Many Marines and Sailors return from deployment with mental health problems related to their experiences. One such problem is posttraumatic stress disorder (PTSD), which involves symptoms such as persistent unwanted memories of traumatic events, avoidance of reminders of the events, excessive watchfulness, jumpiness and irritability. Current therapies for PTSD focus chiefly on fear related to life-threat and were developed chiefly on civilians. We developed and piloted tested a psychological treatment for PTSD specifically for service members who suffer not only life-threat, but also traumatic loss and inner conflicts from morally challenging experiences. This intervention, Adaptive Disclosure (AD) is an eight-session PTSD treatment that helps Marines to identify unhelpful beliefs about a traumatic event and find ways to move forward. Preliminary clinical data suggests that AD is acceptable to Marines, feasible to implement, and safe and that it reduces PTSD and depression. The primary objective of this randomized controlled non-inferiority trial is to determine whether or not AD is as least as effective as Cognitive Processing Therapy, cognitive only version (CPT-C), which is an empirically validated and commonly used PTSD treatment.

We plan to recruit 266 Marines for this project. They will be randomly assigned to AD or CPT-C and followed during and after treatment. The groups will be compared on measures of mental health (particularly PTSD and depression), work-related functioning, trauma-related beliefs, coping and attitudes about mental health care.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Current PTSD as diagnosed by the CAPS or subsyndromal PTSD (at least meeting criteria A and B) with distress and/or functional impairment as determined by the CAPS and review by study senior clinicians. Co-occurring disorders such as depression, anxiety, or treated substance abuse or dependence problems are permitted.
* Individuals expected to deploy two or more months from the time of referral and/or assessment are eligible. Anyone deploying sooner than that would be unable to complete the entire intervention and thus, are ineligible. Potential enrollees need not be presently deployable.
* Prospective enrollees must be willing to commit to 8 consecutive weekly sessions lasting up to 90 minutes in duration and to complete assessment materials.

Exclusion Criteria:

* Serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months.
* A known, untreated substance abuse or dependence problem. Inclusion is possible if there is evidence that the individual has been afforded and is complying with treatment for the substance problem.
* Serious Axis I mental disorders (those that are normally incompatible with active military service), such as psychotic disorders or bipolar type I, are not eligible.
* Cognitive impairment that would interfere with one's ability to complete the intervention. If a potential participant performs below the mildly impaired range on WAIS-IV Digit Span or CVLT-2, the study neuropsychologist will review the case and make a clinical judgment based on review of testing and, in some cases, additional evaluation as to ability to participate.
* Concurrent enrollment in any cognitive-behavioral treatment, group therapy, or any other treatment that involves systematic disclosure of troubling deployment-related memories. Participants can continue current pharmacological treatment, marital counseling, or any supportive therapy.

Primary outcomes:
measure: Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)
timeFrame: Pre-treatment (baseline), post-treatment (8-12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Naval Hospital Camp Pendelton
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: Veterans Medical Research Foundation
name: Ariel J Lang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Litz BT, Rusowicz-Orazem L, Doros G, Grunthal B, Gray M, Nash W, Lang AJ. Adaptive disclosure, a combat-specific PTSD treatment, versus cognitive-processing therapy, in deployed marines and sailors: A randomized controlled non-inferiority trial. Psychiatry Res. 2021 Mar;297:113761. doi: 10.1016/j.psychres.2021.113761. Epub 2021 Jan 24.