Adaptive Disclosure: A Combat-Specific PTSD Treatment

Posttraumatic Stress Disorder Clinical Trial

Official title:

Adaptive Disclosure: A Combat-Specific PTSD Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628718
• Other study ID #: 100322
• Secondary ID: W81XWH-10-1-0657
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: July 2019

Study information

• Verified date: March 2020
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Adaptive Disclosure (AD)
Adaptive Disclosure (AD) is an eight-session fully manualized and piloted intervention designed specifically for Marines with PTSD stemming from a variety of traumatic deployment experiences. The approach combines imaginal exposure to activate trauma-related emotions and beliefs and cognitive and experiential techniques to modify maladaptive interpretations of the implication of various combat and operational experiences that contribute to symptoms and dysfunction.
• Cognitive Processing Therapy, cognitive version only (CPT-C)
Cognitive Processing Therapy (CPT) is a 12-session manualized therapy for posttraumatic stress disorder. The theory behind CPT conceptualizes PTSD as a disorder of "non-recovery" in which erroneous beliefs about the causes and consequences of traumatic events produce strong negative emotions and prevent accurate processing of the trauma memory and natural emotions emanating from the event. A significant contributor to the interruption of natural recovery process is the ongoing use of avoidance as a coping strategy. CPT incorporates trauma-specific cognitive techniques to help individuals with PTSD more accurately appraise these "stuck points" and progress toward recovery.

Locations

Country	Name	City	State
United States	Naval Hospital Camp Pendelton	Oceanside	California
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	Boston University, United States Naval Medical Center, San Diego, University of California, San Diego, University of Wyoming

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)	Proportion of patients recovered (meets Reliable Change Index (RCI) threshold and has change of at least 2SD from baseline to post-treatment), improved (meets positive RCI threshold), unchanged (does not meet RCI threshold) or deteriorated (meets negative RCI threshold) based on change in the CAPS-IV.	Pre-treatment (baseline), post-treatment (8-12 weeks)