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Adaptive Disclosure

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ClinicalTrials.gov Identifier: NCT01628718
Recruitment Status : Recruiting
First Posted : June 27, 2012
Last Update Posted : October 20, 2017
University of California, San Diego
United States Naval Medical Center, San Diego
University of Wyoming
Boston University
Information provided by (Responsible Party):
Ariel Lang, PhD, Veterans Medical Research Foundation

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.

Condition or disease Intervention/treatment
Posttraumatic Stress Disorder Behavioral: Adaptive Disclosure (AD) Behavioral: Cognitive Processing Therapy, cognitive version only (CPT-C)

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adaptive Disclosure: A Combat-Specific PTSD Treatment
Study Start Date : March 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: CPT-C
Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions.
Behavioral: 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.
Other Name: CPT-C
Experimental: Adaptive Disclosure (AD)
Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions.
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.
Other Name: AD

Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Pre-treatment (baseline), post-treatment (8-12 weeks), and follow-up (3 and 6 months) ]
    To determine whether or not AD is as least as effective as CPT-C in terms of change in psychological health problems over the 8-12 week treatment period.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628718

Contact: Ariel J Lang, PhD 858-5525-8585 ext 6297 ajlang@ucsd.edu

United States, California
Naval Hospital Camp Pendelton Completed
Camp Pendelton, California, United States, 92055-5191
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: Shiva Ghaed, PhD       Shiva.Ghaed@med.navy.mil   
Principal Investigator: Shiva Ghaed, PhD         
Sponsors and Collaborators
Ariel Lang, PhD
University of California, San Diego
United States Naval Medical Center, San Diego
University of Wyoming
Boston University
Principal Investigator: Ariel J Lang, PhD Veterans Medical Research Foundation

Responsible Party: Ariel Lang, PhD, Professor, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01628718     History of Changes
Other Study ID Numbers: 100322
W81XWH-10-1-0657 ( Other Grant/Funding Number: Department of Defense )
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ariel Lang, PhD, Veterans Medical Research Foundation:

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders