Adaptive Disclosure

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Veterans Medical Research Foundation
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01628718
First received: June 19, 2012
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptive Disclosure: A Combat-Specific PTSD Treatment

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Pre-treatment (baseline), post-treatment (8-12 weeks), and follow-up (3 and 6 months) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 266
Study Start Date: March 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628718

Contacts
Contact: Ariel J Lang, PhD 858-246-0631 ajlang@ucsd.edu

Locations
United States, California
Naval Hospital Camp Pendelton Recruiting
Camp Pendelton, California, United States, 92055-5191
Contact: Daniel Wright, PhD       daniel.wright@med.navy.mil   
Sponsors and Collaborators
Ariel Lang, PhD
University of California, San Diego
United States Naval Medical Center, San Diego
University of Wyoming
Boston University
Investigators
Principal Investigator: Ariel J Lang, PhD University California San Diego
  More Information

No publications provided

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
Study First Received: June 19, 2012
Last Updated: March 7, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Veterans Medical Research Foundation:
OEF/OIF
Veterans
Psychotherapy
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014