Adaptive Disclosure: A Combat-Specific PTSD Treatment

NCT01628718 | Completed Results DMC

• 2 other identifiers: 100322W81XWH-10-1-0657
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

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.

Conditions

Posttraumatic Stress Disorder

Keywords

OEF/OIF; Veterans; Psychotherapy; PTSD

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

CPT-C

ACTIVE COMPARATOR

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)

Adaptive Disclosure (AD)

EXPERIMENTAL

Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions.

Behavioral: Adaptive Disclosure (AD)

Interventions

Adaptive Disclosure (AD) BEHAVIORAL

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.

Also known as: AD

Adaptive Disclosure (AD)

Cognitive Processing Therapy, cognitive version only (CPT-C) BEHAVIORAL

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.

Also known as: CPT-C

CPT-C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months.
• 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.

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• United States Naval Medical Center, San Diego: collaborator
• University of Wyoming: collaborator
• Boston University: collaborator
• University of California, San Diego: collaborator

Study Sites (2)

Naval Hospital Camp Pendelton

Oceanside, California, 92055-5191, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Related Publications (1)

• 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.

  PMID: 33540206 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Brett T. Litz, PhD
• Organization: Massachusetts Veterans Epidemiological Research and Information Center

litzb@bu.edu

617-584-9314

Study Officials

• Ariel J Lang, PhD

  Veterans Medical Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluator is blind to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 27, 2012
• Study Start: March 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 9, 2020
• Results First Posted: April 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)