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|ClinicalTrials.gov Identifier: NCT01628718|
Recruitment Status : Recruiting
First Posted : June 27, 2012
Last Update Posted : October 20, 2017
|Condition or disease||Intervention/treatment|
|Posttraumatic Stress Disorder||Behavioral: Adaptive Disclosure (AD) Behavioral: Cognitive Processing Therapy, cognitive version only (CPT-C)|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628718
|Contact: Ariel J Lang, PhD||858-5525-8585 ext email@example.com|
|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|
|Principal Investigator:||Ariel J Lang, PhD||Veterans Medical Research Foundation|