Posttraumatic Stress Disorder
Conditions
Keywords
OEF/OIF, Veterans, Psychotherapy, PTSD
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.
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.
Interventions
BEHAVIORALAdaptive 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.
BEHAVIORALCognitive 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.
Sponsors
United States Naval Medical Center, San Diego
University of Wyoming
Boston University
University of California, San Diego
Veterans Medical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Independent evaluator is blind to treatment assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) | Pre-treatment (baseline), post-treatment (8-12 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CPT-C Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions.
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. | 60 |
| Adaptive Disclosure (AD) Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions.
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. | 62 |
| Total | 122 |
Baseline characteristics
| Characteristic | Adaptive Disclosure (AD) | Total | CPT-C |
|---|---|---|---|
| Age, Continuous | 30.30 years STANDARD_DEVIATION 6.43 | 29.80 years STANDARD_DEVIATION 6.39 | 29.29 years STANDARD_DEVIATION 6.38 |
| PTSD severity as measured by the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) | 74.58 units on a scale STANDARD_DEVIATION 19.25 | 75.54 units on a scale STANDARD_DEVIATION 18.8 | 76.53 units on a scale STANDARD_DEVIATION 18.43 |
| PTSD severity as measures by the PTSD Checklist, military version (PCL-M) | 63.00 units on a scale STANDARD_DEVIATION 11.45 | 62.74 units on a scale STANDARD_DEVIATION 11.22 | 62.47 units on a scale STANDARD_DEVIATION 11.06 |
| Race/Ethnicity, Customized Other Race/Ethnicity | 21 Participants | 45 Participants | 24 Participants |
| Race/Ethnicity, Customized White or Caucasian | 41 Participants | 77 Participants | 36 Participants |
| Region of Enrollment United States | 62 participants | 122 participants | 60 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 56 Participants | 110 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 62 |
| other Total, other adverse events | 4 / 60 | 10 / 62 |
| serious Total, serious adverse events | 1 / 60 | 2 / 62 |
Outcome results
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.
Time frame: Pre-treatment (baseline), post-treatment (8-12 weeks)
Population: Intent to treat
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CPT-C | Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) | Recovered | 8 Participants |
| CPT-C | Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) | Unchanged | 45 Participants |
| CPT-C | Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) | Improved | 7 Participants |
| CPT-C | Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) | Deteriorated | 0 Participants |
| Adaptive Disclosure (AD) | Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) | Deteriorated | 0 Participants |
| Adaptive Disclosure (AD) | Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) | Recovered | 11 Participants |
| Adaptive Disclosure (AD) | Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) | Improved | 4 Participants |
| Adaptive Disclosure (AD) | Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) | Unchanged | 47 Participants |
Comparison: Null hypothesis: AD is inferior to CPT Alternative hypothesis: AD is non-inferior to CPT-Cp-value: 0.0595% CI: [-10.1, 9.44]Regression, Linear