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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-10-1-0657 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Naval Medical Center, San Diego | FED |
| University of Wyoming | OTHER |
| Boston University | OTHER |
| University of California, San Diego |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPT-C | Active Comparator | Cognitive Processing Therapy, cognitive version only (CPT-C) delivered in 12 60-minute one-on-one treatment sessions. |
|
| Adaptive Disclosure (AD) | Experimental | Adaptive Disclosure delivered in eight 90-minute one-on-one treatment sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel J Lang, PhD | Veterans Medical Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Hospital Camp Pendelton | Oceanside | California | 92055-5191 | United States | ||
| Naval Medical Center San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33540206 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to treat | Posted | Count of Participants | Participants | Pre-treatment (baseline), post-treatment (8-12 weeks) |
|
Period of study participation, which is time of enrollment through completion of the follow-up assessment, range approx. 36-40 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcohol poisoning | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased psychiatric symptoms | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett T. Litz, PhD | Massachusetts Veterans Epidemiological Research and Information Center | 617-584-9314 | litzb@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2018 | Mar 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| OTHER |
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Independent evaluator is blind to treatment assignment.
|
|
| 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. |
|
|
| San Diego |
| California |
| 92134 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PTSD severity as measured by the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) | CAPS Total Severity Score was calculated by summing frequency (0-4) and intensity (0-4) ratings for the 17 diagnostic symptoms. Total scores can be interpreted as follows: 0-19=asymptomatic/few symptoms, 20-39=mild PTSD/subthreshold, 40-59=moderate PTSD/threshold, 60-79=severe PTSD symptomatology, >80=extreme PTSD symptomatology. A 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change. | Mean | Standard Deviation | units on a scale |
|
| PTSD severity as measures by the PTSD Checklist, military version (PCL-M) | A total score on the PCL-M is calculated by summing the 17 items (range 17-85), with higher scores indicating more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
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|
|
| 0 |
| 60 |
| 1 |
| 60 |
| 4 |
| 60 |
| EG001 | 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. | 0 | 62 | 2 | 62 | 10 | 62 |
| Dissociative episode | Psychiatric disorders | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Allergic reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Upset stomach | Gastrointestinal disorders | Non-systematic Assessment |
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| Lightheadedness | Nervous system disorders | Non-systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
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