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| ID | Type | Description | Link |
|---|---|---|---|
| I01RX004243 | U.S. NIH Grant/Contract | View source |
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The objective of this project is to test the efficacy of an individual treatment for post-traumatic stress disorder (PTSD) stemming from moral injury called Impact of Killing (IOK), compared to a present-centered therapy (PCT) control condition, and to determine the rehabilitative utility of IOK for Veterans with PTSD. The first aim is to test whether IOK can help improve psychosocial functioning for Veterans, as well as PTSD symptoms. The second aim is to determine whether IOK gains made by Veterans in treatment are durable, as measured by a six-month follow-up assessment. Veterans who kill in war are at increased risk for functional difficulties, PTSD, alcohol abuse, and suicide. Even after current PTSD psychotherapies, most Veterans continue to meet diagnostic criteria for PTSD, highlighting the need for expanding treatments for PTSD and functioning. IOK is a treatment that can be provided following existing PTSD treatments, filling a critical gap for Veterans with moral injury who continue to suffer from mental health symptoms and functional difficulties.
Post-traumatic stress disorder (PTSD) is now the most common mental health diagnosis among the youngest generation of Veterans receiving treatment from the Veterans Health Administration (VHA), necessitating the need for diverse types of targeted care. Although there are two evidence-based psychotherapies (EBP) for PTSD, the vast majority of combat Veterans who receive these treatments still meet diagnostic criteria for PTSD and their functioning continues to be impacted. Furthermore, Veterans that have experienced trauma related to killing have high rates of suicide and more severe PTSD symptoms. Although there have been few studies examining predictors of poor outcomes in EBPs, one area that has recently begun to receive growing attention is moral injury. A recent study found that PTSD and moral injury were distinct constructs with unique signs and symptoms, and preliminary evidence indicates that the feelings of guilt and anger that characterize moral injury associated with trauma such as killing in war may contribute to worsening symptoms over the course of existing treatments. Although PTSD may be one manifestation of psychological trauma related to killing, conceptualization of the impact of killing requires a broader framework. The emerging concept of moral injury offers an alternative context to better understand the many possible outcomes of exposure to killing. For these reasons, the development of targeted moral injury interventions is critical. The investigators designed and received VA funding to conduct a pilot randomized controlled trial (RCT) of the Impact of Killing (IOK) treatment, which can be seamlessly added as a standalone treatment following existing EBPs for PTSD. IOK focuses on key themes including physiology of killing responses, moral injury, self-forgiveness, and improved post-deployment reintegration. The treatment was designed to fit well into already existing systems of care and has been shown to improve functioning, PTSD symptoms, and general psychiatric symptoms following EBP. Whereas the IOK RCT pilot was initially conducted at the San Francisco VA Healthcare System, the investigators' goal is to conduct a fully-powered, multi-site efficacy trial at two regionally-diverse sites with a larger sample size and active control condition. Consequently, the objective of this project is to test the efficacy of an individual treatment for PTSD stemming from moral injury called IOK, compared to a present-centered therapy (PCT) control condition, and to determine the rehabilitative utility of IOK for Veterans seeking treatment for PTSD. The primary outcome is psychosocial functioning. The target population is Veterans who have initiated or completed Cognitive Processing Therapy or Prolonged Exposure Therapy, two EBPs for PTSD, and continue to have PTSD symptoms and moral injury related to killing. Veterans will be randomly assigned to receive either: 1) IOK (10 individual therapy sessions lasting 60-90 minutes) or 2) PCT (sessions of equal duration to IOK). The first aim is to test the efficacy of IOK through measures of psychosocial functioning (primary outcome) and PTSD severity (secondary outcome). The second aim is to determine whether IOK gains made by Veterans are durable. If the aims of this grant are achieved, the investigators will be able to have a moral injury intervention following EBP that can be seamlessly integrated into existing care for one of the most commonly occurring mental health problems in Veterans. Furthermore, suicide is a national priority for VHA, and expanding treatment for PTSD and moral injury has the potential to decrease suicide and improve functioning in Veterans. Finally, IOK offers skills and ways of understanding warzone experiences that can be mastered and can continue to be implemented by Veterans over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Impact of Killing (IOK) | Experimental | Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK . |
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| Present Centered Therapy | Active Comparator | Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impact of Killing (IOK) | Behavioral | Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK . |
|
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Quality of Life-BREF | A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life. | Change from baseline (Week 0) and post-treatment (Week 11) |
| World Health Organization Quality of Life-BREF | A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life. | Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | This measure is used to identify DSM-5 criteria for PTSD. CAPS-5 provides both a dimensional and categorical measure of current PTSD and the frequency and intensity of PTSD-related symptoms. Score range from 0-80 with lower score representing fewer PTSD symptoms. | Change from baseline (Week 0) and post-treatment (Week 11) |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | A 20-item measure that assesses PTSD symptom severity using a 5-point rating scale. The PCL-5 items correspond to the DSM-5 symptoms for PTSD. Total severity can range from 0 to 80. Higher scores indicate greater severity of PTSD symptoms. | Change from baseline (Week 0) and post-treatment (Week 11) |
Inclusion Criteria:
Veterans 18-82 years of age
Veterans who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Post-traumatic Stress Disorder (PTSD) or score 23 or higher on the Clinician-Administered PTSD Scale for DSM-5 (CAPS) screening interview.
Veterans who endorsed killing or being responsible for the death of another in a war zone and report continued distress regarding these events
Veterans who have initiated or completed an evidence-based treatment for PTSD, such as Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE)
If receiving CPT or PE, Veterans must complete treatment and wait two weeks prior to screening
If receiving prescription medication for PTSD, Veterans must be one month stable on medication and not make any changes to medication during the course of the active treatment phase of the study
Exclusion Criteria:
Veterans with current or lifetime diagnosis of a psychotic disorder or current untreated/unmanaged mania.
Veterans with recent suicidal or homicidal behaviors (chronic suicidal ideation is not exclusionary)
Veterans with recent psychiatric hospitalizations
Veterans with moderate or severe alcohol or drug dependence within the past three months
Veterans receiving individual therapy for PTSD or those planning to start skills-based or trauma-focused group psychotherapy will be excluded
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| Name | Affiliation | Role |
|---|---|---|
| Shira Maguen, PhD | San Francisco VA Medical Center, San Francisco, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | 94121-1563 | United States | ||
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Veterans were recruited from 8/12/2019 to 11/30/2024 through direct mailings, advertisements, referrals from VA providers and other VA research studies. Screening procedures comprised a brief phone pre-screener, informed consent , and a diagnostic clinical interview. A total of 100 Veterans completed all screening procedures, were eligible for the study, completed a baseline self-report questionnaire of outcome measures, and were randomly assigned to a treatment condition.
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| ID | Title | Description |
|---|---|---|
| FG000 | Impact of Killing (IOK) | Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK . Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK . |
| FG001 | Present Centered Therapy | Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT) Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
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| Six Month Follow-Up |
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Participants that passed all screening procedures and were eligible for treatment randomization & enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Impact of Killing (IOK) | Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK . Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK . |
| BG001 |
| 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 | World Health Organization Quality of Life-BREF | A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life. | Posted | Mean | Standard Error | score on a scale | Change from baseline (Week 0) and post-treatment (Week 11) |
|
Adverse event data were collected for participants during the treatment phase of the study, from baseline (Week 0) to the post-treatment diagnostic interview (Week 11)
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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 | Impact of Killing (IOK) | Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK . Impact of Killing (IOK): Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK . |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug Relapse | Psychiatric disorders | Non-systematic Assessment | Individual with prior history of a substance use disorder relapsed during treatment and withdrew from the study to focus on substance use therapy. |
The study began prior to the Covid-19 pandemic. Three participants completed all data collection procedures and treatment in-person before the pandemic lockdown. The remaining participants completed some (n=5) or all (n=92) study procedures during the pandemic, through video or in-person appointments (as restrictions were lifted) and paper or electronic data collection methods.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shira Maguen, PhD | San Francisco VA Health Care System | 415-221-4810 | 22511 | Shira.Maguen@va.gov |
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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 | Oct 23, 2025 | Oct 27, 2025 | 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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The investigators propose to conduct a multi-site, randomized, controlled trial to test the efficacy of an individual treatment for PTSD stemming from moral injury called IOK, compared to a present-centered therapy (PCT) control condition.
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The clinical evaluators will be kept blind to treatment condition throughout the study period.
| Present Centered Therapy | Behavioral | Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT) |
|
| PTSD Checklist for DSM-5 (PCL-5) |
A 20-item measure that assesses PTSD symptom severity using a 5-point rating scale. The PCL-5 items correspond to the DSM-5 symptoms for PTSD. Total severity can range from 0 to 80. Higher scores indicate greater severity of PTSD symptoms. |
| Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment) |
| Brief Symptom Inventory (BSI) | A 53-item measure, using a 5-point Likert scale, in which participants rate the extent to which they have been bothered in the past week by various mental health symptoms (e.g., depression, anxiety, hostility, psychoticism, paranoid ideation, etc.). The BSI measures global psychological distress, with scores ranging from 0-53. Higher scores represent more severe psychiatric symptoms. | Change from baseline (Week 0) and post-treatment (Week 11) |
| Trauma-related Guilt Inventory (TRGI) | A 32-item measure, using a 5-point Likert scale, assessing the emotional and cognitive aspects of guilt associated with a specified traumatic event (e.g., combat experience, car accident, physical or sexual abuse, or sudden death of a loved one). The TRGI has main scales representing guilt, distress and guilt cognitions. Scores represent the average for items in the scale and range from 0-4, with higher scores representing greater guilt/distress. | Change from baseline (Week 0) and post-treatment (Week 11) |
| Brief Symptom Inventory (BSI) | A 53-item measure, using a 5-point Likert scale, in which participants rate the extent to which they have been bothered in the past week by various mental health symptoms (e.g., depression, anxiety, hostility, psychoticism, paranoid ideation, etc.). The BSI measures global psychological distress, with scores ranging from 0-53. Higher scores represent more severe psychiatric symptoms. | Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment) |
| Trauma-related Guilt Inventory (TRGI) | A 32-item measure, using a 5-point Likert scale, assessing the emotional and cognitive aspects of guilt associated with a specified traumatic event (e.g., combat experience, car accident, physical or sexual abuse, or sudden death of a loved one). The TRGI has main scales representing guilt, distress and guilt cognitions. Scores represent the average for items in the scale and range from 0-4, with higher scores representing more guilt/distress. | Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment) |
| James J. Peters VA Medical Center, Bronx, NY |
| The Bronx |
| New York |
| 10468 |
| United States |
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| NOT COMPLETED |
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|
| Present Centered Therapy |
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT) Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Present Centered Therapy | Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT) Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT) |
|
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| Primary | World Health Organization Quality of Life-BREF | A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life. | Posted | Mean | Standard Error | score on a scale | Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment) |
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| Secondary | Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | This measure is used to identify DSM-5 criteria for PTSD. CAPS-5 provides both a dimensional and categorical measure of current PTSD and the frequency and intensity of PTSD-related symptoms. Score range from 0-80 with lower score representing fewer PTSD symptoms. | Posted | Mean | Standard Error | score on a scale | Change from baseline (Week 0) and post-treatment (Week 11) |
|
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|
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| Other Pre-specified | PTSD Checklist for DSM-5 (PCL-5) | A 20-item measure that assesses PTSD symptom severity using a 5-point rating scale. The PCL-5 items correspond to the DSM-5 symptoms for PTSD. Total severity can range from 0 to 80. Higher scores indicate greater severity of PTSD symptoms. | Posted | Mean | Standard Error | score on a scale | Change from baseline (Week 0) and post-treatment (Week 11) |
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| Other Pre-specified | PTSD Checklist for DSM-5 (PCL-5) | A 20-item measure that assesses PTSD symptom severity using a 5-point rating scale. The PCL-5 items correspond to the DSM-5 symptoms for PTSD. Total severity can range from 0 to 80. Higher scores indicate greater severity of PTSD symptoms. | Posted | Mean | Standard Error | score on a scale | Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment) |
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|
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| Other Pre-specified | Brief Symptom Inventory (BSI) | A 53-item measure, using a 5-point Likert scale, in which participants rate the extent to which they have been bothered in the past week by various mental health symptoms (e.g., depression, anxiety, hostility, psychoticism, paranoid ideation, etc.). The BSI measures global psychological distress, with scores ranging from 0-53. Higher scores represent more severe psychiatric symptoms. | Posted | Mean | Standard Error | score on a scale | Change from baseline (Week 0) and post-treatment (Week 11) |
|
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|
|
| Other Pre-specified | Trauma-related Guilt Inventory (TRGI) | A 32-item measure, using a 5-point Likert scale, assessing the emotional and cognitive aspects of guilt associated with a specified traumatic event (e.g., combat experience, car accident, physical or sexual abuse, or sudden death of a loved one). The TRGI has main scales representing guilt, distress and guilt cognitions. Scores represent the average for items in the scale and range from 0-4, with higher scores representing greater guilt/distress. | Posted | Mean | Standard Error | score on a scale | Change from baseline (Week 0) and post-treatment (Week 11) |
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| Other Pre-specified | Brief Symptom Inventory (BSI) | A 53-item measure, using a 5-point Likert scale, in which participants rate the extent to which they have been bothered in the past week by various mental health symptoms (e.g., depression, anxiety, hostility, psychoticism, paranoid ideation, etc.). The BSI measures global psychological distress, with scores ranging from 0-53. Higher scores represent more severe psychiatric symptoms. | Posted | Mean | Standard Error | score on a scale | Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment) |
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| Other Pre-specified | Trauma-related Guilt Inventory (TRGI) | A 32-item measure, using a 5-point Likert scale, assessing the emotional and cognitive aspects of guilt associated with a specified traumatic event (e.g., combat experience, car accident, physical or sexual abuse, or sudden death of a loved one). The TRGI has main scales representing guilt, distress and guilt cognitions. Scores represent the average for items in the scale and range from 0-4, with higher scores representing more guilt/distress. | Posted | Mean | Standard Error | score on a scale | Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment) |
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| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Present Centered Therapy | Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT) Present Centered Therapy: Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT) | 0 | 51 | 0 | 51 | 1 | 51 |
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