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A Case Formulation Approach to Cognitive Processing Therapy (CF-CPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407767
Recruitment Status : Not yet recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

Recent estimates suggest that over 610,000 US Veterans treated by the Veterans Health Administration (VHA) suffer from PTSD, a disorder that can be chronic and debilitating. The heterogeneity of the 20 symptoms of PTSD; comorbidity with disorders such as depression, panic, and substance use; high rates of lingering effects of physical injury; and suicidality all contribute to complex clinical presentations and can exact a significant toll on functioning, quality of life, and well-being even decades after exposure to the traumatic event. Perhaps spurred by the President's New Freedom Commission on Mental Health, psychosocial rehabilitation has shifted from the periphery in mental health recovery models to a more primary focus in clinical settings, including recommendations for use of psychosocial rehabilitation techniques in trauma-focused mental health care. Support for the efficacy of psychosocial rehabilitation techniques in PTSD recovery programs has burgeoned in recent years and data supporting psychological treatments for PTSD has increased exponentially, yet the two approaches to recovery have largely remained independent.

Cognitive Processing Therapy (CPT), the evidence-based psychotherapy (EBP) for PTSD most frequently delivered within VHA, yields large magnitude reductions in primary PTSD outcomes. Corresponding gains in occupational, social, leisure, and sexual functioning, and in health-related concerns have also been demonstrated. Despite CPT's effectiveness, there is room for improvement in overall outcomes and patient engagement. Further, improvements in functioning and quality of life are more modest than those observed in PTSD and associated mental health symptoms. Prior work suggests that unaddressed difficulties in functioning contribute to premature dropout from EBPs for PTSD among Veterans. Directly targeting impairments associated with psychosocial functioning has the potential to substantially increase the scope of recovery beyond the core symptoms of PTSD and facilitate greater patient engagement, resulting in more Veterans benefitting from CPT. Modifying the CPT protocol to personalize the intervention for the individual patient has resulted in better overall response rates for a wider variety of patient populations suffering from complicated clinical presentations.

Case formulation (CF) is a well-established approach to cognitive-behavioral treatment that facilitates a collaborative process between providers and patients to guide the tailoring of treatment to meet idiosyncratic patient needs. Integrating CF strategies into the existing CPT protocol will enable providers to personalize CPT to directly address impairment in functioning as well as provide the latitude to directly intervene with the complex challenges that threaten optimal outcomes within the context of trauma-focused therapy. CF-integrated CPT (CF-CPT) expands and enhances the CPT protocol to facilitate a personalized and flexible approach to treating PTSD that prioritizes the administration of the full dose of CPT while expanding the protocol to directly target important domains of functioning and result in more holistic outcomes.

This controlled treatment outcome trial will randomize a national sample of CPT providers (Veteran n = 200; provider n = 50) to either deliver CF-CPT or CPT to compare the relative effectiveness of CF-CPT to CPT in improving primary outcomes, including Veterans' psychosocial functioning, quality of life and well-being over the course of treatment and 3-month follow-up as compared to Veterans who receive standard CPT. Further, Veterans who receive CF-CPT will demonstrate greater reductions in PTSD and depression over the course of treatment and 3-month follow-up than those who receive CPT.

This study also seeks to determine the effectiveness of CF-CPT as compared to CPT in improving Veterans' treatment engagement (CF-CPT will demonstrate higher rates of Veteran treatment completion than CPT).

This study will valuate CF-CPT's indirect impact on Veterans' psychosocial functioning and PTSD/depression symptomology Change in functioning, quality of life, and well-being & PTSD and depression will be associated with improvement in the idiosyncratic clinical challenges targeted by the CF.

This study will also examine between-group differences across secondary outcomes (e.g. anger, anxiety, health concerns, sleep, numbing/reactivity) and describe the frequency and type of the clinical and rehabilitative needs of the Veterans and the type and duration of divergences (e.g. rehabilitative techniques) made by providers.


Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Case Formulation plus Cognitive Processing Therapy Behavioral: Cognitive Processing Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This randomized controlled clinical trial seeks to examine the relative efficacy of a case formulation approach integrated into cognitive processing therapy as compared to standard cognitive processing therapy. Randomization to study condition will occur at the provider level (50 providers will be randomized to either CPT or CF-CPT. Each provider will treat the next 4 eligible veterans (total sample = 200 Veterans) seeking care for PTSD who agree to participate in the study.
Masking: Single (Outcomes Assessor)
Masking Description: Independent evaluators will be blind to treatment condition.
Primary Purpose: Treatment
Official Title: Personalizing Cognitive Processing Therapy With a Case Formulation Approach to Intentionally Target Impairment in Psychosocial Functioning Associated With PTSD
Estimated Study Start Date : January 4, 2021
Estimated Primary Completion Date : December 29, 2023
Estimated Study Completion Date : September 30, 2024

Arm Intervention/treatment
Experimental: Case Formulation plus Cognitive Processing Therapy
The CF approach alters the CPT protocol in two ways: expanding the protocol to intentionally and systematically address impairment in functioning, and enhancing the providers' latitude to navigate challenges to optimal therapy outcomes (COTOS). CF-CPT begins with a formal CF assessment session; elements of CF are then integrated throughout CPT. CF modifications to the original CPT protocol occur in each session by intentionally attending to cognitions that are impeding the patient's functional recovery. The second modification includes enhancing the provider's latitude to diverge from the protocol when clinically wise. CF-CPT provides guidance around the identification, monitoring and management of COTOs, and, importantly, the expedient return to the CPT protocol with continued attention to COTOs.
Behavioral: Case Formulation plus Cognitive Processing Therapy
The CF approach alters the CPT protocol in two ways: expanding the protocol to intentionally and systematically address impairment in functioning, and enhancing the providers' latitude to navigate challenges to optimal therapy outcomes (COTOS). CF-CPT begins with a formal CF assessment session; elements of CF are then integrated throughout CPT. CF modifications to the original CPT protocol occur in each session by intentionally attending to cognitions that are impeding the patient's functional recovery. The second modification includes enhancing the provider's latitude to diverge from the protocol when clinically wise. CF-CPT provides guidance around the identification, monitoring and management of COTOs, and, importantly, the expedient return to the CPT protocol with continued attention to COTOs.

Active Comparator: Cognitive Processing Therapy
CPT is a brief therapy for PTSD predominantly based on cognitive theory. Traditionally delivered over 12 one-hour sessions weekly or twice weekly, CPT is now variable length depending on patient's recovery from PTSD. CPT is delivered in three phases: education, processing, and challenging and focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Changing dysfunctional beliefs alters negative emotions emanating from those beliefs.
Behavioral: Cognitive Processing Therapy
CPT is a brief therapy for PTSD predominantly based on cognitive theory. Traditionally delivered over 12 one-hour sessions weekly or twice weekly, CPT is now variable length depending on patient's recovery from PTSD. CPT is delivered in three phases: education, processing, and challenging and focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Changing dysfunctional beliefs alters negative emotions emanating from those beliefs.




Primary Outcome Measures :
  1. Inventory of Psychosocial Functioning (assessing change over time) [ Time Frame: Assesses functioning over the 30 days prior to baseline assessment, change between baseline and session 6, change over following treatment (post-treatment), and at the 3-month follow-up interval. ]
    This standardized self-report instrument assesses PTSD-related psychosocial functioning. The IPF is an 80-item self-report questionnaire of functional impairment across several domains including relationships, work, parenting, education, and general daily functioning over the past 30 days. Domain scores can range from 0 to 100 with higher values corresponding to higher functioning. Overall functioning score was calculated as the mean of all completed IPF domain scores. As participants may skip certain domains that do not apply to them (thus leading to different sample sizes for analyses predicting different domains of functioning), overall score was calculated as total sum of all completed IPF domain scores divided by the actual number of domains completed by the participant.

  2. Clinician-Administered PTSD Scale-5 (CAPS) (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval. ]

    The CAPS is a 30-item structured interview that corresponds to the DSM-5 criteria for PTSD. The CAPS will be used to make a current (past month) and lifetime diagnosis of PTSD. In addition to assessing the 20 PTSD symptoms, questions target the impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and frequency and intensity of five associated symptoms. For each item, standardized questions and probes are provided.

    CAPS-5 diagnosis demonstrated strong interrater reliability, and test-retest reliability, as well as strong correspondence with a diagnosis based on the CAPS for DSM-IV. CAPS-5 total severity score demonstrated high internal consistency, and interrater reliability, and good test-retest reliability, and good discriminant validity with measures of anxiety, depression, somatization, functional impairment, psychopathy, and alcohol abuse.



Secondary Outcome Measures :
  1. WHO - Disability Assessment Schedule 2.0 (WHODAS-II) (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval. ]
    This widely used self-report questionnaire asks about difficulties experienced in relation to health conditions in six domains: understanding and communicating, getting around, self-care, getting along with people, life activities (work/school), and participation in society. The WHODAS-II has been shown to have high internal consistency, stable factor structure, and high test-retest reliability. Rigorous tests performed during the WHODAS-II development demonstrate its usability across cultures, sexes, and age groups and for a variety of diseases and health conditions. WHODAS-II was specifically developed to measure clinical outcomes and treatment effectiveness over time. It has established sensitivity to symptom change across a wide range of clinical conditions including depression and anxiety disorders, physical illness, and traumatic brain injury.

  2. WHO - Quality of Life - Brief (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval. ]

    The World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment. In addition, there are 2 items that measure overall QOL and general health. The assessment conceptually fits with the WHO definition of QOL. WHOQOL-BREF can provide data for both research and clinical purposes. Although it is a relatively brief instrument, its structure allows one to acquire specific information covering many aspects of life.

    Subscales (domains): Physical Health (7 items) Psychological Health (6 items) Social Relationships (3 items) Environment (8 items)

    Scoring: Items scored 1-5. Raw domain score is the sum of respective item scores. All domain scores are then normalized to a range of 0-100. Refer to user manual for scoring algorithm. SPSS algorithm available for automatic scoring.


  3. Well-Being Inventory (WBI) (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval. ]
    The WBI is a multidimensional instrument that was designed to assess status, functioning, and satisfaction with four key life domains of vocation, finances, health, and social relationships. In total, there are 21 sections of the WBI and 126 questions/statements: 34 items for vocation, 24 for finances, 20 for health, and 48 for social relationships. Throughout the inventory, respondents are instructed to provide responses to categorical items (e.g., yes, no), or to endorse a single response from among statements using a 5-point Likert type response format (e.g., 1 = Never to 5 = Most or all of the time; 1 = Very dissatisfied to 5 = Very satisfied). Measures within each domain may be extracted from the full inventory and are available to use as separate entities depending on the needs of the administrator and/or the purpose of the assessment.

  4. PTSD Checklist-DSM-5 (PCL-5) (assessing change over time) [ Time Frame: Administered at baseline, weekly (during treatment) mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval. ]
    The PCL-5 will also be used to assess PTSD. The DSM 5 civilian version was chosen because it is open to any trauma, not just combat trauma. The PCL-5 is a 20-item self-report measure of PTSD. The items correspond to the DSM-5 symptoms for PTSD and yield a total score and four symptom cluster subscale scores. Higher scores indicate more severe PTSD symptoms with scores above the clinical cutoff of 32 indicating a likely diagnosis of PTSD. The PCL-5 has excellent internal consistency, reliability and validity.

  5. Patient Health Questionnaire - 9 (assessing change over time) [ Time Frame: Administered at baseline, weekly (during treatment), mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval. ]
    The PHQ-9 is the 9-question depression scale of the PHQ aimed to detect the severity of depression. The PHQ is a version of the PRIME-MD, a screening tool that assesses 12 mental and emotional health disorders. The PHQ is a 59-question instrument with modules on mood (PHQ-9), anxiety, alcohol, eating, and somatoform disorders. A 4-point Likert scale, ranging from 0 (not at all) to 3 (almost all of the days), is used for each item. The total score for the nine questions is added up and can range from 0 to 27. A score of greater tan 20 indicates major depression (severe), 15 and 19 indicates major depression (moderately severe), 10 to 14 indicates minor depression, dysthymia, and major depression (mild), and 5 to 9 indicates mild symptoms of depression.

  6. session progress notes (assessing change over time) [ Time Frame: Session progress notes will be written by clinician following each weekly treatment session through study completion (an average of three months). This will reflect participant change and progress over the course of the week as well as current status. ]
    Session progress notes will be gathered from patients medical records and will provide a measure of session content and therapy completion.

  7. DSM-5 Cross-cutting symptom measure (CCSM) (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment). ]
    This measure assesses comorbid mental health conditions. The CCSM consists of 23 questions in a self-report format that evaluates mental health domains that are significant across psychiatric diagnoses. It is quick and easy to administer, taking patients around 5 minutes to complete in the waiting room. There are 13 psychiatric domains in this measure: depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. A 5-point scale (0-4) is used to record responses and reflect how much or how often the person has been concerned by a specific symptom over the previous 2 weeks. Additional inquiry is recommended if an individual scores a mild or slight rating, depending on the psychiatric symptom being investigated. This measure has good test-retest reliability in research settings and is useful and feasible in clinical practice.

  8. Weekly stress inventory (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment). ]
    This inventory measures minor life events and hassles. The WSI is an 87-item self-report scale used to assess the occurrence of minor stressors over a week's time. Individuals rank items on an 8-point Likert scale, with values ranging from 0 (did not occur) to 7 (extremely stressful). Two scores are obtained, the event score (WSI-E) which is the total number of events endorsed and the impact score (WSI-I), which is the summation of the subjective ratings of distress for the items endorsed.

  9. Veterans Rand Short Form (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment). ]
    This measure assesses health conditions and concerns about health conditions. The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status.

  10. Insomnia Severity Index (ISI) (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment). ]
    This measure assesses the presence and severity of insomnia. Subjective sleep disturbance over the past week was also assessed with the Insomnia Severity Index. A seven item measure that assesses perceived insomnia severity and daytime distress caused by insomnia. The scale yields a total score indicating level of insomnia with clinical cutoffs as follows: 0-7 = no clinically significant insomnia, 8-14 = sub-threshold insomnia, 15-21 = moderately severe clinical insomnia, 22-28 = severe clinical insomnia. The ISI has shown good internal consistency (alpha = 0.74) in a clinical sample and high reliability in the current sample (alpha = 0.83).

  11. PEG measure (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment). ]
    This measure assesses chronic pain. The PEG is an ultra-brief measure of pain (derived from the Brief Pain Inventory). The PEG score is the average of the 3 individual item scores. Item 1 uses a Likert scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Items 2 and 3 use a Likert scale ranging from 0 (does not interfere) to 10 (completely interferes). For clinical use, round to the nearest whole number.

  12. State-Trait Anxiety Inventory (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment). ]
    This measure assesses severity of state anxiety (situational) and trait anxiety (enduring). The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale; however, other studies have suggested a higher cut score of 54-55 for older adults.

  13. Emotional Reactivity and Numbing Scale (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment). ]
    This scale assesses affective arousal across the spectrum of aroused and agitated to devoid of emotion and numb. The Emotional Numbing and Re-activity Scale is a self-report measure designed to assess the withdrawal of awareness of emotional responses to events or experiences. 36 items were administered assessing General Numbing (8 items), as well as numbing of the specific emotions of Fear (6 items), Sadness (12 items), and Anger (10 items). Each item is rated on a 5-point Likert-type scale ranging from 1= not at all typical of me to 5=entirely typical of me.

  14. Dimensions of Anger Reactions (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment). ]
    This measure assesses angry reactions/reactivity. The Dimensions of Anger Reactions scale (DAR-5) is a 5-item assessment of recent anger reactions using a 5-point Likert scale from 1 (none or almost none of the time) to 5 (all or almost all of the time). Internal consistency reliability was good for this scale, 0.91.

  15. Beck Suicidal Ideation Scale (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment). ]
    This measure assesses suicidal ideation. This scale is a 19-items instrument that evaluates the presence and intensity of suicidal thoughts in a week before evaluation. Self-reporting edition of the scale was introduced in 1988. Each item is scored based on an ordinal scale from 0 to 2 and the total score is 0 to 38. Individuals answer to the first 5 items which is excerpted. If individual's answer to the fifth item is positive (scores 1 and 2), he/she answers the rest of the items and otherwise the questionnaire is completed.

  16. Brief Addiction Monitor (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment). ]
    This measure assesses alcohol and drug use and craving. The Brief Addiction Monitor (BAM) is a 17-item, multidimensional, progress-monitoring instrument for patients in treatment for a substance use disorder (SUD). The BAM includes items that assess risk factors for substance use, protective factors that support sobriety, and drug and alcohol use (items 4-7G). The BAM produces composite scores for the three aforementioned domains. The instrument can be used in treatment planning, progress monitoring, and group or individual psychotherapies for SUD.

  17. University of Rhode Island Change Assessment (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment). ]
    University of Rhode Island Change Assessment is a widely-used 32-item self-report measure of RTC, which assesses four stages of change (pre-contemplation, contemplation, preparation/action, and maintenance). The factor structure was validated in two outpatient samples and each subscale had good internal consistency (a's = .88 to .89). Items are rated on a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree) and averaged within subscales to create subscale scores. A composite readiness scale also includes cutoffs to produce a stage of change based on the total readiness score, which was used only for descriptive purposes in the current study. The current study utilized the original form of the URICA with specific instructions to focus on "trauma symptoms". This procedure is in line with the majority of previous studies using MI as a precursor to CBT. Internal consistency for each subscale in the current study was high (a's = .80 to .91).

  18. Daily monitoring diary (assessing change over time) [ Time Frame: Administered at baseline, daily throughout therapy, and two weeks following treatment (post-treatment). ]
    This idiosyncratic measures assesses the frequency and severity of any challenges to optimal therapy outcomes described by the participant in the case formulation session. The diaries are locally constructed and assess challenges to optimal therapy outcomes. The frequency and intensity of each challenge is assessed daily on a 0-5 likert scale. Change over time can be calculated using a formula to derive a composite symptom reduction score. This score can be interpreted as a percent improvement over a specified timeframe.

  19. PhenX Demographic Questionaire [ Time Frame: Administered at baseline. ]
    This measure records demographic variables including age, gender, education, marital status, parental status etc.

  20. Life Events Checklist 5 (assessing change over time) [ Time Frame: Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and three months following treatment. . ]

    The Life Events Checklist for DSM-5 (LEC-5) is a self-report measure designed to screen for potentially traumatic events in a respondent's lifetime. The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items.

    The LEC-5 is intended to gather information about the potentially traumatic experiences a person has experienced. There is no formal scoring protocol or interpretation per se, other than identifying whether a person has experienced one or more of the events listed. Respondents indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point nominal scale, and respondents may endorse multiple levels of exposure to the same trauma type. The LEC-5 does not yield a total score or composite score.


  21. Trauma Interview [ Time Frame: Administered at baseline ]
    This locally constructed interview assesses the participant's trauma history over the course of the lifetime.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans with posttraumatic stress disorder (PTSD)

Exclusion Criteria:

  • Study exclusion criteria include active suicidal ideation with intent, homicidality, current mania, psychosis, or serious drug or alcohol abuse that requires immediate medical attention (e.g. inpatient care)
  • Patients should not be participating in another trauma-focused therapy at the time of enrollment but can continue any psychiatric medications (dose must be stable for one month prior to enrollment)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407767


Contacts
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Contact: Tara E Galovski, PhD MA BS (857) 736-4129 Tara.Galovski@va.gov
Contact: Shannon M Kehle-Forbes, PhD (612) 467-4772 Shannon.Kehle-Forbes@va.gov

Locations
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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Contact: Tara E Galovski, PhD MA BS    (857) 736-4129    Tara.Galovski@va.gov   
Contact: Shannon M Kehle-Forbes, PhD    (612) 467-4772    Shannon.Kehle-Forbes@va.gov   
Principal Investigator: Tara Ellen Galovski, PhD MA BS         
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
Contact: Shannon Kehle-Forbes, PhD    612-467-1979    Shannon.Kehle-Forbes@va.gov   
Contact: Siamak Noorbaloochi, PhD    6124682775    Siamak.Noorbaloochi@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Tara Ellen Galovski, PhD MA BS VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04407767    
Other Study ID Numbers: F3369-R
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: In accordance with VA policy, a data sharing plan is not currently in place. However, data use agreements can be crafted and approved by the IRB to share data in the future.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Cognitive Processing Therapy
Case Formulation
Functional Outcomes
Psychosocial Functioning
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders