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Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)

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: NCT04230668
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Candice Monson, Ryerson University

Brief Summary:
Posttraumatic Stress Disorder (PTSD) and Borderline Personality Disorder (BPD) are two mental health conditions that often occur together (i.e., PTSD-BPD), with comorbidity rates as high as 58%. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require that participants cease all suicidal behaviours prior to treatment. Furthermore, no integrated treatment has been innovated to address the specific mechanisms underpinning this comorbidity. We propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy (CPT) plus Suicide Risk Management (SRM), as a briefer (12 sessions) and more efficient treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this uncontrolled study is to collect initial safety and efficacy data on this adapted treatment. Knowledge gleaned from this study will have significant direct clinical implications. Potential risks of the study include individual distress, suicide risk, and residual PTSD and BPD symptoms post-treatment. To minimize risk, study therapists will closely monitor participants using the suicide risk assessment and management protocol. Using this protocol, if participants remain distressed after a therapy session or psychological interview they will be encouraged to discuss their distress with their study assessor or therapist and coached to implement strategies to reduce their distress. If they express self-harming or suicidal urges the study assessor or therapist will implement a standardized protocol to monitor and address any escalations in risk. Potential benefits of this study include reductions in participants' PTSD, BPD and other mental health symptoms. Additionally, the study may benefit others by improving the treatment repertoire for PTSD-BPD with a more succinct treatment that can also be utilized for individuals with suicidal behaviours.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Borderline Personality Disorder Behavioral: Cognitive Processing Therapy with Suicide Risk Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study involves an uncontrolled psychotherapy trial to preliminarily examine the safety, feasibility, and acceptability of 12 sessions of Cognitive Processing Therapy+Suicide Risk Management (SRM) for PTSD-BPD administered twice weekly over 6 weeks.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Study on Cognitive Processing Therapy for Comorbid Posttraumatic Stress Disorder and Borderline Personality Disorder
Estimated Study Start Date : March 30, 2020
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Cognitive Processing Therapy with Suicide Risk Management
    CPT is an evidence-based treatment for PTSD. This first-line treatment for PTSD will be adapted and combined with SRM into 12 60-90min sessions targeting both PTSD and BPD. Individuals assigned to this intervention will attend treatment sessions, and be asked to do treatment homework at home. The primary outcomes are PTSD and BPD severity.


Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale for DSM-5 (Past Month Version) with change measured as mean change from baseline [ Time Frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up ]
    Scores range from 0 to 120, with 120 representing more severe PTSD.

  2. Borderline Symptom List 23 with change measured as mean change from baseline [ Time Frame: Baseline, once a week while in treatment (for 6 weeks) ]
    Scores range from 0 to 92, with 92 representing more severe borderline symptoms.


Secondary Outcome Measures :
  1. Mean Change from Baseline on Self-Injury as measured by the Modified Suicide Attempt Self-Injury Count [ Time Frame: 3-weeks, Post-treatment/6-weeks, 3-month follow-up ]
  2. Mean Change from Baseline on Difficulties in Emotion Regulation Scale [ Time Frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up ]
    Scores range from 0 to 180, with 180 representing less emotional regulation.

  3. Mean Change from Baseline on Posttraumatic Cognition Inventory [ Time Frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up ]
    Scores range from 0 to 21, with 21 representing more post traumatic cognitions.

  4. Beck's Depression Inventory with change measured as mean change from baseline [ Time Frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up ]
    Scores range from 0 to 63, with 63 being the most severe depression.

  5. Spielberger State-Trait Anxiety Inventory with change measured as mean change from baseline [ Time Frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up ]
  6. State-Trait Anger Expression Inventory with change measured as mean change from baseline [ Time Frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up ]
    Scores range from 0 to 40, with 40 representing higher levels of anger.

  7. Social Adjustment Questionnaire with change measured as mean change from baseline [ Time Frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up ]
  8. Trauma-Related Guilt Inventory with change measured as mean change from baseline [ Time Frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up ]
    Scores range from 0 to 4, with 4 representing higher trauma-related guilt.

  9. Suicidal Behaviors Questionnaire-Revised with change measured as mean change from baseline [ Time Frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up ]
    Scores range from 3 to 18, with 18 being higher suicide risk.

  10. Substance Use Inventory with change measured as mean change from baseline [ Time Frame: Baseline, 3-weeks, Post-treatment/6-weeks, 3-months follow-up ]
  11. PTSD Checklist for DSM-5 with change measured as mean change from baseline [ Time Frame: Baseline, once a week while in treatment (for 6 weeks) ]
    Scores on the PCL-5 range from 0 to 80, with 80 being the most severe PTSD symptoms.

  12. Number of participants with treatment related adverse events as measured by the Credibility/Expectancy Questionnaire [ Time Frame: Baseline, 3-weeks, and post-treatment/6-weeks ]
  13. Feasibility as measured by number of treatment sessions attended and rate of participant dropout [ Time Frame: Once a week while in treatment (for 6 weeks) ]


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:

  • Aged 18 years or older
  • Current DSM-5 diagnosis of PTSD and BPD
  • Must be willing to be audio- or videorecorded for assessment and treatment sessions

Exclusion Criteria:

  • Acute mania, acute psychosis, or mental retardation
  • Conditions requiring medical attention to a potentially life-threatening illness (e.g., severe anorexia nervosa)
  • Severe impairments in written and aural comprehension.

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): NCT04230668


Contacts
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Contact: Kristen M Whitifeld, B.A. (Hons) 416-979-5000 ext 2369 impact.lab@ryerson.ca

Locations
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Canada, Ontario
Candice M. Monson
Toronto, Ontario, Canada, M5M 1Y3
Contact: Kristen M Whitfield, B.A. (Hons)    416-979-5000 ext 2369    impact.lab@ryerson.ca   
Sponsors and Collaborators
Ryerson University
Investigators
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Principal Investigator: Candice M Monson, PhD Ryerson University
Publications:
Resick, P. A., Monson, C. M., & Chard, K. M. (2016). Cognitive processing therapy for PTSD: A comprehensive manual. New York, NY: Guilford Press.
Stanley, B., & Brown, G. (2012). Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioural Practice, 19(2), 256-264.

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Responsible Party: Candice Monson, Professor, Ryerson University
ClinicalTrials.gov Identifier: NCT04230668    
Other Study ID Numbers: CPT for PTSD-BPD
CIHR-IRSC:0525007697 ( Other Grant/Funding Number: Canadian Institutes of Health Research Foundation Grant )
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Candice Monson, Ryerson University:
Cognitive Processing Therapy
Suicide Risk Management
Suicide
Self-harm
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders