NCT02574429

Brief Summary

Even though borderline personality disorder (BPD) and posttraumatic stress disorder (PTSD) commonly co-occur, few studies have examined PTSD treatment among individuals with BPD. Additionally, many PTSD research studies exclude individuals with BPD due to their complexity and concerns regarding risk. This study aims to investigate the effectiveness of Cognitive-Processing Therapy Group (an evidenced-based treatment for PTSD) for individuals with these co-occurring disorders following completion of a Dialectical Behavioural Therapy Program (an evidenced-based treatment for BPD). The investigators are using a repeated measures pre and post design. Data will be collected prior to participants starting the CPT group, throughout the duration of the CPT group (i.e., weekly), and following the completion of the CPT group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

2.7 years

First QC Date

September 18, 2015

Last Update Submit

December 14, 2018

Conditions

Borderline Personality DisorderPosttraumatic Stress Disorder

Keywords

Borderline Personality DisorderPosttraumatic Stress DisorderCognitive Processing TherapyGroup TherapyComorbidityDialectical Behavior Therapy

Outcome Measures

Primary Outcomes (1)

  • Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    Self-report measure assessing change in PTSD DSM-5 symptoms are affecting the participant. The investigators are comparing pre-PCL scores to post-PCL scores. In addition, the investigators are interested in examing the pattern of change between sessions.

    Weekly for 13 weeks (course of treatment)

Secondary Outcomes (9)

  • BSL-23

    2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment

  • Ways of Coping Checklist (WCCL)

    2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment

  • Depression, Anxiety, Stress and Suicide Scale (DASS-21)

    2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment

  • Difficulties in Emotion Regulation Scale (DERS)

    2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment

  • Experience of Shame Scale

    2 times - once prior to starting treatment, and once at the end of 13 weeks of treatment

  • +4 more secondary outcomes

Study Arms (1)

Cognitive Processing Therapy

EXPERIMENTAL

Individuals who have either completed Standard Dialectical Behavior Therapy (DBT) for Borderline Personality Disorder (BPD) and/or are currently enrolled in DBT who have co-occuring PTSD.

Behavioral: Cognitive Processing Therapy

Interventions

Cognitive Processing TherapyBEHAVIORAL

Cognitive Processing Therapy is an evidenced-based treatment for PTSD. The investigators are offering CPT group over 13 weeks (12 group sessions \& 1 individual session). CPT focuses on challenging beliefs that developed or were reinforced following the trauma(s).

Also known as: CPT
Cognitive Processing Therapy

Eligibility Criteria

Age17 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals diagnosed with co-occurring BPD/PTSD who are either currently participating in Standard Dialectical Behaviour Therapy (DBT) or who have completed DBT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 3K7, Canada

Location

St Joseph's Healthcare Hamilton, Community Psychiatry Clinic

Hamilton, Ontario, L8N3K7, Canada

Location

MeSH Terms

Conditions

Borderline Personality DisorderStress Disorders, Post-Traumatic

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

October 12, 2015

Study Start

April 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations

CA(2)