Client-directed Cognitive Processing Therapy (CPT)
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Trauma, Sexual assault, Sexual abuse, Physical assault, Physical abuse, PTSD, Interpersonal Violence, Women
Eligibility Criteria
Inclusion Criteria:
- Female, 18 years of age or over, experienced one or more interpersonal violence events, traumatic event happened over a month ago, no traumatic events in the last 3 months, must be proficient in English
Exclusion Criteria:
- Current psychosis, mania, active suicidal ideation; Substance use disorder in the last 6 months; in a relationship with perpetrator of violence
Sites / Locations
- University of Indianapolis
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cognitive Processing Therapy
Arm Description
Cognitive Processing Therapy
Outcomes
Primary Outcome Measures
change in PTSD symptoms
Clinician administered clinical interview (Clinician Administered PTSD Scale) assessing PTSD symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT02684994
First Posted
February 12, 2016
Last Updated
October 16, 2018
Sponsor
University of Indianapolis
1. Study Identification
Unique Protocol Identification Number
NCT02684994
Brief Title
Client-directed Cognitive Processing Therapy
Acronym
CPT
Official Title
Client-directed Cognitive Processing Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Indianapolis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will take place over approximately 6 months and includes 3 assessment appointments (where information will be gathered, but no direct treatment provided) and 12 treatment sessions of cognitive processing therapy if eligible.
Detailed Description
The purpose of this research study is to examine the effectiveness of a client-directed version of a well-supported psychological therapy, cognitive processing therapy (CPT), for the treatment of psychological effects of traumatic experiences. Participants in this study are expected to be women who have experienced one or more interpersonal violence experiences (i.e. physical or sexual assault).
During the first assessment, participants will be interviewed by a qualified investigator/interviewer. The investigator/interviewer will ask participants about life experiences and reactions, including traumatic experiences and symptoms participants might be experiencing. This portion of the study will take approximately 2-3 hours. If participant's assessment reveals that participant is eligible for the study participant will begin the treatment portion of the study. If eligible, participant will also be given a packet of questionnaires to complete before participant's first treatment session. If participant is not eligible for the study, investigator/interviewer will provide participant with a list of referrals from which participant could seek treatment with other agencies.
If participant begins the treatment portion of the study, participant will participate in a client-directed version of cognitive processing therapy (CPT). CPT is a treatment designed to help participant understand the ways participant's traumatic experience has affected various aspects of participant's life (feelings, beliefs, behaviors, etc.). The treatment will consist of four main components: education about trauma responses, experiencing emotions related to the assault, development of skills for examining the truth of thoughts, and examination of beliefs in areas commonly influenced by traumatic experiences. During this treatment, participant will be exploring the ways in which the assault has affected participant's beliefs, such as participant's beliefs about participant's own safety, trust, and ability to have relationships. In the sessions, participant will explore these areas to discover and change the ways participant believes, since the assault has led to feelings of distress, fear, anxiety, and depression. Participant will be asked to do activities in between sessions each week, which will ask participant to think and write about participant's traumatic experiences. The treatment includes 12 sessions, each for one hour. Sessions will be held once or twice a week. The current version of CPT will include all the components of the regular CPT treatment, but may vary in order of sessions. The regular treatment protocol provides sessions in a set order, but the current study will allow participant some choices in when participant complete certain activities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Trauma, Sexual assault, Sexual abuse, Physical assault, Physical abuse, PTSD, Interpersonal Violence, Women
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Processing Therapy
Arm Type
Other
Arm Description
Cognitive Processing Therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Other Intervention Name(s)
CPT, Client-directed CPT
Intervention Description
Cognitive-processing therapy is a well-supported treatment for reactions following traumatic events. It includes 12 individual psychotherapy sessions and consists of 4 components: education about trauma responses, experiencing emotions related to the assault, development of skills for examining the truth of thoughts, and examination of beliefs in areas commonly influenced by the trauma.
Primary Outcome Measure Information:
Title
change in PTSD symptoms
Description
Clinician administered clinical interview (Clinician Administered PTSD Scale) assessing PTSD symptoms
Time Frame
pre-treatment, post-treatment, 3 month follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female, 18 years of age or over, experienced one or more interpersonal violence events, traumatic event happened over a month ago, no traumatic events in the last 3 months, must be proficient in English
Exclusion Criteria:
Current psychosis, mania, active suicidal ideation; Substance use disorder in the last 6 months; in a relationship with perpetrator of violence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa S Elwood, Ph.D.
Organizational Affiliation
University of Indianapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Client-directed Cognitive Processing Therapy
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