Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT02684994
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2016-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Client-directed Cognitive Processing Therapy
Sponsor:
University of Indianapolis
Organization:
Study Overview
Official Title:
Client-directed Cognitive Processing Therapy
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPT
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: