Client-directed Cognitive Processing Therapy

NCT ID: NCT02684994

Last Updated: 2018-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Posttraumatic Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive Processing Therapy

Cognitive Processing Therapy

Group Type OTHER

Cognitive Processing Therapy

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive Processing Therapy

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CPT Client-directed CPT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Indianapolis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lisa S Elwood, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Indianapolis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Indianapolis

Indianapolis, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0619

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognitive Training for PTSD
NCT03316196 COMPLETED NA
Enhancing Memory in CPT for PTSD
NCT06000475 RECRUITING NA