Client-directed Cognitive Processing Therapy

Posttraumatic Stress Disorder Clinical Trial

— CPT  

Official title:

Client-directed Cognitive Processing Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684994
• Other study ID #: 0619
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: August 1, 2018

Study information

• Verified date: October 2018
• Source: University of Indianapolis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Indianapolis	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
University of Indianapolis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in PTSD symptoms	Clinician administered clinical interview (Clinician Administered PTSD Scale) assessing PTSD symptoms	pre-treatment, post-treatment, 3 month follow-up