NCT02684994

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

3.8 years

First QC Date

February 12, 2016

Last Update Submit

October 16, 2018

Conditions

Posttraumatic Stress Disorder

Keywords

TraumaSexual assaultSexual abusePhysical assaultPhysical abusePTSDInterpersonal ViolenceWomen

Outcome Measures

Primary Outcomes (1)

  • change in PTSD symptoms

    Clinician administered clinical interview (Clinician Administered PTSD Scale) assessing PTSD symptoms

    pre-treatment, post-treatment, 3 month follow-up

Study Arms (1)

Cognitive Processing Therapy

OTHER

Cognitive Processing Therapy

Behavioral: Cognitive Processing Therapy

Interventions

Cognitive Processing TherapyBEHAVIORAL

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.

Also known as: CPT, Client-directed CPT
Cognitive Processing Therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current psychosis, mania, active suicidal ideation; Substance use disorder in the last 6 months; in a relationship with perpetrator of violence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Indianapolis

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Lisa S Elwood, Ph.D.

    University of Indianapolis

    PRINCIPAL INVESTIGATOR

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

February 12, 2016

First Posted

February 18, 2016

Study Start

October 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)