NCT00941629

Brief Summary

The purpose of this study is to evaluate the equivalence of CPT treatment delivered remotely via telemental health (TMH) over videoconferencing or via traditional face-to face (FTF) treatment to veterans who have Post-traumatic Stress Disorder (PTSD) from a military-related stressor (i.e., combat, sexual assault, non-combat physical assault). The secondary objective is to determine if patients' ratings of PTSD symptoms, affect, social adjustment, therapy alliance, treatment satisfaction and therapist satisfaction, are equivalent between service-delivery conditions (TMH vs. FTF). A final objective is to develop web-based practice assignments to assist participants in the TMH condition with treatment adherence (completion of the between- session practice assignments).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2009

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

Enrollment Period

3.9 years

First QC Date

July 15, 2009

Last Update Submit

September 30, 2015

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSDTelemedicineClinical TrialPsychotherapy

Outcome Measures

Primary Outcomes (1)

  • The Clinician Administered PTSD Scale(CAPS) score.

    At baseline, post-treatment( after 6 weeks) and the 3-month follow-up period

Study Arms (2)

Cognitive Processing Therapy FTF

ACTIVE COMPARATOR

Cognitive Processing Therapy delivered in traditional face-to-face sessions (FTF)

Behavioral: Cognitive Processing Therapy (CPT)

Cognitive Processing Therapy TMH

EXPERIMENTAL

Cognitive Processing Therapy delivered over videoconferencing equipment to a distant location (or telemental health; TMH)

Behavioral: Cognitive Processing Therapy (CPT)

Interventions

Cognitive Processing Therapy (CPT)BEHAVIORAL

Patients with PTSD receive a trauma-focused, cognitive-behavioral intervention in Face-to -Face treatment.

Also known as: CPT
Cognitive Processing Therapy FTF

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Literate in written English
  • Fluent in spoken English
  • Verified status as an OEF/OIF veteran
  • Current PTSD diagnosis
  • Index traumatic event related to military services
  • If taking psychotropic medication, remains stable

You may not qualify if:

  • Under 18 years of age
  • Not literate in written English
  • Not fluent in spoke English
  • Current uncontrolled psychotic or bipolar disorder
  • Substance dependence
  • Current uncontrolled suicidal or homicidal ideation
  • Significant cognitive impairment that would interfere with completion of therapy tasks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Edward J. Hines Jr. Veterans Hospital, Cares Research Foundation FWA00001322

Hines, Illinois, 60141, United States

Location

Wm. S.Middleton Memorial Veterans Hospital

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

  • Miles SR, Smith TL, Maieritsch KP, Ahearn EP. Fear of Losing Emotional Control Is Associated With Cognitive Processing Therapy Outcomes in U.S. Veterans of Afghanistan and Iraq. J Trauma Stress. 2015 Oct;28(5):475-9. doi: 10.1002/jts.22036. Epub 2015 Sep 23.

    PMID: 26397721DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Tracey L Smith, Ph.D.

    Wm.S. Middleton Memorial Veterans Hospital FWA 00005784

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 17, 2009

Study Start

December 1, 2009

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

October 2, 2015

Record last verified: 2015-09

Locations

US(2)