NCT02295410

Brief Summary

The intent of this study is to assess whether cognitive functioning improves as Post-Traumatic Stress Disorder (PTSD) symptoms decrease as a step toward developing an objective measure of PTSD improvement. The study also evaluates the feasibility and effectiveness of home-based telemental health care (HBTMH) compared to usual care in the treatment of rural Veterans with posttraumatic stress disorder (PTSD). For this assessment-only study, the investigators plan to assess approximately 200 Veterans in total, of which 150 will be undergoing regular evidenced-based therapy (EBT) for PTSD, and 50 will be receiving other treatment as usual (TAU). The 150 veterans in the EBT group will be undergoing Cognitive Processing Therapy (CPT), Cognitive-Behavioral Couple Therapy (CBCT), Prolonged Exposure (PE), or Seeking Safety (SS) treatment for PTSD in clinic or via home-based telemental health (HBTMH). The study will also assess a comparison group of approximately 50 rural Veterans with PTSD diagnoses who are receiving treatment as usual (TAU) (neither EBT nor HBTMH). The HBTMH patients will be recruited from an Office of Rural Health (ORH) funded project to VA Pacific Island Health Care System (VAPIHCS), based at the National Center for PTSD (NCPTSD) and funded to offer 100 rural Veterans mental health treatment in their homes. This research protocol intends to assess rural veterans with PTSD who are being seen within this clinic versus those who have been referred for HBTMH yet who are ineligible for pragmatic purposes, with outcomes including feasibility, cost-effectiveness, and clinical effectiveness. The cognitive change will also be measured in patients with PTSD diagnoses receiving EBT PTSD treatment at VA clinics in the Pacific Islands.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 6, 2017

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

November 12, 2014

Last Update Submit

November 2, 2017

Conditions

Stress Disorders, Post-Traumatic

Keywords

Assessment, PTSD, Veterans

Outcome Measures

Primary Outcomes (1)

  • Change in PCL-M

    Posttraumatic Stress Disorder Checklist- Military (PCL-M) \[repeated measure\]

    approximately 0, 4 and 8 weeks depending on the number of CPT sessions completed.

Secondary Outcomes (7)

  • Change in Simple Reaction Time Throughput

    approximately 0, 4 and 8 weeks depending on the number of CPT sessions completed.

  • Change in Procedural Reaction Time Throughput

    approximately 0, 4 and 8 weeks depending on the number of CPT sessions completed.

  • Go-No Go Throughput

    approximately 0, 4 and 8 weeks depending on the number of CPT sessions completed.

  • Change in Code Substitution (Learning and Recall) Throughput

    approximately 0, 4 and 8 weeks depending on the number of CPT sessions completed.

  • Change in Spacial Processing Throughput

    approximately 0, 4 and 8 weeks depending on the number of CPT sessions completed.

  • +2 more secondary outcomes

Study Arms (2)

Engaged in Home-Based CPT

Home-Based Telemental Health-Patients undergoing Home-Based CPT for PTSD

Behavioral: CPT

Comparison

Treatment as Usual (TAU) Patients NOT receiving regular CPT or other evidence-based therapy for PTSD.

Interventions

CPTBEHAVIORAL
Also known as: Cognitive Processing Therapy
Engaged in Home-Based CPT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Up to 200 Veterans with PTSD who have been referred by their CBOC to the HBTMH PTSD clinic or a VA Clinic will be enrolled in this research study. This sample size is based on the number of treatment subjects intended to be treated by the HBTMH clinic, the VA clinic, and the estimated numbers of subjects who will be ineligible or choose not to participate in the HBTMH treatment. This number should be sufficient given past effect size differences between HBTMH treatment and TAU (Cohen's d effect size averaging about 1.0). It will also allow us to measure changes in psychological and cognitive functioning within treatment subjects over time.

You may qualify if:

  • Participants must have a referral to the HBTMH Clinic or VA clinic for PTSD treatment as well as:
  • ability to use a keyboard
  • the ability to demonstrate a thorough understanding of the study and willingness to participate
  • comfort using a tablet device and the Internet, or willingness to learn
  • have agreed to return the tablet and headset after the study (TAU and HBTMH-only)
  • adequate (or corrected) vision and hearing
  • ability to read and write at an 8th grade level or higher.

You may not qualify if:

  • clinical disqualification (current psychosis, active homicidal or suicidal intent or within the past six months)
  • significant cognitive impairment as determined by inability to sufficiently comprehend the study goals, risks and benefits.
  • To determine this, potential research participants will be asked to summarize the study as explained to them and as presented by the Study Fact Sheet/Consent Form as applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pacific Island Health Care System

Honolulu, Hawaii, 96819, United States

Location

Related Publications (2)

  • Lathan C, Spira JL, Bleiberg J, Vice J, Tsao JW. Defense Automated Neurobehavioral Assessment (DANA)-psychometric properties of a new field-deployable neurocognitive assessment tool. Mil Med. 2013 Apr;178(4):365-71. doi: 10.7205/MILMED-D-12-00438.

    PMID: 23707818BACKGROUND

  • Spira JL, Lathan CE, Bleiberg J, Tsao JW. The impact of multiple concussions on emotional distress, post-concussive symptoms, and neurocognitive functioning in active duty United States marines independent of combat exposure or emotional distress. J Neurotrauma. 2014 Nov 15;31(22):1823-34. doi: 10.1089/neu.2014.3363. Epub 2014 Oct 9.

    PMID: 25003552BACKGROUND

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

  • James Spira, PhD

    NPTSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 20, 2014

Study Start

May 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 6, 2017

Record last verified: 2016-03

Locations

US(1)