NCT02655991

Brief Summary

This study will determine whether telephone support improves clinical outcomes of veterans who begin outpatient treatment for posttraumatic stress disorder. Participants will be randomly assigned to receive either usual care or usual care supplemented by biweekly monitoring and support by telephone during the first 3 months of treatment. Patients in both conditions will be compared on PTSD symptoms, engagement in treatment, violence and drinking at 4 months and 12 months after entering treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
358

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

March 1, 2008

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

6.4 years

First QC Date

January 12, 2016

Last Update Submit

January 12, 2016

Conditions

Stress Disorders, Post-Traumatic

Keywords

Stress Disorders, Post-TraumaticAmbulatory CareTelemedicineRemote ConsultationHealth Services Accessibility

Outcome Measures

Primary Outcomes (1)

  • PTSD Checklist (PCL) Slope

    Slope of improvement on the PTSD Checklist, a self-report measure of PTSD symptoms.

    12 months

Secondary Outcomes (11)

  • PTSD psychotherapy visits - intervention period

    3 months

  • Other mental health visits - intervention period

    3 months

  • Depression slope

    12 months

  • Alcohol problems slope

    12 months

  • Drug problems slope

    12 months

  • +6 more secondary outcomes

Study Arms (2)

Telephone Case Monitoring

EXPERIMENTAL

Telephone care management augmenting treatment as usual

Behavioral: Telephone Case MonitoringBehavioral: Treatment as Usual

Treatment as Usual

ACTIVE COMPARATOR

Case management, psychotherapy, and pharmacotherapy as usual

Behavioral: Treatment as Usual

Interventions

Telephone Case MonitoringBEHAVIORAL

Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy) augmented by up to six fortnightly telephone monitoring and support calls from a case manager during the first three months of treatment.

Telephone Case Monitoring
Treatment as UsualBEHAVIORAL

Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).

Telephone Case MonitoringTreatment as Usual

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • VA patients newly entering outpatient treatment mental health treatment for PTSD starting a new phase of outpatient PTSD treatment (e.g., transitioning from a psycho-education group to active psychotherapy) at one of the study sites.

You may not qualify if:

  • Active duty personnel
  • Cognitive impairment which precludes giving informed consent
  • Initiating residential or inpatient treatment rather than outpatient treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Palo Alto Health Care System (Meno Park Division)

Menlo Park, California, 94025, United States

Location

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

VA Puget Sound Health Care System (American Lake)

Lakewood, Washington, 98493, United States

Location

Related Publications (1)

  • Rosen CS, Azevedo KJ, Tiet QQ, Greene CJ, Wood AE, Calhoun P, Bowe T, Capehart BP, Crawford EF, Greenbaum MA, Harris AH, Hertzberg M, Lindley SE, Smith BN, Schnurr PP. An RCT of Effects of Telephone Care Management on Treatment Adherence and Clinical Outcomes Among Veterans With PTSD. Psychiatr Serv. 2017 Feb 1;68(2):151-158. doi: 10.1176/appi.ps.201600069. Epub 2016 Oct 17.

    PMID: 27745535DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Craig S. Rosen, Ph.D.

    VA Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director, National Center for PTSD

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 14, 2016

Study Start

March 1, 2008

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

US(3)