Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD) (TCM-PTSD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00288860
First received: February 6, 2006
Last updated: October 1, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to test whether providing PTSD patients additional support by telephone (in addition to usual outpatient care) after they discharge from residential treatment improves those patients' outcomes and keeps them out of the hospital longer.


Condition Intervention
Stress Disorders, Post-Traumatic
Behavioral: Telephone case monitoring
Other: Treatment as Usual Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Telephone Case Monitoring for Veterans With PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • a) violence, substance use, PTSD symptoms; b) time to rehospitalization; c) costs [ Time Frame: 4 and 12 months post-discharge (1-8 months post intervention) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • d) depressive symptoms, subjective quality of life [ Time Frame: 4 and 12 months post-discharge (1-8 months post intervention) ] [ Designated as safety issue: No ]

Enrollment: 926
Study Start Date: October 2006
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Telephone monitoring as augmentation to treatment as usual
Behavioral: Telephone case monitoring
Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)
Active Comparator: Arm 2
Treatment as usual
Other: Treatment as Usual Control
Usual outpatient mental health care (psychotherapy and/or medications)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a PTSD diagnosis entering PTSD residential treatment with an intended length of stay of 15 days or longer (patients in brief evaluation or acute stabilization tracks will not be included, as their discharge plan may include readmission to residential treatment within a few months).

Exclusion Criteria:

  1. Patients discharging from residential treatment within four days of admission(insufficient time to consent and assess them);
  2. Active Duty military personnel;
  3. Patients transferred from residential care to an inpatient medical unit due to emergent medical problems;
  4. Patients with traumatic brain injury or other organic impairment that compromises capacity to consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288860

Locations
United States, Arkansas
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, United States, 72114-1706
United States, Michigan
VA Medical Center, Battle Creek
Battle Creek, Michigan, United States, 49015
United States, New York
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, United States, 14215
United States, Pennsylvania
VA Medical Center, Coatesville
Coatesville, Pennsylvania, United States, 19320
United States, Washington
VA Puget Sound Health Care System, Tacoma
Tacoma, Washington, United States, 98493
Sponsors and Collaborators
Investigators
Principal Investigator: Craig S. Rosen, PhD VA Palo Alto Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00288860     History of Changes
Other Study ID Numbers: TEL 03-135
Study First Received: February 6, 2006
Last Updated: October 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
telemedicine
treatment compliance
mental health

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Disease
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014