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

NCT00288860 | Completed Results DMC

• 1 other identifier: TEL 03-135
• Study Type: interventional
• Target: 837
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

telemedicine; treatment compliance; mental health

Outcome Measures

Primary Outcomes (2)

• Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms

  Higher scores are worse outcomes on all four measures: Aggressive behavior (scale from 0-6 types of violent behavior than past four months) - adapted from conflict tactics scale Alcohol problems: Addiction Severity Index Alcohol composite (ranges from 0 to 1) Drug problems: Addiction Severity Index Drug composite (ranges from 0 to 1) PTSD symptoms: DSM IV PTSD Checklist (ranges from 17 to 85)

  12 months post-discharge (8 months post intervention)

• Rehospitalization

  Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program

  12 months post discharge

Secondary Outcomes (1)

• Depressive Symptoms, Subjective Quality of Life

  12 months post-discharge (8 months post intervention)

Study Arms (2)

Telephone Monitoring

EXPERIMENTAL

Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.

Behavioral: Telephone monitoring; Other: Treatment-As-Usual

Treatment-As-Usual

ACTIVE COMPARATOR

Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.

Other: Treatment-As-Usual

Interventions

Telephone monitoring BEHAVIORAL

Three months of biweekly telephone monitoring and support

Telephone Monitoring

Treatment-As-Usual OTHER

Outpatient mental health Treatment As Usual (psychotherapy and/or medications)

Telephone Monitoring; Treatment-As-Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients discharging from residential treatment within four days of admission(insufficient time to consent and assess them);
• Active Duty military personnel;
• Patients transferred from residential care to an inpatient medical unit due to emergent medical problems;
• Patients with traumatic brain injury or other organic impairment that compromises capacity to consent.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (5)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

No. Little Rock, Arkansas, 72114-1706, United States

Location

VA Medical Center, Battle Creek

Battle Creek, Michigan, 49015, United States

Location

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215, United States

Location

VA Medical Center, Coatesville

Coatesville, Pennsylvania, 19320, United States

Location

VA Puget Sound Health Care System, Tacoma

Tacoma, Washington, 98493, United States

Location

Related Publications (2)

• Rosen CS, Tiet QQ, Harris AH, Julian TF, McKay JR, Moore WM, Owen RR, Rogers S, Rosito O, Smith DE, Smith MW, Schnurr PP. Telephone monitoring and support after discharge from residential PTSD treatment: a randomized controlled trial. Psychiatr Serv. 2013 Jan;64(1):13-20. doi: 10.1176/appi.ps.201200142.

  PMID: 23117443 RESULT

• Belsher BE, Tiet QQ, Garvert DW, Rosen CS. Compensation and treatment: disability benefits and outcomes of U.S. veterans receiving residential PTSD treatment. J Trauma Stress. 2012 Oct;25(5):494-502. doi: 10.1002/jts.21747. Epub 2012 Oct 9.

  PMID: 23047625 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Patient Compliance; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Personal Satisfaction

Results Point of Contact

• Title: Craig S. Rosen
• Organization: Nationa Center for PTSD Dissemination & Training Division

craig.rosen@va.gov

650-493-5000

Study Officials

• Craig S. Rosen, PhD

  VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 8, 2006
• Study Start: October 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 25, 2016
• Results First Posted: April 25, 2016

Record last verified: 2016-03

Locations

US (5)