Homecoming Line: Telephone Support for Veterans

Stress Disorders, Post-Traumatic Clinical Trial

— HCL  

Official title:

Homecoming Line: Telephone Support for Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655991
• Other study ID #: W81XWH=08-2-0096
• Status: Completed
• Phase: N/A
• First received: January 12, 2016
• Last updated: January 12, 2016
• Start date: March 2008
• Est. completion date: August 2014

Study information

• Verified date: January 2016
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This multisite randomized controlled trial will test whether a 3-month period of providing telephone monitoring to PTSD patients as a supplement to usual specialty mental health care improves 12-month clinical outcomes (a reduction in PTSD symptoms, violence, and substance use). Secondarily, this study will determine whether telephone monitoring promotes better engagement in outpatient treatment (Number of mental health and psychotherapy visits during the 3-month intervention period).

Demand for VA PTSD treatment is increasing as troops return from combat deployments in Afghanistan and Iraq. Telemedicine is likely to be an important component in developing more effective and efficient models of PTSD care that improves patient functioning and treatment utilization. It is hoped that using telephone case monitoring as an inexpensive adjunct to standard care may improve clinical outcomes and reduce hospitalization among veterans with PTSD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Active duty personnel

• Cognitive impairment which precludes giving informed consent

• Initiating residential or inpatient treatment rather than outpatient treatment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Telephone Case Monitoring
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.
• Treatment as Usual
Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).

Locations

Country	Name	City	State
United States	Durham VA Medical Center	Durham	North Carolina
United States	VA Puget Sound Health Care System (American Lake)	Lakewood	Washington
United States	VA Palo Alto Health Care System (Meno Park Division)	Menlo Park	California

Sponsors (3)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System	Durham VA Medical Center, VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Checklist (PCL) Slope	Slope of improvement on the PTSD Checklist, a self-report measure of PTSD symptoms.	12 months	No
Secondary	PTSD psychotherapy visits - intervention period	Number of psychotherapy visits for PTSD (psychotherapy procedure code + PTSD diagnosis code) completed during the 3 month intervention period.	3 months	No
Secondary	Other mental health visits - intervention period	Number of "other" mental health visits (mental health visits without psychotherapy procedure code and/or without a PTSD diagnosis code) completed during the 3 month intervention period.	3 months	No
Secondary	Depression slope	Slope of improvement on the Center for Epidemiological Studies Scale, a self-report measure of depression symptoms.	12 months	No
Secondary	Alcohol problems slope	Slope of improvement on the Addiction Severity Index Alcohol Composite, a self-report measure of alcohol-related problems.	12 months	No
Secondary	Drug problems slope	Slope of improvement on the Addiction Severity Index Drug Composite, a self-report measure of drug-related problems.	12 months	No
Secondary	Aggression slope	Slope of improvement on a six-item self-report measure of aggressive behaviors, adapted from the Conflict Tactics Scale.	12 months	No
Secondary	Quality of Life slope	Slope of improvement on a self-report quality measure used in the Veterans Affairs Military Stress Treatment Assessment study.	12 months	No
Secondary	PTSD psychotherapy visits -- follow-up period	Number of psychotherapy visits for PTSD (psychotherapy procedure code + PTSD diagnosis code) completed during the post-intervention period (months 4-12).	months 4-12	No
Secondary	Other mental health visits -- follow-up period	Number of "other" mental health visits (mental health visits without psychotherapy procedure code and/or without a PTSD diagnosis code) completed during the post-intervention period (months 4-12).	months 4-12	No
Secondary	Selective serotonin reuptake inhibitor refills (medication possession ratio)	Number of days' supply of selective serotonin reuptake inhibitors (SSRIs) obtained divided by 365 days.	12 months	No
Secondary	Prazosin refills (medication possession ratio)	Number of days' supply of Prazosin obtained divided by 365 days.	12 months	No