NCT Number: NCT02655991
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.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
VA Palo Alto Health Care System (Meno Park Division), Menlo Park, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).
Time frame: 12 months
Slope of improvement on the PTSD Checklist, a self-report measure of PTSD symptoms.
Time frame: 3 months
Number of psychotherapy visits for PTSD (psychotherapy procedure code + PTSD diagnosis code) completed during the 3 month intervention period.
Time frame: 3 months
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.
Time frame: 12 months
Slope of improvement on the Center for Epidemiological Studies Scale, a self-report measure of depression symptoms.
Time frame: 12 months
Slope of improvement on the Addiction Severity Index Alcohol Composite, a self-report measure of alcohol-related problems.
Time frame: 12 months
Slope of improvement on the Addiction Severity Index Drug Composite, a self-report measure of drug-related problems.
Time frame: 12 months
Slope of improvement on a six-item self-report measure of aggressive behaviors, adapted from the Conflict Tactics Scale.
Time frame: 12 months
Slope of improvement on a self-report quality measure used in the Veterans Affairs Military Stress Treatment Assessment study.
Time frame: months 4-12
Number of psychotherapy visits for PTSD (psychotherapy procedure code + PTSD diagnosis code) completed during the post-intervention period (months 4-12).
Time frame: months 4-12
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).
Time frame: 12 months
Number of days' supply of selective serotonin reuptake inhibitors (SSRIs) obtained divided by 365 days.
Time frame: 12 months
Number of days' supply of Prazosin obtained divided by 365 days.
VA Palo Alto Health Care System
Fed
Acronym: HCL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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