Stress Disorders, Post-Traumatic Clinical Trial
— HCLOfficial title:
Homecoming Line: Telephone Support for Veterans
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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 |
Lead Sponsor | Collaborator |
---|---|
VA Palo Alto Health Care System | Durham VA Medical Center, VA Puget Sound Health Care System |
United States,
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 |
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