Stress Disorders, Post-TraumaticHCLNCT02655991
Homecoming Line: Telephone Support for Veterans
A study testing Telephone Case Monitoring and Treatment as Usual in people with Stress Disorders, Post-Traumatic, run by VA Palo Alto Health Care System at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Telephone Case Monitoring and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2008to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Active duty personnel
- Cognitive impairment which precludes giving informed consent
- Initiating residential or inpatient treatment rather than outpatient treatment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Durham VA Medical Center
Durham, North Carolina, 27705
VA Puget Sound Health Care System (American Lake)
Lakewood, Washington, 98493
VA Palo Alto Health Care System (Meno Park Division)
Menlo Park, California, 94025
About this study
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.
Read the detailed 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Telephone Case Monitoring, Treatment as Usual
- Keywords
- Stress Disorders, Post-Traumatic, Ambulatory Care, Telemedicine, Remote Consultation, Health Services Accessibility
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Case MonitoringBehavioural
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 UsualBehavioural
Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).
| Study group | Role | What they receive |
|---|---|---|
| Telephone Case Monitoring | Experimental | Telephone care management augmenting treatment as usual Receives: Behavioral: Telephone Case Monitoring; Behavioral: Treatment as Usual |
| Treatment as Usual | Active comparator | Case management, psychotherapy, and pharmacotherapy as usual Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist (PCL) Slope
Slope of improvement on the PTSD Checklist, a self-report measure of PTSD symptoms.
Measured: 12 months
Secondary outcomes (11)
PTSD psychotherapy visits - intervention period
Number of psychotherapy visits for PTSD (psychotherapy procedure code + PTSD diagnosis code) completed during the 3 month intervention period.
Measured: 3 months
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.
Measured: 3 months
Depression slope
Slope of improvement on the Center for Epidemiological Studies Scale, a self-report measure of depression symptoms.
Measured: 12 months
Alcohol problems slope
Slope of improvement on the Addiction Severity Index Alcohol Composite, a self-report measure of alcohol-related problems.
Measured: 12 months
Drug problems slope
Slope of improvement on the Addiction Severity Index Drug Composite, a self-report measure of drug-related problems.
Measured: 12 months
Aggression slope
Slope of improvement on a six-item self-report measure of aggressive behaviors, adapted from the Conflict Tactics Scale.
Measured: 12 months
Quality of Life slope
Slope of improvement on a self-report quality measure used in the Veterans Affairs Military Stress Treatment Assessment study.
Measured: 12 months
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).
Measured: months 4-12
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).
Measured: months 4-12
Selective serotonin reuptake inhibitor refills (medication possession ratio)
Number of days' supply of selective serotonin reuptake inhibitors (SSRIs) obtained divided by 365 days.
Measured: 12 months
Prazosin refills (medication possession ratio)
Number of days' supply of Prazosin obtained divided by 365 days.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startMar 2008
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Durham VA Medical Center, VA Puget Sound Health Care System
- Responsible party
- Principal investigator, Craig S. Rosen, Ph.D., VA Palo Alto Health Care System
- Investigators
- Craig S. Rosen, Ph.D., Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655991
- Sponsor's protocol ID
- W81XWH=08-2-0096
- Acronym
- HCL
- Status last verified
- Jan 2016
- First submitted
- 12 Jan 2016
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosen CS, Azevedo KJ, Tiet QQ, Greene CJ, Wood AE, Calhoun P, Bowe T, Capehart BP, Crawford EF, Greenbaum MA, Harris AH, Hertzberg M, Lindley SE, Smith BN, Schnurr PP. An RCT of Effects of Telephone Care Management on Treatment Adherence and Clinical Outcomes Among Veterans With PTSD. Psychiatr Serv. 2017 Feb 1;68(2):151-158. doi: 10.1176/appi.ps.201600069. Epub 2016 Oct 17.
PubMed 27745535
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homecoming Line: Telephone Support for Veterans
- ClinicalTrials.gov ID
- NCT02655991
- Acronym / sponsor ID
- HCL / W81XWH=08-2-0096
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Stress Disorders, Post-Traumatic, Ambulatory Care, Telemedicine, Remote Consultation, Health Services Accessibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Collaborators
- Durham VA Medical Center, VA Puget Sound Health Care System
- Study start
- Mar 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Case Monitoring | Experimental | Behavioral: Telephone Case Monitoring, Behavioral: Treatment as UsualTelephone care management augmenting treatment as usual |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualCase management, psychotherapy, and pharmacotherapy as usual |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Active duty personnel
- Cognitive impairment which precludes giving informed consent
- Initiating residential or inpatient treatment rather than outpatient treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone Case MonitoringOutpatient 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. | Behavioural | Telephone Case Monitoring |
| Treatment as UsualOutpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy). | Behavioural | Telephone Case Monitoring, Treatment as Usual |
Primary outcome
PTSD Checklist (PCL) Slope
Time frame: 12 months
Slope of improvement on the PTSD Checklist, a self-report measure of PTSD symptoms.
11 secondary outcomes
PTSD psychotherapy visits - intervention period
Time frame: 3 months
Other mental health visits - intervention period
Time frame: 3 months
Depression slope
Time frame: 12 months
Alcohol problems slope
Time frame: 12 months
Drug problems slope
Time frame: 12 months
Aggression slope
Time frame: 12 months
Quality of Life slope
Time frame: 12 months
PTSD psychotherapy visits -- follow-up period
Time frame: months 4-12
Other mental health visits -- follow-up period
Time frame: months 4-12
Selective serotonin reuptake inhibitor refills (medication possession ratio)
Time frame: 12 months
Prazosin refills (medication possession ratio)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Derived from this study: PubMed 27745535Rosen CS, Azevedo KJ, Tiet QQ, Greene CJ, Wood AE, Calhoun P, Bowe T, Capehart BP, Crawford EF, Greenbaum MA, Harris AH, Hertzberg M, Lindley SE, Smith BN, Schnurr PP. An RCT of Effects of Telephone Care Management on Treatment Adherence and Clinical Outcomes Among Veterans With PTSD. Psychiatr Serv. 2017 Feb 1;68(2):151-158. doi: 10.1176/appi.ps.201600069. Epub 2016 Oct 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig S. Rosen, Ph.D. principal investigator
VA Palo Alto Health Care System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Case Monitoring and Treatment as Usual in people with Stress Disorders, Post-Traumatic, run by VA Palo Alto Health Care System at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist (PCL) Slope (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02655991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.