Stress Disorders, Post-TraumaticTCM-PTSDNCT00288860
Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD)
A study testing Telephone monitoring and Treatment-As-Usual in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Telephone 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
- 837 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2006to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
VA Medical Center, Battle Creek
Battle Creek, Michigan, 49015
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215
VA Medical Center, Coatesville
Coatesville, Pennsylvania, 19320
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, 72114-1706
VA Puget Sound Health Care System, Tacoma
Tacoma, Washington, 98493
About this study
Official title: Telephone Case Monitoring for Veterans With PTSD
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.
Read the detailed description
Background: Poor compliance with aftercare may contribute to high rates of relapse and rehospitalization among Veterans who received residential treatment for posttraumatic stress disorder (PTSD). Telephone case monitoring has been shown to improve treatment adherence and reduced relapse among patients with chronic medical and substance use disorders, but has not been tested in PTSD patients.
Objectives: This multisite randomized controlled trial tested whether augmenting usual aftercare with telephone monitoring improved resulted in 1) improved clinical outcomes (less violence, substance use, and PTSD symptoms; 2) longer time to rehospitalization; 3) better compliance with aftercare in the year after discharge from residential treatment for PTSD.
Methods: This trial recruited 837 subjects from 6 PTSD residential treatment programs at 5 VA medical centers, 94.7% of the 884 projected. Patients who completed at least 14 days of residential PTSD treatment and discharged to VA outpatient care were eligible to participate. Subjects were randomized to usual aftercare care (n = 425) or usual aftercare plus biweekly telephone case monitoring calls during the first three months after discharge (n = 412). Telephone case monitors assessed current problems, encouraged treatment adherence, provided problem-solving support, and alerted providers to emergent care needs. Patient self-report measures of psychiatric symptoms, substance use, and violence were obtained at intake to residential treatment and 4 months (69% completion rate) and 12 months (64% completion rate) after discharge. Retention was lower than the investigators' planned 70% to 75% rate due to difficulty locating some patients who moved (even their collateral informants did not know where they were) and 45 participants asking to discontinue due to lack of time (n = 10), general dissatisfaction with VA (n = 6), distress during phone calls (n = 5), dissatisfaction with compensation (n = 1), or no specified reason (n = 24). Treatment utilization data was obtained from the VA National Patient Care Database.
Intent-to-treat analyses used mixed modeling to compare clinical outcomes in the telephone monitoring and usual care groups and 4 and 12 months after discharge. Survival analysis was used to compare conditions on time to rehospitalization. Having a slightly smaller-than-intended sample size resulted in modest reductions in statistical power, e.g., power to detect the expected d = .25 effect on PTSD outcomes was reduced from about 90% to 82%, and power to detect the anticipated W = .105 difference in rehospitalization rates was reduced from 88% to 85%. Secondary analyses assessed whether differences in outcomes between the telephone case monitoring and usual care groups were mediated by attending more outpatient visits and completing more medication refills. Exploratory analyses examined whether the effect of telephone support on the clinical outcome measures, number of treatment visits, and medication refills was moderated by number of outpatient mental health visits in the prior year, distance from clinic, treatment expectancies, therapeutic alliance, or co-occurring substance use problems.
Status: Enrollment, intervention, data collection, and primary analyses are completed. Primary results have been published in Psychiatric Services (Rosen, Tiet, Harris et al., 2013) and two secondary papers have been published in the Journal of Traumatic Stress (Belsher, Tiet, Garvert, \& Rosen, 2012; Rosen, Adler, \& Tiet, 2013).
A CDMRP-funded study extending this approach to PTSD outpatients at the Durham, Puget Sound and Palo Alto VA medical centers has recently been completed. Initial results of that second trial suggest that telephone care management improved treatment attendance but had weak effects on outcomes.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Telephone monitoring, Treatment-As-Usual
- Keywords
- telemedicine, treatment compliance, mental health
- Medical subject headings
- Stress Disorders, Post-Traumatic, Patient Compliance, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone monitoringBehavioural
Three months of biweekly telephone monitoring and support
Treatment-As-UsualOther
Outpatient mental health Treatment As Usual (psychotherapy and/or medications)
| Study group | Role | What they receive |
|---|---|---|
| Telephone Monitoring | Experimental | Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual. Receives: 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. Receives: Other: Treatment-As-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months post-discharge (8 months post intervention)
Rehospitalization
Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program
Measured: 12 months post discharge
Secondary outcomes (1)
Depressive Symptoms, Subjective Quality of Life
Depression: Center for Epidemiological Studies Scale (ranges from 0 to 60, with higher scores indicating worse depression) Quality of Life: Scale from the Veterans Affairs Military Stress Treatment Assessment (scores range from 1 to 7, with higher scores indicating better quality of life)
Measured: 12 months post-discharge (8 months post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startOct 2006
- Primary completionApr 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 837 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Craig S. Rosen, PhD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288860
- Sponsor's protocol ID
- TEL 03-135
- Acronym
- TCM-PTSD
- Status last verified
- Mar 2016
- First submitted
- 6 Feb 2006
- Last updated
- 25 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23117443Belsher 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.
PubMed 23047625
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Case Monitoring for Veterans With PTSD
- ClinicalTrials.gov ID
- NCT00288860
- Acronym / sponsor ID
- TCM-PTSD / TEL 03-135
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- telemedicine, treatment compliance, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 837 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Feb 2006 (estimated)
- Results
- Posted 25 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Poor compliance with aftercare may contribute to high rates of relapse and rehospitalization among Veterans who received residential treatment for posttraumatic stress disorder (PTSD). Telephone case monitoring has been shown to improve treatment adherence and reduced relapse among patients with chronic medical and substance use disorders, but has not been tested in PTSD patients.
Objectives: This multisite randomized controlled trial tested whether augmenting usual aftercare with telephone monitoring improved resulted in 1) improved clinical outcomes (less violence, substance use, and PTSD symptoms; 2) longer time to rehospitalization; 3) better compliance with aftercare in the year after discharge from residential treatment for PTSD.
Methods: This trial recruited 837 subjects from 6 PTSD residential treatment programs at 5 VA medical centers, 94.7% of the 884 projected. Patients who completed at least 14 days of residential PTSD treatment and discharged to VA outpatient care were eligible to participate. Subjects were randomized to usual aftercare care (n = 425) or usual aftercare plus biweekly telephone case monitoring calls during the first three months after discharge (n = 412). Telephone case monitors assessed current problems, encouraged treatment adherence, provided problem-solving support, and alerted providers to emergent care needs. Patient self-report measures of psychiatric symptoms, substance use, and violence were obtained at intake to residential treatment and 4 months (69% completion rate) and 12 months (64% completion rate) after discharge. Retention was lower than the investigators' planned 70% to 75% rate due to difficulty locating some patients who moved (even their collateral informants did not know where they were) and 45 participants asking to discontinue due to lack of time (n = 10), general dissatisfaction with VA (n = 6), distress during phone calls (n = 5), dissatisfaction with compensation (n = 1), or no specified reason (n = 24). Treatment utilization data was obtained from the VA National Patient Care Database.
Intent-to-treat analyses used mixed modeling to compare clinical outcomes in the telephone monitoring and usual care groups and 4 and 12 months after discharge. Survival analysis was used to compare conditions on time to rehospitalization. Having a slightly smaller-than-intended sample size resulted in modest reductions in statistical power, e.g., power to detect the expected d = .25 effect on PTSD outcomes was reduced from about 90% to 82%, and power to detect the anticipated W = .105 difference in rehospitalization rates was reduced from 88% to 85%. Secondary analyses assessed whether differences in outcomes between the telephone case monitoring and usual care groups were mediated by attending more outpatient visits and completing more medication refills. Exploratory analyses examined whether the effect of telephone support on the clinical outcome measures, number of treatment visits, and medication refills was moderated by number of outpatient mental health visits in the prior year, distance from clinic, treatment expectancies, therapeutic alliance, or co-occurring substance use problems.
Status: Enrollment, intervention, data collection, and primary analyses are completed. Primary results have been published in Psychiatric Services (Rosen, Tiet, Harris et al., 2013) and two secondary papers have been published in the Journal of Traumatic Stress (Belsher, Tiet, Garvert, \& Rosen, 2012; Rosen, Adler, \& Tiet, 2013).
A CDMRP-funded study extending this approach to PTSD outpatients at the Durham, Puget Sound and Palo Alto VA medical centers has recently been completed. Initial results of that second trial suggest that telephone care management improved treatment attendance but had weak effects on outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Monitoring | Experimental | Behavioral: Telephone monitoring, Other: Treatment-As-UsualBiweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual. |
| Treatment-As-Usual | Active comparator | Other: Treatment-As-UsualMental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
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 monitoringThree months of biweekly telephone monitoring and support | Behavioural | Telephone Monitoring |
| Treatment-As-UsualOutpatient mental health Treatment As Usual (psychotherapy and/or medications) | Other | Telephone Monitoring, Treatment-As-Usual |
Primary outcome
Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms
Time frame: 12 months post-discharge (8 months post intervention)
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)
Rehospitalization
Time frame: 12 months post discharge
Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program
1 secondary outcome
Depressive Symptoms, Subjective Quality of Life
Time frame: 12 months post-discharge (8 months post intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23117443Rosen 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.
- Results publication: PubMed 23047625Belsher 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.
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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, PhD principal investigator
VA Palo Alto Health Care System
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone monitoring and Treatment-As-Usual in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 5 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 4 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 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 25 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms (time frame: 12 months post-discharge (8 months post intervention)). The study lists 2 primary outcomes in all. 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 NCT00288860, which also lists 2 linked publications.
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 25 Apr 2016.