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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT00288860
Study groupRoleWhat they receive
Telephone MonitoringExperimentalBiweekly 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-UsualActive comparatorMental 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.

  1. 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)

  2. Rehospitalization

    Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program

    Measured: 12 months post discharge

Secondary outcomes (1)
  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.

  1. First posted8 Feb 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionApr 2011
  4. Study completionDec 2011

Resources

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)
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
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 23117443
  • Belsher 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

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.

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