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Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD)

Telephone Case Monitoring for Veterans With PTSD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00288860
Acronym
TCM-PTSD
Enrollment
837
Registered
2006-02-08
Start date
2006-10-31
Completion date
2011-12-31
Last updated
2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post-Traumatic

Keywords

telemedicine, treatment compliance, mental health

Brief 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.

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.

Interventions

Three months of biweekly telephone monitoring and support

OTHERTreatment-As-Usual

Outpatient mental health Treatment As Usual (psychotherapy and/or medications)

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

1. Patients discharging from residential treatment within four days of admission(insufficient time to consent and assess them); 2. Active Duty military personnel; 3. Patients transferred from residential care to an inpatient medical unit due to emergent medical problems; 4. Patients with traumatic brain injury or other organic impairment that compromises capacity to consent.

Design outcomes

Primary

MeasureTime frameDescription
Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms12 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)
Rehospitalization12 months post dischargeNumber of patients with psychiatric hospitalization within 12 months of discharge from PTSD program

Secondary

MeasureTime frameDescription
Depressive Symptoms, Subjective Quality of Life12 months post-discharge (8 months post intervention)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)

Countries

United States

Participant flow

Recruitment details

Veterans entering treatment in five 30-to-90 day residential treatment programs for posttraumatic stress disorder

Pre-assignment details

926 patients were initially consented into the study. 6 withdrew prior to randomization, and 83 met exclusion criteria after being consent (usually because they were discharged to another inpatient program, not to outpatient care). This left 837 subjects to be randomized.

Participants by arm

ArmCount
Telephone Monitoring
Telephone monitoring as augmentation to treatment as usual Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)
412
Treatment-As-Usual
Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)
425
Total837

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath43
Overall StudyDid not complete intake48
Overall StudyLost to Follow-up7471
Overall StudyWithdrawal by Subject2015

Baseline characteristics

CharacteristicTotalTelephone MonitoringTreatment-As-Usual
Age, Continuous50.0 Years
STANDARD_DEVIATION 0.74
50.2 Years
STANDARD_DEVIATION 0.62
49.9 Years
STANDARD_DEVIATION 0.86
Iraq or Afghanistan veteran
Iraq/Afghanistan veteran
228 participants114 participants114 participants
Iraq or Afghanistan veteran
Served prior to current Iraq/Afghanistan conflicts
609 participants298 participants311 participants
Race/Ethnicity, Customized
African American
180 participants87 participants93 participants
Race/Ethnicity, Customized
Asian American
2 participants2 participants0 participants
Race/Ethnicity, Customized
Caucasian
519 participants263 participants256 participants
Race/Ethnicity, Customized
Latino
45 participants19 participants26 participants
Race/Ethnicity, Customized
Native American
19 participants11 participants8 participants
Race/Ethnicity, Customized
Other
50 participants22 participants28 participants
Race/Ethnicity, Customized
Pacific Islander
4 participants2 participants2 participants
Race/Ethnicity, Customized
Race/ethnicity missing
18 participants6 participants12 participants
Sex: Female, Male
Female
112 Participants55 Participants57 Participants
Sex: Female, Male
Male
725 Participants357 Participants368 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
1 / 4120 / 0
serious
Total, serious adverse events
16 / 41212 / 425

Outcome results

Primary

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)

Time frame: 12 months post-discharge (8 months post intervention)

ArmMeasureGroupValue (MEAN)Dispersion
Telephone MonitoringAggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD SymptomsPTSD Symptoms (PTSD Checklist)63.9 Scores on a scaleStandard Deviation 13
Telephone MonitoringAggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD SymptomsAggressive Behavior3.0 Scores on a scaleStandard Deviation 2.2
Telephone MonitoringAggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD SymptomsAlcohol Problems (ASI)0.15 Scores on a scaleStandard Deviation 0.19
Telephone MonitoringAggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD SymptomsDrug Problems (ASI)0.05 Scores on a scaleStandard Deviation 0.09
Treatment as UsualAggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD SymptomsDrug Problems (ASI)0.05 Scores on a scaleStandard Deviation 0.08
Treatment as UsualAggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD SymptomsPTSD Symptoms (PTSD Checklist)63.4 Scores on a scaleStandard Deviation 12.5
Treatment as UsualAggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD SymptomsAlcohol Problems (ASI)0.17 Scores on a scaleStandard Deviation 0.19
Treatment as UsualAggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD SymptomsAggressive Behavior3.1 Scores on a scaleStandard Deviation 2.2
Primary

Rehospitalization

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

Time frame: 12 months post discharge

ArmMeasureValue (NUMBER)
Telephone MonitoringRehospitalization45 participants
Treatment as UsualRehospitalization55 participants
Secondary

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)

Time frame: 12 months post-discharge (8 months post intervention)

ArmMeasureGroupValue (MEAN)Dispersion
Telephone MonitoringDepressive Symptoms, Subjective Quality of LifeQuality of Life3.3 units on a scaleStandard Deviation 1.1
Telephone MonitoringDepressive Symptoms, Subjective Quality of LifeDepression (CES-D)38.0 units on a scaleStandard Deviation 10.1
Treatment as UsualDepressive Symptoms, Subjective Quality of LifeDepression (CES-D)38.4 units on a scaleStandard Deviation 10.4
Treatment as UsualDepressive Symptoms, Subjective Quality of LifeQuality of Life3.3 units on a scaleStandard Deviation 1.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026