Stress Disorders, Post-Traumatic
Conditions
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
Outpatient mental health Treatment As Usual (psychotherapy and/or medications)
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms | 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 | 12 months post discharge | Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms, Subjective Quality of Life | 12 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
| Arm | Count |
|---|---|
| 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 |
| Total | 837 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 3 |
| Overall Study | Did not complete intake | 4 | 8 |
| Overall Study | Lost to Follow-up | 74 | 71 |
| Overall Study | Withdrawal by Subject | 20 | 15 |
Baseline characteristics
| Characteristic | Total | Telephone Monitoring | Treatment-As-Usual |
|---|---|---|---|
| Age, Continuous | 50.0 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 participants | 114 participants | 114 participants |
| Iraq or Afghanistan veteran Served prior to current Iraq/Afghanistan conflicts | 609 participants | 298 participants | 311 participants |
| Race/Ethnicity, Customized African American | 180 participants | 87 participants | 93 participants |
| Race/Ethnicity, Customized Asian American | 2 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Caucasian | 519 participants | 263 participants | 256 participants |
| Race/Ethnicity, Customized Latino | 45 participants | 19 participants | 26 participants |
| Race/Ethnicity, Customized Native American | 19 participants | 11 participants | 8 participants |
| Race/Ethnicity, Customized Other | 50 participants | 22 participants | 28 participants |
| Race/Ethnicity, Customized Pacific Islander | 4 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Race/ethnicity missing | 18 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 112 Participants | 55 Participants | 57 Participants |
| Sex: Female, Male Male | 725 Participants | 357 Participants | 368 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 412 | 0 / 0 |
| serious Total, serious adverse events | 16 / 412 | 12 / 425 |
Outcome results
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Monitoring | Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms | PTSD Symptoms (PTSD Checklist) | 63.9 Scores on a scale | Standard Deviation 13 |
| Telephone Monitoring | Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms | Aggressive Behavior | 3.0 Scores on a scale | Standard Deviation 2.2 |
| Telephone Monitoring | Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms | Alcohol Problems (ASI) | 0.15 Scores on a scale | Standard Deviation 0.19 |
| Telephone Monitoring | Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms | Drug Problems (ASI) | 0.05 Scores on a scale | Standard Deviation 0.09 |
| Treatment as Usual | Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms | Drug Problems (ASI) | 0.05 Scores on a scale | Standard Deviation 0.08 |
| Treatment as Usual | Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms | PTSD Symptoms (PTSD Checklist) | 63.4 Scores on a scale | Standard Deviation 12.5 |
| Treatment as Usual | Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms | Alcohol Problems (ASI) | 0.17 Scores on a scale | Standard Deviation 0.19 |
| Treatment as Usual | Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms | Aggressive Behavior | 3.1 Scores on a scale | Standard Deviation 2.2 |
Rehospitalization
Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program
Time frame: 12 months post discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telephone Monitoring | Rehospitalization | 45 participants |
| Treatment as Usual | Rehospitalization | 55 participants |
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone Monitoring | Depressive Symptoms, Subjective Quality of Life | Quality of Life | 3.3 units on a scale | Standard Deviation 1.1 |
| Telephone Monitoring | Depressive Symptoms, Subjective Quality of Life | Depression (CES-D) | 38.0 units on a scale | Standard Deviation 10.1 |
| Treatment as Usual | Depressive Symptoms, Subjective Quality of Life | Depression (CES-D) | 38.4 units on a scale | Standard Deviation 10.4 |
| Treatment as Usual | Depressive Symptoms, Subjective Quality of Life | Quality of Life | 3.3 units on a scale | Standard Deviation 1.1 |