Trial Outcomes & Findings for Telephone Case Monitoring (TCM) for Veterans With Post-Traumatic Stress Disorder (PTSD) (NCT NCT00288860)

Last Updated: 2016-04-25

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

837 participants

Primary outcome timeframe

12 months post-discharge (8 months post intervention)

Results posted on

2016-04-25

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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)	Treatment-As-Usual Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)
Overall Study STARTED	412	425
Overall Study Completed Intake Survey	408	417
Overall Study Completed 4 Month fu Survey	275	299
Overall Study Completed 12 Month fu Survey	257	281
Overall Study COMPLETED	310	328
Overall Study NOT COMPLETED	102	97

Reasons for withdrawal

Reasons for withdrawal
Measure	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)	Treatment-As-Usual Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)
Overall Study Did not complete intake	4	8
Overall Study Death	4	3
Overall Study Withdrawal by Subject	20	15
Overall Study Lost to Follow-up	74	71

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telephone Monitoring n=412 Participants 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)	Treatment-As-Usual n=425 Participants Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)	Total n=837 Participants Total of all reporting groups
Age, Continuous	50.2 Years STANDARD_DEVIATION 0.62 • n=5 Participants	49.9 Years STANDARD_DEVIATION 0.86 • n=7 Participants	50.0 Years STANDARD_DEVIATION 0.74 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	57 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	357 Participants n=5 Participants	368 Participants n=7 Participants	725 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	263 participants n=5 Participants	256 participants n=7 Participants	519 participants n=5 Participants
Race/Ethnicity, Customized African American	87 participants n=5 Participants	93 participants n=7 Participants	180 participants n=5 Participants
Race/Ethnicity, Customized Asian American	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Native American	11 participants n=5 Participants	8 participants n=7 Participants	19 participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Latino	19 participants n=5 Participants	26 participants n=7 Participants	45 participants n=5 Participants
Race/Ethnicity, Customized Other	22 participants n=5 Participants	28 participants n=7 Participants	50 participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity missing	6 participants n=5 Participants	12 participants n=7 Participants	18 participants n=5 Participants
Iraq or Afghanistan veteran Iraq/Afghanistan veteran	114 participants n=5 Participants	114 participants n=7 Participants	228 participants n=5 Participants
Iraq or Afghanistan veteran Served prior to current Iraq/Afghanistan conflicts	298 participants n=5 Participants	311 participants n=7 Participants	609 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post-discharge (8 months post intervention)

Outcome measures

Outcome measures
Measure	Telephone Monitoring n=412 Participants 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)	Treatment as Usual n=425 Participants Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)
Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms PTSD Symptoms (PTSD Checklist)	63.9 Scores on a scale Standard Deviation 13.0	63.4 Scores on a scale Standard Deviation 12.5
Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms Aggressive Behavior	3.0 Scores on a scale Standard Deviation 2.2	3.1 Scores on a scale Standard Deviation 2.2
Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms Alcohol Problems (ASI)	0.15 Scores on a scale Standard Deviation 0.19	0.17 Scores on a scale Standard Deviation 0.19
Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms Drug Problems (ASI)	0.05 Scores on a scale Standard Deviation 0.09	0.05 Scores on a scale Standard Deviation 0.08

PRIMARY outcome

Timeframe: 12 months post discharge

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

Outcome measures

Outcome measures
Measure	Telephone Monitoring n=412 Participants 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)	Treatment as Usual n=425 Participants Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)
Rehospitalization	45 participants	55 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Telephone Monitoring n=408 Participants 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)	Treatment as Usual n=417 Participants Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)
Depressive Symptoms, Subjective Quality of Life Depression (CES-D)	38.0 units on a scale Standard Deviation 10.1	38.4 units on a scale Standard Deviation 10.4
Depressive Symptoms, Subjective Quality of Life Quality of Life	3.3 units on a scale Standard Deviation 1.1	3.3 units on a scale Standard Deviation 1.1

Adverse Events

Telephone Monitoring

Serious events: 16 serious events

Other events: 1 other events

Deaths: 0 deaths

Treatment-As-Usual

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Telephone Monitoring n=412 participants at risk 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)	Treatment-As-Usual n=425 participants at risk Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)
Social circumstances Death doe to causes not known	0.97% 4/412 • Number of events 4 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.	0.71% 3/425 • Number of events 3 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.
Injury, poisoning and procedural complications Hospitalization for overdose	0.49% 2/412 • Number of events 2 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.	0.24% 1/425 • Number of events 1 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.
Cardiac disorders Hospitalization for cardiology or chest pain	0.49% 2/412 • Number of events 2 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.	0.24% 1/425 • Number of events 1 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.
Musculoskeletal and connective tissue disorders Scheduled laminotomy	0.24% 1/412 • Number of events 1 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.	0.00% 0/425 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.
Gastrointestinal disorders Gastroenteritis	0.00% 0/412 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.	0.24% 1/425 • Number of events 1 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.
Psychiatric disorders Psychiatric Hospitalization	2.4% 10/412 • Number of events 10 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.	1.6% 7/425 • Number of events 7 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.
Skin and subcutaneous tissue disorders hospitalized for cellulitis	0.00% 0/412 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.	0.24% 1/425 • Number of events 1 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.
Renal and urinary disorders kidney failure	0.24% 1/412 • Number of events 1 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.	0.00% 0/425 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.
Social circumstances Arrest or incarceration	0.49% 2/412 • Number of events 2 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.	0.24% 1/425 • Number of events 1 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.
Social circumstances Admitted to nursing home - reason not known	0.24% 1/412 • Number of events 1 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.	0.00% 0/425 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.

Other adverse events

Other adverse events
Measure	Telephone Monitoring n=412 participants at risk 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)	Treatment-As-Usual n=425 participants at risk Treatment as usual Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)
Psychiatric disorders Phone telephone care management upsetting	0.24% 1/412 • Number of events 1 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.	— 0/0 • 12 months Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.

Additional Information

Craig S. Rosen

Nationa Center for PTSD Dissemination & Training Division

Phone: 650-493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place