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

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ClinicalTrials.gov Identifier: NCT00288860
Recruitment Status : Completed
First Posted : February 8, 2006
Results First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Stress Disorders, Post-Traumatic
Interventions Behavioral: Telephone monitoring
Other: Treatment-As-Usual
Enrollment 837

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.
Arm/Group Title Telephone Monitoring Treatment-As-Usual
Hide Arm/Group Description

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 Control: Usual outpatient mental health care (psychotherapy and/or medications)

Period Title: Overall Study
Started 412 425
Completed Intake Survey 408 417
Completed 4 Month fu Survey 275 299
Completed 12 Month fu Survey 257 281
Completed 310 [1] 328 [2]
Not Completed 102 97
Reason Not Completed
Did not complete intake             4             8
Death             4             3
Withdrawal by Subject             20             15
Lost to Follow-up             74             71
[1]
310 completed either 4 or 12 month survey. Used all with intake (n = 408) in intent-to-treat.
[2]
328 completed 4 or 12 month survey. Used all with intake (n=417) in intent to treat.
Arm/Group Title Telephone Monitoring Treatment-As-Usual Total
Hide Arm/Group Description

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 Control: Usual outpatient mental health care (psychotherapy and/or medications)

Total of all reporting groups
Overall Number of Baseline Participants 412 425 837
Hide Baseline Analysis Population Description
Veterans entering residential treatment for posttraumatic stress disorder.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 412 participants 425 participants 837 participants
50.2  (0.62) 49.9  (0.86) 50.0  (0.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 412 participants 425 participants 837 participants
Female
55
  13.3%
57
  13.4%
112
  13.4%
Male
357
  86.7%
368
  86.6%
725
  86.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 412 participants 425 participants 837 participants
Caucasian 263 256 519
African American 87 93 180
Asian American 2 0 2
Native American 11 8 19
Pacific Islander 2 2 4
Latino 19 26 45
Other 22 28 50
Race/ethnicity missing 6 12 18
Iraq or Afghanistan veteran  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 412 participants 425 participants 837 participants
Iraq/Afghanistan veteran 114 114 228
Served prior to current Iraq/Afghanistan conflicts 298 311 609
1.Primary Outcome
Title Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms
Hide Description

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)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telephone Monitoring Treatment as Usual
Hide Arm/Group Description:

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 Control: Usual outpatient mental health care (psychotherapy and/or medications)

Overall Number of Participants Analyzed 412 425
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
PTSD Symptoms (PTSD Checklist) 63.9  (13.0) 63.4  (12.5)
Aggressive Behavior 3.0  (2.2) 3.1  (2.2)
Alcohol Problems (ASI) 0.15  (0.19) 0.17  (0.19)
Drug Problems (ASI) 0.05  (0.09) 0.05  (0.08)
2.Primary Outcome
Title Rehospitalization
Hide Description Number of patients with psychiatric hospitalization within 12 months of discharge from PTSD program
Time Frame 12 months post discharge
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telephone Monitoring Treatment-As-Usual
Hide Arm/Group Description:

Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.

Telephone monitoring: Three months of biweekly telephone monitoring and support

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

Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.

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

Overall Number of Participants Analyzed 412 425
Measure Type: Number
Unit of Measure: participants
45 55
3.Secondary Outcome
Title Depressive Symptoms, Subjective Quality of Life
Hide Description 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)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telephone Monitoring Treatment-As-Usual
Hide Arm/Group Description:

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 Control: Usual outpatient mental health care (psychotherapy and/or medications)

Overall Number of Participants Analyzed 408 417
Mean (Standard Deviation)
Unit of Measure: units on a scale
Depression (CES-D) 38.0  (10.1) 38.4  (10.4)
Quality of Life 3.3  (1.1) 3.3  (1.1)
Time Frame 12 months
Adverse Event Reporting Description Serious adverse events (primarily death and hospitalizations) were tracked for both arms of the study.
 
Arm/Group Title Telephone Monitoring Treatment-As-Usual
Hide Arm/Group Description

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 Control: Usual outpatient mental health care (psychotherapy and/or medications)

All-Cause Mortality
Telephone Monitoring Treatment-As-Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Telephone Monitoring Treatment-As-Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/412 (3.88%)      12/425 (2.82%)    
Cardiac disorders     
Hospitalization for cardiology or chest pain *  2/412 (0.49%)  2 1/425 (0.24%)  1
Gastrointestinal disorders     
Gastroenteritis *  0/412 (0.00%)  0 1/425 (0.24%)  1
Injury, poisoning and procedural complications     
Hospitalization for overdose *  2/412 (0.49%)  2 1/425 (0.24%)  1
Musculoskeletal and connective tissue disorders     
Scheduled laminotomy *  1/412 (0.24%)  1 0/425 (0.00%)  0
Psychiatric disorders     
Psychiatric Hospitalization *  10/412 (2.43%)  10 7/425 (1.65%)  7
Renal and urinary disorders     
kidney failure *  1/412 (0.24%)  1 0/425 (0.00%)  0
Skin and subcutaneous tissue disorders     
hospitalized for cellulitis *  0/412 (0.00%)  0 1/425 (0.24%)  1
Social circumstances     
Death doe to causes not known * [1]  4/412 (0.97%)  4 3/425 (0.71%)  3
Arrest or incarceration *  2/412 (0.49%)  2 1/425 (0.24%)  1
Admitted to nursing home - reason not known *  1/412 (0.24%)  1 0/425 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Cause of death not specified
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Telephone Monitoring Treatment-As-Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/412 (0.24%)      0/0    
Psychiatric disorders     
Phone telephone care management upsetting * [1]  1/412 (0.24%)  1 0/0  0
*
Indicates events were collected by non-systematic assessment
[1]
Telephone Monitoring arm: Participant was sufficiently upset by telephone calls to ask to discontinue intervention. Treatment as Usual arm: Not applicable (0 subjects at risk) because did not receive this intervention
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Craig S. Rosen
Organization: Nationa Center for PTSD Dissemination & Training Division
Phone: 650-493-5000 ext 22812
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00288860     History of Changes
Other Study ID Numbers: TEL 03-135
First Submitted: February 6, 2006
First Posted: February 8, 2006
Results First Submitted: October 3, 2014
Results First Posted: April 25, 2016
Last Update Posted: April 25, 2016