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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00288860
First received: February 6, 2006
Last updated: March 22, 2016
Last verified: March 2016
Results First Received: October 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Stress Disorders, Post-Traumatic
Interventions: Behavioral: Telephone monitoring
Other: Treatment-As-Usual

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Veterans entering treatment in five 30-to-90 day residential treatment programs for posttraumatic stress disorder

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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)


Participant Flow:   Overall Study
    Telephone Monitoring     Treatment-As-Usual  
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  
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Veterans entering residential treatment for posttraumatic stress disorder.

Reporting Groups
  Description
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)

Total Total of all reporting groups

Baseline Measures
    Telephone Monitoring     Treatment-As-Usual     Total  
Number of Participants  
[units: participants]
  412     425     837  
Age  
[units: Years]
Mean (Standard Deviation)
  50.2  (0.62)     49.9  (0.86)     50.0  (0.74)  
Gender  
[units: participants]
     
Female     55     57     112  
Male     357     368     725  
Race/Ethnicity, Customized  
[units: 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  
[units: participants]
     
Iraq/Afghanistan veteran     114     114     228  
Served prior to current Iraq/Afghanistan conflicts     298     311     609  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Aggressive Behavior; Alcohol Misuse; Drug Misuse; PTSD Symptoms   [ Time Frame: 12 months post-discharge (8 months post intervention) ]

2.  Primary:   Rehospitalization   [ Time Frame: 12 months post discharge ]

3.  Secondary:   Depressive Symptoms, Subjective Quality of Life   [ Time Frame: 12 months post-discharge (8 months post intervention) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: craig.rosen@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00288860     History of Changes
Other Study ID Numbers: TEL 03-135
Study First Received: February 6, 2006
Results First Received: October 3, 2014
Last Updated: March 22, 2016
Health Authority: United States: Federal Government