Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00118534
First received: July 1, 2005
Last updated: January 24, 2014
Last verified: January 2014
Results First Received: August 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Mental Health
Stress Disorders, Post-Traumatic
Substance-Related Disorders
Tobacco Use Disorder
Interventions: Behavioral: Integrated Care for Smoking Cessation in PTSD patients
Behavioral: Standard of Care

  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
Recruitment occurred between November 2004 and December 2007, with follow-up continuing until July 2009.943 patients were recruited from outpatient PTSD clinics at 10 VA medical centers and followed up for a minimum of 18 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients gave written informed consent before enrollment.

Reporting Groups
  Description
Integrated Care Integration of smoking cessation therapy with PTSD therapy.
Standard of Care Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.

Participant Flow:   Overall Study
    Integrated Care     Standard of Care  
STARTED     472     471  
COMPLETED     472     471  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
Integrated Care Integration of smoking cessation therapy with PTSD therapy.
Standard of Care Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
Total Total of all reporting groups

Baseline Measures
    Integrated Care     Standard of Care     Total  
Number of Participants  
[units: participants]
  472     471     943  
Age  
[units: years]
Mean ( Full Range )
  54.4  
  ( 22 to 80 )  
  54.7  
  ( 23 to 81 )  
  54.56  
  ( 22 to 81 )  
Gender  
[units: participants]
     
Female     28     32     60  
Male     444     439     883  
Region of Enrollment  
[units: participants]
     
United States     472     471     943  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization   [ Time Frame: between 6 and 18 months ]

2.  Secondary:   Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months   [ Time Frame: between 6 and 18 months ]

3.  Secondary:   Clinician Administered PTSD Scale (CAPS)   [ Time Frame: Baseline and 18 months ]

4.  Secondary:   PTSD Checklist   [ Time Frame: Baseline and 3 months ]

5.  Secondary:   PTSD Checklist   [ Time Frame: Baseline and 6 months ]

6.  Secondary:   PTSD Checklist   [ Time Frame: Baseline and 9 months ]

7.  Secondary:   PTSD Checklist   [ Time Frame: Baseline and 12 months ]

8.  Secondary:   PTSD Checklist   [ Time Frame: Baseline and 15 months ]

9.  Secondary:   PTSD Checklist   [ Time Frame: Baseline and 18 months ]

10.  Secondary:   Patient Health Questionnaire-9 (PHQ-9)   [ Time Frame: Baseline and 3 months ]

11.  Secondary:   Patient Health Questionnaire-9 (PHQ-9)   [ Time Frame: Baseline and 6 months ]

12.  Secondary:   Patient Health Questionnaire-9 (PHQ-9)   [ Time Frame: Baseline and 9 months ]

13.  Secondary:   Patient Health Questionnaire-9 (PHQ-9)   [ Time Frame: Baseline and 12 months ]

14.  Secondary:   Patient Health Questionnaire (PHQ-9)   [ Time Frame: Baseline and 15 months ]

15.  Secondary:   Patient Health Questionnaire-9 (PHQ-9)   [ Time Frame: Baseline and 18 months ]

16.  Secondary:   7-day Point Prevalence Abstinence - Self Reported   [ Time Frame: 3 months ]

17.  Secondary:   7-day Point Prevalence Abstinence - Self Reported   [ Time Frame: 6 months ]

18.  Secondary:   7-day Point Prevalence Abstinence - Self Reported   [ Time Frame: 9 months ]

19.  Secondary:   7-day Point Prevalence Abstinence - Self Reported   [ Time Frame: 12 months ]

20.  Secondary:   7-day Point Prevalence Abstinence - Self Reported   [ Time Frame: 15 months ]

21.  Secondary:   7-day Point Prevalence Abstinence - Self Reported   [ Time Frame: 18 months ]

22.  Secondary:   7-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 3 months ]

23.  Secondary:   7-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 6 months ]

24.  Secondary:   7-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 9 months ]

25.  Secondary:   7-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 12 months ]

26.  Secondary:   7-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 15 months ]

27.  Secondary:   7-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 18 months ]

28.  Secondary:   30-day Point Prevalence Abstinence – Self Reported   [ Time Frame: 3 months ]

29.  Secondary:   30-day Point Prevalence Abstinence – Self Reported   [ Time Frame: 6 months ]

30.  Secondary:   30-day Point Prevalence Abstinence – Self Reported   [ Time Frame: 9 months ]

31.  Secondary:   30-day Point Prevalence Abstinence – Self Reported   [ Time Frame: 12 months ]

32.  Secondary:   30-day Point Prevalence Abstinence – Self Reported   [ Time Frame: 15 months ]

33.  Secondary:   30-day Point Prevalence Abstinence – Self Reported   [ Time Frame: 18 months ]

34.  Secondary:   30-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 3 months ]

35.  Secondary:   30-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 6 months ]

36.  Secondary:   30-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 9 months ]

37.  Secondary:   30-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 12 months ]

38.  Secondary:   30-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 15 months ]

39.  Secondary:   30-day Point Prevalence Abstinence – Bio-Verified   [ Time Frame: 18 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Miles McFall
Organization: VA Puget Sound (Seattle)
phone: (206) 764-2177
e-mail: Miles.McFall@va.gov


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00118534     History of Changes
Other Study ID Numbers: 519
Study First Received: July 1, 2005
Results First Received: August 22, 2013
Last Updated: January 24, 2014
Health Authority: United States: Federal Government