Trial Outcomes & Findings for CPT and Smoking Cessation (NCT NCT01901848)
NCT ID: NCT01901848
Last Updated: 2018-09-11
Results Overview
7-day point prevalence abstinence is defined as participant reporting no smoking occasions in the 7 days preceding the 6-month follow-up appointment. The 6-month follow-up occurs 6 months after the initial scheduled quit date.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
69 participants
Primary outcome timeframe
6-month follow-up
Results posted on
2018-09-11
Participant Flow
A total of 69 participants consented before the screening session. Nineteen were excluded, and 50 were randomized. As a result, there were 69 who consented, but only 50 are included in the flow diagram for the trial.
Participant milestones
| Measure |
CPT+ICSC
This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Cognitive Processing Therapy (CPT): CPT is based on a social cognitive theory of PTSD that includes primary emotional responses to traumatic events such as fear, anger, and sadness, as well as secondary emotions resulting from a patient's faulty interpretations of the traumatic event. CPT addresses PTSD by facilitating affective expression so that affective components of the trauma memory can be altered. In addition, faulty beliefs about the trauma are challenged and modified using Socratic questioning.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum,
|
Present-focused ICSC
This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.
Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
smokefreeVET: SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking.
|
|---|---|---|
|
Randomized and Treated
STARTED
|
25
|
25
|
|
Randomized and Treated
COMPLETED
|
22
|
19
|
|
Randomized and Treated
NOT COMPLETED
|
3
|
6
|
|
Removed From Analyses
STARTED
|
22
|
19
|
|
Removed From Analyses
COMPLETED
|
12
|
19
|
|
Removed From Analyses
NOT COMPLETED
|
10
|
0
|
Reasons for withdrawal
| Measure |
CPT+ICSC
This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Cognitive Processing Therapy (CPT): CPT is based on a social cognitive theory of PTSD that includes primary emotional responses to traumatic events such as fear, anger, and sadness, as well as secondary emotions resulting from a patient's faulty interpretations of the traumatic event. CPT addresses PTSD by facilitating affective expression so that affective components of the trauma memory can be altered. In addition, faulty beliefs about the trauma are challenged and modified using Socratic questioning.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum,
|
Present-focused ICSC
This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.
Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
smokefreeVET: SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking.
|
|---|---|---|
|
Randomized and Treated
Lost to Follow-up
|
3
|
6
|
|
Removed From Analyses
CPT practice cases to establish fidelity
|
10
|
0
|
Baseline Characteristics
CPT and Smoking Cessation
Baseline characteristics by cohort
| Measure |
CPT+ICSC
n=15 Participants
This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Cognitive Processing Therapy (CPT): In CPT, faulty beliefs about the trauma are challenged and modified using Socratic questioning.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum,
|
Present-focused ICSC
n=25 Participants
This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.
Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
smokefreeVET: SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
53.3 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
49.5 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian, not Hispanic
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6-month follow-up7-day point prevalence abstinence is defined as participant reporting no smoking occasions in the 7 days preceding the 6-month follow-up appointment. The 6-month follow-up occurs 6 months after the initial scheduled quit date.
Outcome measures
| Measure |
CPT+ICSC
n=15 Participants
This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Cognitive Processing Therapy (CPT): In CPT, faulty beliefs about the trauma are challenged and modified using Socratic questioning.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum,
|
Present-focused ICSC
n=25 Participants
This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.
Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
smokefreeVET: SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking.
|
|---|---|---|
|
Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up.
|
2 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 6-month follow-upSelf-reported 7-day point prevalence smoking abstinence was bioverified by breath carbon monoxide level of \< 4 parts per million at the 6-month follow-up.
Outcome measures
| Measure |
CPT+ICSC
n=15 Participants
This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Cognitive Processing Therapy (CPT): In CPT, faulty beliefs about the trauma are challenged and modified using Socratic questioning.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum,
|
Present-focused ICSC
n=25 Participants
This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.
Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
smokefreeVET: SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking.
|
|---|---|---|
|
Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million.
|
2 Participants
|
4 Participants
|
Adverse Events
CPT+ICSC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Present-focused ICSC
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CPT+ICSC
n=15 participants at risk
This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Cognitive Processing Therapy (CPT): In CPT, faulty beliefs about the trauma are challenged and modified using Socratic questioning.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum,
|
Present-focused ICSC
n=25 participants at risk
This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.
Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
smokefreeVET: SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization due to alcohol intoxication/withdrawal
|
0.00%
0/15 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
4.0%
1/25 • Number of events 1 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
|
General disorders
Hospitalization due to antibiotic reaction
|
0.00%
0/15 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
4.0%
1/25 • Number of events 1 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
Other adverse events
| Measure |
CPT+ICSC
n=15 participants at risk
This arm includes 12 sessions of combined Cognitive Processing Therapy (CPT) and Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Cognitive Processing Therapy (CPT): In CPT, faulty beliefs about the trauma are challenged and modified using Socratic questioning.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum,
|
Present-focused ICSC
n=25 participants at risk
This arm includes 12 sessions of Integrated Care for Smoking Cessation (ICSC), involvement in smokefreeVET.gov's text messaging program for smoking cessation, Bupropion use, and nicotine replacement therapy.
Bupropion: Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
nicotine replacement therapy (NRT): NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.
Integrated Care for Smoking Cessation (ICSC): ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
smokefreeVET: SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking.
|
|---|---|---|
|
Psychiatric disorders
Increased anxiety
|
0.00%
0/15 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
8.0%
2/25 • Number of events 2 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
0.00%
0/15 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
8.0%
2/25 • Number of events 2 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
|
Reproductive system and breast disorders
Cervicalgia
|
6.7%
1/15 • Number of events 1 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
0.00%
0/25 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
|
Gastrointestinal disorders
Stomach pain/flank pain
|
0.00%
0/15 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
8.0%
2/25 • Number of events 2 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
|
General disorders
Flu-like symptoms
|
6.7%
1/15 • Number of events 1 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
0.00%
0/25 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
|
Musculoskeletal and connective tissue disorders
Increased arthritis symptoms
|
6.7%
1/15 • Number of events 1 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
0.00%
0/25 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
|
Skin and subcutaneous tissue disorders
Itchiness/skin irritation at site of nicotine patch
|
6.7%
1/15 • Number of events 1 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
0.00%
0/25 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
8.0%
2/25 • Number of events 2 • For participants in the CPT+ICSC condition, adverse event data were collected for approximately 8 months. For participants in the ICSC condition, adverse event data were collected for up to 12 months.
n/a; clinicaltrials.gov definition used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place