SmokingPhase 1TXTNCT01454999
Cell Phone-Based Expert Systems for Smoking Cessation
A Phase 1 study testing CTI in people with Smoking, run by VA Pacific Islands Health Care System at 1 site in United States.
Trial summary
This project aims to enhance the emotional and physical well-being of veterans through the reduction of smoking by utilizing a web-based, computerized tailored intervention (CTI) with feedback messages delivered via cell phone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- CTI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female veterans, OIF/OEF service preferred 18 years or older Current cigarette smoker Own cell phone with text messaging capabilities Ability to read and comprehend English Beginner level computer literacy Access to a computer with Internet connectivity
Who cannot join
- Lack of basic computer literacy Non-smoker (includes smokeless tobacco use) Unable to read and comprehend English No access to computer with Internet connectivity (applicable if no project computer with Internet access can be arranged) Non-owner of cell phone with text messaging capabilities
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pacific Islands Health Care System
Honolulu, Hawaii, 96819
About this study
This project aims to enhance the emotional and physical well-being of veterans through the reduction of smoking by utilizing a web-based, computerized tailored intervention (CTI) with feedback messages delivered via cell phone. CTIs have shown increasing promise as useful behavior change programs for improved health behaviors. A variety of modalities are to deliver personalized CTI information and feedback; however, the ubiquity and sophistication of today's wireless mobile technologies represent new modes of delivery for empirically based smoking cessation and other behavioral health interventions. The CTI is based on the empirically-supported Transtheoretical Model of Behavior Change (TTM). A web-based CTI modified for a veteran population will be used to pilot test the effectiveness of the CTI alone and CTI plus individualized text messaging enhancements. The pilot study is a randomized controlled trial to assess the cell phone's feasibility as an intervention modality for changing smoking behaviors. This will be the first study to adapt a smoking cessation Internet-based CTI to provide personalized feedback on a cell phone to reduce smoking behaviors in military veterans.
Read the detailed description
Objective: This project examined the effectiveness of tailored text messages as an enhancement to a computerized tailored intervention (CTI) for smoking cessation with Veterans. It was theorized that the ubiquity and sophistication of today's wireless mobile technologies would represent new modes of delivery for empirically based smoking cessation and other behavioral health interventions. CTIs have shown increasing promise as useful behavior change programs for improved health behaviors; however, the ubiquity and sophistication of today's wireless mobile technologies represent new modes of delivery for evidence-based smoking cessation and other behavioral health interventions. The CTI was based on the Transtheoretical Model of Behavior Change (TTM) and developed by Pro-Change Behavior Systems, Inc.
Research Design: This randomized, prospective pilot employed a 2 (group) x 3 (timepoint) research design. Veteran smokers were recruited nationally from direct mailings, Facebook ads, community newsletters, posters, and flyers. In addition to the randomized control trial (RCT), a focus group (n=9) and individual usability tests (n=5) were conducted in order to assess the acceptability of the graphic user interface, questions, tailoring and program content to Veteran smokers. The pilot study tested the effectiveness of the CTI alone and CTI plus individualized text messaging enhancements in reducing smoking behavior in Veterans. In addition to smoking cessation, readiness to change other negative health behaviors � such as alcohol use, healthy eating, and exercise � was also assessed.
Summary of Research Methodology and Procedures: Usability Testing: Five separate usability tests were conducted for the CTI smoking cessation program using a combination of the Think Aloud protocol and Wizard of Oz approach. Usability testing software was used to take notes and record participant interactions with the program. Participants provided qualitative and quantitative feedback on overall presentation and usability of the program. All interview data were coded, categorized, and summarized in a feedback report so that revisions to the system could be adapted. Pilot Study: At all three timepoints, participants completed a brief Health Risk Intervention (HRI), two additional smoking assessments, and the smoking cessation (SC) intervention. The HRI assessment determined baseline readiness to change for smoking and several other related health behaviors, and the smoking cessation intervention provided assessment and feedback about participants' confidence to quit smoking, decisional balance, and use of various change strategies. Following the baseline HRI and SC intervention, the CTI system randomized participants into either the treatment group (Tx), who also received the CTI only, or the treatment-plus group (Tx-plus), who received the CTI and tailored text messages. The study was conducted as entirely anonymous. All participants were given three months' access to the web-based CTI system. The Tx participants received only the online feedback narratives/report that all participants received upon completion of the online Smoking Cessation intervention. Tx-plus participants also received individualized text messages on their cell phones 2-5 times per week (the number of messages correlated with the participant's stage of change) that provide expert guidance, encouragement, and reminders that support their smoking cessation efforts.
Findings: Four-hundred and forty-six Veterans were recruited at baseline. All participants were active smokers, distributed across the stages of change as 11.9% in Precontemplation (n=53; not intending to change in the next 6 months); 63% in Contemplation (n=281; intending to change in the next 6 months), and 25.1% in Preparation (n=112; intending to change in the next 30 days). Two-hundred and thirty-five individuals (52.7%) completed the one-month and three-month follow-ups: n=116 in the treatment group (CTI only; Tx) and n=119 in the treatment-plus group (CTI plus text messages; Tx-plus). Results indicated that the CTI-plus-text-messaging intervention outperformed the CTI-only intervention at an unprecedented quit rate. For those participants in the Tx group 32.8% had quit smoking at three-month follow-up; however, those in the Tx-plus group had quit rates of 43.2%. These findings are highly encouraging, and exceed those quit rates found for other CTI interventions for both groups by almost 15% (Krebs, Prochaska \& Rossi, 2010).
Summary of Participant Experiences: While data are available only for those participants who completed the study, indications from the User Satisfaction Scale, as well as the open-ended questions, were that Veterans found the CTI and tailored text messages to be both appropriate and relevant. In addition, participants in the Tx-plus group also indicated that the text messages were helpful, timely and useful. There were no adverse events to report.
Summary of Current Risk - Potential Benefit Assessment based on Study Results: This study was able to demonstrate that the TTM is an appropriate model to promote multiple behavior change in Veterans. Furthermore, the addition of tailored text messages increased the effect of the smoking cessation intervention (CTI) and improved quit rates in the Tx-plus group to levels that are unprecedented in the literature. Additionally, individuals who were at risk for other health behaviors progressed to A or M without intervention. For Veterans who are not ready for in-person psychotherapy, have practical issues attending therapy sessions, or fear stigma associated with seeking mental health care, this Veteran-tailored, motivational enhancement CTI may provide unique benefits. In addition, Veterans who smoke and have comorbid behavioral risk factors may find this CTI sufficient to resolve their problems. In this sense, the adapted CTI will make evidence-based mental health care more accessible to Veterans in need without adding concerns about stigma and costs.
Impact/Significance: This is the Final Abstract for this research project. This study was the first to adapt a smoking cessation Internet-based CTI to provide personalized feedback on a cell phone to reduce smoking behaviors in military Veterans. The findings suggest that behavior change interventions can be successfully delivered to Veterans via the Internet, and that tailored text messaging can significantly enhance the intervention effects.
- Conditions
- Smoking
- Being tested
- CTI
- Keywords
- veteran, smoking, stage of change, cell phone, computerized tailored intervention
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTIBehavioural
Web-based computerized, tailored intervention (CTI) for smoking cessation, based on the transtheoretical model of change.
| Study group | Role | What they receive |
|---|---|---|
| CTI | Experimental | Web-based computerized, tailored intervention (CTI) for smoking cessation, based on the transtheoretical model of change. Receives: Behavioral: CTI |
| CTI + text | Experimental | Web-based computerized, tailored intervention (CTI) for smoking cessation, based on the transtheoretical model of change. Tailored feedback messages based on stage of change will also be sent by cell phone. Receives: Behavioral: CTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking prevalence
7-day point prevalence (self-report)
Measured: 3-months
Secondary outcomes (1)
Stage of Change
Progress through states of change for smoking cessation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startSep 2009
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Pacific Islands Health Care System
- Sponsor type
- US federal agency
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Patricia J Jordan, PhD, Principal investigator, Pacific Health Research & Education Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454999
- Sponsor's protocol ID
- 2009-05/PJJ 0001
- Acronym
- TXT
- Status last verified
- Mar 2016
- First submitted
- 14 Oct 2011
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Phone-Based Expert Systems for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01454999
- Acronym / sponsor ID
- TXT / 2009-05/PJJ 0001
- Conditions
- Smoking
- Keywords
- veteran, smoking, stage of change, cell phone, computerized tailored intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- VA Pacific Islands Health Care SystemUS federal agency
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Sep 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to enhance the emotional and physical well-being of veterans through the reduction of smoking by utilizing a web-based, computerized tailored intervention (CTI) with feedback messages delivered via cell phone. CTIs have shown increasing promise as useful behavior change programs for improved health behaviors. A variety of modalities are to deliver personalized CTI information and feedback; however, the ubiquity and sophistication of today's wireless mobile technologies represent new modes of delivery for empirically based smoking cessation and other behavioral health interventions. The CTI is based on the empirically-supported Transtheoretical Model of Behavior Change (TTM). A web-based CTI modified for a veteran population will be used to pilot test the effectiveness of the CTI alone and CTI plus individualized text messaging enhancements. The pilot study is a randomized controlled trial to assess the cell phone's feasibility as an intervention modality for changing smoking behaviors. This will be the first study to adapt a smoking cessation Internet-based CTI to provide personalized feedback on a cell phone to reduce smoking behaviors in military veterans.
Detailed description
Objective: This project examined the effectiveness of tailored text messages as an enhancement to a computerized tailored intervention (CTI) for smoking cessation with Veterans. It was theorized that the ubiquity and sophistication of today's wireless mobile technologies would represent new modes of delivery for empirically based smoking cessation and other behavioral health interventions. CTIs have shown increasing promise as useful behavior change programs for improved health behaviors; however, the ubiquity and sophistication of today's wireless mobile technologies represent new modes of delivery for evidence-based smoking cessation and other behavioral health interventions. The CTI was based on the Transtheoretical Model of Behavior Change (TTM) and developed by Pro-Change Behavior Systems, Inc.
Research Design: This randomized, prospective pilot employed a 2 (group) x 3 (timepoint) research design. Veteran smokers were recruited nationally from direct mailings, Facebook ads, community newsletters, posters, and flyers. In addition to the randomized control trial (RCT), a focus group (n=9) and individual usability tests (n=5) were conducted in order to assess the acceptability of the graphic user interface, questions, tailoring and program content to Veteran smokers. The pilot study tested the effectiveness of the CTI alone and CTI plus individualized text messaging enhancements in reducing smoking behavior in Veterans. In addition to smoking cessation, readiness to change other negative health behaviors � such as alcohol use, healthy eating, and exercise � was also assessed.
Summary of Research Methodology and Procedures: Usability Testing: Five separate usability tests were conducted for the CTI smoking cessation program using a combination of the Think Aloud protocol and Wizard of Oz approach. Usability testing software was used to take notes and record participant interactions with the program. Participants provided qualitative and quantitative feedback on overall presentation and usability of the program. All interview data were coded, categorized, and summarized in a feedback report so that revisions to the system could be adapted. Pilot Study: At all three timepoints, participants completed a brief Health Risk Intervention (HRI), two additional smoking assessments, and the smoking cessation (SC) intervention. The HRI assessment determined baseline readiness to change for smoking and several other related health behaviors, and the smoking cessation intervention provided assessment and feedback about participants' confidence to quit smoking, decisional balance, and use of various change strategies. Following the baseline HRI and SC intervention, the CTI system randomized participants into either the treatment group (Tx), who also received the CTI only, or the treatment-plus group (Tx-plus), who received the CTI and tailored text messages. The study was conducted as entirely anonymous. All participants were given three months' access to the web-based CTI system. The Tx participants received only the online feedback narratives/report that all participants received upon completion of the online Smoking Cessation intervention. Tx-plus participants also received individualized text messages on their cell phones 2-5 times per week (the number of messages correlated with the participant's stage of change) that provide expert guidance, encouragement, and reminders that support their smoking cessation efforts.
Findings: Four-hundred and forty-six Veterans were recruited at baseline. All participants were active smokers, distributed across the stages of change as 11.9% in Precontemplation (n=53; not intending to change in the next 6 months); 63% in Contemplation (n=281; intending to change in the next 6 months), and 25.1% in Preparation (n=112; intending to change in the next 30 days). Two-hundred and thirty-five individuals (52.7%) completed the one-month and three-month follow-ups: n=116 in the treatment group (CTI only; Tx) and n=119 in the treatment-plus group (CTI plus text messages; Tx-plus). Results indicated that the CTI-plus-text-messaging intervention outperformed the CTI-only intervention at an unprecedented quit rate. For those participants in the Tx group 32.8% had quit smoking at three-month follow-up; however, those in the Tx-plus group had quit rates of 43.2%. These findings are highly encouraging, and exceed those quit rates found for other CTI interventions for both groups by almost 15% (Krebs, Prochaska \& Rossi, 2010).
Summary of Participant Experiences: While data are available only for those participants who completed the study, indications from the User Satisfaction Scale, as well as the open-ended questions, were that Veterans found the CTI and tailored text messages to be both appropriate and relevant. In addition, participants in the Tx-plus group also indicated that the text messages were helpful, timely and useful. There were no adverse events to report.
Summary of Current Risk - Potential Benefit Assessment based on Study Results: This study was able to demonstrate that the TTM is an appropriate model to promote multiple behavior change in Veterans. Furthermore, the addition of tailored text messages increased the effect of the smoking cessation intervention (CTI) and improved quit rates in the Tx-plus group to levels that are unprecedented in the literature. Additionally, individuals who were at risk for other health behaviors progressed to A or M without intervention. For Veterans who are not ready for in-person psychotherapy, have practical issues attending therapy sessions, or fear stigma associated with seeking mental health care, this Veteran-tailored, motivational enhancement CTI may provide unique benefits. In addition, Veterans who smoke and have comorbid behavioral risk factors may find this CTI sufficient to resolve their problems. In this sense, the adapted CTI will make evidence-based mental health care more accessible to Veterans in need without adding concerns about stigma and costs.
Impact/Significance: This is the Final Abstract for this research project. This study was the first to adapt a smoking cessation Internet-based CTI to provide personalized feedback on a cell phone to reduce smoking behaviors in military Veterans. The findings suggest that behavior change interventions can be successfully delivered to Veterans via the Internet, and that tailored text messaging can significantly enhance the intervention effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTI | Experimental | Behavioral: CTIWeb-based computerized, tailored intervention (CTI) for smoking cessation, based on the transtheoretical model of change. |
| CTI + text | Experimental | Behavioral: CTIWeb-based computerized, tailored intervention (CTI) for smoking cessation, based on the transtheoretical model of change. Tailored feedback messages based on stage of change will also be sent by cell phone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female veterans, OIF/OEF service preferred 18 years or older Current cigarette smoker Own cell phone with text messaging capabilities Ability to read and comprehend English Beginner level computer literacy Access to a computer with Internet connectivity
Key exclusion criteria (1 listed)
- Lack of basic computer literacy Non-smoker (includes smokeless tobacco use) Unable to read and comprehend English No access to computer with Internet connectivity (applicable if no project computer with Internet access can be arranged) Non-owner of cell phone with text messaging capabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTIWeb-based computerized, tailored intervention (CTI) for smoking cessation, based on the transtheoretical model of change. | Behavioural | CTI, CTI + text |
Primary outcome
Smoking prevalence
Time frame: 3-months
7-day point prevalence (self-report)
1 secondary outcome
Stage of Change
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia J Jordan, PhD principal investigator
Pacific Health Research & Education Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTI in people with Smoking, run by VA Pacific Islands Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking prevalence (time frame: 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.