Smoking CessationNCT02997657
Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
A study testing Positive Psychotherapy and Standard smoking cessation counseling in people with Smoking Cessation, run by Brown University at 2 sites in United States.
Trial summary
Positive Psychotherapy for Smoking Cessation (PPT-S) addresses an array of risk factors for poor smoking outcomes (low positive affect, depressive symptoms, and cynical cognitions), while also providing skills that may buffer against stress and negative affect. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Positive Psychotherapy and Standard smoking cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- be 18 years of age or older
- smoke at least 5 cigarettes per day for longer than one year with no current regular use of other nicotine/tobacco products including e-cigarettes
- have a baseline carbon monoxide level of at least 4 ppm
- be willing to use the nicotine patch
- report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking (where 10 = extremely important);
- have an active cell phone and be willing to send and receive text messages for the duration of the intervention.
Who cannot join
- 1. Contact study site for details
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Partners Healthcare and Massachusetts General Hospital
Boston, Massachusetts, 02114
Center for Alcohol and Addiction Studies, Brown University
Providence, Rhode Island, 02912
About this study
Positive Psychotherapy for Smoking Cessation (PPT-S) addresses an array of risk factors for poor smoking outcomes (low positive affect, depressive symptoms, and cynical cognitions), while also providing skills that may buffer against stress and negative affect. The overall objective of this project is to conduct a randomized controlled trial to test the efficacy of PPT-S, enhanced with text messaging, compared to a time-matched behavioral smoking cessation treatment. Participants in both treatment conditions will receive nicotine replacement therapy and a validated text-messaging intervention for smoking cessation that monitors progress in quitting smoking and extends smoking counseling outside of the individual face-to-face context.
- Conditions
- Smoking Cessation
- Being tested
- Positive Psychotherapy, Standard smoking cessation counseling
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive PsychotherapyBehavioural
Exercises designed to boost moods, positive behaviors, and positive cognitions.
Standard smoking cessation counselingBehavioural
Counseling designed to provide support and problem solving for smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychotherapy for Smoking Cessation | Experimental | Smoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors. Receives: Behavioral: Positive Psychotherapy; Behavioral: Standard smoking cessation counseling |
| Standard smoking cessation treatment | Active comparator | Smoking cessation counseling that provides support and problem solving skills for avoiding smoking. Receives: Behavioral: Standard smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point Prevalence Smoking Abstinence at 12 Weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Measured: 12 weeks
7-day Point Prevalence Smoking Abstinence at 26 Weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Measured: 26 weeks
7-day Point Prevalence Smoking Abstinence at 52 Weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Measured: 52 weeks
Continuous Smoking Abstinence
Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks
Measured: 52 weeks
Secondary outcomes (3)
Engagement in PPT-consistent Quitting Strategies
Engaging in strategies consistent with the positive psychology exercises taught in the trial. Nine strategies are assessed on 1 to 5 scale with 5 reflecting greater use of the strategies. The total score is the average across the 9 item.
Measured: During treatment - weeks 1-4 after quit date
Residual Attraction to Smoking
Self-report residual attraction to smoking. Three questions are dichotomized and any positive response indicating residual attraction to smoking is coded as a 1 with any having only negative responses is coded as 0 - no residual attraction.
Measured: At end of treatment (4 weeks after quit date)
Self-efficacy for Resisting Smoking
Self-reported confidence in remaining abstinent from smoking. The 9-item scale uses a 1-5 response scale and the total score is the average of those 9 responses, where higher scores represent higher confidence in resisting smoking.
Measured: At end of treatment (4 weeks after quit date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startSep 2016
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Truth Initiative
- Responsible party
- Principal investigator, Christopher W. Kahler, Brown University
- Investigators
- Christopher Kahler, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997657
- Sponsor's protocol ID
- R01CA201262
- Status last verified
- Feb 2023
- First submitted
- 5 Dec 2016
- Last updated
- 1 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02997657
- Acronym / sponsor ID
- R01CA201262
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Truth Initiative
- Study start
- Sep 2016 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Posted 1 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Positive Psychotherapy for Smoking Cessation (PPT-S) addresses an array of risk factors for poor smoking outcomes (low positive affect, depressive symptoms, and cynical cognitions), while also providing skills that may buffer against stress and negative affect. The overall objective of this project is to conduct a randomized controlled trial to test the efficacy of PPT-S, enhanced with text messaging, compared to a time-matched behavioral smoking cessation treatment. Participants in both treatment conditions will receive nicotine replacement therapy and a validated text-messaging intervention for smoking cessation that monitors progress in quitting smoking and extends smoking counseling outside of the individual face-to-face context.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Psychotherapy for Smoking Cessation | Experimental | Behavioral: Positive Psychotherapy, Behavioral: Standard smoking cessation counselingSmoking cessation treatment that incorporates exercises and text messages derived from positive psychology interventions that are designed to boost positive moods, cognitions, and behaviors. |
| Standard smoking cessation treatment | Active comparator | Behavioral: Standard smoking cessation counselingSmoking cessation counseling that provides support and problem solving skills for avoiding smoking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be 18 years of age or older
- smoke at least 5 cigarettes per day for longer than one year with no current regular use of other nicotine/tobacco products including e-cigarettes
- have a baseline carbon monoxide level of at least 4 ppm
- be willing to use the nicotine patch
- report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking (where 10 = extremely important);
Key exclusion criteria (1 listed)
- 1. Contact study site for details
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 |
|---|---|---|
| Positive PsychotherapyExercises designed to boost moods, positive behaviors, and positive cognitions. | Behavioural | Positive Psychotherapy for Smoking Cessation |
| Standard smoking cessation counselingCounseling designed to provide support and problem solving for smoking cessation | Behavioural | Positive Psychotherapy for Smoking Cessation, Standard smoking cessation treatment |
Primary outcome
7-day Point Prevalence Smoking Abstinence at 12 Weeks
Time frame: 12 weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
7-day Point Prevalence Smoking Abstinence at 26 Weeks
Time frame: 26 weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
7-day Point Prevalence Smoking Abstinence at 52 Weeks
Time frame: 52 weeks
Self-reported smoking abstinence biochemically confirmed with CO and cotinine
Continuous Smoking Abstinence
Time frame: 52 weeks
Self-reported continuous abstinence from cigarette smoking from quit date through the 52-week follow-up biochemically confirmed at 12, 26, and 52 weeks
3 secondary outcomes
Engagement in PPT-consistent Quitting Strategies
Time frame: During treatment - weeks 1-4 after quit date
Residual Attraction to Smoking
Time frame: At end of treatment (4 weeks after quit date)
Self-efficacy for Resisting Smoking
Time frame: At end of treatment (4 weeks after quit date)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Christopher Kahler, PhD principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychotherapy and Standard smoking cessation counseling in people with Smoking Cessation, run by Brown University at 2 sites 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 6 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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
7-day Point Prevalence Smoking Abstinence at 12 Weeks (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 1 Mar 2023.