Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
Phase: NA
Conditions: Smoking Cessation
Sponsor: Brown University

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Study Protocol 
 
Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized 
Controlled Trial 
NCT02997657 
December 22, 2022 
 
Christopher W. Kahler, Ph.D., Principal Investigator 
 
Correspondence concerning this protocol should be addressed to:  
Christopher W. Kahler, Ph.D.,  
Center for Alcohol and Addiction Studies,  
Brown University 
Box G-S121-4, Providence, RI 02912.  
E-mail: Christopher_Kahler@brown.edu 
 
 
 

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Study Aims 
This randomized controlled trial will test the efficacy of Positive Psychotherapy for Smoking 
Cessation plus Text Messaging (PPT-S+) compared to a time-matched ST control plus text 
messaging support for quitting (ST+). We hypothesize that participants in PPT-S+ compared to 
ST+ will display higher rates of biochemically-confirmed 7-day point-prevalence smoking 
abstinence across 12 months of follow-up. 
 
Method 
Note regarding response to Covid pandemic 
The procedures below describe the protocol as implemented prior to March 2020. With social 
distancing and closure to in-person activities, procedures were modified to accomodata remote 
enrollment, assessment, and intervention. Those modification are noted as “AFTER MARCH 
2020” 
Study Setting 
All study procedures will take place at the Center for Alcohol and Addiction Studies in 
the Brown University School of Public Health in Providence, RI or at the Massachusetts General 
Hospital in Boston, MA. AFTER MARCH 2020: All procedures happened online or by 
telephone only. 
 
Participants 
A total of 340 participants will be enrolled in the study over an approximately 3-year 
period, which started in February 2017. Participants must meet the following criteria: 1) be at 
least 18 years of age; 2) smoke at least 5 cigarettes per day for longer than one year; 3) be willing 
to use the nicotine patch; 4) rate the importance of quitting smoking a 5 on a 0 to 10 scale (where 
10 = extremely important); 5) have an active, text-capable cell phone and be willing to send and 
receive text messages for the duration of the intervention. Participants who do not have unlimited 
texting will be compensated an additional $20 to offset any additional costs on their cell phone 
bill. Participants will be excluded from the study, if they meet any of the following criteria: (1) 
are currently experiencing psychotic symptoms, affective disorder, or substance use disorder 
other than nicotine dependence; (2) are concomitantly using other pharmacotherapies for 
smoking cessation; (3) are pregnant or nursing, or (4) have any contraindications to the use of 
transdermal nicotine patch. 
AFTER MARCH 2020: To confirm smoking status at baseline, participants were sent a 
NicAlert test strip for saliva testing of cotinine and completed the test while being observed 
during a Zoom call with a research assistant. A test positive for cotinine was required for 
enrollment. The limit of detection for the NicAlert strip is 30 ng/mL 
 
Outcome Variables 
 

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Primary outcome measures 
The primary outcome for testing intervention efficacy is biochemically verified 7-day 
point-prevalence abstinence at 12-, 26-, and 52-week follow-ups. We will also use the Timeline 
Followback [3, 4] to assess time to first lapse and relapse and continuous abstinence from 
smoking. Participants will provide breath samples for expired carbon monoxide (CO) analysis at 
baseline, each treatment session, and each follow-up interview. At 12-, 26-, and 52-week follow 
ups self-reported smoking abstinence with no other use of nicotine-containing products— 
including nicotine replacement therapy and electronic cigarettes—will be verified by both CO 
(cutoff value of <4ppm) [5] and saliva cotinine radioimmune assay analysis (cutoff value of < 15 
ng/ml) [6]. For those reporting smoking abstinence, but with past 7-day use of other nicotine 
containing products, abstinence will be verified only by CO. Continuous smoking abstinence will 
be defined as self-reporting no cigarettes smoked since quit date with abstinence biochemically 
confirmed at each follow-up or confirmed by collateral reports from significant others.  
 
AFTER MARCH 2020: Self-reported abstinence was biochemically confirmed with a 
NicAlert test which was sent to the participants how and self-administered while being observed 
by the research assistant on Zoom. 
Secondary outcome measures and assessment points 
The secondary outcome of this study is to determine if the effect of PPT-S+ on smoking 
outcome is mediated by greater use of PPT-consistent strategies, reduced attraction to smoking, 
or greater smoking cessation self-efficacy. Participants will complete a Treatment Strategies 
Questionnaire at sessions 4-6 to assess frequency of general smoking cessation strategies usage, 
including planning for high-risk situations, and PPT-consistent strategies. PPT-consistent 
strategies are worded in a general way so that participants in each condition can rate how often 
they have done that activity; PPT-S consistent strategies include intentionally focusing on mental 
health benefits of quitting, using signature strengths, savoring positive experiences, and engaging 
in positive social interactions [2]. For those in PPT-S+, we also will have a record of how many 
PPT-S+ interactive texts were responded to, which will be coded according to whether the 
exercise was completed. In both conditions, we will calculate a variable reflecting the percent of 
responses to interactive messages. Smoking cessation self-efficacy will be measured at each 
counseling session using a well-validated 9-item scale [7]. Residual attraction to smoking (e.g., 
“Does smoking have any attraction for you now?”) will be assessed at the end of the treatment 
(i.e. 4 weeks after quite date) with a validated 3-item scale [8]. 
 
Recruitment Procedures 
Participants will be recruited through advertisements localized to the greater Providence, 
RI and Boston, MA region on public transportation, newspaper, radio, and local television. The 
advertisements give potential participants the information to call or text the study phone number 
or visit the study website for more information. Additionally, a social media campaign will be 
used including an interactive study website. Participants will have the opportunity to complete an 
online screener to determine eligibility. 
 

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Procedure Overview  
Prospective participants will be screened either by telephone or by an online web portal 
system according to the inclusion criteria. Participants meeting inclusion criteria will be invited 
to the study sites to complete a baseline interview to confirm eligibility. Eligible participants will 
be randomized and start counseling within a week of the baseline interview. Quit date will be 
scheduled for all participants to coincide with their third session of counseling. Participants will 
be assessed on a variety of interview, self-report, and biochemical measures at baseline and each 
treatment session, and at 12, 26, and 52 weeks after quit date. Interviewers conducting follow-
ups will not be aware of participants’ assigned treatment condition.  
AFTER MARCH 2020: All assessments and counseling occurred by telephone or Zoom 
videoconferencing. 
Assessments 
Baseline Assessment  
At baseline, participants will complete written informed consent. They will then complete 
written questionnaires and interviews to determine eligibility for the study, including a medical 
history screen. A blood pressure reading will be taken to exclude participants who have elevated 
blood pressure that would require medical treatment. Because nicotine patch is contraindicated 
for nursing and pregnant women, all women of childbearing age will be administered a 
pregnancy test to ensure non-pregnant status. If pregnant, they will be referred to other treatment. 
Participants will be paid $20 for completing the baseline assessment. 
 
AFTER MARCH 2020: No blood pressure readings or pregnancy tests were done. 
Follow-up Interviews  
Participants will return to the study sites to complete in-person follow-ups at 12, 26, and 
52 weeks after their scheduled quit date. To increase retention, participants will be paid up to 
$120 for completing assessments according to the following schedule: $35 for 12-week follow-
up (plus $20 for those without unlimited texting), $35 for the 26-week follow-up, and $50 for the 
52-week follow-up. These payments are not contingent upon smoking status. When necessary, 
relatives or friends listed by participants as potential locators will provide information about 
participants' whereabouts.  
 
Randomization procedures 
After completing baseline appointment procedures, eligible participants will be 
randomized to either PPT-S+ or ST+ by the Project Coordinator, who is not involved in 
conducting assessments or providing treatment. The urn randomization technique[1] will be used 
to ensure that treatment groups are balanced on gender, PA, and level of cigarette dependence. 
Research assistants will not be informed of treatment condition assignment. The positive affect 
subscale of the Center for Epidemiologic Studies – Depression scale (CES-D PA) [9] will be 
used to measure participants’ PA over the past week; this scale has been shown to predict 
smoking outcome [4] and moderate the effect of PPT-S [19]. Participants’ level of cigarette 

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dependence will be measured via the Fagerström Test for Cigarette Dependence [10, 11]. 
Condition assignment will be placed in sealed folders, which the counselor will open when 
participants report to the study center for the initial session of counseling, at which point 
randomization is considered complete. 
 
Details of the intervention and control 
Nicotine Replacement Therapy 
All participants will be provided an eight week supply of transdermal nicotine patch with 
initial patch dosage (7mg, 14mg, or 21mg) based on their smoking rate at baseline following the 
product recommendations.  
Behavioral Treatment Conditions 
All participants will receive a common core of behavioral smoking cessation counseling 
which includes instructions for using the nicotine patch, a text messaging support program, and 6 
weekly sessions of counseling. The first session of counseling lasts about 50 minutes with the 
remaining sessions lasting about 35 minutes. All participants have a target quit date set for 
session 3 (2 weeks post initial counseling session). Participants who relapse to smoking after 
session 3 may set a new quit date, but the initially scheduled quit date remains as the date on 
which other study procedures (e.g., follow-up visits) are based.  
 
Counselor Qualifications, Training, and Supervision 
Qualifications for study counselors are a master’s degree or above with experience in 
behavioral health counseling. All counselors will conduct both PPT-S+ and ST+ sessions. 
Counselors will participate in approximately 20 hours of training prior to delivering 
interventions. Training will include an overview of PPT-S+ and ST+ protocols, review of 
manuals and handouts, and practice role-play exercises along with selected readings on treatment 
of tobacco use and positive psychology. Additionally, counselors will be asked to listen to 
several of the audiotape samples from the randomized controlled pilot study and will conduct 
mock sessions with one another.  
Counselors will participate in weekly supervision sessions. All sessions will be 
audiotaped, and a session from every fifth case will be rated for adherence and competence. 
Counselors will be provided feedback on adherence to manual components, level of skill 
delivering components, use of appropriate structure and focus, empathy and facilitation of the 
therapeutic alliance. Counselors who deviate from the protocol will be monitored closely and 
may be asked to role-play protocols until their performance meets acceptable standards. 
Treatment integrity for PPT-S+ and ST+ as described in the treatment protocols will be 
assessed with adherence checklists. Ratings of treatment adherence will be conducted by a 
research assistant unaffiliated with treatment delivery using checklists containing each of the 
critical topics of the treatment session outlines in each condition. Checklists will be summed to 
indicate the proportion of intended topics that were covered in a treatment session. Session tapes 
will be rated only after participants’ follow-ups are completed. A second research assistant will 
rate one-fifth of sessions as a reliability check.  

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Standard Treatment+ (ST+) 
ST+ is based on clinical practice guidelines[12] and focuses on recognizing and problem 
solving potential causes of smoking relapse, providing support and reinforcement of success, and 
encouraging participants to seek support for smoking cessation outside of treatment[13]. When 
necessary, the counselor discusses strategies for managing relapses to smoking. The elements of 
the standard smoking cessation content in both interventions is shown in Table 1. In ST+, about 
20 minutes of each session are dedicated to teaching progressive muscle relaxation, which is 
used to match contact time with PPT-S+ while keeping the amount of time focused on smoking 
in both PPT-S+ and ST+ similar. Relaxation training has not been shown to improve smoking 
abstinence[12]. Participants are instructed to use relaxation techniques to reduce stress in their 
day-to-day life as needed.  
 
PPT-S+  
Modeled after our previous pilot [2], the PPT-S+ condition shares the same fundamental 
smoking cessation components with ST+, but also integrates positive psychology concepts. PPT-
S+ focuses on accentuating individuals’ strengths (e.g., humor, perseverance, kindness, 
spirituality) and linking them to behavior change, which is intended to enhance self-efficacy and 
development of a non-smoker identity, both potential key predictors of immediate and long-term 
smoking outcomes [8, 14]. PPT-S+ is also gained-framed [15, 16] to highlight that quitting 
smoking can be a rewarding challenge that enhances mental health [17-19]. Research has shown 
that positive self-affirmations [20] can reduce defensiveness about health information leading to 
increased behavioral intentions [21]. Finally, PPT-S+ focuses on increasing attention to the daily 
experience of positive events, as well as increasing positive social interactions and maintaining 
PA.  
PA is distinct from negative affect both conceptually and empirically [22]. Some studies 
have suggested that low PA prior to smoking cessation treatment may have a unique association 
with poor smoking outcomes independent of depressive symptoms [23], although a recent study 
did not support this conclusion [24]. Both reductions in PA leading up to quit date and low PA 
after quitting have been implicated in smoking relapse [25, 26]. By focusing specifically on 
maintaining PA, PPT-S+ seeks to reduce the relative attractiveness of smoking as a mood 
enhancer and to enhance self-efficacy for remaining abstinent. Prior research has suggested that a 
behavioral activation approach to increasing positive reinforcement during smoking cessation 
has promise [27]. The PPT-S+ approach toward increasing positive reinforcement is distinct 
from that of behavioral activation, but both approaches may operate through similar mechanisms 
to affect smoking outcomes—providing alternatives for enhancing positive affect other than 
smoking.  
The PPT-S+ model acknowledges that PPT-S+ may directly enhance positive affect, 
given prior research on positive psychology interventions. It also acknowledges that individuals 
with greater positive affect may find it easier to engage in PPT-S+ strategies. In our pilot trial, 
the effect of PPT-S was, in fact, stronger among those with higher levels of positive affect prior 
to treatment[19]. However, results also suggested that it was use of PPT-S strategies that was 
more predictive of long-term outcome than positive affect itself. 

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The following intervention elements are unique to PPT-S+ (see Table 1 for timing of 
interventions): 
PPT-S Model of Smoking Cessation. PPT-S+ highlights that despite initial withdrawal 
symptoms, quitting smoking results in improved mental health and reduced stress [17, 19, 28-
31]. The importance of attending to positive experiences and having positive social interactions 
when quitting is emphasized, noting that these experiences help people manage future obstacles. 
Counselors note that the exercises taught in PPT-S+ can be more difficult to complete during 
periods of stress or low mood, but that regular practice of the exercises has been shown to 
increase satisfaction with life and positive moods and reduce depression. 
Positive Introductions. PPT-S+ begins by introducing the concept of signature strengths 
and how those can be important in quitting smoking. Participants are provided feedback about 
their top five signature strengths based on the Values in Actions Survey [32], which assesses 24 
signature personality strengths such as Love of Learning, Kindness, Appreciation of Beauty, and 
Gratitude. Participants are asked to share how they have demonstrated use of one of these 
strengths in a recent situation. 
Using Signature Strengths. Counselors highlight the role that signature strengths play in 
leading an engaged life and handling challenges. Throughout treatment, participants are asked to 
consider how they can employ their signature strengths to help them manage high-risk situations 
for smoking. For example, someone with high Love of Learning may be encouraged to seek out 
information on the health benefits of quitting smoking, whereas someone high in Kindness may 
be encouraged to use some of their money saved from not smoking to treat a friend to dinner. 
Three Good Things. At session 1, participants are instructed to record by text messaging 
three good things that happened each day. This exercise has been shown to have rapid and 
lasting effects on reducing depressive symptoms and increasing happiness [33]. This exercise is 
continued through session 3, at which point participants can choose whether to continue the 
exercise over the following weeks. 
Savoring. At session 2, counselors introduce the concept of savoring positive 
experiences, including sensory experiences (e.g., savoring chocolate rather than eating it in one 
bite), positive memories, and accomplishments. They assign participants to savor at least two 
experiences each day for two weeks and to record what they savored at the end of each day by 
text messaging. They continue this exercise through session 4. 
Active/Constructive Responding. At session 4, participants are instructed to listen 
carefully when people they care about report good events. They are instructed to go out of their 
way to respond actively and constructively to these events and to keep a record of these 
experiences through daily text messaging. 
Savoring Acts of Kindness. This exercise begins at session 5 and asks participants to 
become aware of when they exhibit kind behavior toward another person (or note others being 
kind) and to savor the kind behavior by noticing it and writing it down. Participants are asked to 
text the kind acts they did or witnessed each day. This exercise is based on a prior study showing 
that writing down one’s acts of kindness enhanced well-being [34]. 
Maintenance Exercise. In the final session, participants discuss their experiences with the 
PPT-S+ exercises and choose which exercise to continue over the next two weeks.  
 
Text Messaging  
Participants in both ST+ and PPT-S+ receive a core set of text messages to support 
smoking cessation, following the TXT-2-Quit (T2Q) program developed by Bock and colleagues 

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[35]. The frequency of T2Q messages in PPT-S+ is reduced somewhat to accommodate the PPT-
specific texts without creating unequal response burden between study arms. Participants will 
enroll in the program at baseline by responding to a text message. T2Q is an 8-week core 
program of daily texts tailored to the user’s phase of quitting (e.g., preparing to quit, early weeks 
of active quitting, sustaining a recent quit, relapsed, preparing to make a second quit attempt). 
Message content includes behavioral (e.g. “Keep a stress ball handy to squeeze during times of 
intense craving.”), motivational messages (e.g. “You decided to quit smoking and you’re doing 
it. You’re awesome”) and information on dealing with nicotine dependence and withdrawal (e.g., 
“The worst of nicotine withdrawal is over in a few weeks, but breaking the smoking habit comes 
more slowly.”). T2Q is flexible, allowing for special messages for each phase of quitting (e.g., 
recently quit, recently relapsed, maintaining abstinence, etc.) and allowing participants to set a 
unique quit date.  
All participants will set a quit date to coincide with session 3 of counseling, but the 
program can accommodate those who need to set another quit date. Individuals who relapse are 
encouraged to make another attempt at cessation, and more intensive messaging is given to those 
recently quit or relapsed. Participants in ST+ receive 1 message per day leading up to a quit date, 
4 messages per day in the 2 weeks immediately after quit date, and 2 messages per day in the 
four weeks after that. Those in PPT-S+ receive slightly fewer T2Q texts: 1 message per day 
leading up to a quit date and 2 messages per day in the 4 weeks after their quit date. Additional 
help is available on demand through automated motivational messages sent in response to a 
texted key word (e.g., “crave” or “slip”) [35]. 
 
Text Messaging in PPT-S+ 
In addition to T2Q messages, participants in PPT-S+ will receive daily texts intended to 
increase positive cognitions and engagement with exercises and to prompt participants to 
consider their signature strengths and how these can be used to facilitate quitting. Morning texts 
provide static messages relevant to a given exercise (“Notice what good things happen in other 
people's lives.  Help them celebrate.  It makes you both feel good!”), while afternoon/evening 
texts are interactive and ask for open-ended descriptions of what participants did to complete that 
day’s exercise (“Did you find at least one chance today to respond actively and with enthusiasm 
to someone’s good news?”), with a reminder sent after one hour if no response is received. These 
responses are tabulated for the smoking cessation counselor. Text messages specific to an 
exercise are initiated at the respective counseling session at which that exercise is introduced by 
texting a key word, e.g., ‘Savor,’ to initiate the savoring texts. The exercise continues each day 
following the session until that exercise is replaced by a new exercise. At session 6, participants 
choose which exercise they want to continue and receive texts based on their choice for an 
additional two weeks. The texting protocol for PPT-S+ was developed and finalized based on 
pilot testing done with nine participants prior to initiating the randomized trial.  
 
Masking/blinding 
Participants will be randomized to ST+ or PPT-S+ after completing their baseline 
assessment by the Project Coordinator, who does not conduct outcome assessments. Due to the 
timing of the randomization procedures, project staff who conduct the baseline visit will have no 
way of knowing participants’ study condition. Staff conducting follow-up outcome assessments 
will not be informed of condition assignment.  

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4.9 Timeline  
Recruitment began in February 2017 and will continue until approximately April of 2020. 
Follow-ups will continue throughout this time and will be completed in mid-2021.  
AFTER MARCH 2020: Given that recruitment had not yet reached its final goal, we 
restarted enrollment of new participants in June of 2020 and continue to enroll new participants 
through September 2020 with all follow-ups completed by December 2021. 
 
Sample size calculations  
We estimated abstinence rates in PPT-S+ by roughly averaging and rounding the 
abstinence rates seen in our developmental trial [18] and pilot randomized controlled trial [19]. 
For PPT-S+, we estimated 45%, 30%, and 25% abstinence at 12, 26, and 52 weeks, with 20% 
continuously abstinent. Results of the pilot study suggested differences in abstinence rates 
between PPT-S and ST that ranged from roughly 12% to 15% [19]. Therefore, for ST+, we 
estimated 30%, 17.5%, and 12.5% abstinence at 12, 26, and 52 weeks, with 8% continuously 
abstinent; such effects would represent a clinically meaningful effect for PPT-S+.  
For the analysis of point prevalence abstinence over time, we used a covariance matrix 
based on our past trial [19] and a program developed for power analysis for generalized 
estimating equations [36] and determined that a sample size of 272 participants would be needed 
to achieve power of .80 given our estimated abstinence rates. For the single measure of verified 
continuous abstinence, 298 participants are needed for power of .80. To allow for up to 10% of 
participants being lost to follow-up, however, we allowed for an initial sample of 340 in order to 
ensure adequate statistical power for our analyses.  
 
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Table 1 
Smoking cessation and PPT-S+ treatment components by session 
Session # 
Smoking Cessation Components 
PPT-S+ Components 
1 
Reasons for quitting 
Smoking as physical addiction and habit 
Identifying high-risk situations 
Positive Introductions 
PPT-S+ Model of Smoking Cessation 
3 Good Things  
2 
Proper use of the nicotine patch 
Planning for high-risk situations 
Social support for quitting 
Preparing for quit date 
3 Good Things 
Savoring 
Signature strengths in quitting smoking 
3 (quit date) 
Quit date review 
Starting nicotine patch 
Planning for high-risk situations 
3 Good Things (optional) 
Savoring 
Signature strengths in quitting smoking 
4 
Managing smoking ‘slips’ 
Nicotine patch review  
Planning for high-risk situations 
3 Good Things (optional) 
Active/Constructive Responding 
Signature strengths in quitting smoking 
5 
Benefits of quitting 
Managing smoking ‘slips’ 
Nicotine patch review 
Planning for high-risk situations 
3 Good Things (optional) 
Savoring Acts of Kindness 
Signature strengths in quitting smoking 
 
Benefits of quitting 
Managing smoking ‘slips’ 
Nicotine patch tapering 
Planning for high-risk situations 
Review of PPT-S+ exercises 
Choosing PPT-S+ exercises to continue 
Note. PPT-S+ = positive psychotherapy for smoking cessation plus text messaging