The techniques used in ACT target the following six main processes [37]: (1) acceptance—willingness to experience the natural flow of thoughts, feelings, and sensations (not trying to suppress them); (2) cognitive defusion—ability to recognize thoughts and images as just words and pictures, not as real events; (3) being present—focus on the present in a nonjudgmental way; (4) self-as context—exposure to experiential processes to promote awareness of one’s own flow of experiences without attachment to them; (5) values—awareness and clarification of personal values and goals; and (6) committed action—willingness to behave in line with values and goals, even in the presence of discomfort.

The baseline behavioral treatment was developed using an ACT-based smoking cessation protocol described in existing publications on ACT and smoking cessation [38-40]. This baseline treatment protocol was then adapted to also address depression and anxiety and to be culturally appropriate for Latine adults. The behavioral health and cultural adaptations were informed by an existing framework for adaptation [41,42], the first author’s training on the ACT therapeutic model, and expert consultation. A literature review informed changes to content and to the frequency and duration of sessions.

Adaptations of the baseline protocol to address co-occurring depression and anxiety entailed the proactive inclusion of emotional dysregulation discussions and experiences as part of the treatment. Regardless of participants’ initiative to share their experiences with mood management, the health counselor proactively inquires about the person’s psychological distress, validates their pain, and highlights that facing discomfort is an inevitable human experience oftentimes necessary for valued living. ACT works to enhance an individual’s ability and willingness to experience undesirable or adverse thoughts and feelings, which is expected to assist individuals in developing broader alternatives to mood management. Adaptations of the baseline protocol to be culturally appropriate for Latine individuals started with the labeling of the treatment. For instance, given Latine individuals’ stigma related to seeking behavioral health help [43], we chose to call the treatment a “wellness program” so it could be better received by the Latine community. Similarly, we use the terms “health counselor” and “health counseling” to refer to the therapist and the treatment sessions, respectively, to increase openness to the program. Adaptations were also based on the ideas of cross-cultural communication [44,45] as well as the integration of Latine values (eg, familism, personalism, and collectivism) and context (eg, heritage group, acculturation, and enculturation) [46].

The treatment manual includes overall training modules that cover the ACT model, tobacco dependence, depression, anxiety, Latine cultural values, and a session-by-session guideline that includes the core aspects of ACT and their applications for treatment of tobacco dependence and depression or anxiety. The participant’s guide mirrored the counselors’ treatment manual content in a more simplified manner and includes practice exercises.

The treatment protocol consists of 8 one-hour individual sessions. Session 1 entails the contextual interview (focused on smoking and psychological distress) and offers didactic information about the effectiveness and use of NRT. The contextual interview is organized around valued domains of living (ie, relationships, health, work, education, and leisure) and the functionality of smoking. Sessions 2-7 focus on each one of the 6 core ACT processes [23,37]. Session 2 focuses on clarifying participants’ overall values and those involved in quitting smoking, as well as the discrepancies between current behaviors and values. Session 3 focuses on discussing and demonstrating what SMART goals are (ie, specific, meaningful, adaptive, realistic, and timebound) and the development of a preliminary plan to stop smoking, including setting a quit date. Session 4 introduces participants to mindfulness and helps them notice their internal and external triggers as they occur and to recognize the link between connecting with emotions and the ability to act on them. Session 5 aims to increase participants’ willingness to accept cravings and withdrawal symptoms as a typical experience of the quitting process and develop motivation and skills to deal with them without smoking. Session 6 helps participants identify and defuse (or to get “unhooked”) from thoughts that limit their achievement of quitting smoking and mood-related behavioral goals. In this context, defusion is to see thoughts simply as thoughts rather than as a literal truth that can control one’s behavior. Session 7 guides participants to connect with a transcendent sense of self that is separate from their own internal experience but provides a safe place to observe them. Session 8 focuses on overall experiences during the wellness program as well as the creation of an individual self-care plan for the future, including value-based actions. All sessions include experiential exercises and metaphors tailored to the participant’s situation. Latine-specific issues are incorporated into each session. Participants are instructed to engage in value-based actions as homework assignments between sessions. Table 1 below shows a summary of the session-by-session content with focal exercises [47].

Health counselors with at least a master level degree in clinical or counseling psychology are trained to provide the PRESENT Wellness Program. Specifically, the health counselors undergo about 100 hours of specialized training in tobacco dependence treatment and ACT, including didactic, experiential, and applied training. Before engaging with study participants, health counselors role-play the treatment sessions and have to demonstrate ACT competency, measured by the ACT Core Competency Rating Form [37].

NRT is offered as part of the PRESENT Wellness Program. The selected NRT is the nicotine patch because it is frontline therapy for smoking cessation, is safe, well-tolerated, and available over the counter [22]. Also, the nicotine patch has proven effective among smokers with depression and anxiety symptomatology [48]. Participants are given 6 weeks of nicotine patches and are told to start using them 1 week before the quit day, which is encouraged on Session 3. Participants smoking more than 10 cigarettes per day are given 4 weeks of 21-mg patches, 1 week of 14-mg patches, and 1 week of 7-mg patches. Participants who smoke 5-10 cigarettes per day are given 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.

Participants are mainly recruited through community outreach, social and print media (eg, local newspaper), flyers, and the ResearchMatch platform [52]. To determine eligibility criteria, interested people complete a phone screening with project staff or complete a self-screening accessed via a QR code located in the study flyer. Individuals who are ineligible or decline participation are given self-help materials and referrals to other cessation programs. Eligible individuals are scheduled for their first appointment.

During the in-person baseline visit, study personnel provide a detailed description of the study, answer questions, and obtain informed consent. Enrolled participants complete web-based baseline questionnaires, biochemical verification of smoking status (via a CO test), and their first health counseling session.

The health counseling component consists of 8 one-hour individual sessions (1 in person and 7 by phone) completed within a 3-month period. The initial 2-week nicotine patch is dispensed at the first face-to-face visit and then sent biweekly by regular mail. Participants receive only the number of patches necessary to last 2 weeks, plus several extra patches should a patch fall off or become torn.

Treatment fidelity refers to the extent to which an intervention is delivered as planned. To ensure treatment fidelity, all sessions are recorded and a random sample of at least 15% are coded using the following two forms: (1) an investigator-developed checklist to track fidelity to treatment content per session and (2) the ACT Core Competency Rating Form to determine adherence to an ACT therapeutic approach [37]. The checklist entails a list of all session components (per session), which are marked as covered or not covered. The rating is calculated by assigning 10 points to each component marked as covered and dividing by the maximum number of components in that particular session (see the Multimedia Appendix 1). In the ACT Core Competency Rating Form, the rater evaluates the counselor’s competency in ACT on a scale of 1-7, from “never true” to “always true.” The supervisor provides written feedback based on the ratings of the rated sessions. Low treatment adherence is addressed by additional training and repeated assessment of adherence on additional cases. Treatment fidelity is attained when 85% or more (ie, ≥8) of the session components were covered and when receiving an overall rating of adequate or above adequate delivery (eg, ≥5) of the ACT essential components.

After the final health counseling session, participants attend 2 in-person follow-up visits, at 1-week and 1-month posttreatment, in which they complete a CO test as well as web-based questionnaires about tobacco use, depression, anxiety, and ACT-related constructs. At the 1-month visit, participants rate the degree of acceptability and helpfulness of each ACT component and their satisfaction with the PRESENT Wellness Program.

Participants are compensated in the form of gift cards for each of the in-person visits in which they complete assessments (ie, US $30 for baseline and 1 week after end of treatment; and US $40 for 1-month posttreatment follow-up). Thus, participants could receive a maximum total of US $100/person for the completion of assessments and health counseling sessions.

The primary outcomes of the study are feasibility of recruitment, feasibility of retention, and treatment acceptability. The feasibility of recruitment will be measured by the proportion of participants who consented to participate and attended the baseline session out of the number of individuals who were eligible. The feasibility of retention will be measured by the number of health sessions completed and the rate of follow-up visit completion. Treatment acceptability will be measured by the Program Acceptability Questions (see the Multimedia Appendix 2), an investigator-developed questionnaire rating the degree of acceptability and helpfulness of the PRESENT Wellness Program. The questionnaire contains 7 items categorized on a 5-point Likert scale ranging from “Completely Disagree” to “Completely Agree.” Higher scores indicate higher acceptability. A sample item is “This program has helped in my acceptance of my physical cravings, emotions, and thoughts that cue my smoking.”

Data analyses in the context of a pilot study are not hypothesis-driven but serve to provide information regarding feasibility and acceptability of the intervention [55]. As such, data analyses will include descriptive statistics (eg, mean tests and proportions) about screening, recruitment, retention, process assessments, and treatment acceptability. We will use descriptive analysis techniques to present participants’ characteristics, as well as their scores on secondary outcome measures at the 3 different time points (baseline, 1 week after end of treatment, and 1-month posttreatment).