iQuit Mindfully: Text Messaging for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.

Detailed Description
-----------------
This study is a pilot investigation of mindfulness-based smoking cessation treatment incorporating between-session text messaging (iQuit Mindfully). Participants will be randomly assigned to one of two groups: Mindfulness-based Addiction Treatment (MBAT) or iQuit Mindfully (MBAT with the addition of between-session text messages). All participants will receive in-person group treatment based on the 8-week MBAT protocol in addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit Mindfully will receive additional support via text messaging. Assessments will occur at baseline, at each of the weekly in-person visits, at end of treatment, and at 1-month follow-up. Feasibility, smoking abstinence, mindfulness practice, and indicators of tobacco dependence and psychological well-being will be assessed.

Official Title
-----------------
iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

Conditions
-----------------
Cigarette Smoking

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based Addiction Treatment
* Behavioral: iQuit Mindfully
* Behavioral: Self-Help guide
* Drug: Nicotine Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-65 years current smoker with history of >5 cigarettes/day for past year (and expired carbon monoxide >6 parts per million [ppm]) motivated to quit within next 30 days valid home address in the greater Atlanta, Georgia area functioning telephone number own a mobile phone with text messaging capacity can speak, read, and write in English at least a sixth-grade level of health literacy Exclusion Criteria: contraindication for nicotine patch active substance abuse/dependence regular use of tobacco products other than cigarettes current use of tobacco cessation medications pregnancy or lactation household member enrolled in the study current diagnosis of schizophrenia or bipolar disorder, or use of antipsychotic medications clinically significant depressive symptoms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness-based Addiction Treatment (MBAT)<br>Nicotine patch; self-help guide; MBAT | Behavioral: Mindfulness-based Addiction Treatment<br>* Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).<br>Behavioral: Self-Help guide<br>* Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).<br>Drug: Nicotine Patch<br>* Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.<br>* Other names: Generic Nicotine Patch;|
| Experimental: iQuit Mindfully<br>Nicotine patch; self-help guide; MBAT; text messaging | Behavioral: Mindfulness-based Addiction Treatment<br>* Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).<br>Behavioral: iQuit Mindfully<br>* iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.<br>* Other names: Mindfulness-based text messaging for smoking cessation;Behavioral: Self-Help guide<br>* Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).<br>Drug: Nicotine Patch<br>* Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.<br>* Other names: Generic Nicotine Patch;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Abstinence | Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide <6 parts per million (ppm) | End of Treatment (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Engagement | Number of participants who respond to interactive text messages | Over the 8-week treatment period | 
| Participant Ratings | Perceived Text Message Helpfulness (minimum value 1 [not at all helpful], maximum value 10 [extremely helpful], higher scores mean better outcome) | End of Treatment (8 weeks) | 
| Attrition | Number of participants who do not attend end-of-treatment session | End of treatment (8 weeks) |