Motivating Smokers With Mobility Impairments to Quit Smoking (ABLE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01585610|
Recruitment Status : Unknown
Verified May 2015 by Belinda Borrelli, The Miriam Hospital.
Recruitment status was: Active, not recruiting
First Posted : April 26, 2012
Last Update Posted : May 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Behavioral: DVD Intervention Behavioral: Standard Care Printed Materials||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||560 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Motivating Smokers With Mobility Impairments to Quit Smoking|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||May 2016|
|Experimental: DVD Program||
Behavioral: DVD Intervention
Four theory-based intervention DVDs will be provided to participants in this arm, the first in the home after Baseline assessment and the next 3 at 1-month intervals by mail. DVDs focus on motivating smoking cessation among people with mobility impairments using Behavioral Activation as the primary theoretical construct. Short (< 5 min.) phone calls will also be placed to each participant in between DVD deliveries and after receipt of DVD 4.
|Active Comparator: Standard Care Printed Materials||
Behavioral: Standard Care Printed Materials
Four sets of standard smoking cessation printed materials will be provided to participants in this arm, the first in the home after Baseline assessment and the next 3 at 1-month intervals by mail. Short (< 5 min.) phone calls will also be placed to each participant in between materials deliveries and after the 4th and final set is sent by mail.
- Smoking Status: 7-day and 30-day point prevalence [ Time Frame: 1 and 6 months Post-Intervention ]Seven-day point prevalence abstinence (no smoking at all in the previous seven days) will be assessed by self-report. We will also assess 30 day point-prevalence abstinence (no smoking at all in the previous 30 days) by self-report. Participants who have switched to other forms of tobacco will be considered "smokers." Participants who self-report no smoking will be asked to provide a Carbon Monoxide (CO) breath sample. Participants who have a CO < 10ppm will be considered abstinent.
- Participant Satisfaction [ Time Frame: 2, 6, 10, and 14 weeks after Baseline ]Participant satisfaction will be assessed during phone calls in the intervention period in two ways: 1) the Educational Materials Review Form Questionnaire (EMRFQ), and 2) participants' open-ended opinions about the most recent mailing (what they liked most, least, did they retain the video/print-based material, and was there anything objectionable). These will be used to evaluate DVDs and print material on: ease of use and understanding, degree of helpfulness, ability to attract attention and change behavior, and usefulness for national distribution.
- Use of Intervention Materials [ Time Frame: 2, 6, 10, and 14 weeks after Baseline ]During follow-up phone calls in between mailings we will assess the length of time spent watching the video or reading the print materials, segments viewed or chapters read, and whether others in the household viewed the video or print-based materials. Participants will be asked simple recall questions about segments viewed or chapters read (characters, storyline, etc.) so that those who viewed the materials will be able to answer them easily.
- Motivation to Quit [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ]We will use the Contemplation Ladder.205 Validity studies have shown associations with cognitive and behavioral indices of readiness to consider smoking cessation and with making quit attempts (e.g., intention to quit, nicotine dependence).We will also assess Stage of Change to compare its predictive and concurrent validity with this measure. We will assess motivation at baseline to assess equivalency between groups, and analyze as a covariate if necessary.
- Self-Efficacy [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ]The Generalized Self-Efficacy Scale is a 10-item scale that assesses one's belief in the ability to respond and cope with novel or difficult situations and unexpected setbacks or obstacles. Self-efficacy to quit smoking will be assessed with a 15-item version of the Confidence Questionnaire. We will assess the mediational role of both general and specific self-efficacy in predicting outcome.
- Depressed Mood [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ]Depressed Mood will be assessed with the 20-item Center for Epidemiologic Studies Depression Scale (CES-D210). Depressed mood is associated with difficulty quitting smoking and staying quit.Our DVD intervention will target depressed mood and assess a mediator of treatment outcome.
- Perceived Stress [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ]The 4-item Perceived Stress Scale will be used to assess the degree to which participants perceive their environment and their experiences as stressful. The scale correlates well with scores on life-event measures, and has demonstrated good reliability. Our intervention will target stress because levels of stress can impact quitting and because a number of studies have found that persons with physical disabilities report elevated perceived stress scores. Our DVD Intervention will target stress and assess its role as a mediator of treatment outcome
- Positive Affect [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ]We will use the Positive and Negative Affect Scale (PANAS; Watson et al 1998). The PANAS is a self-report state mood questionnaire that has a positive and negative affect subscale. Positive affect has been associated with quitting smoking and is a predictor of health and disability across many samples. Our DVD Intervention will target positive affect and we will assess the role of positive affect as a mediator of treatment outcome.
- Behavioral Activation: Goal Setting and Achievement [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ](Borrelli & Mermelstein). Subgoal setting will be the total number of goals set since last contact. Subgoal achievement will be the number of goals met between assessments vs the number of goals set for that time period. We will examine whether number of goals set, proportion of goals achieved, or the type of subgoal achieved (direct or indirect), have effects on follow-up smoking status. We will assess this measure as a mediator of treatment outcome.
- Behavioral Activation: Pleasant activities [ Time Frame: Baseline & 1 and 6 mos Post-Intervention ]The Pleasant Events Schedule measures an individual's frequency and subjective pleasure of various potentially reinforcing events and activities. Activities cover two primary areas: passive or active and social or non-social. Participants rate each item for frequency during the past month, and subjective enjoyability during that same month. We will assess this measure as a mediator of treatment outcome.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585610
|United States, Rhode Island|
|The Miriam Hospital|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Belinda Borrelli, PhD||The Miriam Hospital|