Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder.

Abstract

INTRODUCTION\nSmokers with bipolar disorder (BD) are less successful at quitting than the general population. In this study, we evaluated in a pilot randomized controlled trial a novel, targeted, web-based intervention for smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability.\n\n\nMETHODS\nDaily smokers (n=51) with bipolar I or II disorder were recruited from four US sites and randomly assigned to one of two web-based smoking cessation interventions-ACT-based WebQuit Plus (n=25) or Smokefree.gov (n=26) over a 10-week treatment period. All participants received nicotine patch for 8 weeks. Key outcomes were trial design feasibility, intervention acceptability, and cessation at end-of-treatment and 1-month follow-up.\n\n\nRESULTS\nWe screened 119 to enroll 51 participants (target sample size=60) over 24 months. The most common reason for ineligibility was inability to attend study appointments. Retention was 73% at end-of-treatment and 80% at follow-up, with no differences by arm. Mean number of logins was twice as high for WebQuit Plus (10.3 vs. 5.3). Usefulness of program skills was rated higher for WebQuit Plus (75% vs. 29%). Biochemically-confirmed, 7-day abstinence at end-of-treatment was 12% in WebQuit Plus vs. 8% in Smokefree.gov (OR=1.46, 95% CI=0.21-9.97). At follow-up, abstinence rates were 8% in both arms.\n\n\nCONCLUSIONS\nTrial design produced favorable retention rates, although alternative recruitment methods will be needed for a larger trial. At end-of-treatment, acceptability and estimated effect size of WebQuit Plus relative to Smokefree.gov were promising and support continued program refinement and evaluation.\n\n\nIMPLICATIONS\nIn this first randomized, controlled trial of a targeted intervention for smokers with bipolar disorder, we found that the ACT-based WebQuit Plus intervention, delivered in combination with nicotine patch, had promising acceptability and cessation outcomes relative to Smokefree.gov. The observed signals for acceptability and cessation suggest that the WebQuit Plus program should be refined based on participant feedback and evaluated in a larger trial. Feasibility findings from this study also provide direction for refining trial procedures to enhance recruitment of smokers with bipolar disorder.