Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder
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Introduction: Smokers 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. Aims and Methods: Daily 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. Results: We screened 119 to enroll 51 participants (target sample size = 60) over 24 months. The most common reason for ineligibility was the inability to attend study appointments. Retention was 73% at end of treatment and 80% at follow-up, with no differences by arm. The mean number of logins was twice as high for WebQuit Plus (10.3 vs. 5.3). The 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 versus 8% in Smokefree.gov (odds ratio = 1.46, 95% confidence interval = 0.21 to 9.97). At follow-up, abstinence rates were 8% in both arms. Conclusions: Trial 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. Implications: In this first randomized controlled trial of a targeted intervention for smokers with BD, we found that the ACT-based WebQuit Plus intervention, delivered in combination with the 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 the recruitment of smokers with BD.
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Presently, there is limited evidence for the efficacy of smartphone apps delivering behavioral smoking cessation interventions for individuals with mental health disorders; most studies have been limited to small pilot RCTs and single-arm studies.
“Presently, there is limited evidence for the efficacy of smartphone apps delivering behavioral smoking cessation interventions for individuals with mental health disorders. Most studies have been limited to small pilot randomized controlled trials (RCTs) and single-arm studies [43, 44, 45, 46, 47].”
From Can an Acceptance and Commitment Therapy-Based Smartphone App Help Individuals with Mental Health Disorders Quit Smoking? (2024) · cites this paper as [43]
ACT was delivered on the web without therapist guidance in 7 studies.
“and without therapist guidance in 7 studies [13-19].”
18 studies directly targeted people with depressive symptoms.
“Moreover, 18 studies directly targeted people with depressive symptoms [14,21,23-25,27,30-40].”
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- Authors
- Heffner, J. L., Kelly, M. M., Waxmonsky, J., Mattocks, K., Serfozo, E., Bricker, J. B., Mull, K. E., Watson, N. L., & Ostacher, M.
- Affiliations
- Fred Hutch Cancer Center (US)
- University of Massachusetts Chan Medical School (US)
- University of Colorado Anschutz (US)
- VA Central Western Massachusetts Healthcare System (US)
- University of Washington (US)
- VA Palo Alto Health Care System (US)
- Corresponding author
- Heffner, Jaimee L
- ORCID
- Venue
- Nicotine & Tobacco Research
- Publisher
- Oxford University Press (OUP)
- Published
- 2019-12-26
- Volume
- 22
- Issue
- 9
- Pages
- 1543-1552
- ISSN
- 1462-2203 (ISSN-L)
- 1469-994X
- PMC
- PMC7443589
- OpenAlex
- W2997807317
- Cited by
- 39
- References
- 48
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 6 · 2023: 8 · 2022: 10 · 2021: 4 · 2020: 1 · 2018: 1
- FWCI
- 2.57
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Nicotine & Tobacco Research (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute on Drug Abuse
- National Institutes of Health (#R34DA040119)
- National Network of Depression Centers
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Keywords
- bipolar disorder, smoking cessation, acceptance and commitment therapy, online intervention, nicotine patch, abstinence, treatment acceptability, trial feasibility, recruitment (clinical trials), retention, intervention dissemination, recruitment strategies, participant feedback, participant retention, intervention refinement
- MeSH terms
- Smokers, Bipolar Disorder, Female, Humans, Male, Middle Aged, Pilot Projects, Tobacco Use Disorder, United States, Health Behavior, Smoking Cessation, Internet, Acceptance and Commitment Therapy
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