Smoking remains the leading cause of morbidity and mortality worldwide. Approximately 50% of smokers die due to smoking-related illnesses unless they quit. While smoking prevalence has diminished in high-income countries, it remains disproportionately high among individuals with mental health disorders. In the UK, smoking prevalence was estimated at 32% among individuals with anxiety or depression, whereas in the U.S., it was 36% among those with depression and 30% among those with anxiety. Smoking elevates the risk of cardiovascular disease and cancer, yet cessation may enhance mental health. Several psychological therapies and treatments may integrate cessation assistance, potentially enhancing health outcomes.
The recent pilot study, published in Addiction, aimed to assess the feasibility and acceptability of integrating smoking cessation treatments with standard Improving Access to Psychological Therapies (IAPT) care (cognitive behavioral therapy [CBT]), evaluating its impact on study completion, participants and physician acceptance and preliminary health or clinical outcomes. This study also examined the feasibility of a multi-center randomized controlled trial, focusing on recruitment, randomization, collection of data, and trial protocols.
Integrating smoking cessation treatment as part of the usual psychological care for depression and anxiety (ESCAPE) study design was used. It was a pragmatic, multi-center, two-armed, randomized, controlled, acceptable, and feasible clinical trial with nested qualitative techniques (ISRCTN99531779). Participants with depression or anxiety treatment (n = 157) were recruited from the four UK National Health Service (NHS) trust services between June 1, 2018, and August 31, 2021. During the coronavirus disease 2019 (COVID-19) pandemic, 135 participants took part in the study.
Individuals aged ≥18 years, smoking daily for more than one year, and those with a Patient Health Questionnaire-9 (PHQ-9) score of ≥ 10 or a Generalized Anxiety Disorder Questionnaire-7 (GAD-7) score of ≥ 8 were included. Participants with prior IAPT treatment, pregnant women, and breastfeeding women were excluded.
The treatment group (n = 68, mean age = 37.4±13.3 years, 67.6% female, 89.7% White) received standard care along with integrated pharmacological and behavioral cessation support. The control group (n = 67, mean age = 33.7±11.9 years, 59.7% female, 89.6% White) received only standard CBT care. This study included follow-ups at 3 and 6 months. The primary endpoint was study completion at 3 months, whereas secondary endpoints were satisfaction, acceptability, data completeness, mental health, and feasibility.
Results found that cessation treatment had no significant impact on the study completion rate at 3 months (Odds ratio [OR] = 0.81, 95% confidence interval [CI] = 0.31 to 2.09, P = 0.79) and at 6 months. For the 3-month follow-up, 90% (19/21) of participants from the treatment group were satisfied with the intervention.
Approximately 61% (11/18) of IAPT practitioners were satisfied with the delivery of cessation treatment, and 83% (15/18) expressed willingness to offer it again. The treatment group received an average of 3.7±2.1 smoking cessation sessions. Smoking cessation assessment appointments averaged 17±8.3 minutes, while follow-up sessions lasted 11.2±5.7 minutes. At the start of the 3-month follow-up call, 7/45 (16%) participants in the control group and 8/53 (15%) in the treatment group knew the allocations, whereas 6/45 (13%) and 8/46 (17%) were aware by 6 months.
Using complete-case data at the 3-month follow-up period, the clinical outcomes, including GAD-7 scores, were found to be 9.5±5.6 in the treatment group and 9.0±6.1 in the control group. PHQ-9 was found to be 9.9±5.8 and 9.9±6.2, cigarettes per day (CPD) were 8.7±8.6 and 9.7±5.8, and the Heaviness of Smoking Index (HIS) was 1.7±1.6 and 1.7±1.4. GAD-7 and PHQ-9 mean scores improved during 3 months and PHQ-9 during 6 months in participants who had stopped smoking.
During the 3–3-month follow-up, treatment had no statistically significant effect on mental health, with a PHQ-9 difference coefficient of 0.01 (95% CI = −2.19 to 2.22) and a GAD-7 coefficient of 0.65 (95% CI = −1.59 to 2.90). However, it significantly enhanced abstinence rates, with OR = 8.69 (95% CI = 1.11 to 396.26).
This study’s limitations include the inability to record IAPT sessions, partial researcher building (13-16% of follow-ups), slower recruitment due to COVID-19, potential socioeconomic biases, and occasional trainer availability.
In conclusion, this study found that the smoking cessation treatment was well received, did not impact IAPT retention, and improved cessation rates without worsening mental health. However, future trials must address feasibility concerns related to implementation and recruitment.
Reference: Taylor GMJ, Sawyer K, Jacobsen P, et al. Integrating smoking cessation treatment as part of usual psychological care for depression and anxiety (ESCAPE): A randomized and controlled, multi-center, acceptability, and feasibility trial with nested qualitative methods. Addiction. 2025. doi:10.1111/add.16718
