Integrating the "Quit and Stay Quit Monday" Model into Smoking Cessation Services for Smokers with Mental Health Conditions: A Pilot Randomized Controlled Trial.

Introduction: People with mental health conditions (MHCs) are less likely to achieve long-term abstinence than people without MHCs. The Quit and Stay Quit Monday (QSQM) model offers a long-term approach to treating tobacco use by encouraging people to quit, requit, or recommit to quit smoking every Monday.

Aim: To evaluate the efficacy, patient satisfaction, and patient engagement with an intervention that integrated the QSQM model into multicomponent smoking cessation services among people with an MHC.

Methods: This was a randomized controlled pilot trial. Eligibility criteria were as follows: (1) ≥18 years old, (2) smoked a cigarette in the past 30 days, (3) diagnosis of an ICD-10 MHC, (4) interest in quitting smoking, (5) able to receive services in English, and (5) had an active email and a cell phone. The intervention group (n = 33) received QSQM-focused telephone coaching, a weekly QSQM email newsletter, a SmokefreeTXT anchored around a Monday quit date, and 4 weeks of nicotine replacement therapy (NRT). The control group (n = 36) received information about contacting their state Quitline for usual services. Primary outcomes were self-reported quit attempts, 7-day abstinence, and intervention satisfaction at 3 months.

Results: Twenty-four participants (73%) in the intervention group began telephone coaching, 26 (79%) enrolled in the QSQM email newsletter, 19 (58%) enrolled in SmokefreeTXT, and 15 (46%) used NRT. Using a penalized intent-to-treat approach, quit attempts in the intervention and control groups were 63.6% and 38.9% (OR 2.75, 95% CI 1.03-7.30), respectively. Seven-day abstinence in the two groups was 12.1% and 5.6% (OR 2.35, 95% CI 0.40-13.74), respectively. Of the 15 intervention group participants who set a quit date during the intervention, 13 (86.7%) selected a Monday quit day. Qualitative interviews revealed positive participant experiences with picking a Monday quit day. On follow-up surveys, 89.5%, 69.3%, and 64.3% of intervention participants reported that the counseling, QSQM email, and text messaging, respectively, were very or somewhat helpful.

Conclusions: The QSQM model was acceptable and potentially efficacious among people with MHCs, but intervention engagement and satisfaction were modest. Future research should adapt or develop new QSQM delivery approaches to improve patient engagement and potential efficacy of the model. This trial is registered with clinicaltrials.gov (NCT04512248).