Addictive behaviors research group. University of Oviedo, Spain. The efficacy of Behavioral Activation and voucher-based Contingency Management for cigarette smokers with depression: a Randomized Controlled Trial Alba González-Roz, Sara Weidberg, Ángel García-Pérez, Víctor Martínez-Loredo & Roberto Secades-Villa Addictive behaviors research group. University of Oviedo, Spain. Alba González De La Roz albagroz@cop.es GRUPO DE CONDUCTAS ADICTIVAS Universidad de Oviedo http://www.unioviedo.es/gca/ +36 985 10 41 89

Acknowledgements and Disclosure of Interest This work was supported by the Ministry of Economy and Competitiveness (MINECO) Ref. PSI2015-64371P and by a predoctoral grant from the Spanish Government Ref. BES-2016-076663 Conflict of interest: none to declare PI: Roberto Secades-Villa.

Background Current stimates indicate that 23.95% of Spanish people are current smokers (National Institute of Statistics, 2011-2012). Smokers with depression show High levels of nicotine dependence (Goodchild, Nargis, & Tursan d´Espaignet, 2017) More difficulty in quitting smoking (Cinciripini et al., 2003; Zyeldonis et al., 2008) Higher relapse rates (Brodbeck, 2014; Zvolensky, 2015) Some studies reported promising results when adding mood management interventions (e.g.., Behavioral Activation) to standard smoking cessation treatments, but the scarce evidence precludes from yielding conclusions on the effectiveness of Mood Management interventions. Contingency Management (CM) has extensively demonstated its efficacy in reducing tobacco use among special populations including adults with severe psychiatric disorders such as schizophrenia (Gallagher et al., 2007; Tidey et al., 2002; 2011). CM interventions for smoking have not been implemented in smokers with major depression (Tidey, 2012).

Aims of the study To analyze whether adding a CM component to a Cognitive Behavioral Treatment (CBT) + BA intervention would significantly increase rates of: adherence to treatment, smoking cessation and depressive symptoms among treatment-seeking smokers with elevated depressive symptoms.

Participants EXCLUSION INCLUSION CRITERIA CRITERIA Randomized (n = 74) INCLUSION CRITERIA EXCLUSION CRITERIA Allocation CBT + BA (n= 41) ¨ Received allocated intervention (n= 41) CBT + BA + CM (n= 33) ¨ Received allocated intervention (n= 33) Severe psychiatric disorder SUDs Suicide risk Receiving other cessation treatment ≥18 years old ≥10 cig/day MDD (SCID I-CV: DSM-IV-TR) ≥14 on BDI-II Discontinued intervention (i.e., not willing to quit) (n = 3) Completed End of Treatment Assessment (n= 38) Lost to follow-up intervention (i.e., not willing to quit) (n = 2) Completed End of Treatment Assessment (n= 31) Analysis Analysed Intention-to-treat (n= 41) Analysed Intention-to-treat (n= 33)

Treatment protocols CBT + BA TREATMENTS SCHEDULE BA Component Duration: 8 weeks One session per week of 1.5 hours Group-based format: 4 patients CO samples and urine cotinine collected twice a week CBT + BA BA Component Behavioral Activation Treatment for Depression (BATD) Assessment of the function of depressed behavior Strategies for reduncing reinforcement of depressed behavior Information gathering Establishment of patient rapport Monitoring daily activities Scheduling activities CBT Component Nicotine fading (30%/week) Information about tobacco Self-monitoring of smoking Feedback consumption (CO & cotinine) Behavioral contract Stimulus control Training in alternative behaviors Strategies for controlling nicotine withdrawal symptoms Relapse prevention strategies

CBT + BA + CM Abstinence criteria Cotinine < 80ng/ml CO < 4 ppm CM Component SESSION 1 A 2 A 3 A 4 A 5 A 6 A 7 A 8 SESSION 1 B 2 B 3 B 4 B 5 B 6 B 7 B Abstinence criteria Cotinine < 80ng/ml CO < 4 ppm The maximum amount that patients could earn was 175€ (US$ 190) R+ R+ R+ R+ R+ R+ R+ 10 15 20 25 30 35 40

COMBINATION OF TWO STRATEGIES: (1) Number of cigarettes per day ex.: 20 – 18 – 12 – 8 – 0 – 0 – 0 - 0 (2) Change to other cigarette brands with lower nicotine level ex. 0.8mg – S1: 0.6mg – S2: 0.4mg – s3: 0.2 mg – s4: 0.1 mg – 0.2mg – 0 – 0 – 0 – 0 Nicotine Fading WEEK 1 70% nicotine intake WEEK 2 40% nicotine intake WEEK 3 10% nicotine intake WEEK 4 WEEK 5 0% Abstinence WEEK 6 WEEK 7 0% Abstinence WEEK 8

Individualized cotinine reductions in urine samples

Sample Characteristics CBT + BA (n = 41) CBT + BA + CM (n = 33) p value Age (years)a 51.58 ± 9.55 52.71 ± 8.54 .596 Gender (% women) 75 82.4 .630 CO (ppm)a 27.08 ± 16.58 20.79 ± 8.01 .038 Cotinine (ng/ml) 2650.58 ± 1368.82 2410.65± 1040.34 .407 Cigarettes per daya 23.75 ± 8.46 21.24 ± 8.36 .204 Years of smokinga 32.80 ± 10.53 32.71 ± 8.87 .967 Fagerström Testa 6.07 ± 1.77 6.03 ± 2.22 .063 BDI-IIa 26.72 ± 9.65 30.42 ± 8.50 .091 Current diagnosis 22 26 .080 Single episode 31.8 15.4 - Recurrent episode 63.6 57.7 Chronic disorder 4.5 26.9 BADSa 23.63 ± 6.007 21.97 ±7.88 .31 EROSa 33.17±19.80 26.36±18.68 .14 Note. CBT= Cognitive-Behavioral Treatment; BA= Behavioral Activation; CM= Contingency Management; CO (ppm) = carbon monoxide (parts per million); BDI-II = Beck Depression Inventory; BADS-SF = Behavioral Activation for Depression scale-short form ; EROS = The Environmental Reward Contingency Scale; a = Mean ± SD

Attendance to all treatment sessions CBT+BA+CM 93.5% SESSIONS CBT+BA 71.1% p = 0.039, Cramer’s V = .29

In-treatment Abstinence CBT+BA CBT+BA+MC p =.55 DAYS OF ABSTINENCE

Depressive Symptomatology CBT + BA CBT + BA + CM p Intake 26.72 ± 9.65 30.42 ± 8.50 .091 EOT 11.87 ± 8.61 11.10 ± 6.86 .68

Relapse curve

Conclusions It is noteworthy that a 68% of the total sample achieved abstinence at the end of treatment, which is substantially higher than reported by previous studies using either BA protocols or pharmacotherapy. A greater percentage of patients receiving CBT+BA+CM attended to all therapy and midweek between sessions compared to those in the CBT+BA condition. The CBT+BA and CBT+BA+CM treatments brought about significant reductions in both smoking and depression at the end-of-treatment Despite both treatments promoted high abstinence rates and largely reduced depressive symptoms, results suggest that including a CM protocol could enhance smoking abstinence.

Addictive behaviors research group. University of Oviedo, Spain. Contingency Management and Behavioral Activation for smokers with depression Thanks for listening Alba González-Roz, Sara Weidberg, Ángel García-Pérez, Víctor Martínez-Loredo & Roberto Secades-Villa Addictive behaviors research group. University of Oviedo, Spain. Alba González De La Roz albagroz@cop.es GRUPO DE CONDUCTAS ADICTIVAS Universidad de Oviedo http://www.unioviedo.es/gca/ +36 985 10 41 89