scholarly journals A Randomised Controlled Trial of Inhibitory Control Training for Smoking Cessation: Outcomes, Mediators and Methodological Considerations

2021 ◽  
Vol 12 ◽  
Author(s):  
Laura K. Hughes ◽  
Melissa J. Hayden ◽  
Jason Bos ◽  
Natalia S. Lawrence ◽  
George J. Youssef ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Active Control ◽  
Nicotine Dependence ◽  
Inhibitory Control ◽  
Controlled Trial ◽  
Health Behaviours ◽  
Control Group ◽  
Post Intervention ◽  
Methodological Considerations

Objective: Inhibitory control training (ICT) has shown promise for improving health behaviours, however, less is known about its mediators of effectiveness. The current paper reports whether ICT reduces smoking-related outcomes such as craving and nicotine dependence, increases motivation to quit and whether reductions in smoking or craving are mediated by response inhibition or a devaluation of smoking stimuli.Method: Adult smokers (minimum 10 cigarettes per day; N = 107, Mage = 46.15 years, 57 female) were randomly allocated to receive 14 days of smoking-specific ICT (named INST; a go/no-go task where participants were trained to not respond to smoking stimuli) or active control training (participants inhibited responding toward neutral stimuli). Participants were followed up to 3-months post-intervention. This trial was preregistered (Australian and New Zealand Clinical Trials Registry ID: ACTRN12617000252314; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370204).Results: There were no significant differences between ICT and active control training groups. Specifically, participants in both groups showed significant reductions in craving, nicotine dependence, motivation and a devaluation (reduced evaluation) of smoking-stimuli up to 3-months follow-up compared to baseline. Inhibition and devaluation of smoking stimuli did not act as mediators. Devaluation of smoking stimuli was an independent predictor of smoking and craving at follow-up.Conclusion: Inhibitory control training (ICT) was no more effective at reducing smoking-related outcomes compared to the active control group, however, significant improvements in craving, dependence indicators and evaluation of smoking stimuli were observed across both groups. A return to basic experimental research may be required to understand the most effective ICT approach to support smoking cessation.

scholarly journals Brief self-affirmation intervention for adults with psoriasis for reducing anxiety and depression and boosting well-being: Evidence from a randomized controlled trial

2021 ◽  
pp. 1-11
Author(s):  
Patryk Łakuta
Keyword(s):  
Mental Health ◽  
Health Outcomes ◽  
Active Control ◽  
Implementation Intentions ◽  
Controlled Trial ◽  
Well Being ◽  
Mental Health Outcomes ◽  
Control Group ◽  
Post Intervention

Abstract Background There are relatively few studies to address mental health implications of self-affirming, especially across groups experiencing a chronic health condition. In this study, short- and longer-term effects of a brief self-affirmation intervention framed in terms of implementation intentions (if-then plans with self-affirming cognitions; S-AII) were evaluated against an active control group (non-affirming implementation intentions; N-AII), matched to the target condition, and mere goal intention condition (a non-active control) in adults with psoriasis. The three pre-registered primary outcomes captured depression, anxiety, and well-being. Methods Adults with psoriasis (N = 175; Mage = 36.53, s.d. = 11.52) were randomized into S-AII, N-AII, or control. Participants' mental health outcomes were assessed prior to randomization (at baseline), at week 2 (post-intervention), and at a 1-month follow-up. Results Linear mixed models were used and results were reported on the intention-to-treat principle. Analyses revealed that S-AII exerted significantly more improvement in the course of well-being (ds > 0.25), depressive symptoms (ds > −0.40), and anxiety (ds > −0.45) than the N-AII and control group at 2-week post-intervention. Though the differences between groups faded at 1-month follow-up, the within-group changes over time for S-AII in all mental health outcomes remained significant. Conclusions Brief and low-intensity S-AII intervention exerted in the short-term a considerable impact on mental health outcomes. The S-AII shows promising results as a relevant public mental health strategy for enhancing well-being and reducing psychological distress. Future studies could consider whether these effects can be further enhanced with booster interventions.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals Robot-assisted gait training to reduce pusher behavior

Neurology ◽  
2018 ◽  
Vol 91 (14) ◽  
pp. e1319-e1327 ◽  
Author(s):  
Jeannine Bergmann ◽  
Carmen Krewer ◽  
Klaus Jahn ◽  
Friedemann Müller
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Gait Training ◽  
Class Ii ◽  
Control Group ◽  
Robot Assisted ◽  
Post Intervention ◽  
Subacute Stroke ◽  
Post Test

ObjectiveTo determine the effects of 2 weeks of intensive robot-assisted gait training (RAGT) on pusher behavior compared to nonrobotic physiotherapy (nR-PT).MethodsIn a single-blind, randomized, controlled trial with 2 parallel arms, we compared 2 weeks of daily RAGT (intervention group) with the same amount of nR-PT (control group). Patients with subacute stroke who had pusher behavior according to the Scale for Contraversive Pushing (SCP) were included. The primary research questions were whether changes in pusher behavior would differ between groups post intervention, and at a follow-up 2 weeks afterward (SCP and Burke Lateropulsion Scale, Class II evidence). Secondary outcomes included the Performance-Oriented Mobility Assessment, the Functional Ambulation Classification, and the Subjective Visual Vertical.ResultsThirty-eight patients were randomized. Thereof, 30 patients received the allocated intervention and were included in the analyses. RAGT led to a larger reduction of pusher behavior than nR-PT at post test (SCP: U = 69.00, r = −0.33, p = 0.037; Burke Lateropulsion Scale: U = 47.500, r = −0.50, p = 0.003) and at follow-up (SCP: U = 54.00, r = −0.44, p = 0.008). Pusher behavior had ceased in 6 of 15 participants in the intervention group and 1 of 15 participants in the control group at post test. At follow-up, 9 of 15 and 5 of 15 participants, respectively, no longer exhibited the behavior.ConclusionsTwo weeks of RAGT seems to persistently reduce pusher behavior, possibly by recalibrating the disturbed inner reference of verticality. The potential benefits of RAGT on pusher behavior and verticality perception require further investigation.Trial registrationGerman Clinical Trials Register (registration number: DRKS00003444).Classification of evidenceThis study provides Class II evidence that RAGT is beneficial to reduce pusher behavior in patients with stroke.

scholarly journals Rewards can be used effectively with repeated exposure to increase liking of vegetables in 4–6-year-old children

2011 ◽  
Vol 16 (5) ◽  
pp. 942-951 ◽  
Author(s):  
Nadia Corsini ◽  
Amy Slater ◽  
Adam Harrison ◽  
Lucy Cooke ◽  
David N Cox
Keyword(s):  
Vegetable Consumption ◽  
Controlled Trial ◽  
South Australia ◽  
Repeated Exposure ◽  
Control Group ◽  
Post Intervention ◽  
Local Media ◽  
Taste Exposure ◽  
And Control

AbstractObjectiveTo examine whether parents offering a sticker reward to their child to taste a vegetable the child does not currently consume is associated with improvements in children's liking and consumption of the vegetable.DesignA randomized controlled trial evaluated the effectiveness of exposure only (EO) and exposure plus reward (E + R), relative to a control group, on children's liking and consumption of a target vegetable. Assessments were conducted at baseline and 2 weeks from baseline (post-intervention). Follow-up assessments were conducted at 4 weeks and 3 months from baseline.SettingThe study took place in Adelaide, South Australia. Participants were self-selected in response to local media advertisements seeking to recruit parents finding it difficult to get their children to eat vegetables.SubjectsParticipants were 185 children (110 boys, seventy-five girls) aged 4–6 years and their primary caregiver/parent (172 mothers, thirteen fathers).ResultsThe E + R group was able to achieve more days of taste exposure. Both EO and E + R increased liking at post-intervention compared with control and no further change occurred over the follow-up period. All groups increased their intake of the target vegetable at post-intervention. Target vegetable consumption continued to increase significantly over the follow-up period for E + R and control but not for EO.ConclusionsThe findings provide support for the effectiveness of using a sticker reward with a repeated exposure strategy. In particular, such rewards can facilitate the actual tastings necessary to change liking.

scholarly journals Randomised controlled trial of the new short-term online emotion focused training for self-compassion and self-protection in a nonclinical sample

2018 ◽  
Vol 40 (1) ◽  
pp. 333-343 ◽  
Author(s):  
Júlia Halamová ◽  
Martin Kanovský ◽  
Karolína Varšová ◽  
Nuriye Kupeli
Keyword(s):  
Mental Health Professionals ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Population ◽  
Control Group ◽  
Short Term ◽  
Post Intervention ◽  
Self Compassion ◽  
Self Protection

AbstractThe Emotion Focused Training for Self-Compassion and Self-Protection (EFT-SCP) is an intervention developed to increase skills of self-compassion and protective anger with the aim to decrease self-criticism. This novel intervention was developed on the basis of the latest findings on self-criticism from Emotion-focused therapy and previous programs cultivating compassion (namely Compassion Mind Training and Mindful Self-Compassion Program). According to existing research, simply cultivating self-compassion is not always sufficient in reducing self-criticism. Therefore, the EFT-SCP was designed to build self-compassion whilst developing protective anger to combat self-criticism. Our goal was to investigate the efficacy of this new, short-term, online EFT-SCP program in a non-clinical population. A randomized control trial was conducted with pre- and post-intervention measurements and two-month follow-up of self-compassion and self-criticism/reassurance. Convenience sampling was used to recruit participants through a snowballing technique on social media. A total of 123 participants were randomly allocated to the EFT-SCP intervention or to a control condition. The intervention group were instructed through emails to complete an EFT-SCP task every day for 14 consecutive days. The control group did not complete any tasks. Out of 123 participants, 31 from intervention group and 20 from control group completed all measurements. There was a significant effect of the EFT-SCP on increasing self-compassion and self-reassurance scores as reported at two-month follow-up. The EFT-SCP was also effective at reducing self-uncompassionate responding and self-criticism (specifically Hated self) with changes evident at two months post-intervention. These findings are encouraging and suggest that interventions designed to enhance self-compassion and decrease self-criticism can be delivered to broader populations without the direct contact with mental health professionals.

A WeChat-Based Smoking Cessation Intervention for Chinese Smokers: A Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Ting Luo ◽  
Mirandy S. Li ◽  
Donna Williams ◽  
Jackson Fritz ◽  
Kaylin Beiter ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Oral Health ◽  
Health Education ◽  
Nicotine Dependence ◽  
Controlled Trial ◽  
Smoking Cessation Intervention ◽  
Standard Group ◽  
Oral Health Education ◽  
Cessation Intervention

BACKGROUND China is the largest tobacco producer and has the highest number of tobacco consumers in the world. Extensive research has demonstrated ways that social media can assist in quitting smoking. WeChat is the most commonly used social media platform in China; however, it has not yet been used for smoking cessation interventions. OBJECTIVE The objectives of this study are (1) to evaluate the effectiveness of a WeChat-based smoking cessation intervention; and (2) to examine a possible synergistic effect of integrating oral health and smoking-related information into a tailored, Transtheoretical Model (TTM) guided smoking cessation intervention. METHODS Eligible adults were recruited through WeChat from July 1 to August 6, 2019, to participate in a 3-arm, single-blinded, randomized controlled trial. 403 participants were enrolled and randomized into three groups: Standard Group (smoking cessation intervention only, n=136), Enhanced Group (smoking cessation + oral health education interventions, n=136), or Waitlist Group (delayed smoking cessation intervention, n=132). The intervention was delivered through WeChat with total of three weeks. Participants were asked to complete questionnaires at baseline and follow-up assessments as well as process evaluation at each intervention week. The primary outcome was Stage of Change, and the secondary outcomes were 7-day Point Prevalence Abstinence (PPA), 24-hour PPA, daily cigarette use, and nicotine dependence at 4 weeks follow-up after intervention comparing intervention groups and control group. The overall attrition rate was 46%. Paired t-tests, McNemar tests, and linear and logistic regression were used to examine differences in smoking cessation outcomes within and between groups. RESULTS Compared to baseline, at follow-up, all groups experienced smokers had significantly greater reduction in nicotine dependence scores (Standard: 1.8; Enhanced: 1.9, and Waitlist: 0.4). At 4-week follow-up, compared to the Waitlist Group, smokers from the Enhanced Group and the Standard Group had significantly lower nicotine dependence scores, lower daily cigarette use, and were more likely to have stage of change progression movement. Participants in Enhanced Group (β=-1.28, 95%CI: -2.13, -0.44) and the Standard Group (β=-1.13, 95%CI: -1.95, -0.30) also reported larger change in nicotine dependence score, compared to participants in the Waitlist Group. CONCLUSIONS This WeChat-based intervention was overall effective for smoking cessation, with enhanced cessation when additionally incorporating an oral health education intervention. Future smoking cessation programs should consider inclusion of oral health education. More broadly, in light of continued social distancing, WeChat could be considered as a platform for smoking cessation and other behavioral interventions.

scholarly journals Smoking Cessation Program for Inpatients with Substance Use Disorder: A Quasi-Randomized Controlled Trial of Feasibility and Efficacy

2016 ◽  
Vol 22 (5) ◽  
pp. 268-276 ◽  
Author(s):  
Tobias Rüther ◽  
Amelie Ruderer ◽  
Christina Wirth ◽  
Veronika Schuler ◽  
Verena Lang ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Substance Use ◽  
Substance Use Disorder ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Behavioral Program ◽  
Substance Dependent ◽  
Cognitive Behavioral Program

Aims: The present study investigated the feasibility, acceptance and efficacy of a newly developed cognitive behavioral program for smoking cessation/reduction (‘Rethink your Smoking' program, RSP) in inpatients with substance use disorder (SUD). Method: One hundred ninety-nine inpatients with SUD were randomly assigned to either the RSP (n = 101) or a minimal intervention (MI) program (n = 98). In addition, participants were offered optional nicotine replacement therapy. Data from a group of patients with SUD without any intervention (control group, n = 78) were included in the analyses for comparison. Assessments were performed at admission, discharge and follow-up after 3 and 6 months. Results: RSP proved to be feasible and was well accepted by participants. Patients in both interventions showed lower scores for physical nicotine dependence and number of cigarettes smoked per day and higher scores for various motivational parameters at discharge and 3 months later. Both interventions were superior to no intervention, but no differences were found between the RSP and MI. Conclusion: A smoking cessation/reduction program is feasible for substance-dependent in-patients undergoing detoxification. Although the RSP appears to be effective in terms of harm reduction in in-patients with SUD, more cost- and time-efficient programs might also be suitable for this population.

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

scholarly journals Impact of Intensive Gait Training With and Without Electromechanical Assistance in the Chronic Phase After Stroke–A Multi-Arm Randomized Controlled Trial With a 6 and 12 Months Follow Up

2021 ◽  
Vol 15 ◽  
Author(s):  
Susanne Palmcrantz ◽  
Anneli Wall ◽  
Katarina Skough Vreede ◽  
Påvel Lindberg ◽  
Anna Danielsson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Gait Training ◽  
Conventional Group ◽  
Control Group ◽  
Walk Test ◽  
Post Intervention ◽  
Randomized Controlled

Introduction: Movement related impairments and limitations in walking are common long-term after stroke. This multi-arm randomized controlled trial explored the impact of training with an electromechanically assisted gait training (EAGT) system, i.e., the Hybrid Assistive Limb® (HAL), when integrated with conventional rehabilitation focused on gait and mobility.Material and Methods: Participants, aged 18–70 years with lower extremity paresis but able to walk with manual support or supervision 1–10 years after stroke, were randomized to (A) HAL-training on a treadmill, combined with conventional rehabilitation interventions (HAL-group), or (B) conventional rehabilitation interventions only (Conventional group), 3 days/week for 6 weeks, or (C) no intervention (Control group). Participants in the Control group were interviewed weekly regarding their scheduled training. Primary outcome was endurance in walking quantified by the 6 Minute Walk Test (6MWT). A rater blinded to treatment allocation performed assessments pre- and post-intervention and at follow-ups at 6 and 12 months. Baseline assessment included the National Institute of Health Stroke Scale (NIHSS) and the Modified Ranking Scale (MRS). Secondary outcomes included the Fugl Meyer Assessment- Lower Extremity, 10 Meter Walk Test, Berg Balance Scale (BBS), Barthel Index (BI) and perceived mobility with the Stroke Impact Scale.Results: A total of 48 participants completed the intervention period. The HAL-group walked twice as far as the Conventional group during the intervention. Post-intervention, both groups exhibited improved 6 MWT results, while the Control group had declined. A significant improvement was only found in the Conventional group and when compared to the Control group (Tukey HSD p = 0.022), and not between the HAL group and Conventional group (Tukey HSD p = 0.258) or the HAL- group and the Control group (Tukey HSD p = 0.447). There was also a significant decline in the Conventional group from post-intervention to 6 months follow up (p = 0.043). The best fitting model to predict outcome included initial balance (BBS), followed by stroke severity (NIHSS), and dependence in activity and participation (BI and MRS).Conclusion: Intensive conventional gait training induced significant improvements long-term after stroke while integrating treadmill based EAGT had no additional value in this study sample. The results may support cost effective evidence-based interventions for gait training long-term after stroke and further development of EAGT.Trial registration: Published on clinicaltrials.gov (NCT02545088) August 24, 2015.

scholarly journals Exploring Efficacy of a Serious Game (Tobbstop) for Smoking Cessation During Pregnancy: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Francesc X Marin-Gomez ◽  
Rocio Garcia-Moreno Marchán ◽  
Anabel Mayos-Fernandez ◽  
Gemma Flores-Mateo ◽  
Esther Granado-Font ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Tobacco Use ◽  
Controlled Trial ◽  
Intervention Group ◽  
Serious Game ◽  
Control Group ◽  
Randomized Controlled ◽  
Pregnant Smokers

BACKGROUND Tobacco use during pregnancy entails a serious risk to the mother and harmful effects on the development of the child. Europe has the highest tobacco smoking prevalence (19.3%) compared with the 6.8% global mean. Between 20% to 30% of pregnant women used tobacco during pregnancy worldwide. These data emphasize the urgent need for community education and implementation of prevention strategies focused on the risks associated with tobacco use during pregnancy. OBJECTIVE The aim of this study was to investigate the efficacy of an intervention that incorporates a serious game (Tobbstop) to help pregnant smokers quit smoking. METHODS A two-arm randomized controlled trial enrolled 42 women who visited 2 primary care centers in Catalonia, Spain, between March 2015 and November 2016. All participants were pregnant smokers, above 18 years old, attending consultation with a midwife during the first trimester of pregnancy, and had expressed their desire to stop smoking. Participants were randomized to the intervention (n=21) or control group (n=21). The intervention group was instructed to install the game on their mobile phone or tablet and use it for 3 months. Until delivery, all the participants were assessed on their stage of smoking cessation during their follow-up midwife consultations. The primary outcome was continuous tobacco abstinence until delivery confirmed by the amount of carbon monoxide at each visit, measured with a carboxymeter. RESULTS Continuous abstinence until delivery outcome was 57% (12/21) in the intervention group versus 14% (3/21) in the control group (hazard ratio=4.31; 95% CI 1.87-9.97; P=.001). The mean of total days without smoking until delivery was higher in the intervention group (mean 139.75, SD 21.76) compared with the control group (mean 33.28, SD 13.27; P<.001). In addition, a Kapplan-Meier survival analysis showed that intervention group has a higher abstinence rate compared with the control group (log-rank test, χ21=13.91; P<.001). CONCLUSIONS Serious game use is associated with an increased likelihood to maintain abstinence during the intervention period if compared with those not using the game. Pregnancy is an ideal opportunity to intervene and control tobacco use among future mothers. On the other hand, serious games are an emerging technology, growing in importance, which are shown to be a good tool to help quitting smoking during pregnancy and also to maintain this abstinent behavior. However, because of the study design limitations, these outcomes should be interpreted with caution. More research, using larger samples and longer follow-up periods, is needed to replicate the findings of this study. CLINICALTRIAL ClinicalTrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421 (Archived by WebCite at http://www.webcitation.org/75ISc59pB)

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