A dyadic planning intervention to quit smoking in single-smoking couples:design of a randomized controlled trial

BACKGROUND: Tobacco use is the largest preventable cause of death. Smoking cessation interventions that use implementation intentions show promising results. Implementation intentions are if-then plans that specify a certain behaviour within a situational context. This study will examine whether involving a non-smoking partner could improve planning interventions, and whether and which partner interactions underlie this effectiveness. METHODS: This single-blind randomized controlled trial has a longitudinal design with a baseline questionnaire, end-of-day measurements for three weeks starting on the quit date, and a follow-up questionnaire after three months. PARTICIPANTS: single-smoking couples who live together and are in a relationship for more than one year. SETTING: couples are randomized to either a dyadic or individual planning condition. After the intervention the smoker attempts to quit smoking and the diary measurements start. MEASUREMENTS: The primary outcome variable is smoking abstinence. Secondary outcome measures are smoking behaviour and relationship satisfaction. Partner interactions are examined as a possible mediator. DISCUSSION: This RCT is the first to examine the effectiveness of dyadic planning to quit smoking in single-smoking couples. Partner interactions are thought to play an important role during the quit attempt, and therefore in the effectiveness of the intervention. This RCT will provide more insight into which daily partner interactions are beneficial for smoking abstinence and the couples' relationship satisfaction, and whether the type of intervention is related to different types or levels of partner interactions and smoking behaviour. When proven effective, this planning intervention in combination with coaching for the non-smoking partner will be a valuable and low-cost addition to existing smoking interventions. TRIAL REGISTRATION: The trial is retrospectively registered on 19/04/2017 on www.trialregister.nl ( TC: 6398 )

Predictors of digital support services use by informal caregivers:a cross-sectional comparative survey

OBJECTIVES: Digital support services may provide informal caregivers with remote access to information and training about care issues. However, there is limited specific data on how factors such as demographics, socioeconomic resources and the caregiving context may influence caregivers' use of digital support services. The aim of this study is to identify associations between informal caregiver's characteristics and the use of the internet to access digital support services in two countries: Italy and Sweden. SETTING AND PARTICIPANTS: A sample of 663 respondents who have access to the internet participated in a cross-sectional survey by completing the online questionnaire. Respondents were recruited by the Italian National Institute of Health and Science on Ageing and the Swedish Family Care Competence Centre. PRIMARY AND SECONDARY OUTCOME MEASURES: Logistic regression analyses were performed to assess predictors of caregivers' frequent use of the internet to access digital support services. RESULTS: Educational attainment (OR 3.649, 95% CI 1.424 to 9.350, p=0.007), hours per week spent caring (OR 2.928, 95% CI 1.481 to 5.791, p=0.002), total household income (OR 0.378, 95% CI 0.149 to 0.957, p=0.040), care recipient relationship to the caregiver (OR 2.895, 95% CI 1.037 to 8.083, p=0.042) and gender of care recipient (OR 0.575, 95% CI 0.356 to 0.928, p=0.023) were significant predictors in the multivariate analysis for the Italian caregivers group. Hours per week spent caring (OR 2.401, 95% CI 1.105 to 5.218, p=0.027) and age of caregiver (OR 2.237, 95% CI 1.150 to 4.352, p=0.018) were significant predictors in the multivariate analysis for the Swedish caregivers group. CONCLUSIONS: Digital support services could be important tools to empower informal caregivers. When it comes to policy and practice in relation to caregivers, similarly to other broad vulnerable groups, there is no 'one-size-fits-all' approach, and it is therefore important to consider the specific characteristics and needs of both caregivers and care recipients

Recruiting participants for an international mHealth study via Facebook Ads:Experiences from the Untire App RCT

Introduction: Social media recruitment via Facebook Ads seems to be a promising method for large-scale international trials examining the effectiveness of mHealth interventions. However, little is known about this method in terms of strategy, reach, and costs in the context of psycho-oncology. This paper presents the results of the recruitment strategy that was applied in the Untire app study and shows how many participants could be reached using advertisements (i.e., Ads) on Facebook, who participated, and what it cost. Method: The Untire app study is a randomized controlled trial targeted at cancer patients and survivors across four English-speaking countries (i.e., Australia, Canada, the U.K., and the U.S.A.). Reach was assessed by the number of people who were shown the Ads, who clicked on the Ads, and completed study assessments. Demographic characteristics were gathered from Facebook Ads Manager and from online study assessments to describe who was reached. Costs were assessed by the budget spent and the cost per click for Ads, for reaching the study's landing page, and for completing study assessments. To conduct a powered RCT, we needed 164 12-weeks assessments in both the intervention and the control group. Results: From March till October 2018, we used 76 Ads, which were presented to 1.2 million people. 37.376 persons clicked on the study link in the Ads, resulting in 755 baseline completers. Most participants were female (92%), middle-aged (55.5 ± 9.79), and came from the U.K. (72%). The total Facebook advertisement costs from March till October 2018 were €17 k, resulting in an average cost of €0.45 per click on the Ads, €5.55 on average for a person reaching the study's landing page, and €14.89 on average per eligible participant. The costs for every baseline and 12-weeks completer were €22.42 and €47.69, respectively. Discussion: Reaching participants for international mHealth studies in psycho-oncology via Facebook Ads has potential but is costly. The key to reducing costs lies in constant optimization and testing of Ads and refinement of target audience characteristics

Beating Cancer-Related Fatigue With the Untire Mobile App:Protocol for a Waiting List Randomized Controlled Trial

Background: Many cancer patients and survivors worldwide experience disabling fatigue as the main side effect of their illness and the treatments involved. Face-to-face therapy is effective in treating cancer-related fatigue (CRF), but it is also resource-intensive. Offering a self-management program via a mobile phone app (ie, the Untire app), based on elements of effective face-to-face treatments, might increase the number of patients receiving adequate support for fatigue and decrease care costs. Objective: The aim of this protocol is to describe a randomized controlled trial (RCT) to assess the effectiveness of the Untire app in reducing fatigue in cancer patients and survivors after 12 weeks of app use as compared with a waiting list control group. Substudies nested within this trial include questions concerning the reach and costs of online recruitment and uptake and usage of the Untire app. Methods: The Untire app study is a waiting list RCT targeting cancer patients and survivors who experience moderate to severe fatigue via social media (Facebook and Instagram) across 4 English-speaking countries (Australia, Canada, the United Kingdom, and the United States). The Untire app includes psychoeducation and exercises concerning energy conservation, activity management, optimizing restful sleep, mindfulness-based stress reduction, psychosocial support, cognitive behavioral therapy, and physical activity. After randomization, participants in the intervention group could access the Untire app immediately, whereas control participants had no access to the Untire app until the primary follow-up assessment at 12 weeks. Participants completed questionnaires at baseline before randomization and after 4, 8, 12, and 24 weeks. The study outcomes are fatigue (primary) and quality of life (QoL; secondary). Potential moderators and mediators of the hypothesized treatment effect on levels of fatigue and QoL were also assessed. Link clicks and app activation are used to assess reach and uptake, respectively. Log data are used to explore the characteristics of app use. Sample size calculations for the primary outcome showed that we needed to include 164 participants with complete 12-week measures both in the intervention and the control groups. The intention-to-treat approach is used in the primary analyses, which refers to analyzing all participants regardless of their app use. Results: Participants were recruited from March to October 2018. The last participant completed the 24-week assessment in March 2019. Conclusions: This mobile health (mHealth) RCT recruited participants online in multiple countries to examine the uptake and effectiveness of the Untire self-management app to reduce CRF. Many advantages of mHealth apps are assumed, such as the immediate access to the app, the low thresholds to seek support, and the absence of contact with care professionals that will reduce costs. If found effective, this app can easily be offered worldwide to patients experiencing CRF

Beating cancer-related fatigue with the Untire mobile app:Results from a waiting-list randomized controlled trial

Objective: This waiting-list randomized controlled trial examined the effectiveness of a self-management mHealth app in improving fatigue and quality of life (QoL) in cancer patients and survivors. Methods: Persons with cancer-related fatigue (CRF) were recruited across four English speaking countries, via social media, and randomized into intervention (n = 519) and control (n = 280) groups. Whereas the intervention group received immediate access to the Untire app, the control group received access only after 12-weeks. Primary outcomes fatigue severity and interference, and secondary outcome QoL were assessed at baseline, 4, 8, and 12-weeks. We ran generalized linear mixed models for all outcomes to determine the effects of app access (yes/no), over 12-weeks, following the intention-to-treat principle. Results: Compared with the control group, the intervention group showed significantly larger improvements in fatigue severity (d = 0.40), fatigue interference (d = 0.35), and overall QoL on average (d = 0.32) (P's 56). Effects did not depend on education and cancer status. Reliable change analyses indicated that significantly more people showed full recovery for fatigue in the intervention vs the control group (P's =.02). Conclusions: The Untire app can be an effective mHealth solution for cancer patients and survivors with moderate to severe CRF

Ethical review procedures in international internet-based intervention studies

International internet-based studies could be accessible by participants from various countries worldwide. However, the jurisdiction of research ethics committees (RECs) or institutional review boards (IRBs) is bound to geographical state or country borders. How can researchers deal with the geographical boundaries in the jurisdiction of RECs/IRBs versus the worldwide, open character of international internet-based research? Should ethical approval be sought in each country where participants will be recruited? In this paper, we want to share our challenges in setting up the ethical review procedures in an international internet-based mHealth intervention study, to further the discussion on ethical procedures in internet-based research

Daily Support and Negative Control During a Quit Attempt in Single-Smoking Couples

OBJECTIVE: Research has shown a beneficial influence of partner support on smoking cessation. Previous studies mainly focused on support and neglected negative behaviors. Less is known about differences in support perceptions between partners. This study aimed to examine how supportive as well as negative control behaviors relate to smoking and relationship satisfaction in single-smoking couples during a quit attempt. METHOD: Smokers and their nonsmoking partners (n = 170 cohabiting couples) participated in an intensive longitudinal study over 21 days with end-of-day diaries. A dyadic score model was used, emphasizing couple levels and differences for the explanatory variables (i.e., support and negative control) and the outcome variables (smoking [for smokers only]; relationship satisfaction). RESULTS: Smokers whose partner showed more supportive and less negative control behavior had a lower probability of smoking, and both partners had higher relationship satisfaction. On days with more supportive and less negative control behavior than usual, smokers had a lower probability of smoking and both partners had higher relationship satisfaction. For smokers who reported more support than their partner reported providing, the couples' relationship satisfaction was higher and the smokers' relationship satisfaction was higher than their partners'. Differences between received and provided support/control at the between-couple and daily level were unrelated to smoking. CONCLUSIONS: Support seems important during a quit attempt as it was related to a lower probability of smoking and higher relationship satisfaction in couples, while negative control behaviors should be avoided as they were associated with higher probability of smoking and lower relationship satisfaction. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Smoking-Related Social Control in Indonesian Single-Smoker Couples

BACKGROUND: The majority of Indonesian smokers are men and those who are married nearly always have a non-smoking wife (i.e. single-smoker couples). Previous studies have suggested that Indonesian women dislike smoking. However, contesting their husbands' smoking could be seen as disrespectful. In this study, we examine whether, and if so how, wives employ social control tactics to change their husbands' smoking and how the smokers perceive the tactics. METHOD: In-depth interviews (N = 12) with five single-smoker couples (N = 10 individual interviews) and two non-smoking wives of smokers (N = 2) were conducted in Jogjakarta, Indonesia. We used a social control framework and thematic analysis approach to analyse the transcribed interviews. RESULTS: Three themes emerged from smokers and their wives: (1) although the wives know that smoking is bad, they have to tolerate it, (2) wives and their husbands find it important to maintain harmony and (3) their family's needs serve as common ground. All the wives interviewed exerted social control to some degree, especially when they were pregnant or had children. Smokers reacted positively to social control and agreed to child-related house rules, but not to requests to give up smoking. CONCLUSION: Wives do exert social control and smokers are willing to accommodate and adapt their smoking. However, wives' influence on smoking may be limited in Indonesia, and focusing on managing their husbands' smoking at home rather than overall smoking might be more fruitful

Using the Transformative Storytelling Technique to Generate Empowering Narratives for Informal Caregivers:Semistructured Interviews, Thematic Analysis, and Method Demonstration

Background: The transformative storytelling technique is an innovative top-down approach to narrative therapy that aims to provide building blocks for creating flourishing narratives for target groups or populations. This approach acts as a facilitator for implementing the human-centered design in developing digital self-help tools for larger samples or target groups.Objective: This study applied the transformative storytelling technique, as a new approach in mental health, to develop empowering audio narratives for informal caregivers.Methods: A narrative inquiry was conducted with 17 informal caregivers (16 women and 1 man) who completed a semistructured interview, “Caregiver Life Story,” acquiring information about the beginning of the role, rising action, and critical point of the role. The participants' ages ranged from 41 to 84 years, with all participants providing care for at least a 6-month period. This inquiry was guided by the transformative storytelling technique, and aimed to collect data relevant to creating fictional stories based on real-life themes.Results: Twenty-five overall themes were distinguished across three a priori-set categories, providing narrative building blocks for the informal caregiver life stories. The final empowering caregiver life story was created as an example for this study, demonstrating the application of the transformative storytelling technique in an informal care context.Conclusions: The creation of empowering stories for populations or target groups in mental health care requires a unified and guided approach that will follow clear guidelines and storytelling principles. The transformative storytelling technique is a first of its kind in the mental health context, representing an initial step in enabling and supporting the creation of meaningful stories and the development of relatable, but productive, narratives. Such narratives have the potential to serve across media and digital platforms for supporting and improving well-being, and potentially triggering self-change in the target group or population.</p