Randomized Controlled Trials

Background: COVID-19 has taken many lives worldwide and due to this, millions of persons are in grief. When the grief process lasts longer than 6 months, the person is in risk of developing Complicated Grief Disorder (CGD). The CGD is related to serious health consequences. To reduce the probability of developing CGD a preventive intervention could be applied. In developing countries like Mexico, the psychological services are scarce, self-applied interventions could provide support to solve this problem and reduce the health impact even after the pandemic has already finished.

Aims: To design and implement a self-applied intervention composed of 12 modules focused on the decrease of the risk of developing CGD, and increasing the life quality, and as a secondary objective to reduce the symptomatology of anxiety, depression, and increase of sleep quality. The Intervention Duelo COVID (Grief COVID) follows the principles of User Experience (UX) and is designed according to the needs and desires of a sample of the objective participants, to increase the adherence to the self-applied intervention, considered one of the main weaknesses of online interventions.

Methods: A Randomized Controlled Trial will be conducted from the 22nd of December of 2020 to the first of June 2021. The participants will be assigned to an intervention with elements of Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Mindfulness and Positive Psychology. The control group will be a wait-list condition, that
will receive the intervention 1.5–2 months after the pre-measurement were taken. The Power Size Calculation conducted through G∗Power indicated the need for a total of 42 participants, which will be divided by 21 participants in each group. The platform will be delivered through responsive design assuring with this that the intervention will adapt to
the screen size of cellphones, tablets, and computers.

Ethics and Dissemination: The study counts with the approval of the Research Ethics Committee of the Autonomous University of Ciudad Juárez, México, and it is registered in Clinical Trials (NCT04638842). The article is sent and registered in clinical trials before the recruitment started. The results will be reported in future conferences, scientific
publications, and media.

Background: Long-term weight loss maintenance is difficult to achieve. Effectiveness of obesity interventions could be increased by providing extended treatment, and by focusing on person-environment interactions. Ecological Momentary Intervention (EMI) can account for these two factors by allowing an indefinite extension of a treatment protocol in everyday life. EMI relies on observations in daily life to intervene by providing appropriate in-the-moment treatment. The Think Slim intervention is an EMI based on the principles of cognitive behavioural therapy (CBT), and its effectiveness will be investigated in the current study.

There is considerable debate on whether suicide assessment carries an iatrogenic risk for participants/patients. A double-blind randomized controlled trial (registration: R000022314) tested the emotional impact of suicide assessment on participants (n = 259) randomly assigned to experimental (n = 122) or control conditions (n = 137). The experimental condition included the Suicidal Affect-Behavior-Cognition Scale and intensive death-related questions, the control condition a quality of life scale. Both included measures of depression, social support and loneliness. Affective states were assessed immediately before and after testing, and research biases minimized. Post-test debriefing interviews collected qualitative reactions. Experimental participants ranged from nonsuicidal to highly suicidal. Between-groups ANCOVAs and repeated measures ANOVAs showed no differences by study condition, and no pre-post-test affect changes for either condition or suicidal participants (P > 0.10), supporting the null hypothesis of no iatrogenic effects. However, depressive participants in both conditions showed significant decreases in positive affect (P < 0.05). Smallest real difference (SRD) scores approximated clinically meaningful differences and showed 20% of participants had a significant positive survey reaction , 24% a negative reaction, with the rest neutral. Linear regressions revealed depressive symptoms and perceived family support, but not suicidality or other factors, predicted negative affect changes, which was supported by qualitative findings. Social desirability bias was also found in qualitative survey responses. No evidence of iatrogenic effects of suicide assessment were found. Recommendations are made to counter possible negative assessment effects on depressive participants/patients, and nurses and other caregivers are encouraged to talk to patients about suicidal symptoms.

Ideal deliberative democracy seeks to employ unbiased moderators. Yet, a large literature in the field of
mediation suggests the elusiveness of perfect neutrality. Our study thus addresses the following question:
when moderators of deliberations express their own views – even in a limited manner – can they change the
preferences of participants? Using a novel experimental design in a real deliberative decision-making process,
we find that moderators can significantly influence the attitudes and behaviors of participants by expressing
views in a constrained manner. The results of our study have implications for refining epistemic conceptions of
deliberative democracy and for designing more precise empirical investigations of the effects of deliberative
processes on attitudes and behavior. The results also warn of a simple mechanism by which interest groups
might hijack the deliberative decision-making processes used in community driven development projects all
over the world.

Relevant achievements have been accomplished in prevention science with regard to disseminating efficacious parenting interventions among underserved populations. However, widespread disparities in availability of parenting services continue to negatively impact diverse populations in high-income countries (e.g., the USA) and low-and middle-income countries. As a result, a scholarly debate on cultural adaptation has evolved over the years. Specifically, some scholars have argued that in diverse cultural contexts, existing evidence-based parenting interventions should be delivered with strict fidelity to ensure effectiveness. Others have emphasized the need for cultural adaptations of interventions when disseminated among diverse populations. In this paper, we propose that discussions on cultural adaptation should be conceptualized as a Bboth-and,^ rather than an Beither-or^ process. To justify this stance, we describe three distinct parenting intervention projects to illustrate how cultural adaptation and efficacy of evidence-based interventions can be achieved using contrasting approaches and frameworks, depending on cultural preferences and available resources of local contexts. Further, we suggest the need to develop guidelines for consistent reporting of cultural adaptation procedures as a critical component of future investigations. This discussion is relevant for the broader public health field and prevention science.

To evaluate the comparative effectiveness of a classroom-based psychoeducation and skills intervention (tier 1) and a school-based trauma- and grief-focused group treatment (tier 2) of a three-tiered mental health program for adolescents exposed to severe war-related trauma, traumatic bereavement, and postwar adversity.

Background: Although orthodontic white spot lesions (WSLs) are one of the most often and most evident adverse effects of comprehensive fixed appliance treatment, the efficacy of interventions for WSLs has not yet been adequately assessed in an evidence-based manner. Objective: Aim of this systematic review was to assess the therapeutic and adverse effects of interventions to treat post-orthodontic WSLs from randomized trials in human patients. Search methods: An unrestricted electronic search of eight databases from inception to May 2016. Selection criteria: Randomized controlled trials assessing any interventions for post-orthodontic WSLs on human patients. Data collection and analysis: After duplicate study selection, data extraction, and risk of bias assessment according to the Cochrane guidelines, random-effects meta-analyses of mean differences (MDs), standardized mean differences (SMDs), and odds ratios (ORs), including their 95% confidence intervals (CIs) were performed, followed by subgroup and sensitivity analyses. Results: A total of 20 unique studies and a total of 942 (42 per cent male and 58% per cent female) patients were included, with an average age of 16.2 years and a mean number of 8.2 WSLs (range 2.2 to 45.4) per patient. These were allocated to adjunct treatment with casein phosphopeptide-stabilized amorphous calcium phosphate creams, external tooth bleaching, low-or high-concentration fluoride films, gels, mouthrinses or varnishes, resin infiltration, miswak chewing sticks, bioactive glass toothpastse, or to no adjunct treatment (i.e. conventional oral hygiene). The monthly use of fluoride varnish was the best supplement to improve WSLs in terms of lesion area (1 trial; MD = −0.80 mm 2 ; 95% CI = −1.10, −0.50 mm 2 ; P < 0.05; high quality) and enamel fluorescence (3 trials; SMD = −0.92; 95% CI = −1.32, −0.52; P < 0.05; high quality), followed by the use of fluoride film. WSL treatment did not provide a considerable improvement in their clinical evaluation (3 trials; OR = 0.97; 95% CI = 0.60, 1.56; P > 0.05; moderate quality), with imprecision due to small sample size being the main limitation of existing evidence. Conclusions: Based on the existing trials, interventions for post-orthodontic WSLs, mainly fluoride varnish, seem to be effective, but further research is needed to elucidate their clinical relevance. Registration: PROSPERO (CRD42016037538)

Il progetto “Benessere digitale - scuole” ha
completato il primo esperimento randomizzato
in Italia sull’efficacia dell’educazione ai
media. L’impatto di un intervento organico di
media education è stato infatti testato in un
campione di classi selezionate casualmente,
confrontate con un campione di controllo.

The “Digital Well-being - Schools” project carried out the first randomised trial in Italy on the efficacy of digital media education. The intervention was focused in particular on mobile media management in a permanent connection environment. The impact of the intervention was tested in a sample of randomly selected classes, compared with a control sample.

Emotional distress is common during chemothera-py, and supportive interventions during this time are often required. Mindfulness-based interventions appear promising amongst cancer survivors, but scant research has been conducted amongst patients undergoing acute treatment. This trial compared the efficacy of a brief mindfulness-based intervention (bMBT) with relaxation therapy on reducing distress amongst chemotherapy patients. Sixty-eight people receiving first-line chemotherapy at Auckland City Hospital were randomised to bMBT (n = 32) or relaxation training groups (n = 36). In both conditions, participants attended three 90-min weekly sessions. Overall distress (distress thermometer (DT); impact thermometer (IT)), cancer-related stress (Impact Events Scale–Cancer (IES-C)), cancer symptom distress (Memorial Symptom Assessment Scale–Short Form (MSAS-SF)) and social avoidance (SA) were assessed at enrolment , post-intervention and at 3-month follow-up. Both groups reported reductions in overall and cancer-related stress over time. Immediately post-intervention, however, bMBT (but not relaxation training) participants reported increased symptom distress, marginally increased social avoidance and decreased quality of life. So whilst overall distress and cancer distress declined in both groups, the mindfulness intervention was associated with increased symptom distress and social avoidance and reduced quality of life. This report presents a randomised controlled trial of a mindfulness-based intervention during chemotherapy and suggests that care is needed in employing mindfulness-based interventions in acute health treatment contexts.

Objectives. This study examines the feasibility and acceptability of a local adaptation of a mindfulness-based cognitive therapy (MBCT) program for Filipino school children, called Kamalayan, that was facilitated by trained public school teachers. It also
presents preliminary evidence of program effects on the children’s depressive and anxiety symptoms and difficulties in emotion regulation.

Methods. We utilized a randomized controlled design with an active control condition. Filipino elementary and high school students aged 9 to 16 years old from low-resource schools were randomly assigned to the Kamalayan (n = 87) or the active control Handicrafts condition (n = 99). Changes in outcomes from baseline, immediate post-intervention, and 2-month follow-up were assessed using multilevel modeling.

Results Participation in the Kamalayan program did not affect depression, anxiety, or emotion regulation. Impulse control difficulties increased for the Handicrafts group across post-intervention and follow-up but remained stable for Kamalayan participants. Depressive symptoms decreased over time for the Handicrafts group but remained stable for the Kamalayan condition. Implementation issues qualify the absence of program effects, such as the impracticability of delivering after-school
sessions in the public school context, program content that may be discordant with cognitive-developmental and cultural considerations, and the inadequacy of the personal mindfulness practice of the paraprofessional facilitators.

Conclusions The findings reaffirm the importance of using active control groups and considering the capacities of facilitators in evaluating the effects of mindfulness-based interventions. Testing mindfulness-based interventions in low-resource, non-Western school settings require deeper contextual adaptation and facilitator preparation.