A randomized controlled pilot study of a cognitive-behavioral video game intervention for the promotion of active aging.

Background: Due to the accessibility barriers of in-person programs for active aging, the development of programs that use innovative technologies is needed. Video games can be an engaging tool for disseminating active aging interventions. Objective: The objective of this pilot study was to analyze the feasibility of a cognitive-behavioral intervention to promote active aging administered through a video game. Methods: Fifty-five participants (63.6% women, mean age = 53.0 years) were randomly assigned to a cognitive-behavioral intervention to promote active aging administered through an interactive multimedia online video game with a complementary app (CBI-V; n = 29) or to a control group that received nonspecific online information (CG; n = 26). Results: Only 3.6% of the participants dropped out of the study (6.9% in CBI-V and 0.0% in CG; without significant differences between groups). The mean number of modules completed was 7.6 (SD = 0.9) out of 8 in the CBI-V and 7.9 (SD = 0.5) in the control group (CG), without significant between-group differences. In the CBI-V, the mean total time dedicated to the game was 516.8 min (SD = 94.3), including 143.2 min (SD = 31.6) of cognitive training tasks, and the mean of completed tasks was 206.2 (SD = 33.7) out of 259. Participants were highly engaged (M = 39.9, SD = 8.6) and satisfied (M = 25.8, SD = 4.5) with the intervention. After the intervention, the CBI-V group significantly improved on SF-36 dimensions of General Health (p = .0386), Vitality (p = .0283), Social Functioning (p = .0130), and Physical Summary Index (p = .0370) compared to the CG, with medium effect sizes (d = 0.56-0.75). Conclusions: The results demonstrate the feasibility of the video game intervention to promote active aging and encourage conducting a large-scale randomized controlled trial.

Efficacy of a Cognitive Behavioral Intervention for the Prevention of Depression in Nonprofessional Caregivers Administered through a Smartphone App: A Randomized Controlled Trial.

Due to the limited availability of in-person interventions for caregivers, the development of effective programs that use new technologies to prevent depression is needed. The goal of this research was to assess the efficacy of a cognitive behavioral intervention for the prevention of depression, administered to nonprofessional caregivers through a smartphone application (app). One hundred and seventy-five caregivers were randomly assigned to either an app-based cognitive behavioral intervention (CBIA), the CBIA intervention plus a telephone conference call (CBIA + CC), or an attention control group (ACG). At post-intervention, the incidence of depression was lower in the CBIA and CBIA + CC compared to the ACG (1.7% and 0.0% vs. 7.9%, respectively). The absolute risk, relative risk, and number needed to treat compared to the ACG were 6.2%, 21.6%, and 16 for the CBIA, whilst they were 8%, 0.0%, and 13 for the CBIA + CC. Depressive symptomatology was significantly lower in the CBIA and CBIA + CC compared to the ACG (d = 0.84, Cliff's δ = 0.49; d = 1.56, Cliff's δ = 0.72), as well as in the CBIA + CC compared to the CBIA (d = 0.72, Cliff's δ = 0.44). The prevention of depression was more likely in participants who received the CBIA, and adding the conference call in the CBIA + CC group improved the likelihood of this.

Reliability and Validity of the Geriatric Depression Scale in a Sample of Portuguese Older Adults with Mild-to-Moderate Cognitive Impairment.

Although the Geriatric Depression Scale (GDS) is a well-established instrument for the assessment of depressive symptoms in older adults, this has not been validated specifically for Portuguese older adults with cognitive impairment. The objective of this study was to analyze the psychometric properties of two Portuguese versions of the GDS (GDS-27 and GDS-15) in a sample of Portuguese older adults with mild-to-moderate cognitive impairment. Clinicians assessed for major depressive disorder and cognitive functioning in 117 participants with mild-to-moderate cognitive decline (76.9% female, Mage = 83.66 years). The internal consistency of GDS-27 and GDS-15 were 0.874 and 0.812, respectively. There was a significant correlation between GDS-27 and GDS-15 with the Beck Depression Inventory-II (GDS-27: rho = 0.738, p < 0.001; GDS-15: rho = 0.760, p < 0.001), suggesting good validity. A cutoff point of 15/16 in GDS-27 and 8/9 in GDS-15 resulted in the identification of persons with depression (GDS-27: sensitivity 100%, specificity 63%; GDS-15: sensitivity 90%, specificity 62%). Overall, the GDS-27 and GDS-15 are reliable and valid instruments for the assessment of depression in Portuguese-speaking older adults with cognitive impairment.

A pilot study for a smartphone app for the prevention of depression in non-professional caregivers.

OBJECTIVES: The main objective of the current study was to evaluate the feasibility and acceptability of a cognitive-behavioral prevention intervention administered through a smartphone app in non-professional caregivers with symptoms of depression. The secondary objective was to make a preliminary evaluation of its effectiveness either alone or supplemented with telephone conference calls. METHODS: Eighty-seven participants (Mage = 51.8 years) were randomly assigned to an app-based cognitive-behavioral intervention (CBIA; n = 29), CBIA supplemented with telephone conference calls (CBIA + CC; n = 28), or an attention control group (ACG; n = 30). The participants for both interventions received five cognitive-behavioral modules through the app, and those in CBIA + CC an additional 30-minute phone call in each module. RESULTS: 3.4% of caregivers dropped out. In all groups, the number of modules completed was high. Participants completed a high percentage of the homework and were highly satisfied with both CBIA and CBIA + CC. At post-intervention, there was a lower incidence of depression and depressive symptoms for CBIA + CC compared with CBIA, and for CBIA and CBIA + CC compared with ACG. CONCLUSION: The results supported the feasibility and acceptability of the cognitive-behavioral intervention, and demonstrated that telephone contact improves its effectiveness.

Epidemiological characteristics and hospitalization trajectories prior to suicide in Galicia between 2013 and 2016.

INTRODUCTION: Addressing suicide requires an understanding of regional patterns of epidemiology, with health variables being central. However, the clinical profile of people who commit suicide has received little attention. The objectives of this study were to analyze the sociodemographic, clinical, and forensic characteristics of persons who committed suicide in Galicia between 2013 and 2016, analyze suicide mortality rates, and identify trajectories of hospitalizations and associated variables. MATERIAL AND METHODS: A population study was carried out on the 1354 people who died by suicide in Galicia. RESULTS: The most common profile was a retired man, 57.9 years old (SD=18.5), from an urban and inner area. 43.6% had been previously hospitalized, 41.6% had been diagnosed with physical disorders, and 26.8% with mental disorders. 48.2% had been prescribed psychiatric medications and 29.6% had received outpatient psychiatric care. The highest prevalence of death by suicide (27.5%) was in 2014, with the predominant method being hanging (59.1%). The average raw rate was 12.3/100,000. Three trajectories of hospitalizations emerged: 94.83% had experienced few hospitalizations; 2.95% an increasing pattern; and 2.22% a decreasing pattern. These trajectories were associated with number of psychiatric appointments, prescription of psychiatric medications, and diagnoses of physical and mental disorders. CONCLUSIONS: These findings are crucial for detection and prevention.

Quality of Life and Sexual Satisfaction in Women with Breast Cancer Undergoing a Surgical Treatment and in Their Male Partners.

This study aimed to determine the quality of life and sexual satisfaction in a sample of 389 women with breast cancer who underwent a surgical treatment and 366 men who were these women's partners. The sample was recruited from the Portuguese League Against Cancer by 10 trained psychologists who assessed the quality of life and sexual satisfaction of the participants. Data on the sociodemographic variables, diagnosis and treatment in the female participants, relationship with their partner, anxiety and depression, and body image were also collected. It was found that 76.6% and 54.2% of the women had low physical and mental health, respectively, while 100% of partners had acceptable physical and mental health. The predictors of women's physical health were months since surgery, current treatment, completed treatments, satisfaction with the current relationship with their partner, lower anxiety and depression, and better body image. The predictors of women's mental health were months since diagnosis and treatment completion, satisfaction with partner support during the illness, lower anxiety and depression, and better body image. The predictors of both physical and mental health of partners were lower anxiety and depression. In addition, 88.4% of women and 100% of partners presented with sexual dysfunction. The predictors of women's sexual satisfaction were being older, satisfaction with their relationship with their partner before the illness, lower anxiety and depression, and better body image. The predictors of sexual satisfaction of the male partners were psychological/psychiatric support, satisfaction with their current relationship with their partner, and lower anxiety and depression. These findings suggest that interventions targeted at the quality of life of women and sexual satisfaction with a couple perspective are needed.

Sleep Disturbance, Psychological Distress and Perceived Burden in Female Family Caregivers of Dependent Patients with Dementia: A Case-Control Study.

This case-control study analyzed the sleep disturbance, psychological distress and perceived burden in female family caregivers of dependent people with dementia (n = 74) compared with female family caregivers of dependent people without dementia (n = 74) and with age-matched non-caregiver control females (n = 74). Participants completed the Pittsburgh Sleep Quality Index (PSQI), the 12-item General Health Questionnaire (GHQ-12), the Caregiver Burden Inventory (CBI) and an ad hoc questionnaire to collect sociodemographic data. There were significant differences between the groups in PSQI total (F = 24.93; p < 0.001), psychological distress (F = 26.71; p < 0.001) and in all sleep domains assessed: subjective sleep quality (F = 16.19; p < 0.001), sleep latency (F = 9.5; p< 0.001), sleep duration (F = 18.57; p < 0.001), habitual sleep efficiency (F = 19.77; p < 0.001), sleep disturbances (F = 9.22; p < 0.001), use of sleep medications (F = 4.24; p< 0.01) and daytime dysfunction (F = 5.57; p < 0.01). In all measures, the female family caregivers of dependent people with dementia showed the significantly higher mean scores. Regarding the two groups of female caregivers, statistically significant differences were found in daily hours of care (t = −2.45; p < 0.05) and perceived burden (t = −3.65; p < 0.001), as well as in the following dimensions of caregiver burden: time-dependence burden (t = −5.09; p < 0.001), developmental burden (t = −2.42; p < 0.05) and physical burden (t = −2.89; p < 0.01). These findings suggest that female family caregivers of dependent patients with dementia should be subject to psychopathological screening and preventive cognitive-behavioral interventions in clinical practice in primary health care.

Efficacy and moderators of cognitive therapy versus behavioural activation for adults with depression: study protocol of a systematic review and meta-analysis of individual participant data.

BACKGROUND: Cognitive therapy and behavioural activation are both widely applied and effective psychotherapies for depression, but it is unclear which works best for whom. Individual participant data (IPD) meta-analysis allows for examining moderators at the participant level and can provide more precise effect estimates than conventional meta-analysis, which is based on study-level data. AIMS: This article describes the protocol for a systematic review and IPD meta-analysis that aims to compare the efficacy of cognitive therapy and behavioural activation for adults with depression, and to explore moderators of treatment effect. (PROSPERO: CRD42022341602). METHOD: Systematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library, to identify randomised clinical trials comparing cognitive therapy and behavioural activation for adult acute-phase depression. Investigators of these trials will be invited to share their participant-level data. One-stage IPD meta-analyses will be conducted with mixed-effects models to assess treatment effects and to examine various available demographic, clinical and psychological participant characteristics as potential moderators. The primary outcome measure will be depressive symptom level at treatment completion. Secondary outcomes will include post-treatment anxiety, interpersonal functioning and quality of life, as well as follow-up outcomes. CONCLUSIONS: To the best of our knowledge, this will be the first IPD meta-analysis concerning cognitive therapy versus behavioural activation for adult depression. This study has the potential to enhance our knowledge of depression treatment by using state-of-the-art statistical techniques to compare the efficacy of two widely used psychotherapies, and by shedding more light on which of these treatments might work best for whom.

Prevalence and Associated Factors with Poor Sleep Quality in Non-Professional Caregivers.

This study aimed to determine the prevalence and associated factors of poor sleep quality in non-professional caregivers. With this purpose, cross-sectional data were collected from 201 dependent people's family caregivers using the Pittsburgh Sleep Quality Index (PSQI), the Caregiver Burden Inventory (CBI), the General Health Questionnaire (GHQ-12), and an ad hoc questionnaire to obtain sociodemographic data. A total of 153 family caregivers were categorized as poor sleepers (PSQI > 5), resulting in a prevalence of poor sleep quality of 76.1% (95% CI = 70.5-82.5). Poor sleepers were more likely to care for persons with mental disorders (χ2 = 7.31; p < 0.01) and scored significantly higher on perceived burden (z = -4.44; p < 0.001), psychological distress (z = -6.24; p < 0.001), and in all the PSQI subscales (p < 0.001), compared with good sleepers (PSQI ≤ 5). By contrast, no differences were found between poor and good sleepers in age, gender, years providing care, and daily hours of care. Multiple linear regression analysis showed that the factors of caregiver burden (ß = 0.15; p < 0.05) and psychological distress (ß = 0.53; p < 0.001) were significantly associated with sleep quality in dependent people's family caregivers. Cognitive-behavioral strategies to improve sleep quality in the primary health care of family caregivers are suggested.

Sexual Victimization and Mental Health in Female University Students.

Although sexual assaults on female university students are a public health concern, studies that have examined this issue have not used behaviorally specific definitions of the various types of sexual victimization. Furthermore, hardly any data exists on female Spanish university students. The objectives of this study were to analyze the prevalence of different forms of sexual assault against female Spanish university students, determine the risk factors associated with sexual assault, analyze the association between sexual victimization and mental health problems, and determine the differential risk of more serious types of sexual assault. A cross-sectional study was conducted among a random sample of 871 students from the University of Santiago de Compostela (Spain) (mean age 20.7 years, SD = 2.8). The current study assessed various types of sexual violence (i.e., unwanted sexual contact, attempted coercion, coercion, attempted rape, rape), as well as rates of depression, anxiety, stress, eating disorders, substance abuse, suicide risk, and suicide attempts. Of the female students surveyed, 28.5% had suffered some form of sexual violence during the previous year, 22.3% reported unwanted sexual contact, 8.8% attempted coercion, 6.5% coercion, 10.4% attempted rape, and 7.9% had been raped. Lower risk was associated with having a partner and being heterosexual. Being 18 years of age and prior experiences of sexual victimization were associated with higher risk. Being the victim of attempted coercion was associated with a higher risk of depression, while victims of attempted rape were at higher risk for substance use. Rape victims were at the highest risk for all mental health conditions studied, with the exception of suicide attempts. Due to the high rates at which Spanish female university students experience sexual violence, planning and resources are needed to address their mental health needs, especially those who are victims of rape.

Factorial Structure and Psychometric Properties of the Spanish Version of the Pittsburgh Sleep Quality Index in Non-Professional Caregivers.

Although sleep issues are among the symptoms commonly experienced by the non-professional caregiver population, and the Pittsburgh Sleep Quality Index (PSQI) is the most widely used instrument for the assessment of sleep quality, this has not been validated specifically for this population. The objective of this study was to analyze the factorial structure and psychometric properties of the Spanish version of the PSQI in a sample of Spanish non-professional caregivers. Trained clinical psychologists assessed sleep quality using the PSQI, as well as caregiver burden and psychological distress in 201 non-professional caregivers (87.1% female, Mage = 56.2 years). The internal consistency of the PSQI was 0.75. The two-factor model (Sleep quality and Disturbances) had an acceptable fit to the data, was found to be superior to the one-factor model, and more parsimonious than the three-factor model. There was a significant correlation between the PSQI and caregiver burden, as well as between the PSQI and psychological distress (p < 0.001 in all cases). A total score ≥ 9 allowed the identification of caregivers with possible anxiety and depression disorders (sensitivity 70.5%, specificity 71.9%). The results show that the PSQI is a reliable and valid instrument for the assessment of sleep quality in caregivers.

Development of a Videogame for the Promotion of Active Aging Through Depression Prevention, Healthy Lifestyle Habits, and Cognitive Stimulation for Middle-to-Older Aged Adults.

Objective: The objective of this pilot study was to analyze the efficacy on perceived health and the feasibility of a multicomponent psychological intervention to promote active aging through depression prevention, healthy lifestyle habits, and cognitive stimulation in middle-to-older adulthood administered through an interactive multimedia online videogame with a complementary smartphone app. Materials and Methods: Twenty-five participants from the general population aged 45 or older with computer and smartphone access and no difficulties in communication, sensory or mental health condition (64.0% women, mean age 54.9 years) participated in the intervention, which consisted of eight modules with tasks between sessions. The multicomponent intervention consisted of three components (depression prevention, healthy lifestyle habits, and cognitive stimulation) and was administered using an interactive online multimedia videogame (graphic adventure type), with a complementary smartphone app. Perceived health, dropouts, adherence to the intervention (performed modules and completed intersession tasks), and engagement were independently assessed. Results: After the intervention, participants exhibited significant improvement in their scores for General Health, Physical Functioning, Social Functioning, and Mental Health, with effect sizes ranging from small (d = 0.38) to medium (d = 0.59). The dropout rate was only 8%. The mean number of completed modules was 7.5 (SD = 1.8), and the mean number of tasks performed was 232.4 (out of 259) (SD = 15.4). Participants were highly satisfied (M = 27.7; SD = 3.1) and engaged (M = 42.7; SD = 4.7) with the intervention. Conclusion: The results support the efficacy and feasibility of using the videogame to promote active aging, and they encourage further evaluation through a randomized-controlled clinical trial. ClinicalTrials.gov NCT03643237.

Symptoms of Depression, Anxiety, and Stress and Prevalence of Major Depression and Its Predictors in Female University Students.

Depression, anxiety and stress are increasingly concerning phenomena in our society, with serious consequences on physical and mental health. The repercussions may be particularly devastating in particular population subgroups, such as female university students. The purpose of this study was to determine the levels of depression, anxiety, and stress and the prevalence of depression and associated factors, in Spanish university women. A cross-sectional study was conducted with a random sample of 871 students from the Santiago de Compostela University (mean age 20.7 years, SD = 2.8). Information was collected on sociodemographic and academic characteristics; symptoms of depression, anxiety, and stress; diagnosis of major depression; optimism, resilience, social support, life engagement, and five personality domains, using validated instruments. Of the participants, 18.1%, 22.8% and 13.5% presented with severe/very severe levels of depression, anxiety and stress, respectively. A total of 12.9% had major depression. Higher life engagement was associated with lower risk of depression (OR = 0.92, 95% CI 0.87-0.98), while higher levels of neuroticism (OR = 1.20, 95% CI, 1.12-1.28) and openness to experience (OR = 1.08, 95% CI, 1.02-1.14) were associated with greater risk. These findings reveal an alarming percentage of female university students who experience major depression and severe/very severe stress.

Long-Term Effects of a Cognitive Behavioral Conference Call Intervention on Depression in Non-Professional Caregivers.

Recent evidence supports the efficacy of conference call cognitive-behavioral interventions in preventing depression in caregivers at post-intervention, but we do not know whether the results are sustained long term. The main objective of this study was to evaluate the long-term efficacy of a cognitive-behavioral intervention administered by telephone conference call in preventing depression in caregivers with elevated depressive symptoms, comparing all components of the intervention versus only the behavioral ones. A randomized controlled trial was conducted using a dismantling strategy. At total of 219 caregivers were randomly assigned to a cognitive-behavioral conference call intervention (CBCC; n = 69), a behavioral-activation conference call intervention (BACC; n = 70), or a usual care control group (CG, n = 80). Information was collected on depressive symptoms and depression at pre-intervention and at 1, 3, 6, 12, and 36 months post-intervention. At 36 months, there was a reduction in depressive symptoms (p < 0.001) and a lower incidence of major depressive episodes in both the CBCC and BACC groups compared to CG (8.7%, 8.6%, and 33.7%, respectively). The results show that a conference call intervention was effective in the long term to prevent depression in caregivers and that the behavioral-activation component was comparable to the complete cognitive-behavioral protocol.

Brief Psychological Intervention Through Mobile App and Conference Calls for the Prevention of Depression in Non-Professional Caregivers: A Pilot Study.

Despite its potential, no intervention aimed at non-professional caregivers administered through a smartphone app has been proven to prevent depression. The objective of this pilot study was to evaluate the efficacy and feasibility of an indicated depression-prevention intervention for non-professional caregivers administered through an app with the addition of conference-call contact. The intervention was administered to 31 caregivers (Mean age = 54.0 years, 93.5% women). An independent evaluation determined the incidence of depression, depressive symptoms, risk of developing depression, and the variables in the theoretical model (positive environmental reinforcement, negative automatic thoughts) at the pre-intervention and post-intervention, as well as the one- and three-month follow-ups. The incidence of depression at 3 months of follow-up was 6.5%. There was a significant reduction in depressive symptoms (p < 0.001) and in the risk of developing depression (p < 0.001) at the post-intervention and at the one- and three-month follow-ups. The model's variables improved significantly after the intervention and were associated with post-intervention depressive symptoms. The intervention was more effective in caregivers who had a lower level of depressive symptoms at the pre-intervention. Adherence and satisfaction with the intervention were high. The results encourage future research using a randomized controlled clinical trial.

Analysis of the Components of a Cognitive-Behavioral Intervention for the prevention of Depression Administered via Conference Call to Nonprofessional Caregivers: A Randomized Controlled Trial.

Effective and accessible interventions for indicated prevention of depression are necessary and lacking, especially for informal caregivers. Although telephone-based interventions could increase the accessibility for caregivers, randomized controlled trials are scarce, with no examination of prevention to date. Moreover, the efficacy of specific therapeutic components in preventive cognitive-behavioral programs is unknown. The main objective of this study was to evaluate the efficacy of a telephone-administered psychological preventive intervention in informal caregivers with high depressive symptoms. A total of 219 caregivers were randomized to a cognitive-behavioral conference call intervention (CBCC, n = 69), a behavioral-activation conference call intervention (BACC, n = 70), or a usual care control group (CG, n = 80). Both interventions consisted of five 90-minute group sessions. At the post-intervention, incidence of depression was lower in CBCC and BACC compared to CG (1.5% and 1.4% vs. 8.8%). Relative risk was 0.17 for the CBCC and 0.16 for the BACC, and the number-needed-to-treat was 14 in both groups. Depressive symptoms were significantly lower in BACC and BACC groups compared to CG (d = 1.16 and 1.29), with no significant differences between CBCC and BACC groups. The conference call intervention was effective in preventing depression and the behavioral-activation component (BACC) was comparable to the CBCC intervention.

Identification of non-professional caregivers with high resilience using sociodemographic, care, and personal and social development variables.

Objectives: Despite the importance of resilience in well-being and adaptation to the role of caregiver in non-professional caregivers, research on resilience in this population has been scarce and contradictory, and has methodological limitations. The objective of this study was to identify subgroups of caregivers with high levels of resilience based on a series of predictors including sociodemographic variables and variables related to care and personal and social development.Method: 294 non-professional caregivers (89.8% women) with a mean age of 55.3 years (SD = 10.9) were randomly selected. Trained evaluators collected the sociodemographic variables of the person in care and the caregiver and on the care situation, self-esteem, social support, emotional distress and resilience.Results: The Classification Tree Analysis (CTA) showed that self-esteem was the main predictor of high resilience. Additional predictors were: (1) for those with high self-esteem, longer duration of care; (2) for those with low self-esteem, less emotional distress; (3) for those with less emotional distress, shorter duration of care.Conclusion: The results offer guidelines for developing programs to promote high resilience.

Problem-solving intervention to prevent depression in non-professional caregivers: a randomized controlled trial with 8 years of follow-up.

BACKGROUND: Studies of psychological interventions for the prevention of depression have found significant effects in the short-term, but the long-term efficacy has yet to be determined. This study evaluated the 8-year effect of a randomized controlled trial for indicated prevention of depression in female caregivers. METHODS: A total of 173 non-professional female caregivers with subclinical depressive symptoms not meeting criteria for a major depressive episode (MDE) were randomized to either a brief problem-solving intervention (n = 89) or usual-care control group (n = 84). Blinded evaluators conducted an assessment at the 8-year follow-up. The primary outcome was Depression Status, defined by diagnoses of MDE since the 1-year follow-up using the Structured Clinical Interview for the Disorders of the DSM-5. The secondary outcome was current Depressive Symptom Severity. Regression analyses were conducted to evaluate the effect of the intervention on the outcomes. RESULTS: There were no significant differences in the Depression Status between the problem-solving (30.3%) and control groups (26.2%) (adjusted OR 1.25, 95% CI -0.58 to 2.69). Depressive Symptom Severity, however, was significantly lower in the problem-solving group compared to the control group at this follow-up, amounting to a small effect size of Cohen's d = 0.39 (adjusted B = -3.32, p = 0.018). CONCLUSIONS: This is the first study to assess such a long-term follow-up of intervention of indicated prevention of depression. Results seem to indicate that the protective effect of the intervention became smaller over time during follow-up. Future research should replicate these results.

Cognitive-behavioral intervention via interactive multimedia online video game for active aging: study protocol for a randomized controlled trial.

BACKGROUND: Due to the progressive aging of the population, programs to promote active aging have been recommended. However, older adults have difficulty accessing them. Interventions administered through online video games may increase their accessibility, and complementing these with a smartphone app will likely increase adherence and allow for ongoing professional monitoring. The objective of this study is to evaluate the efficacy of a cognitive-behavioral intervention for active aging administered through an online interactive multimedia video game that includes a smartphone app companion. The secondary objectives are to analyze the moderators and mediators of the change in the outcome variables and to evaluate the adherence to the intervention. METHODS/DESIGN: A randomized controlled clinical trial will be conducted. Adults 45 years and older will be randomly assigned to a cognitive-behavioral intervention administered through an online multimedia video game that includes a smartphone app companion or to a control group that will receive online information on active aging (274 participants per group). The intervention will be administered in eight weekly 45-min modules. An investigator-blinded evaluation will be conducted using online self-administered tests at baseline, post-intervention, and 6- and 12-month follow-ups. The primary outcome will be mental health status as evaluated using the 36-item Short-Form Health Survey (SF-36) at post-intervention. Secondary outcomes will be emotional well-being, depressive symptoms, reinforcement, negative thoughts, self-reported memory, cognitive task performance, sleep hygiene behaviors, physical activity, eating habits, body mass index, social support, dropout, treatment adherence, and satisfaction with the intervention. DISCUSSION: If the results are favorable, this study would involve the development of the first evidence-based active aging promotion intervention based on a video game that includes a smartphone app companion, providing evidence on its efficacy, accessibility, and clinical utility. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03643237. Registered 27 August 2018.

A Randomized Controlled Trial on the Effects of Electromyographic Biofeedback on Quality of Life and Bowel Symptoms in Elderly Women With Dyssynergic Defecation.

Dyssynergic defecation is a usual cause of chronic constipation in elderly women, with a negative impact on health-related quality of life. The present randomized controlled trial aims to evaluate the effects of behavioral treatment through electromyographic biofeedback (EMG-BF) on quality of life and bowel symptoms in elderly women with dyssynergic defecation. Twenty chronically constipated elderly women, due to dyssynergic defecation, were enrolled in the study. Outcome measures included weekly stool frequency, anismus index, severity of patient-reported chronic constipation symptoms (abdominal, rectal, and stool symptoms), and overall measure of quality of life. After 1 month of baseline, participants were randomly assigned to either EMG-BF group (n = 10) or control group (n = 10). Three months after treatment, female patients were once again assessed following the same procedure in baseline. One-way multivariate analysis of variance MANOVA revealed no significant differences between the groups before treatment in any of the measured dependent variables (Wilks's λ = 0.74; F6,13 = 0.77; p = 0.61). Likewise, univariate analysis showed no differences between the groups, either in terms of age (F1,18 = 0.96; p = 0.34) or mean disease duration (F1,18 = 2.99; p = 0.11). Three months after treatment, MANOVA revealed statistically significant differences between the groups (Wilks's λ = 0.29; F6,13 = 5.19; p < 0.01). These differences were significant in all outcome measures. EMG-BF produces significant improvements in bowel symptoms and health-related quality of life of elderly women with dyssynergic defecation.