A randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol.

BACKGROUND: Already a major health concern, late-life depression (LLD) is expected to form an increasing problem in the aging population. Moreover, despite current treatments, LLD is associated with a poor long-term prognosis and high rate of chronicity. Treatment provision and treatment accordingly warrant improvement, where add-on treatments might contribute to the efficacy of conventional therapies. Although it is known that impaired cognitive control contributes to LDD, it is not targeted sufficiently by current interventions. Research on cognitive control training (CCT) shows promising results on depressive symptoms, cognitive performance, and overall functioning. However, further research is needed to determine the long-term effects of CCT on LLD, its cost-effectiveness, and mechanisms of change. METHODS: In the current multicenter randomized controlled trial (RCT) with a between-subjects design participants aged 60 years and over with a current LLD receiving treatment as usual (TAU) are randomized to add-on CCT or placebo training. Randomization is stratified by depression severity. Participants will receive eight online CCT or placebo sessions spread across four consecutive weeks. They will complete a post-training assessment after 1 month and three follow-up assessments scheduled three, six and 12 months after completing the training. We expect CCT and TAU to be more (cost-)effective in reducing depressive symptoms than placebo training and TAU. Additionally, we will be looking at secondary clinical, cognitive and global functioning outcomes and likely mechanisms of change (e.g., improved cognitive functioning, reduced rumination, and improved inhibition of negative stimuli). DISCUSSION: The proposed RCT aims to contribute to the clinical and scientific knowledge on the long-term effects of CCT as an add-on treatment for LLD. Cost-effectiveness is particularly relevant considering the expected volume of the target demographic. The study will be a pragmatic trial with few inclusion restrictions, providing information on feasibility of web-based trainings in clinical settings. The outcomes are potentially generalizable to guidelines for treatment of LLD. TRIAL REGISTRATION: This trial is registered in the Netherlands Trial Register (code: NL7639 ). Registered 3 april 2019.

The Bittersweet Effects of COVID-19 on Mental Health: Results of an Online Survey among a Sample of the Dutch Population Five Weeks after Relaxation of Lockdown Restrictions.

Previous research shows that crises can have both negative and positive mental health effects on the population. The current study explored these effects in the context of the COVID-19 pandemic after relaxation of governmental measures. An online survey was administered among a representative sample of the Dutch population (n = 1519) in June 2020, ten weeks after the peak of COVID-19 had passed, and five weeks after restrictions were relaxed. Participants were asked about mental health, adverse events during COVID-19, and about any positive effects of the pandemic. Most participants (80%, n = 1207) reported no change in mental health since the COVID-19 pandemic. This was also the case among respondents who had experienced an adverse event. Protective factors of mental health were being male and high levels of positive mental well-being. Risk factors were emotional loneliness and the experience of adverse life events. Social loneliness was positively associated with stable mental health, stressing the importance of meaningful relationships. Note that 58% of participants reported positive effects of the pandemic, the most common of which were rest, working from home, and feeling more socially connected. In summary, 10 weeks after the start of the crisis, and 5 weeks after relaxation of the restrictions, most people remained stable during the crisis, and were even able to report positive effects.

Validation of the Flourishing Scale in a sample of people with suboptimal levels of mental well-being.

BACKGROUND: There is growing interest in measuring the eudaimonic perspective of mental well-being (social and psychological well-being) alongside existing measures of the hedonic perspective of mental well-being (subjective well-being). The Flourishing Scale (FS) assesses core aspects of social-psychological functioning and is now widely used in research in practice. However, the reliability and validity of eudaimonic measures such as the FS has not yet been tested in people with low or moderate levels of well-being. This group is at risk for developing mental disorders and, therefore, an important target group for public mental health. METHODS: We extensively evaluated the psychometric properties of the 8-item FS in a sample of adults with low or moderate levels of well-being in The Netherlands (N = 275) using confirmatory factor analysis (CFA), item response theory analysis and a multitrait matrix. RESULTS: The unidimensional structure of the scale was confirmed with CFA and an adequate fit to the Rasch model. However, our sample showed positive skewness of the scale, but lacked measurement precision at the higher end of the social-psychological continuum. In general, the multitrait matrix demonstrated the convergent validity of the scale, with strong to weak correlations between the FS and (1) overall well-being, (2) social and psychological well-being (3) positive eudaimonic states, (4) hedonic states, (5) psychopathology and (6) personality traits. Nevertheless, relatively low correlations were found, specifically in comparison with the Mental Health Continuum-Short Form (MHC-SF). CONCLUSIONS: The FS seems a reliable and valid instrument for measuring social-psychological functioning in adults with suboptimal well-being, but its use in intervention studies and clinical practice might be debatable. Therefore, the FS seems most suitable to include in epidemiological studies alongside existing hedonic measures to more fully capture mental well-being. Future research should examine the temporal stability of the FS and the consequences of the positive skewness and limited external validity of the scale found in the current study.

Improving work functioning and mental health of health care employees using an e-mental health approach to workers' health surveillance: pretest-posttest study.

BACKGROUND: Mental health complaints are quite common in health care employees and can have adverse effects on work functioning. The aim of this study was to evaluate an e-mental health (EMH) approach to workers' health surveillance (WHS) for nurses and allied health professionals. Using the waiting-list group of a previous randomized controlled trial with high dropout and low compliance to the intervention, we studied the pre- and posteffects of the EMH approach in a larger group of participants. METHODS: We applied a pretest-posttest study design. The WHS consisted of online screening on impaired work functioning and mental health followed by online automatically generated personalized feedback, online tailored advice, and access to self-help EMH interventions. The effects on work functioning, stress, and work-related fatigue after 3 months were analyzed using paired t tests and effect sizes. RESULTS: One hundred and twenty-eight nurses and allied health professionals participated at pretest as well as posttest. Significant improvements were found on work functioning (p = 0.01) and work-related fatigue (p < 0.01). Work functioning had relevantly improved in 30% of participants. A small meaningful effect on stress was found (Cohen d = .23) in the participants who had logged onto an EMH intervention (20%, n = 26). CONCLUSION: The EMH approach to WHS improves the work functioning and mental health of nurses and allied health professionals. However, because we found small effects and participation in the offered EMH interventions was low, there is ample room for improvement.

Mental Vitality @ Work: The effectiveness of a mental module for workers' health surveillance for nurses and allied health professionals, comparing two approaches in a cluster-randomised controlled trial.

PURPOSE: The aim of this study was to compare two approaches for a worker's health surveillance (WHS) mental module on work functioning and work-related mental health. METHODS: Nurses and allied health professionals from one organisation were cluster-randomised at ward level to e-mental health care (EMH) (N = 579) or occupational physician care (OP) (N = 591). Both groups received screening and personalised feedback on impaired work functioning and mental health. Positively screened participants received an invitation to follow a self-help EMH intervention, or for a consultation with an OP. The primary outcome was impaired work functioning. Follow-up was performed after 3 and 6 months. Linear mixed models were applied to determine differences. Non-inferiority of the EMH-care approach was demonstrated if the mean absolute improvement on work functioning in the OP-care group was ≤10 points higher than the EMH-care group. RESULTS: Analyses were performed on the positively screened participants (almost 80 %) (EMH N = 75; OP N = 108) and all participants (EMH N = 98; OP N = 142). Both groups improved over time regarding impaired work functioning. A considerable percentage of participants had improved relevantly at follow-up regarding work functioning (3 months: EMH 30 %, OP 46 %; 6 months: EMH 36 %, OP 41 %) compared to baseline. No statistically significant differences were found between the groups, and the difference did not exceed the pre-defined criterion for non-inferiority. CONCLUSION: The OP-care approach for a WHS mental module trended towards better performance in targeting work functioning, but our findings indicate that the EMH-care approach was non-inferior. However, the high dropout rate and low compliance to EMH interventions should be taken into account.

An Internet-based intervention to promote mental fitness for mildly depressed adults: randomized controlled trial.

BACKGROUND: Depression is a worldwide problem warranting global solutions to tackle it. Enhancing well-being has benefits in its own right and could be a good strategy for preventing depression. Providing well-being interventions via the Internet may have synergetic effects. OBJECTIVE: Psyfit ("mental fitness online") is a fully automated self-help intervention to improve well-being based on positive psychology. This study examines the clinical effects of this intervention. METHODS: We conducted a 2-armed randomized controlled trial that compared the effects of access to Psyfit for 2 months (n=143) to a waiting-list control condition (n=141). Mild to moderately depressed adults in the general population seeking self-help were recruited. Primary outcome was well-being measured by Mental Health Continuum-Short Form (MHC-SF) and WHO Well-being Index (WHO-5); secondary outcomes were depressive symptoms, anxiety, vitality, and general health measured by Center for Epidemiological Studies Depression Scale (CES-D), Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and Medical Outcomes Study-Short Form (MOS-SF) vitality and general health subscales, respectively. Online measurements were taken at baseline, 2 months, and 6 months after baseline. RESULTS: The dropout rate was 37.8% in the Psyfit group and 22.7% in the control group. At 2-month follow-up, Psyfit tended to be more effective in enhancing well-being (nonsignificantly for MHC-SF: Cohen's d=0.27, P=.06; significantly for WHO-5: Cohen's d=0.31, P=.01), compared to the waiting-list control group. For the secondary outcomes, small but significant effects were found for general health (Cohen's d=0.14, P=.01), vitality (d=0.22, P=.02), anxiety symptoms (Cohen's d=0.32, P=.001), and depressive symptoms (Cohen's d=0.36, P=.02). At 6-month follow-up, there were no significant effects on well-being (MHC-SF: Cohen's d=0.01, P=.90; WHO-5: Cohen's d=0.26, P=.11), whereas depressive symptoms (Cohen's d=0.35, P=.02) and anxiety symptoms (Cohen's d=0.35, P=.001) were still significantly reduced compared to the control group. There was no clear dose-response relationship between adherence and effectiveness, although some significant differences appeared across most outcomes in favor of those completing at least 1 lesson in the intervention. CONCLUSIONS: This study shows that an online well-being intervention can effectively enhance well-being (at least in the short-term and for 1 well-being measure) and can help to reduce anxiety and depression symptoms. Further research should focus on increasing adherence and motivation, reaching and serving lower-educated people, and widening the target group to include people with different levels of depressive symptoms. TRIAL REGISTRATION: Netherlands Trial Register (NTR) number: NTR2126; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2126 (archived by WebCite at http://www.webcitation.org/6IIiVrLcO).

Effect of an E-mental health approach to workers' health surveillance versus control group on work functioning of hospital employees: a cluster-RCT.

OBJECTIVE: To evaluate an e-mental health (EMH) approach to workers' health surveillance (WHS) targeting work functioning (WF) and mental health (MH) of healthcare professionals in a randomised controlled trial. METHODS: Nurses and allied health professionals (N = 1140) were cluster-randomised at ward level to the intervention (IG) or control group (CG). The intervention consisted of two parts: (a) online screening and personalised feedback on impaired WF and MH, followed by (b) a tailored offer of self-help EMH interventions. CG received none of these parts. Primary outcome was impaired WF (Nurses Work Functioning Questionnaire), assessed at baseline and after three and six months. Analyses were performed in the positively screened subgroup (i) and in all participants (ii). RESULTS: Participation rate at baseline was 32% (NIG = 178; NCG = 188). Eighty-two percent screened positive for at least mild impairments in WF and/or MH (NIG = 139; NCG = 161). All IG-participants (N = 178) received part (a) of the intervention, nine participants (all positively screened, 6%) followed an EMH intervention to at least some extent. Regarding the subgroup of positively screened participants (i), both IG and CG improved over time regarding WF (non-significant between-group difference). After six months, 36% of positively screened IG-participants (18/50) had a relevant WF improvement compared to baseline, versus 28% (32/115) of positively screened CG-participants (non-significant difference). In the complete sample (ii), IG and CG improved over time but IG further improved between three and six months while CG did not (significant interaction effect). CONCLUSIONS: In our study with a full compliance rate of 6% and substantial drop-out leading to a small and underpowered sample, we could not demonstrate that an EMH-approach to WHS is more effective to improve WF and MH than a control group. The effect found in the complete sample of participants is not easily interpreted. Reported results may be useful for future meta-analytic work. TRIAL REGISTRATION: Dutch Trial Register NTR2786.

Mental Vitality @ Work--a workers' health surveillance mental module for nurses and allied health care professionals: process evaluation of a randomized controlled trial.

OBJECTIVE: To evaluate the process of workers' health surveillance (WHS) targeting work functioning and mental health of health care professionals, alongside a randomized controlled trial comparing two strategies. METHODS: Nurses and allied health care professionals working in one hospital were invited. Process indicators were assessed using methods such as questionnaires and track-and-trace data. RESULTS: All participants (32%; N = 369) received screening and personalized feedback. In group 1, 41% went to a preventive consultation with their occupational physician. Protocol adherence of participating occupational physicians (n = 5) was high. They regarded the WHS mental module to be meaningful. In group 2, 16% logged into an e-mental health intervention. Most participants would appreciate a future offer of the WHS. CONCLUSIONS: The WHS mental module was well received and fitted in the occupational health service activities. Nevertheless, response and compliance should be improved.

Positive psychology interventions: a meta-analysis of randomized controlled studies.

BACKGROUND: The use of positive psychological interventions may be considered as a complementary strategy in mental health promotion and treatment. The present article constitutes a meta-analytical study of the effectiveness of positive psychology interventions for the general public and for individuals with specific psychosocial problems. METHODS: We conducted a systematic literature search using PubMed, PsychInfo, the Cochrane register, and manual searches. Forty articles, describing 39 studies, totaling 6,139 participants, met the criteria for inclusion. The outcome measures used were subjective well-being, psychological well-being and depression. Positive psychology interventions included self-help interventions, group training and individual therapy. RESULTS: The standardized mean difference was 0.34 for subjective well-being, 0.20 for psychological well-being and 0.23 for depression indicating small effects for positive psychology interventions. At follow-up from three to six months, effect sizes are small, but still significant for subjective well-being and psychological well-being, indicating that effects are fairly sustainable. Heterogeneity was rather high, due to the wide diversity of the studies included. Several variables moderated the impact on depression: Interventions were more effective if they were of longer duration, if recruitment was conducted via referral or hospital, if interventions were delivered to people with certain psychosocial problems and on an individual basis, and if the study design was of low quality. Moreover, indications for publication bias were found, and the quality of the studies varied considerably. CONCLUSIONS: The results of this meta-analysis show that positive psychology interventions can be effective in the enhancement of subjective well-being and psychological well-being, as well as in helping to reduce depressive symptoms. Additional high-quality peer-reviewed studies in diverse (clinical) populations are needed to strengthen the evidence-base for positive psychology interventions.

The impact of emotional well-being on long-term recovery and survival in physical illness: a meta-analysis.

This meta-analysis synthesized studies on emotional well-being as predictor of the prognosis of physical illness, while in addition evaluating the impact of putative moderators, namely constructs of well-being, health-related outcome, year of publication, follow-up time and methodological quality of the included studies. The search in reference lists and electronic databases (Medline and PsycInfo) identified 17 eligible studies examining the impact of general well-being, positive affect and life satisfaction on recovery and survival in physically ill patients. Meta-analytically combining these studies revealed a Likelihood Ratio of 1.14, indicating a small but significant effect. Higher levels of emotional well-being are beneficial for recovery and survival in physically ill patients. The findings show that emotional well-being predicts long-term prognosis of physical illness. This suggests that enhancement of emotional well-being may improve the prognosis of physical illness, which should be investigated by future research.

Internet-based intervention to promote mental fitness in mildly depressed adults: design of a randomized controlled trial.

BACKGROUND: Investing in mental well-being is considered a supplement to current mental health service delivery in which the treatment and prevention of mental disorders are core components. It may be possible for people to enhance their well-being by boosting their "mental fitness." OBJECTIVE: Psyfit, an online, multi-component, fully automated self-help intervention, was developed with the aim of improving well-being and reducing depressive symptoms. The efficacy and cost-effectiveness of this intervention will be examined in a randomized controlled trial. METHODS: In this two-armed randomized controlled trial, a total of 290 participants will be assigned to use Psyfit (experimental condition) or to a 6-month waiting list (control condition). Adults with mild to moderate depressive symptoms interested in improving their mental fitness will be recruited from the general population through advertisements on the Internet and in newspapers. Online measurements by self-assessment will be made prior to randomization (pre-test), 2 months after baseline (post-test), and 6 months after baseline (follow-up). RESULTS: The primary outcome is well-being. Secondary outcomes are depressive symptoms, general health, vitality, and economic costs. Analysis will be conducted in accordance with the intention-to-treat principle. CONCLUSIONS: This study will examine the efficacy and cost-effectiveness of an online intervention that aims to promote well-being in people with elevated levels of depressive symptoms. If shown to be effective, the intervention could prove to be an affordable and widely accessible intervention to improve well-being in the general population. TRIAL REGISTRATION: The study is registered with the Netherlands Trial Register, part of the Dutch Cochrane Centre (NTR2126).

Alcohol and drug prevention in nightlife settings: a review of experimental studies.

This study examines the evidence regarding the effectiveness of interventions aimed at the prevention of harmful alcohol and drug use in nightlife settings. A literature search was conducted in 2009. Of 161 studies, 17 experimental studies were included in the review, 15 alcohol-related and two drug-related studies. The results show that preventive substance abuse interventions in nightlife settings can effectively reduce high-risk alcohol consumption, alcohol-related injury, violent crimes, access to alcohol by underage youth, and alcohol service to intoxicated people. A combination of approaches such as enforcement activities seem to be facilitating factors. However, results should be considered cautiously as more gold standard (cost-) effectiveness research is required, in particular directed at drug prevention and educational interventions in nightlife settings.

The Mental Vitality @ Work study: design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals.

BACKGROUND: Employees in health care service are at high risk for developing mental health complaints. The effects of mental health complaints on work can have serious consequences for the quality of care provided by these workers. To help health service workers remain healthy and productive, preventive actions are necessary. A Workers' Health Surveillance (WHS) mental module may be an effective strategy to monitor and promote good (mental) health and work performance. The objective of this paper is to describe the design of a three arm cluster randomized controlled trial on the effectiveness of a WHS mental module for nurses and allied health professionals. Two strategies for this WHS mental module will be compared along with data from a control group. Additionally, the cost effectiveness of the approaches will be evaluated from a societal perspective. METHODS: The study is designed as a cluster randomized controlled trial consisting of three arms (two intervention groups, 1 control group) with randomization at ward level. The study population consists of 86 departments in one Dutch academic medical center with a total of 1731 nurses and allied health professionals. At baseline, after three months and after six months of follow-up, outcomes will be assessed by online questionnaires. In both intervention arms, participants will complete a screening to detect problems in mental health and work functioning and receive feedback on their screening results. In cases of impairments in mental health or work functioning in the first intervention arm, a consultation with an occupational physician will be offered. The second intervention arm offers a choice of self-help e-mental health interventions, which will be tailored based on each individual's mental health state and work functioning. The primary outcomes will be help-seeking behavior and work functioning. Secondary outcomes will be mental health and wellbeing. Furthermore, cost-effectiveness in both intervention arms will be assessed, and a process evaluation will be performed. DISCUSSION: When it is proven effective compared to a control group, a WHS mental module for nurses and allied health professionals could be implemented and used on a regular basis by occupational health services in hospitals to improve employees' mental health and work functioning. TRIAL REGISTRATION: NTR2786.

Avoiding counterproductive results: an experimental pretest of a harm reduction intervention on attitude toward party drugs among users and nonusers.

In two experimental studies, the authors tested written health education materials on the personal acceptance of party drug use. Following a harm reduction strategy, the materials provided information on minimizing potential hazards associated with drug use. Among users and nonusers, potential aversive effects of these materials were examined on measures of attitude, intention, and outcome expectancy toward party drug use. Participants were recruited in the city center of Maastricht, The Netherlands, in nightlife settings that were popular among young people. In the first experiment, a leaflet on ecstasy use was evaluated among ecstasy users and nonusers. Results showed neither health promoting effects, nor counterproductive results on the outcome measures. In the second experiment, the effects of two different formats (leaflet vs. infocard) about two different kinds of party drugs (ecstasy vs. GHB) were compared within a nonusing population. Again, results showed no positive changes on the outcome measures toward ecstasy use as a result of exposure to the ecstasy materials. However, exposure to the GHB materials resulted into a more negative attitude toward GHB use (leaflet and infocard) and lower estimates of the likelihood of positive outcomes of use (infocard). The study's limitations and implications are discussed, including the need for experimental pretesting.

Cannabis use and the risk of later schizophrenia: a review.

AIM: To study the role of cannabis use in the onset of symptoms and disorders in the schizophrenia spectrum. DESIGN: Review of five population-based, longitudinal studies on the relationship between cannabis use and problems ranging from the experience of psychotic symptoms to hospitalization with a confirmed diagnosis of schizophrenia. Several hypotheses are examined that may explain this relationship: (1) self-medication; (2) effects of other drugs; (3) confounding; (4) stronger effect in predisposed people, and (5) etiological hypothesis. FINDINGS: Hypotheses 1 and 2 can be dismissed; hypothesis 3 is still open to debate, and converging evidence is found for hypotheses 4 and 5-antecedent cannabis use appears to act as a risk factor in the onset of schizophrenia, especially in vulnerable people, but also in people without prior history. CONCLUSION: There is an intrinsic message here for public health, but how that message is to be translated into action is not immediately clear.