Positive functioning as an outcome in its own right.
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1401 to 1425 of 6,178Compassion-focused therapy as guided self-help for enhancing public mental health: A randomized controlled trial.
Objective: Despite promising results for compassion-focused therapy (CFT) as self-help, larger-scale trials including long-term follow-up data are needed to establish its effectiveness in the context of public mental health. Empirical evidence supporting its effectiveness in improving well-being is lacking. In a randomized controlled trial, the effects of CFT as guided self-help on well-being were evaluated.
Method: Adults (mean age = 52.87, SD = 9.99, 74.8% female) with low to moderate levels of well-being were recruited in the Dutch population and randomized to CFT (n = 120) or a waitlist control group (n = 122). Participants completed the Mental Health Continuum-Short Form (well-being), Hospital Anxiety and Depression Scale (depression and anxiety), Perceived Stress Scale (stress), Self-Compassion Scale-Short Form (self-compassion), Forms of Self-Criticizing/Attacking and Reassurance …
matched on Mental Health (mesh), well-being (text)
Improving Social Support for Older Adults Through Technology: Findings From the PRISM Randomized Controlled Trial.
Objectives: Information and communication technology holds promise in terms of providing support and reducing isolation among older adults. We evaluated the impact of a specially designed computer system for older adults, the Personal Reminder Information and Social Management (PRISM) system.
Design, setting, and participants: The trial was a multisite randomized field trial conducted at 3 sites. PRISM was compared to a Binder condition wherein participants received a notebook that contained paper content similar to that contained in PRISM. The sample included 300 older adults at risk for social isolation who lived independently in the community (Mage = 76.15 years). Primary outcome measures included indices of social isolation, social support, loneliness, and well-being. Secondary outcome measures included indices of computer proficiency and attitudes toward technology. Data were collec…
matched on Mental Health (mesh), well-being (text)
Benefit-finding and effect on caregiver depression: A double-blind randomized controlled trial.
Objective: To examine the effects of using cognitive reappraisal to find positive gains on caregivers' depressive symptoms, burden, and psychological well-being.
Method: Ninety-six caregivers of persons with Alzheimer's disease were randomly assigned to receive a benefit-finding intervention or 1 of 2 treatment-as-usual conditions, namely, simplified psychoeducation (lectures only; SIM-PE) or standard psychoeducation (STD-PE). Each participant received 4 biweekly interventions of 3 hr each, over a 2-month period, at home.
Results: Results showed that benefit-finding participants reported lower depressive symptoms after treatment, when compared with either SIM-PE (d = -0.46) or STD-PE (d = -0.50) participants. They also reported less role overload when compared with STD-PE participants (d = -0.46). Self-efficacy in controlling upsetting thoughts was a mediator for some of the treatment ef…
matched on Mental Health (mesh), well-being (text)
Reducing the rate and duration of Re-ADMISsions among patients with unipolar disorder and bipolar disorder using smartphone-based monitoring and treatment - the RADMIS trials: study protocol for two randomized controlled trials.
Background: Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality due to mental and substance use disorders, and burden society with the highest health care costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric hospitalization are a major burden. Smartphones comprise an innovative and unique platform for the monitoring and treatment of depression and mania. No prior trial has investigated whether the use of a smartphone-based system can prevent re-admission among patients discharged from hospital. The present RADMIS trials aim to investigate whether using a smartphone-based monitoring and treatment system, including an integrated clinical feedback loop, reduces the rate and duration of re-admissions more than standard treatment in unipolar disorder and bipolar disorder.
Methods: The RADMIS trials use a randomize…
matched on Mental Health (mesh), quality of life (text)
Clarkson S, Axford N, Berry V, Edwards RT, Bjornstad G, Wrigley Z, Charles J, Hoare Z, Ukoumunne OC, Matthews J, Hutchings J (2016)randomised controlled trialMEDLINE-indexed journal, not yet read by usBMC public health10 citations Effectiveness and micro-costing of the KiVa school-based bullying prevention programme in Wales: study protocol for a pragmatic definitive parallel group cluster randomised controlled trial.
Background: Bullying refers to verbal, physical or psychological aggression repeated over time that is intended to cause harm or distress to the victims who are unable to defend themselves. It is a key public health priority owing to its widespread prevalence in schools and harmful short- and long-term effects on victims' well-being. There is a need to strengthen the evidence base by testing innovative approaches to preventing bullying. KiVa is a school-based bullying prevention programme with universal and indicated elements and an emphasis on changing bystander behaviour. It achieved promising results in a large trial in Finland, and now requires testing in other countries. This paper describes the protocol for a cluster randomised controlled trial (RCT) of KiVa in Wales.
Methods/design: The study uses a two-arm waitlist control pragmatic definitive parallel group cluster RCT design wi…
matched on Mental Health (mesh), well-being (text)
Study protocol for a randomized clinical trial of a fatherhood intervention for African American non-resident fathers: Can we improve father and child outcomes?
Purpose: African American (AA) fathers who live apart from their children face multiple obstacles to consistent and positive involvement with their children. Consequently, significant numbers of children are bereft of their father's positive involvement. Intervention research that is explicitly focused on promoting the positive involvement of non-resident AA fathers with their young children is limited. The purpose of this article is to describe the study protocol of a randomized trial (RCT) designed to test the Building Bridges to Fatherhood program against a financial literacy comparison condition; and discuss early implementation challenges.
Methods: Fathers (n=180) are recruited to attend 10 group meetings, reimbursed for transportation, given dinner and activity vouchers for spending time with their child, and incentivized with a $40 gift card at each data collection time point. Mot…
matched on Mental Health (mesh), well-being (text)
Hendrix CC, Bailey DE, Steinhauser KE, Olsen MK, Stechuchak KM, Lowman SG, Schwartz AJ, Riedel RF, Keefe FJ, Porter LS, Tulsky JA (2016)randomised controlled trialMEDLINE-indexed journal, not yet read by usSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer117 citations Effects of enhanced caregiver training program on cancer caregiver's self-efficacy, preparedness, and psychological well-being.
Purpose: We examined the effects of an enhanced informal caregiver training (Enhanced-CT) protocol in cancer symptom and caregiver stress management to caregivers of hospitalized cancer patients.
Methods: We recruited adult patients in oncology units and their informal caregivers. We utilized a two-armed, randomized controlled trial design with data collected at baseline, post-training, and at 2 and 4 weeks after hospital discharge. Primary outcomes were self-efficacy for managing patients' cancer symptoms and caregiver stress and preparedness for caregiving. Secondary outcomes were caregiver depression, anxiety, and burden. The education comparison (EDUC) group received information about community resources. We used general linear models to test for differences in the Enhanced-CT relative to the EDUC group.
Results: We consented and randomized 138 dyads: Enhanced-CT = 68 and EDUC = 70. …
matched on Mental Health (mesh), well-being (text)
Does the Five Facet Mindfulness Questionnaire measure what we think it does? Construct validity evidence from an active controlled randomized clinical trial.
The current study attempted a rigorous test of the construct validity of a widely used self-report measure of dispositional mindfulness, the Five Facet Mindfulness Questionnaire (FFMQ), within the context of an active controlled randomized trial (n = 130). The trial included three arms: mindfulness-based stress reduction (MBSR), an active control condition that did not include instruction in mindfulness meditation (Health Enhancement Program [HEP]), and a waitlist control condition. Partial evidence for the convergent validity of the FFMQ was shown in correlations at baseline between FFMQ facets and measures of psychological symptoms and psychological well-being. In addition, facets of the FFMQ were shown to increase over the course of an MBSR intervention relative to a waitlist control condition. However, the FFMQ failed to show discriminant validity. Specifically, facets of the FFMQ we…
matched on Mental Health (mesh), well-being (text)
The way to a man's heart is through his stomach?: a mixed methods study on causal mechanisms through which cash and in-kind food transfers decreased intimate partner violence.
Background: Intimate partner violence (IPV) is highly prevalent and has detrimental effects on the physical and mental health of women across the world. Despite emerging evidence on the impacts of cash transfers on intimate partner violence, the pathways through which reductions in violence occur remain under-explored. A randomised controlled trial of a cash and in-kind food transfer programme on the northern border of Ecuador showed that transfers reduced physical or sexual violence by 30 %. This mixed methods study aimed to understand the pathways that led to this reduction.
Methods: We conducted a mixed methods study that combined secondary analysis from a randomised controlled trial relating to the impact of a transfer programme on IPV with in-depth interviews and focus group discussions with male and female beneficiaries. A sequential analysis strategy was followed, whereby qualitat…
matched on Mental Health (mesh), well-being (text)
High-Intensity Interval Training for Cognitive and Mental Health in Adolescents.
Purpose: Emerging literature suggests that physical activity and fitness may have a positive effect on cognitive and mental health in adolescents. The purpose of the current study was to evaluate the efficacy of two high-intensity interval training (HIIT) protocols for improving cognitive and mental health outcomes (executive function, psychological well-being, psychological distress, and physical self-concept) in adolescents.
Methods: Participants (n = 65; mean age = 15.8 ± 0.6 yr) were randomized to three conditions: aerobic exercise program (AEP; n = 21), resistance and aerobic program (RAP; n = 22), and control (n = 22). HIIT sessions (8-10 min per session) were delivered during physical education lessons or at lunchtime three times per week for 8 wk. Assessments were conducted at baseline and immediately postintervention to detect changes in executive function (trail making test), p…
matched on Mental Health (mesh), well-being (text)
Rationale and study protocol for 'Switch-off 4 Healthy Minds' (S4HM): a cluster randomized controlled trial to reduce recreational screen time in adolescents.
Introduction: Excessive recreational screen time (i.e., screen use for entertainment) is a global public health issue associated with adverse mental and physical health outcomes. Considering the growing popularity of screen-based recreation in adolescents, there is a need to identify effective strategies for reducing screen time among adolescents. The aim of this paper is to report the rationale and study protocol for the 'Switch-off 4 Healthy Minds' (S4HM) study, an intervention designed to reduce recreational screen time among adolescents.
Methods: The S4HM intervention will be evaluated using a cluster randomized controlled trial in eight secondary schools (N=322 students) in New South Wales, Australia. The 6-month multi-component intervention will encourage adolescents to manage their recreational screen time using a range of evidence-based strategies. The intervention is grounded in…
matched on Mental Health (mesh), well-being (text)
A randomised controlled intervention trial evaluating the efficacy of a Mediterranean dietary pattern on cognitive function and psychological wellbeing in healthy older adults: the MedLey study.
Background: The incidence of age-related cognitive decline is rising considerably around the world. There is evidence from a number of recent cross-sectional and prospective studies indicating positive associations between the Mediterranean dietary pattern (MedDiet) and improved cognitive outcomes among the elderly including, reduced age-related cognitive decline and enhanced age-related cognitive performance. However, to date no study has validated these associations in healthy older adult populations (≥65 years and above) with randomised evidence. The main aim of the present study is to provide justified evidence regarding the efficacy of a MedDiet approach to safely reduce the onset of cognitive decline, and promote optimal cognitive performance among healthy older adults using rigorous, randomised intervention methodology.
Methods/design: MedLey is a 6-month, randomised controlled 2-…
matched on Mental Health (mesh), well-being (text)
Annual high-dose vitamin D3 and mental well-being: randomised controlled trial.
Background: Epidemiological evidence supports a relationship between vitamin D and mental well-being, although evidence from large-scale placebo-controlled intervention trials is lacking.
Aims: To examine if vitamin D supplementation has a beneficial effect on mood in community-dwelling older women; if a single annual large dose of vitamin D has a role in the prevention of depressive symptoms; and if there is an association between serum 25-hydroxyvitamin D levels and mental health.
Method: A double-blind, randomised, placebo-controlled trial of women aged 70 or older (the Vital D Study: ISRCTN83409867 and ACTR12605000658617). Participants were randomly assigned to receive 500 000 IU vitamin D(3) (cholecalciferol) orally or placebo every autumn/winter for 3-5 consecutive years. The tools utilised at various time points were the General Health Questionnaire, the 12-item Short Form Health …
matched on Mental Health (mesh), well-being (text)
Feinberg ME, Jones DE, Kan ML, Goslin MC (2010)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43)85 citations Effects of family foundations on parents and children: 3.5 years after baseline.
This study investigated the ability of a psychosocial prevention program implemented through childbirth education programs to enhance the coparental and couple relationship, parental mental health, the parent-child relationship, and child outcomes. A sample of 169 heterosexual, adult couples expecting their first child was randomized to intervention and control conditions. The intervention families participated in Family Foundations, a series of eight classes delivered before and after birth, which was designed as a universal prevention program (i.e., applicable to all couples, not just those at high risk). Intent-to-treat analyses utilizing data collected from child age 6 months through 3 years indicated significant program effects on parental stress and self-efficacy, coparenting, harsh parenting, and children's emotional adjustment among all families, and maternal depression among coh…
matched on Mental Health (mesh), well-being (text)
Mental health promotion as a new goal in public mental health care: a randomized controlled trial of an intervention enhancing psychological flexibility.
Objectives: We assessed whether an intervention based on acceptance and commitment therapy (ACT) and mindfulness was successful in promoting positive mental health by enhancing psychological flexibility.
Methods: Participants were 93 adults with mild to moderate psychological distress. They were randomly assigned to the group intervention (n = 49) or to a waiting-list control group (n = 44). Participants completed measures before and after the intervention as well as 3 months later at follow-up to assess mental health in terms of emotional, psychological, and social well-being (Mental Health Continuum-Short Form) as well as psychological flexibility (i.e., acceptance of present experiences and value-based behavior, Acceptance and Action Questionnaire-II).
Results: Regression analyses showed that compared with the participants on the waiting list, participants in the ACT and mindfulness i…
matched on Mental Health (mesh), well-being (text)
Peer-group support intervention improves the psychosocial well-being of AIDS orphans: cluster randomized trial.
Accumulating evidence suggests that AIDS orphanhood status is accompanied by increased levels of psychological distress such as anxiety, depression, intense guilt, shame, and anger. However, few studies have examined the possible reduction of psychological distress in AIDS orphans through the help of interventions that promote well-being. The objective of the study was to evaluate the effects of a school-based peer-group support intervention combined with periodic somatic health assessments and treatment on the psychosocial well-being of AIDS orphans in the Mbarara District of southwestern Uganda. In a cluster randomized controlled design, 326 AIDS orphans aged 10-15 years were assigned to either peer-group support intervention combined with monthly somatic healthcare (n=159) or control group (n=167) for follow-up assessment. Baseline and 10 week follow-up psychological assessments were …
matched on Mental Health (mesh), well-being (text)
Ethyl-eicosapentaenoic acid for the treatment of psychological distress and depressive symptoms in middle-aged women: a double-blind, placebo-controlled, randomized clinical trial.
Background: Psychological distress (PD) and depressive symptoms are commonly observed during menopausal transition. Studies suggest that omega-3 (n-3) fatty acids may help alleviate depression.
Objective: The objective was to compare enriched ethyl-eicosapentaenoic acid (E-EPA) supplementation with placebo for the treatment of PD and depressive symptoms in middle-aged women.
Design: Women with moderate-to-severe PD (n = 120) were randomly assigned to receive 1.05 g E-EPA/d plus 0.15 g ethyl-docosahexaenoic acid/d (n = 59) or placebo (n = 61) for 8 wk. The main outcomes were 8-wk changes in PD scores [Psychological General Well-Being Schedule (PGWB)] and depressive scales [20-item Hopkins Symptom Checklist Depression Scale (HSCL-D-20) and the 21-item Hamilton Depression Rating Scale (HAM-D-21)].
Results: At baseline, women with PD were mildly to moderately depressed, and 24% met the major…
matched on Mental Health (mesh), well-being (text)
Feinberg ME, Kan ML (2008)randomised controlled trialMEDLINE-indexed journal, not yet read by usJournal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43)194 citations Establishing family foundations: intervention effects on coparenting, parent/infant well-being, and parent-child relations.
This study investigated the ability of a theoretically driven, psychosocial prevention program implemented through childbirth education programs to enhance the coparental relationship, parental mental health, the parent-child relationship, and infant emotional and physiological regulation. A sample of 169 heterosexual, adult couples who were expecting their 1st child was randomized to intervention and control conditions. The intervention families participated in Family Foundations, a series of 8 classes, delivered before and after birth, that was designed as a universal prevention program (i.e., it was applicable to all couples, not just those at high risk). Intent-to-treat analyses indicated significant program effects on coparental support, maternal depression and anxiety, distress in the parent-child relationship, and several indicators of infant regulation. Intervention effects were …
matched on Mental Health (mesh), well-being (text)
Maternal mental health predicts risk of developmental problems at 3 years of age: follow up of a community based trial.
Background: Undetected and untreated developmental problems can have a significant economic and social impact on society. Intervention to ameliorate potential developmental problems requires early identification of children at risk of future learning and behaviour difficulties. The objective of this study was to estimate the prevalence of risk for developmental problems among preschool children born to medically low risk women and identify factors that influence outcomes.
Methods: Mothers who had participated in a prenatal trial were followed up three years post partum to answer a telephone questionnaire. Questions were related to child health and development, child care, medical care, mother's lifestyle, well-being, and parenting style. The main outcome measure was risk for developmental problems using the Parents' Evaluation of Developmental Status (PEDS).
Results: Of 791 children, 11%…
matched on Mental Health (mesh), well-being (text)
Coll-Planas L, Carbó-Cardeña A, Jansson A, Dostálová V, Bartova A, Rautiainen L, Kolster A, Masó-Aguado M, Briones-Buixassa L, Blancafort-Alias S, Roqué-Figuls M, Sachs AL, Casajuana C, Siebert U, Rochau U, Puntscher S, Holmerová I, Pitkala KH, Litt JS (2024)clinical trialMEDLINE-indexed journal, not yet read by usBMC public health15 citations Nature-based social interventions to address loneliness among vulnerable populations: a common study protocol for three related randomized controlled trials in Barcelona, Helsinki, and Prague within the RECETAS European project.
Background: The negative effects of loneliness on population health and wellbeing requires interventions that transcend the medical system and leverage social, cultural, and public health system resources. Group-based social interventions are a potential method to alleviate loneliness. Moreover, nature, as part of our social and health infrastructure, may be an important part of the solutions that are needed to address loneliness. The RECETAS European project H2020 (Re-imagining Environments for Connection and Engagement: Testing Actions for Social Prescribing in Natural Spaces) is an international research project aiming to develop and test the effectiveness of nature-based social interventions to reduce loneliness and increase health-related quality of life.
Methods: This article describes the three related randomized controlled trials (RCTs) that will be implemented: the RECETAS-BCN T…
matched on Quality of Life (mesh), quality of life (text)
Kersten CM, Hermelijn SM, Dossche LWJ, Muthialu N, Losty PD, Schurink M, Rietman AB, Poley MJ, van Rosmalen J, Zanen-van den Adel TPL, Ciet P, von der Thüsen J, Brosens E, Ijsselstijn H, Tiddens HAWM, Wijnen RMH, Schnater JM (2023)clinical trialMEDLINE-indexed journal, not yet read by usBMJ open18 citations COllaborative Neonatal Network for the first European CPAM Trial (CONNECT): a study protocol for a randomised controlled trial.
Introduction: Consensus is lacking on the optimal management of asymptomatic congenital pulmonary airway malformation (CPAM). For future studies, the CONNECT consortium (the COllaborative Neonatal Network for the first European CPAM Trial)-an international collaboration of specialised caregivers-has established consensus on a core outcome set of outcome parameters concerning respiratory insufficiency, surgical complications, mass effect and multifocal disease. These outcome parameters have been incorporated in the CONNECT trial, a randomised controlled trial which, in order to develop evidence-based practice, aims to compare conservative and surgical management of patients with an asymptomatic CPAM.
Methods and analysis: Children are eligible for inclusion after the CPAM diagnosis has been confirmed on postnatal chest CT scan and they remain asymptomatic. On inclusion, children are rando…
matched on Quality of Life (mesh), quality of life (text)
Thurston C, Bezuidenhout L, Humphries S, Johansson S, von Koch L, Häger CK, Holmlund L, Sundberg CJ, Garcia-Ptacek S, Kwak L, Nilsson M, English C, Conradsson DM (2023)clinical trialMEDLINE-indexed journal, not yet read by usBMC neurology12 citations Mobile health to promote physical activity in people post stroke or transient ischemic attack - study protocol for a feasibility randomised controlled trial.
Background: Physical activity is essential to improve health and reduce the risk of recurrence of stroke or transient ischemic attack (TIA). Still, people post stroke or TIA are often physically inactive and the availability of physical activity promotion services are often limited. This study builds on an existing Australian telehealth-delivered programme (i-REBOUND- Let's get moving) which provides support for home-based physical activity for people post stroke or TIA. The aim of this study is to test the feasibility, acceptability, and preliminary effects of a mobile Health (mHealth) version of the i-REBOUND programme for the promotion of physical activity in people post stroke or TIA living in Sweden.
Methods: One hundred and twenty participants with stroke or TIA will be recruited via advertisement. A parallel-group feasibility randomised controlled trial design with a 1:1 allocatio…
matched on Quality of Life (mesh), quality of life (text)
The effectiveness and cost-effectiveness of Acceptance and Commitment Therapy as a transdiagnostic intervention for transitional-age youth: study protocol of a randomized controlled trial.
Background: Although the prevalence of psychological problems in transitional-age youth (i.e., youth aged 15 to 25; TAY) is high, TAY are much less likely to receive age-appropriate treatments for their psychological problems compared to younger adolescents or older adults. Hence, effective interventions for TAY seem warranted. ACT your way is a transdiagnostic treatment, specifically developed for TAY, based on the principles of Acceptance and Commitment Therapy (ACT). ACT your way is not directed primarily at symptom reduction, but mainly aims to change the underlying mechanism of psychopathology, namely increasing TAY's psychological flexibility. Meta-analyses show that ACT is an effective treatment for adults with diverse types of psychopathology. Less is known about the effectiveness of ACT for TAY. Therefore, the goal of this study is to examine the effectiveness and cost-effective…
matched on Quality of Life (mesh), quality of life (text)
Acceptability and feasibility of the NPS MedicineWise mobile phone application in supporting medication adherence in patients with chronic heart failure: Protocol for a pilot study.
Introduction: Heart failure (HF) is an increasing global concern. Despite evidence-based pharmacotherapy, morbidity and mortality remain high in HF. Medication non-adherence is a crucial factor in optimising clinical outcomes. A growing number of smartphone applications (apps) assist management. While evidence support their use to promote treatment adherence, apps alone may not be the solution. The objective of this pilot study is to assess the acceptability and feasibility of a tiered intervention added to the NPS MedicineWise dose reminder app (MedicineWise app) in supporting medication adherence in HF.
Methods and analysis: This prospective, single-blinded, randomised controlled trial will recruit 55 Australian patients with HF to be randomly assigned to either intervention (MedicineWise app + usual care) or control (usual care alone) arm. Control participants will remain unaware of t…
matched on Quality of Life (mesh), quality of life (text)
Roux A, Cholerton R, Sicsic J, Moumjid N, French DP, Giorgi Rossi P, Balleyguier C, Guindy M, Gilbert FJ, Burrion JB, Castells X, Ritchie D, Keatley D, Baron C, Delaloge S, de Montgolfier S (2022)clinical trialMEDLINE-indexed journal, not yet read by usBMC cancer72 citations Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial.
Background: The MyPeBS study is an ongoing randomised controlled trial testing whether a risk-stratified breast cancer screening strategy is non-inferior, or eventually superior, to standard age-based screening at reducing incidence of stage 2 or more cancers. This large European Commission-funded initiative aims to include 85,000 women aged 40 to 70 years, without prior breast cancer and not previously identified at high risk in six countries (Belgium, France, Italy, Israel, Spain, UK). A specific work package within MyPeBS examines psychological, socio-economic and ethical aspects of this new screening strategy. It compares women's reported data and outcomes in both trial arms on the following issues: general anxiety, cancer-related worry, understanding of breast cancer screening strategy and information-seeking behaviour, socio-demographic and economic characteristics, quality of life…
matched on Quality of Life (mesh), quality of life (text)