scholarly journals Clinical effectiveness of group cognitive-behavioural therapy for depressed older people in primary care: A randomised controlled trial

Salud Mental ◽  
2015 ◽  
Vol 38 (1) ◽  
pp. 33-39 ◽  
Author(s):  
Carmen García ◽  
◽  
Felipe Vázquez ◽  
Fabián Avalos ◽  
Leslie Viridiana Robles ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Mental Health Professionals ◽  
Controlled Trial ◽  
Intervention Group ◽  
World Health ◽  
Control Group ◽  
Baseline Phase ◽  
Family Doctors ◽  
Randomised Controlled

Abstract Background. Depression is associated with an increased use of medical resources and reduced quality of life, cognitive functions, functionality and general health. The treatment of depression is limited by the scarcity of mental health professionals, as reflected in the mental health atlas of the World Health Organization. Method. A randomised controlled trial that was not blinded was conducted. Family doctors referred patients older than 60 years who were suspected to have depression to the screening module. The PHQ-9 questionnaire, the Six-Item Screener, and previous diagnosis for psychiatric disorders were collected. Major depression was excluded. Those with a score from two to six on the PHQ-9 and with no comorbidities were referred to the Baseline Phase. A simple random process without blocking was applied. Groups of 7-10 participants engaged in weekly sessions over the course of three months. The control group was referred to their family physician. Reduction in depression score of the PHQ-9 was the main outcome. Results and discussion. There were 40 patients in the control group (CG) and 41 in the intervention group (IG). 84% were women, 41% married and 41% reported at least primary education. The mean age for the GC was 69.7 years vs. 71.3 in the GI. The baseline mean MMSE score was 23.7 in the GC and 24.1 in the IG. No significant baseline differences between groups were reported. In the IG, 56% of the participants (n=23) displayed a decrease that was greater than or equal to 5 points on the PHQ-9 compared with 30% (n=12) in the control group. The CT group evidenced a marginal improvement.

scholarly journals IDTWO: A Protocol for a Randomised Controlled Trial of a Web-Based Mental Health Intervention for Australians with Intellectual Disability

2021 ◽  
Vol 18 (5) ◽  
pp. 2473
Author(s):  
Peter A. Baldwin ◽  
Victoria Rasmussen ◽  
Julian N. Trollor ◽  
Jenna L. Zhao ◽  
Josephine Anderson ◽  
...  
Keyword(s):  
Mental Health ◽  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
World Health ◽  
Control Group ◽  
Waitlist Control ◽  
Cognitive Behaviour ◽  
Randomised Controlled

People with intellectual disability (ID) experience higher rates of mental illness and reduced access to appropriate care and treatment. Tailored electronic mental health (eMH) programs offer opportunities to address these disparities. The aim of this study is to examine whether a fully automated and self-guided eMH program tailored to the needs of people with ID can reduce symptoms of anxiety and depression and improve daily functioning in people with borderline-to-mild ID. Australians with borderline-to-mild ID, aged 16 years and older with mild-to-moderate depression and/or anxiety symptoms will be eligible to participate with the help of a nominated carer, if necessary. A randomised controlled trial with a sample size of 150 participants divided into treatment and waitlist control arms will be conducted. Participants randomised to the intervention group will have full access to the Healthy Mind program for eight weeks. The waitlist control group will gain full access to the program following the eight-week treatment period. Efficacy will be assessed on the Anxiety, Depression, and Mood Scale; Kessler-10; and the World Health Organisation Disability Assessment Schedule 2.0 across three time-points (baseline, eight weeks, and three months). We expect that people who use the intervention will report reduced depression and anxiety, relative to the control group. To our knowledge, this is the first study to examine the effectiveness of a fully automated eMH program for improving mental health in people with ID. We expect our study to render new knowledge on the delivery and effects of internet-based cognitive behaviour therapy (CBT) tools for people with ID.

scholarly journals Is there an app for that? A cluster randomised controlled trial of a mobile app–based mental health intervention

2019 ◽  
Vol 26 (3) ◽  
pp. 1538-1559 ◽  
Author(s):  
Rachel Kenny ◽  
Amanda Fitzgerald ◽  
Ricardo Segurado ◽  
Barbara Dooley
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Mobile App ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled

Demand for the use of mobile apps in mental health interventions has grown in recent years, particularly among adolescents who experience elevated levels of distress. However, there is a scarcity of evidence for the effectiveness of these tools within this population. The aim of this study was to test the effectiveness of CopeSmart, a mental health mobile app, using a multicentre cluster randomised controlled trial design. Participants were 15–18-years-olds (N = 560) recruited from 10 schools randomly assigned to an intervention or control condition. Intervention participants used the app over a 4-week period. Multi-level modelling analyses revealed no significant changes in the intervention group from pre-test to post-test, when compared to the control group, in terms of emotional distress, well-being, emotional self-awareness or coping strategies. Findings suggest that a 4-week app-based intervention may not be enough to elicit intra-personal changes in mental health outcomes in a general adolescent population.

scholarly journals Effects of a culturally tailored parenting support programme in Somali-born parents’ mental health and sense of competence in parenting: a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e017600 ◽  
Author(s):  
Fatumo Osman ◽  
Raziye Salari ◽  
Marie Klingberg-Allvin ◽  
Ulla-Karin Schön ◽  
Renée Flacking
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Parenting Support ◽  
Sense Of Competence ◽  
Support Programme ◽  
Culturally Tailored ◽  
Randomised Controlled

ObjectivesTo evaluate the effectiveness of a culturally tailored parenting support programme on Somali-born parents’ mental health and sense of competence in parenting.DesignRandomised controlled trial.SettingA city in the middle of Sweden.ParticipantsSomali-born parents (n=120) with children aged 11–16 years and self-perceived stress in their parenting were randomised to an intervention group (n=60) or a waiting-list control group (n=60).InterventionParents in the intervention group received culturally tailored societal information combined with the Connect parenting programme during 12 weeks for 1–2 hours per week. The intervention consisted of a standardised training programme delivered by nine group leaders of Somali background.OutcomeThe General Health Questionnaire 12 was used to measure parents’ mental health and the Parenting Sense of Competence scale to measure parent satisfaction and efficacy in the parent role. Analysis was conducted using intention-to-treat principles.ResultsThe results indicated that parents in the intervention group showed significant improvement in mental health compared with the parents in the control group at a 2-month follow-up: B=3.62, 95% CI 2.01 to 5.18, p<0.001. Further, significant improvement was found for efficacy (B=−6.72, 95% CI −8.15 to −5.28, p<0.001) and satisfaction (B=−4.48, 95% CI −6.27 to −2.69, p<0.001) for parents in the intervention group. Parents’ satisfaction mediated the intervention effect on parental mental health (β=−0.88, 95% CI −1.84 to −0.16, p=0.047).ConclusionThe culturally tailored parenting support programme led to improved mental health of Somali-born parents and their sense of competence in parenting 2 months after the intervention. The study underlines the importance of acknowledging immigrant parents’ need for societal information in parent support programmes and the importance of delivering these programmes in a culturally sensitive manner.Clinical trial registrationNCT02114593.

scholarly journals The side effects of service changes: exploring the longitudinal impact of participation in a randomised controlled trial (DOORWAYS) on staff perceptions of barriers to change

2019 ◽  
Author(s):  
Caroline Laker ◽  
Matteo Cella ◽  
Felicity Callard ◽  
Til Wykes
Keyword(s):  
Mental Health ◽  
Controlled Trial ◽  
Occupational Status ◽  
Intervention Group ◽  
Direct Care ◽  
Care Staff ◽  
Control Group ◽  
Staff Perceptions ◽  
Barriers To Change ◽  
Randomised Controlled

Abstract Background Staff and service users have expressed concerns that service improvements in U.K. mental health wards have been slow or transient. It is possible that certain changes are positive for some (e.g. service users), but negative for others (e.g. staff), which may affect implementation success. In this study, we explore whether a programme of change to improve the therapeutic milieu on mental health wards influenced staff perceptions of barriers to change, 12 months after implementation. Method A cluster randomised controlled trial called DOORWAYS was conducted on eight inner-city U.K. acute mental health wards. Randomisation was achieved using a list randomly generated by a computer. A psychologist trained ward staff (mainly nurses) to deliver evidence-based groups and supported their initial implementation. The impact of these changes was measured over 12 months (when 4 wards were randomised), according to nurses’ perceptions of barriers to change (VOCALISE), using unstructured multivariate linear regression models. This innovative analysis method allows maximum use of data in randomised controlled trials with reduced sample sizes due to substantial drop out rates. The contextual influences of occupational status (staff) and of workplace setting (ward) were also considered. Results Staff who participated in the intervention had significantly worse perceptions of barriers to change at follow up. The perceptions of staff in the control group did not change over time. In both groups (N=120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward. Across time, direct care staff in the intervention group became more negative than those in the control group. Conclusion Participation in this program of change, worsened staff perceptions of barriers to change. In addition, occupational status (being from the direct care group) had a negative effect on perceptions of barriers to change, an effect that continued across time and was worse in the intervention group. Those providing direct care should be offered extra support when changes are introduced and through the implementation process. More effort should be placed around reducing the perceived burden of innovation for staff in mental health wards.

scholarly journals Multicentre, randomised controlled trial of PDSAFE, a physiotherapist-delivered fall prevention programme for people with Parkinson’s

2019 ◽  
Vol 90 (7) ◽  
pp. 774-782 ◽  
Author(s):  
Kim Chivers Seymour ◽  
Ruth Pickering ◽  
Lynn Rochester ◽  
Helen C Roberts ◽  
Claire Ballinger ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Fall Prevention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Prevention Programme ◽  
Control Group ◽  
Chair Stand ◽  
Subgroup Analyses ◽  
Randomised Controlled ◽  
Fall Prevention Programme

ObjectiveTo estimate the effect of a physiotherapist-delivered fall prevention programme for people with Parkinson’s (PwP).MethodsPeople at risk of falls with confirmed Parkinson’s were recruited to this multicentre, pragmatic, investigator blind, individually randomised controlled trial with prespecified subgroup analyses. 474 PwP (Hoehn and Yahr 1–4) were randomised: 238 allocated to a physiotherapy programme and 236 to control. All participants had routine care; the control group received a DVD about Parkinson’s and single advice session at trial completion. The intervention group (PDSAFE) had an individually tailored, progressive home-based fall avoidance strategy training programme with balance and strengthening exercises. The primary outcome was risk of repeat falling, collected by self-report monthly diaries, 0–6 months after randomisation. Secondary outcomes included Mini-BESTest for balance, chair stand test, falls efficacy, freezing of gait, health-related quality of life (EuroQol EQ-5D), Geriatric Depression Scale, Physical Activity Scale for the Elderly and Parkinson’s Disease Questionnaire, fractures and rate of near falling.ResultsAverage age is 72 years and 266 (56%) were men. By 6 months, 116 (55%) of the control group and 125 (61.5%) of the intervention group reported repeat falls (controlled OR 1.21, 95% CI 0.74 to 1.98, p=0.447). Secondary subgroup analyses suggested a different response to the intervention between moderate and severe disease severity groups. Balance, falls efficacy and chair stand time improved with near falls reduced in the intervention arm.ConclusionPDSAFE did not reduce falling in this pragmatic trial of PwP. Other functional tasks improved and reduced fall rates were apparent among those with moderate disease.Trial registration numberISRCTN48152791.

scholarly journals Efficacy of a smartphone-based coaching program for addiction prevention among apprentices: study protocol of a cluster-randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Severin Haug ◽  
Raquel Paz Castro ◽  
Andreas Wenger ◽  
Michael P. Schaub
Keyword(s):  
Randomised Controlled Trial ◽  
Cigarette Smoking ◽  
Internet Use ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Addiction Prevention ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background A large proportion of apprentices shows addictive behaviours like cigarette smoking, alcohol, cannabis, or compulsive Internet use, others do not show such behaviours at all. ready4life is a smartphone application-based coaching program for apprentices, which takes into account the heterogeneity of adolescent addictive behaviour by promoting life skills and reducing risk behaviours. The main objective of the planned study is to test the efficacy of ready4life for addiction prevention among apprentices in Switzerland within a controlled trial. Methods/design The efficacy of the ready4life coaching program will be tested in comparison to an assessment only control group, within a cluster-randomised controlled trial with one follow-up assessment after 6 months. At the beginning of the program, participants of the intervention group will receive an individual profile, showing areas in which they have sufficient resources and in which there is a need for coaching. Based on this feedback, they can select two out of the following six program modules: stress, social skills, Internet use, tobacco/e-cigarettes, cannabis, and alcohol. Participants of the intervention group will receive individualised coaching by a conversational agent (chatbot) for a period of four months. The coaching relies on motivational and social-cognitive principles of behaviour change. Within weekly dialogues, the coach provides individually tailored information in different formats, such as videoclips, texts, or pictures. Study participants will be 1318 apprentices with a minimum age of 15, recruited in approximately 100 vocational school classes in Switzerland. Primary outcome will be a composite measure for addictive behaviours including (1) at risk-drinking, (2) tobacco/e-cigarette smoking, (3) cannabis use, and (4) problematic Internet use. Discussion The study will reveal whether this universally implementable but individually tailored intervention approach is effective in preventing the onset and escalation of addictive behaviors among apprentices. Trial registration ISRCTN59908406 (registration date: 21/10/2020).

scholarly journals Enhancing help-seeking behaviour among men who have sex with men at risk for sexually transmitted infections: the syn.bas.in randomised controlled trial

2020 ◽  
pp. sextrans-2020-054438 ◽  
Author(s):  
Roeland Christiaan Alfons Achterbergh ◽  
Martijn S van Rooijen ◽  
Wim van den Brink ◽  
Anders Boyd ◽  
Henry John Christiaan de Vries
Keyword(s):  
Mental Health ◽  
Substance Use ◽  
Randomised Controlled Trial ◽  
Help Seeking ◽  
Controlled Trial ◽  
Risk Behaviour ◽  
Control Group ◽  
Help Seeking Behaviour ◽  
Sex With Men ◽  
Randomised Controlled

ObjectivesMen who have sex with men (MSM) are at increased risk for STIs and mental disorders. Syndemic theory holds that psychosocial issues co-occur and interact, and thus increase sexual risk behaviour. Psychosocial issue identification, referral and management might reduce risk behaviour.MethodsIn the syndemic-based intervention study, an open-label randomised controlled trial, MSM were enrolled at the STI outpatient clinic of the Public Health Service of Amsterdam. We screened participants using validated questionnaires on the following problem domains: alcohol and substance use, sexual compulsivity, anxiety, depression, attention deficit hyperactivity disorder, alexithymia, intimate partner violence and childhood sexual abuse. Individuals were randomly assigned (1:1) to receive either tailored, face-to-face feedback and help-seeking advice on mental health screening, or no feedback and no help-seeking advice. Participants were followed trimonthly for a year. The primary outcomes were self-reported and confirmed help-seeking behaviour.ResultsWe included 155 MSM: 76 in the intervention group and 79 in the control group. At inclusion, 128 participants (83.1%) scored positive in at least one problem domain. We found no significant differences in self-reported or confirmed help-seeking behaviour between the intervention and the control group: 41% vs 29% (p=0.14) and 28% vs 22% (p=0.44), respectively. There were also no differences in STI incidence and condomless anal sex acts between the two groups.ConclusionScreening showed high prevalence of problems related to mental health and substance use, while tailored feedback, advice and referral did not significantly increase help-seeking behaviour. Other interventions are needed to tackle the high burden of mental disorders among MSM.Trial registration numberNCT02859935.

scholarly journals Assessment of the Effectiveness of a Computerised Decision-Support Tool for Health Professionals for the Prevention and Treatment of Childhood Obesity. Results from a Randomised Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 706 ◽  
Author(s):  
George Moschonis ◽  
Maria Michalopoulou ◽  
Konstantina Tsoutsoulopoulou ◽  
Elpis Vlachopapadopoulou ◽  
Stefanos Michalacos ◽  
...  
Keyword(s):  
Decision Support ◽  
Childhood Obesity ◽  
Randomised Controlled Trial ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decision Support Tool ◽  
Control Group ◽  
Support Tool ◽  
Randomised Controlled

We examined the effectiveness of a computerised decision-support tool (DST), designed for paediatric healthcare professionals, as a means to tackle childhood obesity. A randomised controlled trial was conducted with 65 families of 6–12-year old overweight or obese children. Paediatricians, paediatric endocrinologists and a dietitian in two children’s hospitals implemented the intervention. The intervention group (IG) received personalised meal plans and lifestyle optimisation recommendations via the DST, while families in the control group (CG) received general recommendations. After three months of intervention, the IG had a significant change in dietary fibre and sucrose intake by 4.1 and −4.6 g/day, respectively. In addition, the IG significantly reduced consumption of sweets (i.e., chocolates and cakes) and salty snacks (i.e., potato chips) by −0.1 and −0.3 portions/day, respectively. Furthermore, the CG had a significant increase of body weight and waist circumference by 1.4 kg and 2.1 cm, respectively, while Body Mass Index (BMI) decreased only in the IG by −0.4 kg/m2. However, the aforementioned findings did not differ significantly between study groups. In conclusion, these findings indicate the dynamics of the DST in supporting paediatric healthcare professionals to improve the effectiveness of care in modifying obesity-related behaviours. Further research is needed to confirm these findings.

scholarly journals Postcards from the EDge: 5-year outcomes of a randomised controlled trial for hospital-treated self-poisoning

2013 ◽  
Vol 202 (5) ◽  
pp. 372-380 ◽  
Author(s):  
Gregory L. Carter ◽  
Kerrie Clover ◽  
Ian M. Whyte ◽  
Andrew H. Dawson ◽  
Catherine D'Este
Keyword(s):  
Randomised Controlled Trial ◽  
Psychiatric Hospital ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Treatment As Usual ◽  
Psychiatric Admissions ◽  
Bed Days ◽  
Randomised Controlled ◽  
Event Rates

BackgroundRepetition of hospital-treated self-poisoning and admission to psychiatric hospital are both common in individuals who self-poison.AimsTo evaluate efficacy of postcard intervention after 5 years.MethodA randomised controlled trial of individuals who have self-poisoned: postcard intervention (eight in 12 months) plus treatment as usualv.treatment as usual. Our primary outcomes were self-poisoning admissions and psychiatric admissions (proportions and event rates).ResultsThere was no difference between groups for any repeat-episode self-poisoning admission (intervention group: 24.9%, 95% CI 20.6-29.5; control group: 27.2%, 95% CI 22.8-31.8) but there was a significant reduction in event rates (incidence risk ratio (IRR)=0.54, 95% CI 0.37-0.81), saving 306 bed days. There was no difference for any psychiatric admission (intervention group: 38.1%, 95% CI 33.1-43.2; control group: 35.5%, 95% CI 30.8-40.5) but there was a significant reduction in event rates (IRR=0.66, 95% CI 0.47-0.91), saving 2565 bed days.ConclusionsA postcard intervention halved self-poisoning events and reduced psychiatric admissions by a third after 5 years. Substantial savings occurred in general hospital and psychiatric hospital bed days.

scholarly journals Effects of a kindergarten intervention on vegetables served and staff’s food-related practices: results of a cluster randomised controlled trial – the BRA study

2020 ◽  
Vol 23 (6) ◽  
pp. 1117-1126
Author(s):  
Anne Himberg-Sundet ◽  
Anne Lene Kristiansen ◽  
Lene Frost Andersen ◽  
Mona Bjelland ◽  
Nanna Lien
Keyword(s):  
Randomised Controlled Trial ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Public And Private ◽  
Cluster Randomised ◽  
Block Randomisation ◽  
Randomised Controlled

AbstractObjective:The aim of the current study was to evaluate the effect on frequency, variety and amount of vegetables served and staff’s food-related practices in the multicomponent BRA intervention.Design:Cluster randomised controlled trial, conducted between Spring 2015 and Spring 2016. For allocation of the kindergartens, a stratified block randomisation was used. Data were collected in three ways: (i) a questionnaire for pedagogical leaders assessing the variety and frequency of vegetables served, including staff’s food-related practices assumed to be related to vegetable intake; (ii) a questionnaire for kindergarten assistants assessing staff’s food-related practices; (iii) a 5-d weighted vegetable diary assessing amount of vegetables served in a department.Setting:The target group for this study was public and private kindergartens in the counties of Vestfold and Buskerud, Norway.Participants:A total of seventy-three kindergartens participated.Results:At follow-up I, the amount of vegetables served increased by approximately 20 g per person per day (P = 0·002), and the variety in served vegetables increased by one-and-a-half kind per month (P = 0·014) in the intervention group compared to the control group. No effects on the frequency of vegetables served or on staff’s food-related practices were found.Conclusions:The BRA intervention was successful in increasing the amount and variety of vegetables served within intervention kindergartens. Further research is needed to understand the mechanisms that can affect the staff’s food-related practices.

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