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

Abstract Background Staff and service users have expressed concerns that service improvements in British 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 British, inner-city 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. Trial registration ISRCTN, ISRCTN 06545047. Registered 29/04/2010, https://www.isrctn.com/search?q=06545047

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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.

10.21203/rs.2.12594/v3 ◽

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.

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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.

10.21203/rs.2.12594/v2 ◽

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.

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

Health Informatics Journal ◽

10.1177/1460458219884195 ◽

2019 ◽

Vol 26 (3) ◽

pp. 1538-1559 ◽

Cited By ~ 3

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.

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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 ◽

10.1136/bmjopen-2017-017600 ◽

2017 ◽

Vol 7 (12) ◽

pp. e017600 ◽

Cited By ~ 7

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.

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

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18052473 ◽

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.

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

Salud Mental ◽

10.17711/sm.0185-3325.2015.004 ◽

2015 ◽

Vol 38 (1) ◽

pp. 33-39 ◽

Cited By ~ 6

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.

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The effect of vitamin D and magnesium supplementation on the mental health status of attention-deficit hyperactive children: a randomized controlled trial

BMC Pediatrics ◽

10.1186/s12887-021-02631-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mostafa Hemamy ◽

Naseh Pahlavani ◽

Alireza Amanollahi ◽

Sheikh Mohammed Shriful Islam ◽

Jenna McVicar ◽

...

Keyword(s):

Mental Health ◽

Vitamin D ◽

Attention Deficit ◽

Controlled Trial ◽

Neurodevelopmental Disorder ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Magnesium Supplementation ◽

Children With Adhd

Abstract Background Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in people with ADHD. The aim of this study is to determine the effect of vitamin D and magnesium supplementation on mental health in children with ADHD. Methods We conducted a randomized, double blind, placebo-controlled clinical trial of 66 children with ADHD. Participants were randomly allocated to receive both vitamin D (50,000 IU/week) plus magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8-weeks. Strengths and difficulties questionnaire was used to evaluate children’s mental health at baseline and the end of the study. Results After eight weeks of intervention, the serum levels of 25-hydroxy-vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also, children receiving vitamin D plus magnesium showed a significant reduction in emotional problems (p = 0.001), conduct problems (p = 0.002), peer problems (p = 0.001), prosocial score (p = 0.007), total difficulties (p = 0.001), externalizing score (p = 0.001), and internalizing score (p = 0.001) compared with children treated with the placebo. Conclusion Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation for a duration of 8-weeks could improve the behavioral function and mental health of children with ADHD. However, further well-designed studies with a larger sample size are needed. Trial registration IRCT2016030326886N1.

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Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-040108 ◽

2020 ◽

Vol 10 (12) ◽

pp. e040108

Author(s):

Rowan W Johnson ◽

Sian A Williams ◽

Daniel F Gucciardi ◽

Natasha Bear ◽

Noula Gibson

Keyword(s):

Exercise Prescription ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Programme ◽

Home Exercise ◽

Control Group ◽

Neurodevelopmental Disabilities ◽

Home Exercise Programme ◽

Exercise Programmes ◽

Randomised Controlled

ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.

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A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

BMC Public Health ◽

10.1186/s12889-021-11357-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

M. A. Greidanus ◽

A. E. de Rijk ◽

A. G. E. M. de Boer ◽

M. E. M. M. Bos ◽

P. W. Plaisier ◽

...

Keyword(s):

Return To Work ◽

Cancer Survivors ◽

Controlled Trial ◽

Intervention Group ◽

Work Outcomes ◽

Feasibility Trial ◽

Control Group ◽

Secondary Effect ◽

Quality Of Working Life ◽

Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

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