scholarly journals Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e025288 ◽  
Author(s):  
Maren Schick ◽  
Sabine Roesner ◽  
Ariane Germeyer ◽  
Markus Moessner ◽  
Stephanie Bauer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Text Messages ◽  
Fertility Treatment ◽  
Psychosocial Burden ◽  
Waiting Period ◽  
Positive Adjustment ◽  
Psychosocial Counselling ◽  
Randomised Controlled

IntroductionInfertility generally counts as a profound crisis in the lives of couples and as an emotionally stressful experience. For couples undergoing fertility treatment, this is especially true of the waiting period following embryo transfer, which couples say is the most stressful period during treatment. However, at this specific phase, psychosocial counselling is not always available on the spot. The aim of this randomised controlled trial (RCT) study was to test the Positive Adjustment Coping Intervention (PACI), a low-dose, smartphone-supported psychological intervention for women and men undergoing fertility treatment.Methods and analysisThe effectiveness of PACI is tested by means of a prospective two-arm RCT. During the 14-day waiting period between oocyte puncture/oocyte thawing and pregnancy test, participants are randomly assigned to one of the two groups, and both women and men receive daily text messages on their smartphones. One group receives text messages with statements reflecting positive-adjustment coping attitudes, the other group messages containing cognitive distractions. The primary outcome of this study is the reduction of psychosocial burden during the waiting period of reproductive treatment. Furthermore, we want to assess whether there are differences between the interventions in a pre-post assessment. The secondary outcomes are information on perceived effectiveness and practicability of the intervention one month after the waiting period.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Heidelberg University Faculty of Medicine (S-074/2017). Study findings are planned for dissemination via peer-reviewed journal articles and at national and international conferences.Trial registration numberNCT03118219; Pre-results.Protocol versionVersion 2.0 dated 18/02/2019.

scholarly journals Attachment-oriented psychological intervention for couples facing breast cancer: protocol of a randomised controlled trial

2014 ◽  
Vol 2 (1) ◽  
Author(s):  
Anne Nicolaisen ◽  
Dorte G Hansen ◽  
Mariët Hagedoorn ◽  
Henrik E Flyger ◽  
Nina Rottmann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomised Controlled Trial ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e022205 ◽  
Author(s):  
Esther Williamson ◽  
Lesley Ward ◽  
Karan Vadher ◽  
Susan J Dutton ◽  
Ben Parker ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Best Practice ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Community Dwelling ◽  
Neurogenic Claudication ◽  
Randomised Controlled

IntroductionNeurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention.Methods and analysisThis is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target sample size is a minimum of 402. The BOOST programme consists of an individual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by ‘intention to treat’. There is a parallel health economic evaluation and qualitative study.Ethics and disseminationEthical approval was given on 3 March 2016 (National Research Ethics Committee number: 16/LO/0349). This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials checklist. The results will be reported at conferences and in peer-reviewed publications using the Consolidated Standards of Reporting Trials guidelines. A plain English summary will be published on the BOOST website.Trial registration numberISRCTN12698674; Pre-results.

scholarly journals Effect of home-based specialised palliative care and dyadic psychological intervention on caregiver anxiety and depression: a randomised controlled trial

2018 ◽  
Vol 119 (11) ◽  
pp. 1307-1315 ◽  
Author(s):  
Annika von Heymann-Horan ◽  
Pernille Bidstrup ◽  
Mai-Britt Guldin ◽  
Per Sjøgren ◽  
Elisabeth Anne Wreford Andersen ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Anxiety And Depression ◽  
Home Based ◽  
Randomised Controlled ◽  
Caregiver Anxiety

scholarly journals Optimising implementation strategies of the first scaleup of a primary care psychological intervention for common mental disorders in Sub-Saharan Africa: a mixed methods study protocol for the optimised Friendship Bench (OptFB)

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e045481
Author(s):  
Ruth Verhey ◽  
Charmaine Chitiyo ◽  
Sandra Ngonidzashe Mboweni ◽  
Ephraim Chiriseri ◽  
Dixon Chibanda ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Mental Disorders ◽  
Common Mental Disorders ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Implementation Strategies ◽  
Evaluation Framework ◽  
Sub Saharan Africa ◽  
Clinical Trial Registry ◽  
Randomised Controlled

IntroductionCommon mental disorders (CMDs) are a leading cause of disability globally. CMDs are highly prevalent in Zimbabwe and have been addressed by an evidence-based, task-shifting psychological intervention called the Friendship Bench (FB). The task-shifted FB programme guides clients through problem-solving therapy. It was scaled up across 36 implementation sites in Zimbabwe in 2016.Methods and analysisThis study will employ a mixed-method framework. It aims to: (1) use quantitative survey methodologies organised around the Reach, Effectiveness, Adoption and Implementation and Maintenance evaluation framework to assess the current scaleup of the FB intervention and classify 36 clinics according to levels of performance; (2) use qualitative focus group discussions and semistructured interviews organised around the Consolidated Framework for Implementation Research to analyse determinants of implementation success, as well as elucidate heterogeneity in implementation strategies through comparing high-performing and low-performing clinics; and (3) use the results from aims 1 and 2 to develop strategies to optimise the Friendship Bench intervention and apply this model in a cluster randomised controlled trial to evaluate potential improvements among low-performing clinics. The trial will be registered with the Pan African Clinical Trial Registry (www.pactr.org). The planned randomised controlled trial for the third research aim will be registered after completing aims one and two because the intervention is dependent on knowledge generated during these phases.Ethics and disseminationThe research protocol received full authorisation from the Medical Research Council of Zimbabwe (MRCZ A/242). It is anticipated that changes in data collection tools and consent forms will take place at all three phases of the study and approval from MRCZ will be sought. All interview partners will be asked for informed consent. The research team will prioritise open-access publications to disseminate research results.

scholarly journals Targeted, structured text messaging to improve dietary and lifestyle behaviours for people on maintenance haemodialysis (KIDNEYTEXT): study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e023545 ◽  
Author(s):  
Jessica Stevenson ◽  
Katrina L Campbell ◽  
Mark Brown ◽  
Jonathan Craig ◽  
Kirsten Howard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Text Messaging ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Messages ◽  
Dietary Guidelines ◽  
Drop Out ◽  
Local Health ◽  
Lifestyle Behaviours ◽  
Randomised Controlled

IntroductionManaging nutrition is critical for reducing morbidity and mortality in patients on haemodialysis but adherence to the complex dietary restrictions remains problematic. Innovative interventions to enhance the delivery of nutritional care are needed. The aim of this phase II trial is to evaluate the feasibility and effectiveness of a targeted mobile phone text messaging system to improve dietary and lifestyle behaviours in patients on long-term haemodialysis.Methods and analysisSingle-blinded randomised controlled trial with 6 months of follow-up in 130 patients on haemodialysis who will be randomised to either standard care or KIDNEYTEXT. The KIDNEYTEXT intervention group will receive three text messages per week for 6 months. The text messages provide customised dietary information and advice based on renal dietary guidelines and general healthy eating dietary guidelines, and motivation and support to improve behaviours. The primary outcome is feasibility including recruitment rate, drop-out rate, adherence to renal dietary recommendations, participant satisfaction and a process evaluation using semistructured interviews with a subset of purposively sampled participants. Secondary and exploratory outcomes include a range of clinical and behavioural outcomes and a healthcare utilisation cost analysis will be undertaken.Ethics and disseminationThe study has been approved by the Western Sydney Local Health District Human Research Ethics Committee—Westmead. Results will be presented at scientific meetings and published in peer-reviewed publications.Trial registration numberACTRN12617001084370; Pre-results.

scholarly journals Estimating psychological treatment effects from a randomised controlled trial with both non-compliance and loss to follow-up

2003 ◽  
Vol 183 (4) ◽  
pp. 323-331 ◽  
Author(s):  
G. Dunn ◽  
M. Maracy ◽  
C. Dowrick ◽  
J. L. Ayuso-Mateos ◽  
O. S. Dalgard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Psychological Intervention ◽  
Psychological Treatment ◽  
Causal Effect ◽  
Controlled Trial ◽  
Loss To Follow Up ◽  
Average Causal Effect ◽  
Trial Subject ◽  
Randomised Controlled

BackgroundThe Outcomes of Depression International Network (ODIN) trial evaluated the effect of two psychological interventions for the treatment of depression in primary care. Only about half of the patients in the treatment arm complied with the offer of treatment, prompting the question: ‘what was the effect of treatment in those patients who actually received it?’AimsTo illustrate the estimation of the effect of receipt of treatment in a randomised controlled trial subject to non-compliance and loss to follow-up.MethodWe estimated the complier average causal effect (CACE) of treatment.ResultsIn the ODIN trial the effect of receipt of psychological intervention (an average of about 4 points on the Beck Depression Inventory) is about twice that of offering it.ConclusionsThe statistical analysis of the results of a clinical trial subject to noncompliance to allocated treatment is now reasonably straightforward through estimation of a CACE and investigators should be encouraged to present the results of analyses of this type as a routine component of a trial report.

scholarly journals A Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) for first-time families: study protocol of a three-arm randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
See Ling Loy ◽  
Thilagamangai ◽  
Joyce Teo ◽  
Sze Wern Chan ◽  
Nurul Khairani Abdul Razak ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Child Health ◽  
Linear Models ◽  
Controlled Trial ◽  
Text Messages ◽  
Feeding Practice ◽  
Learning Ecosystem ◽  
Mental Wellness ◽  
Randomised Controlled ◽  
First Time

Abstract Background Enhanced parenting self-efficacy (PSE) contributes to positive parenting and future parental-child health. First-time parents, in particular, are in need of support since the pregnancy until post-delivery to strengthen their early PSE. However, there is a lack of effective and sustainable relevant programmes in the community. The Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) aims to develop a self-learning eco-community throughout the pregnancy and early childhood to promote PSE among first-time parents. We apply choice architecture strategy using behavioural nudges and midwife-led continuity care during the first 1000 days, and test their effects on PSE and mother-child health for first-time families in Singapore. Methods This three-arm randomised controlled trial will recruit up to 750 pregnant women from the KK Women’s and Children’s Hospital, Singapore. Participants will be randomly assigned to receive: (1) standard routine care; (2) behavioural nudges (text messages) along with the use of a social media platform; or (3) midwife-led continuity care involving individualised teleconferencing sessions, during pregnancy and post-delivery. Using web-based questionnaires, participants will be assessed for baseline socio-demography and health status in the first visit, with follow-up assessments in the third trimester, at birth, 6-week (primary end-point), 6-, 12-, 18- and 24-month post-delivery. The primary outcome is PSE. Secondary outcomes include health and birth experience, mental wellness, feeding practice, maternal and child nutritional status. Intention-to-treat and per-protocol analyses will be performed using general linear models to test the effects of interventions across three arms. Recruitment has begun in June 2020 and is estimated to complete in September 2022. Discussion This study may identify a sustainable effective strategy in the community by helping first-time parents to have a positive experience during the pregnancy, childbirth and parenthood, leading to an enhanced PSE and health outcomes for both mother and child. Findings from this study will provide insight into the implementation of early parenting and mother-child care programmes. Trial registration ClinicalTrials.gov NCT04275765. Registered on 19 February 2020.

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