scholarly journals The Moo’D Study: protocol for a randomised controlled trial of A2 beta-casein only versus conventional dairy products in women with low mood

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Meghan Hockey ◽  
Hajara Aslam ◽  
Michael Berk ◽  
Julie A. Pasco ◽  
Anu Ruusunen ◽  
...  
Keyword(s):  
Psychological Distress ◽  
Randomised Controlled Trial ◽  
Dairy Products ◽  
Controlled Trial ◽  
Milk Proteins ◽  
Major Protein ◽  
Public Health Importance ◽  
Low Mood ◽  
Beta Casein ◽  
Randomised Controlled

Abstract Background Beta-casein is a major protein in cow’s milk, of which A1 and A2 are the most frequent variants. Recent evidence implicates A1 beta-casein consumption in mechanisms that are of potential importance to mental health, yet its possible effects on psychological endpoints remains unknown. The primary aim of the study is to evaluate the comparative effects of consumption of dairy products containing A2 beta-casein versus conventional dairy (i.e. containing both A1 and A2 beta-casein) on symptoms of psychological distress in women with low mood. Methods ‘The Moo’D Study’ is a 16-week, superiority, 1:1 parallel group, triple-blinded, randomised controlled trial. Ninety women with low mood (Patient Health Questionnaire score ≥ 5) will be randomised to consume either A2 beta-casein only or conventional dairy products. The primary outcome, symptoms of psychological distress, will be measured by the 21-item Depression, Anxiety and Stress Scale. Secondary outcomes will include symptoms of depression, anxiety and stress, severity of low mood, cognition, gut microbiota composition, gut symptomatology, markers of immune function, gut inflammation, systemic metabolites, endothelial integrity and oxidative stress, body composition, perceived wellbeing, sleep, quality of life, resource use and cost-effectiveness. Discussion This study will advance our understanding of the possible impact of milk proteins on psychological distress in women as well as elucidate mechanisms underpinning any association. Given dairy products form a substantial component of traditional and Western diets, the implications of these findings are likely to be of clinical and public health importance. Trial registration The trial protocol has been prospectively registered with the Australia and New Zealand Clinical Trials Registry, ACTRN12618002023235. Registered on 17 December 2018.

scholarly journals Mindful gratitude journaling: psychological distress, quality of life and suffering in advanced cancer: a randomised controlled trial

2021 ◽  
pp. bmjspcare-2021-003068
Author(s):  
Ting Ting Tan ◽  
Maw Pin Tan ◽  
Chee Loong Lam ◽  
Ee Chin Loh ◽  
David Paul Capelle ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Randomised Controlled Trial ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
Randomised Controlled

ContextNumerous studies have shown that gratitude can reduce stress and improve quality of life.ObjectiveOur study aimed to examine the effect of mindful gratitude journaling on suffering, psychological distress and quality of life of patients with advanced cancer.MethodsWe conducted a parallel-group, blinded, randomised controlled trial at the University of Malaya Medical Centre, Malaysia. Ninety-two adult patients with advanced cancer, and an overall suffering score ≥4/10 based on the Suffering Pictogram were recruited and randomly assigned to either a mindful gratitude journaling group (N=49) or a routine journaling group (N=43).ResultsAfter 1 week, there were significant reductions in the overall suffering score from the baseline in both the intervention group (mean difference in overall suffering score=−2.0, 95% CI=−2.7 to −1.4, t=−6.125, p=0.000) and the control group (mean difference in overall suffering score=−1.6, 95% CI=−2.3 to −0.8, t=−4.106, p=0.037). There were also significant improvements in the total Hospital Anxiety and Depression Scale score (mean difference=−3.4, 95% CI=−5.3 to −1.5, t=−3.525, p=0.000) and the total Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being score (mean difference=7.3, 95% CI=1.5 to 13.1, t=2.460, p=0.014) in the intervention group after 7 days, but not in the control group.ConclusionThe results provide evidence that 7 days of mindful gratitude journaling could positively affect the state of suffering, psychological distress and quality of life of patients with advanced cancer.Trial registration numberThe trial was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1261800172191) and conducted in accordance with the Declaration of Helsinki.

scholarly journals Positive Mental Training in patients with Multiple Sclerosis experiencing psychological distress: A Preliminary Randomised Controlled Trial

2021 ◽  
Author(s):  
Katy Muray ◽  
Giulia Melchiorre ◽  
Alastair Dobbin ◽  
Killian A Welch
Keyword(s):  
Multiple Sclerosis ◽  
Psychological Distress ◽  
Randomised Controlled Trial ◽  
Low Cost ◽  
Controlled Trial ◽  
Control Group ◽  
Mental Training ◽  
Current Form ◽  
Self Rated Health ◽  
Randomised Controlled

Introduction: Psychological distress is a major issue in multiple sclerosis (MS), having a significant impact on quality of life. Antidepressants are generally unhelpful for subsyndromal symptomatology, and psychological treatment approaches often not accessible or too cognitively demanding for some patients. There is an urgent need for low-cost interventions to improve wellbeing in MS. Methods: This was a pilot randomised controlled trial (RCT) of Positive Mental Training (PosMT), a low intensity intervention providing training in positivity, optimism and resilience previously shown to improve anxious and depressive symptomotology. 28 patients with MS were randomised to the intervention and 30 to the control group. Results: Follow-up data was obtained from 39 patents. The majority of participants receiving PosMT reported that they had used the intervention, with few reporting side effects. The intervention group reported a significant improvement in self-rated health as measured by the EuroQual visual analogue scale, F(4,34) = 3.204, p = 0.025, R2 = 0.274. Discussion: This preliminary RCT found that PosMT in its current form could be used by patients with MS with little difficulty. Despite the small size of the study, allocation to the intervention was found to be associated with a significant improvement in self-rated health. Given the low cost of PosMT and its easy availability (it can simply be downloaded from a website), this pilot RCT suggests it could be a useful tool for MS patients. We believe this intervention warrants further study, ideally in a large multi-centre RCT.

Effect of a narrative intervention on individual-level abortion stigma: a randomised controlled trial

2021 ◽  
pp. bmjsrh-2021-201055
Author(s):  
Maryl Goldberg Sackeim ◽  
Soo Young Lee ◽  
Sara Newton ◽  
Diane Lauderdale ◽  
Melissa Gilliam
Keyword(s):  
Psychological Distress ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Stigma Scale ◽  
Individual Level ◽  
Narrative Intervention ◽  
Randomised Controlled ◽  
Score Range

ObjectiveTo evaluate the effect of a narrative intervention on individual-level abortion stigma in patients undergoing abortion.Study designThis randomised controlled trial examined individual-level abortion stigma and psychological distress among patients undergoing outpatient abortion. Patients were randomised to a narrative intervention verus usual care. The intervention consisted of viewing a digital narrative and responding to a writing prompt. Abortion stigma was measured using the Individual Level Abortion Stigma Scale (ILAS) and psychological distress was assessed with a modified Profile of Mood States-Short Form (POMS-SF) at baseline and after 2 weeks. The primary outcome compared change in ILAS score from baseline to follow-up between groups. The secondary outcome compared change in the modified POMS-SF score.ResultsWe randomised 215 participants. Baseline characteristics were similar between groups. Overall baseline stigma scores were low. The study groups did not differ significantly in the primary ILAS outcome (mean change=0.07 in both groups with score range 0 to 3.5, 95% CI -0.11 to 0.11, p=0.98). There was also no significant difference in the secondary modified POMS-SF outcome (mean change −0.64 for the intervention group and −0.65 for the control group with score range −8 to 8, 95% CI -1.10 to 1.12, p=0.98). Black participants, comprising the majority, demonstrated lower levels of individual-level abortion stigma and psychological distress at baseline than participants identifying with any other race (mean baseline ILAS score of 0.70 vs 1.00 and mean modified POMS-SF score of −3.00 vs −1.45, 95% CI 0.12 to 0.46 and 95% CI 0.28 to 2.01, p=0.001 and p=0.02, respectively).ConclusionsPatients who participated in a narrative intervention did not score lower on an individual-level abortion stigma scale compared with a control group at 2-week follow-up. Demographic characteristics may predict levels of individual-level abortion stigma and psychological distress among patients seeking abortion.

scholarly journals Self Help Plus: study protocol for a cluster-randomised controlled trial of guided self-help with South Sudanese refugee women in Uganda

2018 ◽  
Vol 5 ◽  
Author(s):  
F. L. Brown ◽  
K. Carswell ◽  
J. Augustinavicius ◽  
A. Adaku ◽  
M. R. Leku ◽  
...  
Keyword(s):  
Psychological Distress ◽  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Refugee Women ◽  
South Sudanese ◽  
Self Help ◽  
Cluster Randomised ◽  
Randomised Controlled

Background.Exposure to armed conflict and forced displacement constitute significant risks for mental health. Existing evidence-based psychological interventions have limitations for scaling-up in low-resource humanitarian settings. The WHO has developed a guided self-help intervention, Self Help Plus (SH+), which is brief, implemented by non-specialists, and designed to be delivered to people with and without specific mental disorders. This paper outlines the study protocol for an evaluation of the SH+ intervention in northern Uganda, with South Sudanese refugee women.Methods.A two-arm, single-blind cluster-randomised controlled trial will be conducted in 14 villages in Rhino Camp refugee settlement, with at least 588 women experiencing psychological distress. Villages will be randomly assigned to receive either SH+ with enhanced usual care (EUC), or EUC alone. SH+ is a five-session guided self-help intervention delivered in workshops with audio-recorded materials and accompanying pictorial guide. The primary outcome is reduction in overall psychological distress over time, with 3 months post-treatment as the primary end-point. Secondary outcomes are self-defined psychosocial concerns, depression and post-traumatic stress disorder symptoms, hazardous alcohol use, feelings of anger, interethnic relations, psychological flexibility, functional impairment and subjective wellbeing. Psychological flexibility is a hypothesised mediator, and past trauma history and intervention attendance will be explored as potential moderators.Discussion.This trial will provide important information on the effectiveness of a scalable, guided self-help intervention for improving psychological health and wellbeing among people affected by adversity.Trial Registration:ISRCTN50148022; registered 13/03/2017.

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