Tag: RCT: Randomised Control Trial

Are Mindfulness-Based Interventions Useful for Nursing Students?

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Research Paper Title

The effects of mindfulness-based interventions on nursing students: A meta-analysis.

Background

Recently, mindfulness interventions have been extensively applied in the field of nursing education. However, no consensus has been reached on whether these interventions can reduce anxiety and depression in nursing students.

This meta-analysis was designed to determine the effect of mindfulness interventions on levels of depression, anxiety, stress and mindfulness for nursing students. It was a meta-analysis of randomised controlled trials.

Methods

The following Chinese and English databases were searched for relevant articles: Pubmed, Embase, Cochrane library, Web of Science, CNKI (China National Knowledge Infrastructure) and Wanfang. The search encompassed the establishment of these databases up until January 2020. Two reviewers separately entered the data into Review Manager Software 5.3.

Results

A total of 10 randomised controlled trials (RCTs) were reviewed. It was found that mindfulness interventions significantly lowered levels of depression (SMD = -0.42, 95% CI:-0.56 to -0.28, P < 0.001), anxiety (SMD = -0.32, 95% CI:-0.47 to -0.17, P < 0.001) and stress (SMD = -0.50, 95% CI:-0.65 to -0.35, P < 0.001) in nursing students. Furthermore, the interventions raised levels of mindfulness in this group (SMD = 0.54, 95% CI:0.33-0.75, P < 0.001).

Conclusions

Mindfulness interventions can significantly reduce nursing students’ negative emotions, helping them to manage their stress and anxiety. College nursing educators should consider adopting mindfulness interventions in nursing education to promote the mental health of students.

Reference

Chen, X., Zhang, B., Jin, S-X., Quan, Y-X., Zhang, X-W. & Cui, X-S. (2021) The effects of mindfulness-based interventions on nursing students: A meta-analysis. Nurse Education Today. doi: 10.1016/j.nedt.2020.104718. Online ahead of print.

Should we use tRNS (with the Current Stimulation Parameters) as a Therapeutic Intervention for the Treatment of Depression?

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Research Paper Title

Transcranial random noise stimulation for the acute treatment of depression: a randomised controlled trial.

Background

Transcranial electrical stimulation has broad potential as a treatment for depression.

Transcranial random noise stimulation (tRNS), which delivers randomly fluctuating current intensities, may have greater cortical excitatory effects compared to other forms of transcranial electrical stimulation.

The researchers therefore aimed to investigate the antidepressant efficacy of tRNS.

Methods

Depressed participants were randomly assigned by computer number generator to receive 20 sessions of either active or sham tRNS over four weeks in a double-blinded, parallel group randomised-controlled trial.

tRNS was delivered for 30mins with a direct current offset of 2mA and a random noise range of 2mA. Primary analyses assessed changes in depression severity using the Montgomery-Asperg Depression Rating Scale (MADRS).

Neuroplasticity, neuropsychological, and safety outcomes were analysed as secondary measures.

Results

69 participants were randomised, of which three discontinued treatment early leaving 66 (sham n = 34, active n = 32) for per-protocol analysis.

Depression severity scores reduced in both groups (MADRS reduction in sham = 7.0 [95%CI 5.0-8.9]; and active = 5.2 [95%CI 3.2-7.3]).

However, there were no differences between active and sham groups in the reduction of depressive symptoms, or the number of participants meeting response (sham = 14.7%; active = 3.1%) and remission criteria (sham = 5.9%; active = 0%).

Erythema, paraesthesia, fatigue, and dizziness/light-headedness occurred more frequently in the active tRNS group.

Neuroplasticity, neuropsychological and acute cognitive effects were comparable between groups.

Conclusions

The researchers suggest the results do not support the use of tRNS with the current stimulation parameters as a therapeutic intervention for the treatment of depression.

Reference

Nikolin, S., Alonzo, A., Martin, D., Gálvez, V., Buten, S., Taylor, R., Goldstein, J., Oxley, C., Hadzi-Pavlovic, D. & Loo, C.K. (2020) Transcranial random noise stimulation for the acute treatment of depression: a randomized controlled trial. The International Journal of Neuropsychopharmacology. pii: pyz072. doi: 10.1093/ijnp/pyz072. [Epub ahead of print].

Primary Care Physicians & the Mental Health Gap Action Programme (mhGAP)

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Research Paper Title

Building capacity in mental health care in low- and middle-income countries by training primary care physicians using the mhGAP: a randomized controlled trial.

Background

To address the rise in mental health conditions in Tunisia, a training based on the Mental Health Gap Action Programme (mhGAP) Intervention Guide (IG) was offered to primary care physicians (PCPs) working in the Greater Tunis area.

Non-specialists (such as PCPs)’ training is an internationally supported way to target untreated mental health symptoms.

Methods

The researchers aimed to evaluate the programme’s impact on PCPs’ mental health knowledge, attitudes, self-efficacy and self-reported practice, immediately following and 18 months after training.

They conducted an exploratory trial with a combination of designs: a pretest-posttest control group design and a one-group pretest-posttest design were used to assess the training’s short-term impact; and a repeated measures design was used to assess the training’s long-term impact.

The former relied on a delayed-intervention strategy: participants assigned to the control group (Group 2) received the training after the intervention group (Group 1).

The intervention consisted of a weekly mhGAP-based training session (totalling 6 weeks), comprising lectures, discussions, role plays and a support session offered by trainers.

Data were collected at baseline, following Group 1’s training, following Group 2’s training and 18 months after training. Descriptive, bivariate and ANOVA analyses were conducted.

Overall, 112 PCPs were randomised to either Group 1 (n = 52) or Group 2 (n = 60).

Results

The training had a statistically significant short-term impact on mental health knowledge, attitudes and self-efficacy scores but not on self-reported practice.

When comparing pre-training results and results 18 months after training, these changes were maintained.

PCPs reported a decrease in referral rates to specialised services 18 months after training in comparison to pre-training.

Conclusions

The mhGAP-based training might be useful to increase mental health knowledge and self-efficacy, and decrease reported referral rates and negative mental health attitudes among PCPs in Tunisia and other low- and middle-income countries.

Future studies should examine relationships among these outcome variables.

Reference

Spagnolo, J., Champagne, F., Leduc, N., Rivard, M., Melki, W., Piat, M., Laporta, M., Guesmi, I., Bram, N. & Charfi, F. (2019) Building capacity in mental health care in low- and middle-income countries by training primary care physicians using the mhGAP: a randomized controlled trial. Health Policy and Planning. pii: czz138. doi: 10.1093/heapol/czz138. [Epub ahead of print].

Comparing the Effectiveness of Prompt Mental Health Care to Treatment as Usual

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Research Paper Title

Effectiveness of Prompt Mental Health Care, the Norwegian Version of Improving Access to Psychological Therapies: A Randomized Controlled Trial.

Background

The innovative treatment model Improving Access to Psychological Therapies (IAPT) and its Norwegian adaptation, Prompt Mental Health Care (PMHC), have been evaluated by cohort studies only. Albeit yielding promising results, the extent to which these are attributable to the treatment thus remains unsettled.

Therefore the objective of this research was to investigate the effectiveness of the PMHC treatment compared to treatment as usual (TAU) at 6-month follow-up.

Methods

A randomised controlled trial with parallel assignment was performed in two PMHC sites (Sandnes and Kristiansand) and enrolled clients between November 9, 2015 and August 31, 2017. Participants were 681 adults (aged ≥18 years) considered for admission to PMHC due to anxiety and/or mild to moderate depression (Patient Health Questionnaire [PHQ-9]/Generalised Anxiety Disorder scale [GAD-7] scores above cutoff). These were randomly assigned (70:30 ratio; n = 463 to PMHC, n = 218 to TAU) with simple randomisation within each site with no further constraints. The main outcomes were recovery rates and changes in symptoms of depression (PHQ-9) and anxiety (GAD-7) between baseline and follow-up. Primary outcome data were available for 73/67% in PMHC/TAU. Sensitivity analyses based on observed patterns of missingness were also conducted. Secondary outcomes were work participation, functional status, health-related quality of life, and mental well-being.

Results

A reliable recovery rate of 58.5% was observed in the PMHC group and of 31.9% in the TAU group, equalling a between-group effect size of 0.61 (95% CI 0.37 to 0.85, p < 0.001). The differences in degree of improvement between PMHC and TAU yielded an effect size of -0.88 (95% CI -1.23 to -0.43, p < 0.001) for PHQ-9 and -0.60 (95% CI -0.90 to -0.30, p < 0.001) for GAD-7 in favour of PMHC. All sensitivity analyses pointed in the same direction, with small variations in point estimates. Findings were slightly more robust for depressive than anxiety symptoms. PMHC was also more effective than TAU in improving all secondary outcomes, except for work participation (z = 0.415, p = 0.69).

Conclusions

The PMHC treatment was substantially more effective than TAU in alleviating the burden of anxiety and depression. This adaptation of IAPT is considered a viable supplement to existing health services to increase access to effective treatment for adults who suffer from anxiety and mild to moderate depression. A potential effect on work participation needs further examination.

Reference

Knapstad, M., Lervik, L.V., Sæther, S.M.M., Aarø, L.E. & Smith, O.R.F. (2019) Effectiveness of Prompt Mental Health Care, the Norwegian Version of Improving Access to Psychological Therapies: A Randomized Controlled Trial. Psychotherapy and Psychosomatics. 1-16. doi: 10.1159/000504453. [Epub ahead of print].

What is the Evidence for the Use of Nutrient Supplements in the Treatment of Mental Disorders?

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Research Paper Title

The efficacy and safety of nutrient supplements in the treatment of mental disorders: a meta-review of meta-analyses of randomized controlled trials.

Background

The role of nutrition in mental health is becoming increasingly acknowledged. Along with dietary intake, nutrition can also be obtained from “nutrient supplements”, such as polyunsaturated fatty acids (PUFAs), vitamins, minerals, antioxidants, amino acids and pre/probiotic supplements.

Recently, a large number of meta-analyses have emerged examining nutrient supplements in the treatment of mental disorders.

Methods

To produce a meta-review of this top-tier evidence, the researchers identified, synthesised and appraised all meta-analyses of randomised controlled trials (RCTs) reporting on the efficacy and safety of nutrient supplements in common and severe mental disorders.

Results

Their systematic search identified 33 meta-analyses of placebo-controlled RCTs, with primary analyses including outcome data from 10,951 individuals. The strongest evidence was found for PUFAs (particularly as eicosapentaenoic acid) as an adjunctive treatment for depression.

More nascent evidence suggested that PUFAs may also be beneficial for attention-deficit/hyperactivity disorder, whereas there was no evidence for schizophrenia.

Folate-based supplements were widely researched as adjunctive treatments for depression and schizophrenia, with positive effects from RCTs of high dose methylfolate in major depressive disorder.

There was emergent evidence for N-acetylcysteine as a useful adjunctive treatment in mood disorders and schizophrenia.

All nutrient supplements had good safety profiles, with no evidence of serious adverse effects or contraindications with psychiatric medications.

Conclusions

In conclusion, clinicians should be informed of the nutrient supplements with established efficacy for certain conditions (such as eicosapentaenoic acid in depression), but also made aware of those currently lacking evidentiary support.

Future research should aim to determine which individuals may benefit most from evidence-based supplements, to further elucidate the underlying mechanisms.

Reference

Firth, J., Teasdale, S.B., Allott, K., Siskind, D., Marz, W., Cotter, J., Veronese, N., Schuch, F., Smith, L., Solmi, M., Carvalho, A.F., Vancampfort, D., Berk, M., Stubbs, B> & Sarris, J. (2019) The efficacy and safety of nutrient supplements in the treatment of mental disorders: a meta-review of meta-analyses of randomized controlled trials. World Psychiatry. 18, pp.308-324.