MENTAL HEALTH
Opportunities and challenges to delivering a trial for depressive symptoms in primary care during the COVID-19 pandemic: insights from the Alpha-Stim-D randomised controlled trial
Randomised controlled trials (RCTs) are considered the most powerful research design for evidence-based practice, but recruitment challenges can increase costs and delay completion and implementation, making successful recruitment especially crucial in mental health research. While remote recruitment strategies and digital health interventions are increasingly used, evidence on effective methods to improve recruitment to remotely delivered mental health trials remains limited. The Alpha Stim-D Trial, a multi-centre double-blind RCT addressing depressive symptoms in primary care for participants aged 16 years and above, faced a six-month recruitment delay due to the COVID-19 pandemic but still met its recruitment target and achieved high retention rates. Several recruitment strategies were implemented and adapted during the pandemic, including shifting from in-person to remote recruitment approaches; systematic recruitment using postal invitations generated from criteria-specific searches of electronic health records was introduced alongside opportunistic recruitment to boost referrals and reduce the burden on referring sites. Collaboration with key stakeholders, such as primary care clinicians and Patient and Public Involvement and Engagement (PPI/E) representatives, provided valuable input on strategies, while study researchers played a vital role in building rapport with participants and maintaining communication throughout the process. The findings suggest that trial processes can significantly influence recruitment, highlighting the importance of regularly reviewing strategies, utilising remote approaches to enhance reach and flexibility, reducing site burden, engaging stakeholders, and fostering strong researcher–participant relationships to maximise recruitment success.
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”Flow” Transcranial Direct Current Stimulation (tDCS) for Depression Treatment in a Primary Healthcare General Practice—Depression, Functioning, and Health-Related Quality of Life Outcomes 2024 (Griffiths C, Silva KM da, Jiang H, Smart D, Zafar A)
Flow FL-100 is a transcranial direct current stimulation (tDCS) device designed for self-administration at home alongside a software application that delivers wellbeing behaviour therapy training, with existing evidence supporting its effectiveness in treating depressive symptoms. This post-marketing study aimed to evaluate the impact of Flow on depression among primary care general practice patients with depressive symptoms using an open-label cohort design without a control group. Eligible participants were aged 18 years or older and reported depression symptoms; they self-administered five 30-minute tDCS sessions per week for the first three weeks, followed by three sessions per week thereafter. Assessments were conducted at three, six, and ten weeks using the self-report Montgomery-Åsberg Depression Rating Scale (MADRS-S). Remission rates were 29–30% at three weeks, 33–34% at six weeks, and 50% at ten weeks, with significant improvements and large effect sizes observed across all time points. These findings suggest that Flow tDCS can be effectively integrated into primary care services, is acceptable for patient use, and offers an effective treatment option for depression either alongside or as an alternative to antidepressants and psychotherapy, supporting the case for its broader availability in general practice.
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“Flow” Transcranial Direct Current Stimulation (tDCS) for Depression Treatment in a Primary Healthcare General Practice-An Open-Label Cohort Study Measuring Montgomery-Åsberg Depression Rating Scale (MADRS-S) Outcomes 2024 (Griffiths C, Jiang H, Smart D, Zafar A)
Flow FL-100 is a transcranial direct current stimulation (tDCS) device self-administered at home alongside a software application that provides wellbeing behaviour therapy training, with existing evidence supporting its effectiveness in treating depressive symptoms. This post-marketing study evaluated the effect of Flow on depression, functioning, and health-related quality of life among primary care patients with depressive symptoms using an open-label cohort design without a control group. Thirty-one adults completed six weeks of Flow treatment (mean age 45.6 years, SD = 13.72, range 20–75 years; 77.4% female). Pre- and post-intervention assessments included the Patient Health Questionnaire (PHQ-9), Work and Social Adjustment Scale (WSAS), and European Quality of Life Five Dimension (EQ-5D-5L). Results showed PHQ-9 reliable improvement and remission rates of 58.1% and 32.3%, with significant improvements in PHQ-9 and WSAS scores and large effect sizes. EQ-5D-5L outcomes indicated significant gains in three dimensions and in the health index score with medium effect sizes. These findings suggest that Flow tDCS can be feasibly delivered in primary care settings, with patients adhering to the treatment course, and provide further support for its effectiveness as a depression treatment, highlighting its potential for wider availability in general practice as an alternative or complement to antidepressants and psychotherapy.
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Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trial 2023 (Morriss R, Patel S, Boutry C, Patel P, Guo B, Briley PM)
Randomised sham-controlled trials of cranial electrostimulation with the Alpha-Stim Anxiety Insomnia and Depression (AID) device have shown improvements in anxiety and depression, but no adequately powered sham-controlled trials have been conducted in major depression. The Alpha-Stim-D trial was a multicentre, parallel-group, double-blind RCT across 25 primary care centres in England, evaluating whether active Alpha-Stim AID was superior to sham in treating major depression. Eligible participants (aged ≥16 years, diagnosed with primary major depression, PHQ-9 score 10–19, and with recent antidepressant use) were randomly assigned (1:1) to receive daily 1 h active (100 μA) or sham treatment for 8 weeks, with stratification by region, anxiety disorder, and antidepressant use. Exclusion criteria included persistent suicidality, neurological conditions, substance use or eating disorders, bipolar disorder, psychosis, or recent psychological treatment. Randomisation and masking applied to participants, assessors, and analysts. The primary outcome was change in GRID-HDRS-17 score from baseline to 16 weeks, analysed by intention to treat. Between Sept 2020 and Jan 2022, 236 participants were randomised (118 per group; mean age 38 years, 66% women). At 16 weeks, follow-up rates were 86% in the active group and 83% in the sham group. Mean GRID-HDRS-17 change was –5.9 (95% CI –7.1 to –4.8) with active treatment and –6.5 (–7.7 to –5.4) with sham, with no significant difference (–0.6 [95% CI –1.0 to 2.2], p=0.46). Adverse events occurred in 7% of participants (similar across groups), with one unrelated serious adverse event in the sham group. These findings indicate that active Alpha-Stim AID was not superior to sham in reducing depression symptoms in major depression.