The level of mood disorders like depression and anxiety is projected to rise across the globe.
Even before the COVID-19 pandemic began, the World Health Organisation (WHO) revealed a 13% rise in mental health and substance abuse disorders in the past decade.1
The onset of the pandemic has impacted the mental health of millions of people around the world. Everyone has been affected to at least some degree by factors like ongoing stress, financial instability, fear, loss, social isolation, and disruption in usual healthcare. While vaccinations have helped people feel more hopeful about a gradual return to normalcy, global mental health issues continue to be a significant concern for the entire population.
Rising rates of mental health disorders
The global rate of mental health conditions has risen since the pandemic began, with reports from 32 different countries pointing to an overall incidence of 28% for depression, 26.9% for anxiety, 24.1% for post-traumatic stress symptoms, 36.5% for stress, 50% for psychological distress, and 27.6% for sleep problems, according to a 2021 systematic review and meta-analysis.2
For many people, the pandemic has affected areas of daily life, including finances, employment concerns or job loss, general health issues, and family and other significant relationships. Others have struggled with challenges such as lack of control, disrupted routines, social distancing, isolation from friends and family, working from home, dealing with the subsequent impact on relationships, and an overall decreased ability to cope.
A cross-sectional online survey in a UK cohort examined potential risk factors for depression, anxiety, and stress among 3,097 study participants. The results identified factors such as being younger, female, and a member of a COVID-19 risk group as key influences for increased stress, anxiety, and depression.3 Results of a systematic review and meta-analyses published also confirmed these factors, finding that having a pre-existing mental health condition and experiencing concerns about getting infected with the COVID-19 virus were potential additional risk factors.4
The response to the pandemic in terms of lockdowns and other measures has also impacted people’s mental health and wellbeing. One survey compared the impact of the pandemic response on the mental health of participants, including factors such as differences in the management of lockdowns, border closures, and travel restrictions. The results of the survey showed that 25% of responders reported a “subjective worsening of the general psychological symptoms” like anxiety, stress, and depression.5
Prioritising mental health for clinical trial participants
Reducing the patient burden is especially important in psychiatric studies. The COVID-19 pandemic accelerated and increased adoption of decentralised and hybrid trials, which reduce the need for site and patient interactions, allowing for greater cost efficiency and increased patient centricity. These trials also minimise the risk of clinical trial disruption and patients’ heightened anxiety and sleep disturbances, which can add variability in critical situations such as the ongoing pandemic.
Additionally, the use of digital health technologies, along with home healthcare visits and telehealth, may improve monitoring of clinical trial participation. Accellacare In-Home Services, plus the use of telemedicine, a fully-compliant remote Source Data Verification process, and FIRECREST eViewer and eConsent, make it convenient for the patient to complete the protocol assessments and stay engaged throughout the clinical study.
Looking to the future
Due to the ongoing and evolving nature of the pandemic, it’s hard to predict the exact long-term impact that it will have on mental health symptoms and disorders.6 While public and mental health interventions remain one way to promote mental health and wellness in the general public, the lessons learned during the COVID-19 pandemic will accelerate adoption of decentralised and hybrid trials, the use of digital health technologies, and home healthcare visits and telehealth. All these together may improve the monitoring of clinical trial participation, easing site and patient burdens.
Learn more about our experience in psychiatric clinical trials.
References:
- https://www.who.int/health-topics/mental-health#tab=tab_2
- https://www.nature.com/articles/s41598-021-89700-8
- https://bmjopen.bmj.com/content/10/9/e040620
- https://pubmed.ncbi.nlm.nih.gov/33781283/
- https://bmcpsychology.biomedcentral.com/articles/10.1186/s40359-021-00565-y
- https://www.annualreviews.org/doi/10.1146/annurev-publhealth-032013-182435
In this section
-
Digital Disruption
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
- Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Demystifying EU CTR, MDR and IVDR
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
-
Respiratory
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Therapeutic spotlight: Precision medicine considerations in rare diseases
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Blended solutions insights
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel