Eligible intervention studies must be:1) done to improve mental health with people with COVID-19; or 2) designed to specifically target COVID-19 related mental health concerns in people not identified as having COVID-19; interventions in this group that are not described as addressing mental health symptoms from COVID-19 or that are not tailored to address COVID-19 challenges will be excluded.
Summary of Eligible Trials Results
We have identified and extracted data from twenty-one eligible trials; fifteen of the trials included between 29 and 200 people with suspected or confirmed COVID-19 infection from China (N=14) and Iran (N=1) (6696, 30785, 32977, 39213, 41224, 51216, 51224, 68574, 70884, 84523, 84623, 86553, 86557, 92880, 102957); two trials included 42 and 100 Chinese people with pre-existing medical conditions (84404, 95905); one trial included 60 Chinese people without COVID-19 infection in an intensive care unit (ICU) (52979); and three trials included general population samples of 670 people from Sweden (101948), 148 people from China (57582) and 430 people from various unspecified countries (8007).
Among trials testing interventions aimed to improve mental health outcomes for people with suspected or confirmed COVID-19 infection, one (6696) tested the effect of progressive muscle relaxation, three (39213, 41224, 70884) compared enhanced psychological interventions versus standard psychological therapies, two (32977, 51216) tested traditional Chinese music therapies, one (51224) tested a writing exercise, five (84523, 86553, 86557, 102957) tested enhanced nursing techniques versus standard care, two (92880, 84623) tested Baduanjin exercise interventions, one (30785) tested a combination of psychotherapy, music therapy, and physical exercise compared to standard care, and one (68574) tested an improved isolation environment with psychological therapy versus standard care.
Among trials testing interventions on people with pre-existing medical conditions, one (84404) compared the effects of psychological counselling on depression and anxiety compared to standard care. Another (95905) compared the effects of COVID-19-related education via brochures and one-on-one health counseling on depression and anxiety compared to standard care.
One trial (52979) on Chinese ICU patients without COVID-19, tested the effects of broadly described psychological care on patient anxiety compared to standard care.
Among trials testing interventions on general population samples, one (8007) tested a very brief exercise in which an international pool of paid online volunteers were asked to write psychologically affirming text. Their stress and well-being were compared immediately after to the stress and well-being of participants who wrote text about a colour. Another trial (57582), compared the effects of online mindfulness-based stress-reduction group therapy (2 times per week for 2 weeks) on participant depression, anxiety, and mental health function compared to an online mental health education intervention.
One trial of interest (101948) tested the effect of a self-directed, online cognitive behavioral intervention for anxiety and depression in a sample of the Swedish general population (N=335), compared to a waitlist group (N=335). The intervention participants received 3-week access to an established online cognitive behavioral intervention for worry-related problems plus additional modules adapted specifically for dysfunctional COVID-19 worry. Modules include text, tasks, and digital worksheets to record progress. The authors reported a standardized mean effect size of Hedges’ g = 0.57 (95% CI 0.40 to 0.73) for anxiety and Hedges’ g = 0.36 (95%CI .20 to 0.52) for depression. Trial reporting was high quality and there were no serious risk of bias concerns (table pending).
Summary of Registrations
We have identified 73 registrations for trials that appear to be eligible once completed. All but 6 of the interventions where delivery method is reported provide videoconference or teleconference interactive interventions or self-help interventions delivered via websites or videos. One intervention provides in-person peer-support for hospital staff. Two other interventions provide in-person psychological counseling to COVID-19 patients. A similar intervention provides Basic Body Awareness training for medical staff and COVID-19 patients at a hospital. An intervention in Belgium provides face to face counseling from community health workers. One US trial tests the effects of aromatherapy on anxiety in people with likely COVID-19 infection.
Of the 73 trial registrations, 27 target the general population, 14 target medical staff, 9 target patients infected with COVID-19, 9 target people with pre-existing mental health conditions, 9 target people with pre-existing medical conditions, 1 targets university students, 3 target close contacts of COVID-19 patients, and 1 targets US veterans. One trial based in the US plans to enrol 30,000 Isha yoga practitioners to test a deep breathing intervention. A trial in the Australian general population plans to enrol 9000 participants in online neighborhood engagement challenges. One trial, in Canadian medical staff, plans to enrol 1000 participants to test its peer-support model. Another trial plans to enrol 1080 American and Canadian physician residents to test virtual peer-support sessions. One trial, in the German general population, plans to enrol 600 participants to test an online modular support program. One trial, in the Canadian general population plans to enrol 600 participants to test a virtual fitness intervention. One trial, in Spain, plans to enrol 560 medical staff to test a psychoeducation app. A trial in the German general population plans to enrol 544 participants to test a livestream exercise intervention. A trial in the American general population plans to enrol 500 participants to test an ultra-brief online anxiety normalizing program. One trial, in the Canadian general population, plans to enrol 490 participants to test a workout app intervention. One trial, in the American general population, plans to enrol 400 participants to test a meditation app; 31 trials will attempt to enrol between 100 and 300 participants; the rest plan to enrol fewer than 100 participants. Registered trials are from Australia (N = 6), Brazil (N=2), Belgium (N=2), Canada (N = 8), China (N = 5), Denmark (N = 1), France (N = 2), Germany (N = 4), Honduras (N=1), Hungary (N=1), Israel (N=1), Iran (N = 7), Malaysia (N=1), Mexico (N=1), Oman (N=1), Spain (N = 5), Sweden (N = 4), Turkey (N = 3), the United Kingdom (N=2), and the United States (N=14).
Most of the registered trials plan to recruit a small sample of participants and use standard interventions not adapted for COVID-19 (e.g., meditation, exercise). There are several feasibly implemented COVID-19 tailored interventions being tested that may be useful for rapid uptake, pending results. One trial, in Canadian medical staff, plans to enrol 1000 participants to test a peer-support model in a stepped-wedge trial (NCT04373382, results expected February 2022). Another trial, which plans to enrol 600 participants, is testing an online modular support program to encourage coping with COVID-19 in the German general population (NCT04324190, results were expected July 2020). Another trial of interest is enrolling 195 participants with the rare autoimmune disease scleroderma and at least mild symptoms of anxiety and testing the effect of a videoconference-delivered group intervention on anxiety (NCT04335279, results were expected July 2020).
The majority of identified trials do not provide results that can be meaningfully interpreted due to small sample sizes, poor reporting, and risk of bias concerns. Additionally, most trials use standard interventions not adapted for COVID-19 (e.g., exercise, standard psychotherapy) which limits their potential to inform health policy during the pandemic. However, some trials (e.g. 101948) do provide evidence for feasibly implemented COVID-19 tailored interventions that may be relevant to the general population. Large trials with relevance to vulnerable groups are pending.
RESEARCH QUESTION 3:
Effects of Interventions on Mental Health Symptoms
Manzoni GM, Pagnini F, Castelnuovo G, et al. Relaxation training for anxiety: a ten-years systematic review with meta-analysis. BMC Psychiatry. 2008;8:41.
Kim HS, Kim EJ. Effects of relaxation therapy on anxiety disorders: a systematic review and meta-analysis. Arch Psychiatr Nurs. 2018;32:278-284.
REGISTERED TRIAL CHARACTERISTICS
*Abbreviations: ACQ= Anxiety Control Questionnaire; aMBI-HSS= Abbreviated Maslach Burnout Inventory- Human Services Survey; ASI-3= Anxiety Sensitivity Index; BAI= Beck Anxiety Inventory; BBQ= Brunnsviken Brief Quality of Life Scale; BDI= Beck Depression Inventory; BHS= Beck Hopelessness Scale; BRS= Brief Resilience Scale; BVK= Berner Verbitterungsinventar Kurzversion; CAS= Coronavirus Anxiety Scale; CD-RISC= Connor-Davidson Resilience Scale; CES-D= Center for Epidemiologic Studies Depression Scale; CRISIS= CoRonavIruS Health Impact Survey; DASS-21= Depression, Anxiety; DTS= Davidson Trauma Scale; Stress; EPDS= Edinburgh Postnatal Depression Scale; EQ-5D-5L= Quality of Life Measure; FCOR= Fear of Coronavirus; FFMQ= Five-Facet Mindfulness Questionnaire; FS= Psychological Flourishing Scale; GAD-7= Generalized Anxiety Disorder; GBQ= Goldard Burnout Questionnaire; GDS= Geriatric Depression Scale; GHQ= General Health Questionnaire; HADS= Hospital Anxiety and Depression Scale; HADS-A= Hospital Anxiety and Depression Scale-Anxiety; HADS-D= Hospital Anxiety and Depression Scale-Depression; HAM-A= Hamilton Anxiety Rating Scale; HAM-D= Hamilton Rating Scale for Depression; HAQ= Health Anxiety Questionnaire; IES-R= Impact of Events Scale Revised; K10= Kessler Psychological Distress Scale; LOT-R= Revised Life Orientation Test; MADRS= Montgomery-Asberg Depression Rating Scale; MASQ= Mood and Anxiety Symptom Questionnaire; MBI= Maslach Burnout Inventory; NR= Not Reported; NRS= Non-Random controlled intervention Study; OASIS= Overall Anxiety Severity and Impairment Scale; ODSIS= Overall Depression Severity and Impairment Scale; OSI-R= Occupational Stress Inventory-Revised; PCL-5= PTSD Checklist; PC-PTSD= Primary Care PTSD Screen for DSM-5; PDQ= Parkinson’s Disease Quality of Life Scale; PHQ-9= Patient Health Questionnaire; PROMIS= Patient-Reported Outcomes Measurement Information System; PS = Parenting Stress Scale; PSS/PSS-10= Perceived Stress Scale; PSWQ= Penn State Worry Questionnaire; PTSS= Post-Traumatic Stress Symptoms Subscale; Q-LES-Q= The Quality of Life Enjoyment and Satisfaction Questionnaire; QWL= Quality of Work Life; RCT= Randomized Controlled Trial; RS= Resilience Scale; SBQ-R= Suicide Behavior Questionnaire Revised; SEK-27= Emotion regulation skills; SF-12= Short Form Health Survey; SF-36= Short-Form-36 (SF-36) Health Survey - Mental Health Component; SPTSMY= Scale of Post-traumatic Stress Traits in Mexican Youth Exposed to Social Violence; SRS-13= Smith Relaxation State Inventory; STAI= State Anxiety Inventory; S-STS= Sheehan Suicidality Tracking Scale; SUD= Subjective Units of Distress Scale; SUPPH= Strategies Used by People to Promote Health Questionnaire; SWE= Skala zur Allgemeinen Selbstwirksamkeit; UCLA-8= University of California Los Angeles Loneliness Scale; ULS= UCLA Loneliness Scale (Döring & Bortz, 1993); VAS= Visual Analogue Scale; WE-MWBS= Warwick Edinburgh Mental Wellbeing Scale; WFS= Widespread Fear Scale; WHO-5= WHO (Five) Wellbeing Index; WHOQOL-BREF= World Health Organization Quality of Life Questionnaire Bref; ZSAS= Zung Self-rating Anxiety Scale; ZSDS= Zung Self-rating Depression Scale
*Pregnant women were coded under the pre-existing medical condition population; All hospital staff are coded as medical staff.
*Funding: Some registries do not discriminate between funder and sponsor. If only the researcher’s institution was listed as a sponsor, funder was coded as NR.
COMPLETED TRIAL CHARACTERISTICS
COMPLETED TRIAL OUTCOMES
*Abbreviations: NR= Not Reported; DASS-21= Depression, Anxiety, and Stress Scale; GAD-7= Generalized Anxiety Disorder; HADS= Hospital Anxiety and Depression Scale; IDA= Irritability, Depression, Anxiety Scale; MADRS= Montgomery Åsberg Depression Rating Scale; NR= Not Reported; PHQ-9= Patient Health Questionnaire; PSS= Perceived Stress Scale; RCT = Randomized Controlled Trial; SCL-25= Symptom Check List; SSS-8= Somatic Symptom Scale; STAI= State Anxiety Inventory; WE-MWBS= Warwick Edinburgh Mental Wellbeing Scale; WHO-QOL= World Health Organization- Quality of Life; ZSAS= Zung Self-Rating Anxiety Scale; ZSDS= Zung Self-Rating Depression Scale
*A positive effect size indicates that the effect favored the intervention