Online cognitive behavioural therapy as a psychological vaccine against stress during the COVID-19 pandemic in pregnant women: A randomised controlled trial
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SUBMITTER: Puertas-Gonzalez J
PROVIDER: S-EPMC9259661 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionWorries about the immediate and long-term consequences of the COVID-19 pandemic may for some individuals develop into pervasive worry that is disproportionate in its intensity or duration and significantly interferes with everyday life.ObjectiveThe aim of this study was to investigate if a brief self-guided, online psychological intervention can reduce the degree of dysfunctional worry related to the COVID-19 pandemic and associated symptoms.Methods670 adults from the Swedish general population reporting daily uncontrollable worry about CO-VID-19 and its possible consequences (e.g., illness, death, the economy, one's family) were randomised (1:1 ratio) to a 3-week self-guided, online cognitive behavioural intervention targeting dysfunctional COVID-19 worry and associated symptoms, or a waiting list of equal duration. The primary outcome measure was a COVID-19 adapted version of the Generalised Anxiety Disorder 7-item scale administered at baseline and weeks 1-3 (primary endpoint). Follow-up assessments were conducted 1 month after treatment completion. The trial was registered on ClinicalTrials.gov (NCT04341922) before inclusion of the first participant.ResultsThe main pre-specified intention-to-treat analysis indicated significant reductions in COVID-19-related worry for the intervention group compared to the waiting list (β = 1.14, Z = 9.27, p < 0.001), corresponding to a medium effect size (bootstrapped d = 0.74 [95% CI: 0.58-0.90]). Improvements were also seen on all secondary measures, including mood, daily functioning, insomnia, and intolerance of uncertainty. Participant satisfaction was high. No serious adverse events were recorded.ConclusionsA brief digital and easily scalable self-guided psychological intervention can significantly reduce dysfunctional worry and associated behavioural symptoms related to the COVID-19 pandemic.
| S-EPMC7801992 | biostudies-literature
Project description:ObjectiveThe aim of this study is to assess the impact of the COVID-19 pandemic on mental health, type of delivery, and neonatal feeding of pregnant women with or without SARS-CoV-2 infection during gestation.Study designThe study was conducted online, and anonymous survey was distributed to mothers that delivered during the COVID-19 pandemic.ResultsThe survey was completed by 286 women, and 64 women (22.4%) had COVID-19 during pregnancy. Women that had SARS-CoV-2 infection during pregnancy or at time of delivery had a significantly higher probability of being separated from the newborn (p < 0.0001) and a significantly lower probability of breastfeeding (p < 0.0001). The Edinburg Postnatal Depression Scale, to assess if mothers had symptoms of postnatal depression, showed that items suggestive of postnatal depression were relatively frequent in the whole cohort. However, women with SARS-CoV-2 infection during pregnancy reported higher probability of responses suggestive of postnatal depression in eight out of 10 items, with statistically significant differences in three items.ConclusionThe COVID-19 pandemic affected the type of delivery and breastfeeding of pregnant women, particularly when they had SARS-CoV-2 infection. This, in turn, had an impact on the psychological status of the interviewed mothers, aspects that could benefit of special support.
| S-EPMC9039297 | biostudies-literature
Project description:IntroductionThe traumatic death of a loved one, such as death due to a traffic accident, can precipitate persistent complex bereavement disorder (PCBD) and comorbid post-traumatic stress disorder (PTSD) and depression. Waitlist-controlled trials have shown that grief-specific cognitive-behavioural therapy (CBT) is an effective treatment for such mental health problems. This is the first study that will examine the effectiveness of online CBT (vs waitlist controls) in a sample exclusively comprised of people bereaved by a traumatic death. Our primary hypothesis is that people allocated to the online CBT condition will show larger reductions in PCBD, PTSD and depression symptom levels at post-treatment than people allocated to a waitlist. We further expect that reductions in symptom levels during treatment are associated with reductions of negative cognitions and avoidance behaviours and the experience of fewer accident-related stressors. Moreover, the effect of the quality of the therapeutic alliance on treatment effects and drop-out rates will be explored.Methods and analysisA two-arm (online CBT vs waiting list) open-label parallel randomised controlled trial will be conducted. Participants will complete questionnaires at pretreatment and 12 and 20 weeks after study enrolment. Eligible for participation are Dutch adults who lost a loved one at least 1 year earlier due to a traffic accident and report clinically relevant levels of PCBD, PTSD and/or depression. Multilevel modelling will be used.Ethics and disseminationEthics approval has been received by the Medical Ethics Review Board of the University Medical Center Groningen (METc UMCG: M20.252121). This study will provide new insights in the effectiveness of online CBT for traumatically bereaved people. If the treatment is demonstrated to be effective, it will be made publicly accessible. Findings will be disseminated among lay people (eg, through newsletters and media performances), our collaborators (eg, through presentations at support organisations), and clinicians and researchers (eg, through conference presentations and scientific journal articles).Trial registration numberNL7497.
| S-EPMC7473627 | biostudies-literature
Project description:AimTo evaluate psychological stress among pregnant and puerperal women in Japan during the coronavirus disease 2019 (COVID-19) pandemic.MethodsIn this cross-sectional study, we recruited pregnant women and puerperal women who delivered between January and September 2020 in Japan, using an online questionnaire. Participants were divided into low, middle, and high groups according to the degree of the epidemic in their region of residence. Related factors were analyzed using the chi-squared test. The relationship between COVID-19 epidemic regions and depression risks and anxiety using the Edinburgh Postnatal Depression Scale (EPDS) and Kessler 6 scale (K6) was evaluated using a univariate and multivariable logistic regression model.ResultsOverall, 7775 cases, including 4798 pregnant and 2977 puerperal women, were analyzed. The prevalence of high EPDS and K6 scores was significantly increased in pregnant women in the high than those in the low epidemic regions (EPDS: adjusted odds ratio [aOR] 1.453, 95% confidence interval [CI] 1.205-1.753; K6: aOR 1.601, 95% CI 1.338-1.918). There was no difference in EPDS score, but the prevalence of high K6 scores was significantly increased in puerperal women in the high than those in the low epidemic regions (aOR 1.342, 95% CI 1.066-1.690). Further, restriction on going to their hometown for delivery increased the prevalence of high EPDS scores among pregnant (aOR 1.663, 95% CI 1.296-2.133) and puerperal women (aOR 1.604, 95% CI 1.006-2.557).ConclusionsDecreased support due to the COVID-19 pandemic affected the psychological status of pregnant and puerperal women; hence, investing medical resources in their healthcare essential.
| S-EPMC8447435 | biostudies-literature
Project description:AimThe present study aimed to investigate the construct structure behind the psychosocial response, behavioral response, prenatal depression, and post-traumatic stress disorder (PTSD) in pregnant women during the COVID-19 pandemic in China.MethodThe validated Chinese version of the Edinburgh Postnatal Depression Scale (EPDS), PTSD CheckList (PCL)-6, and two newly established scales for COVID-19-related psychological and behavioral responses were used. Structural equation modeling (SEM) analysis was applied to evaluate the structural relationships of psychological and behavioral responses during the COVID-19 pandemic.ResultsOf the 1,908 mothers who completed the questionnaires, 1,099 met the criteria for perinatal depression, and 287 were positively screened for PTSD, where 264 women exceed the cut-off points for both. Pregnant women with full-time or part-time jobs tended to have the lowest scores of EPDS (10.07 ± 5.11, P < 0.001) and stress levels (23.85 ± 7.96, P = 0.004), yet they were more likely to change their behavior in accordance with the COVID-19 outbreak (13.35 ± 3.42, P = 0.025). The structural model fit the data (χ2 = 43.260, p < 0.001) and resulted in satisfactory fit indices (CFI = 0.984, TLI = 0.959, RMSEA = 0.072, and χ2/df = 10.815), all path loadings were significant (p < 0.05). The SEM indicates that the level of QoL was attributable to the occurrence of PND, leading to PTSD, and COVID-19 related behavioral and psychological responses.ConclusionThe inter-relationships between the COVID-19-related psychosocial and behavioral responses have been assessed, indicating that the pandemic increased the burden of perinatal depression. Psychoeducation, as well as other psychological interventions, may be needed to alleviate the COVID-19-based anxiety and increase their engagement in protective behaviors.
| S-EPMC9323087 | biostudies-literature
Project description:IntroductionHazardous alcohol and drug use is associated with substantial morbidity, mortality and societal cost worldwide. Yet, only a minority of those struggling with substance use concerns receive specialised services. Numerous barriers to care exist, highlighting the need for scalable and engaging treatment alternatives. Online interventions have exhibited promise in the reduction of substance use, although studies to date highlight the key importance of patient engagement to optimise clinical outcomes. Peer support may provide a way to engage patients using online interventions. The goal of this study is to evaluate the efficacy and cost-effectiveness of Breaking Free Online (BFO), an online cognitive-behavioural intervention for substance use, delivered with and without peer support.Methods and analysisA total of 225 outpatients receiving standard care will be randomised to receive clinical monitoring with group peer support, with BFO alone, or with BFO with individual peer support, in an 8-week trial with a 6-month follow-up. The primary outcome is substance use frequency; secondary outcomes include substance use problems, depression, anxiety, quality of life, treatment engagement and cost-effectiveness. Mixed effects models will be used to test hypotheses, and thematic analysis of qualitative data will be undertaken.Ethics and disseminationThe protocol has received approval by the Centre for Addiction and Mental Health Research Ethics Board. Results will help to optimise the effectiveness of structured online substance use interventions provided as an adjunct to standard care in hospital-based treatment programmes. Findings will be disseminated through presentations and publications to scholarly and knowledge user audiences.Trial registration numberNCT05127733.
| S-EPMC9748960 | biostudies-literature
Project description:BackgroundFollowing the H1N1 influenza pandemic in 2009, pregnant women were recommended to receive both seasonal (TIV) and H1N1 influenza vaccines. This study presents incidence of adverse birth and pregnancy outcomes among a population of pregnant women immunized with TIV and H1N1 vaccines at Kaiser Permanente Northern California during 2009-2010.MethodsWe telephone surveyed pregnant Kaiser Permanente Northern California members to assess non-medically-attended reactions following H1N1, TIV or both vaccines during 2009-2010 (n=5365) in a separate study. Here we assessed preterm birth (<37weeks), very preterm birth (<32weeks), low birth weight (<2500 g, LBW), very low birth weight (<1500g), small for gestational age, spontaneous abortions, stillbirths and congenital anomalies among this cohort by comparing incidence and 95% confidence intervals between the following immunization groups: TIV only, H1N1 only, H1N1 prior to TIV immunization, TIV prior to H1N1 and both immunizations given at the same time.ResultsResults did not vary significantly between groups. Comparing H1N1 with TIV, incidence were similar for preterm births (6.37vs 6.28/100 births), very preterm births (5.30vs 8.29/1000 births), LBW (4.19vs 2.90/100 births), very LBW (4.54vs 5.52/1000 births), small for gestational age (9.99vs 9.24/1000 births), spontaneous abortion (7.10vs 6.83/1000 pregnancies), stillbirths (7.10vs 4.57/1000 pregnancies), and congenital anomalies (2.66vs 2.43/100 births).ConclusionsAlthough constrained by small sample size, complex vaccine groups, and differential vaccine availability during 2009-2010, this study found no difference in adverse birth outcomes between H1N1 vaccine and TIV.
| S-EPMC6708558 | biostudies-literature
Project description:We investigated the Th1 protective and regulatory T and B cell (Treg and Breg) responses to pH1N1 monovalent influenza vaccine (IIV1) in HIV-infected pregnant women on combination antiretroviral therapy (cART). Peripheral blood mononuclear cells (PBMCs) from 52 study participants were cryopreserved before and after vaccination and analyzed by flow cytometry. pH1N1-specific Th1, Treg, and Breg responses were measured in PBMCs after in vitro stimulation with pH1N1 and control antigen. The cohort analysis did not detect changes in pH1N1-Th1, Treg, or Breg subsets postvaccination. However, individual analyses distinguished subjects who mounted vigorous Th1 responses postvaccination from others who did not. Postvaccination, high pH1N1-Th1 correlated with high pH1N1-Treg and Breg responses, suggesting that low influenza effector responses did not result from excessive vaccine-induced immune regulation. High postvaccination pH1N1-Th1 responses correlated with baseline high PHA- and pH1N1-IFN-? ELISpot and circulating CD4(+)CD39(+)% and CD8(+)CD39(+)% Treg, with low CD8(+) cell numbers and CD19(+)FOXP3(+)% Breg, but not with CD4(+) cell numbers or HIV viral load. These data highlight the heterogeneity of T cell responses to vaccines in HIV-infected individuals on cART. Predictors of robust Th1 responses to IIV include CD8(+) cell numbers, T cell functionality, and circulating Breg and Treg.
| S-EPMC4651022 | biostudies-literature
Project description:IntroductionConcerns about SARS-CoV-2 infection risk in health care settings have resulted in changes in prenatal care and birth plans, such as shifts to in-person visits and increased Cesarean delivery. These changes may affect quality of care and limit opportunities for clinicians to counsel pregnant individuals, who are at higher risk of severe COVID-19 disease and adverse pregnancy outcomes, about prevention and vaccination.MethodsWe conducted a cross-sectional online survey of United States adults on changes in prenatal care, COVID-19 vaccine willingness, and reasons for unwillingness to receive a vaccine. We summarized changes in access to care and examined differences in vaccine willingness between pregnant and propensity-score matched non-pregnant controls using chi-squared tests and multivariable conditional logistic regression.ResultsBetween December 15-23, 2020, 8481 participants completed the survey, of which 233 were pregnant. Three-quarters of pregnant women (n = 186) experienced a change in prenatal care, including format of care (n = 84, 35%) and reduced visits (n = 69, 24%). Two-thirds experienced a change in birth plans, from a hospital birth to home birth (n = 45, 18%) or vaginal birth to a Cesarean delivery (n = 42, 17%). Although 40% of pregnant women (n = 78) were unwilling to receive COVID-19 vaccination, they had higher, though non-significant, odds of reporting willingness to receive vaccination compared to similar non-pregnant women (aOR 1.38, 95% CI: 0.95, 2.00).ConclusionTo support pregnant women through the perinatal care continuum, maternity care teams should develop protocols to foster social support, patient-centered education around infection prevention that focuses on improved risk perception, expected changes in care due to COVID-19, and vaccine effectiveness and safety.
| S-EPMC9281008 | biostudies-literature
Project description:Psychological distress is common in end-stage kidney disease (ESKD) and is associated with poorer health outcomes. Cognitive behavioural therapy (CBT) is recommended in UK clinical guidelines for the management of depression in people with long-term conditions. Access to skilled therapists competent in managing the competing mental and physical health demands of ESKD is limited. Online CBT treatments tailored to the needs of the ESKD population offers a pragmatic solution for under-resourced services. This study examines the feasibility and acceptability of implementing a two-arm parallel randomised controlled trial of online CBT with (intervention arm) and without (control arm) therapist support to improve psychological distress in patients undergoing haemodialysis.Patients will be screened for depression and anxiety while attending for their haemodialysis treatments. We aim to recruit 60 adult patients undergoing haemodialysis who meet criteria for mild to moderately severe symptoms of depression and/or anxiety. Patients will be randomised individually (using a 1:1 computerised sequence ratio) to either online CBT with therapist telephone support (intervention arm), or online CBT with no therapist (control arm). Outcomes include feasibility and acceptability descriptive data on rates of recruitment, randomisation, retention and treatment adherence. Self-report outcomes include measures of depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7), quality of life (Euro-QoL), service use (client service receipt inventory) and illness cognitions (brief illness perception questionnaire). A qualitative process evaluation will also be conducted. The statistician will be blinded to treatment allocation.A National Health Service (NHS) research ethics committee approved the study. Data from this study will provide essential information for the design and testing of further interventions to ameliorate distress in patients undergoing dialysis. Any amendments to the protocol will be submitted to the NHS committee and study sponsor.NCT023528702; Pre-results.
| S-EPMC4838682 | biostudies-other