Using an Electronic Mindfulness-based Intervention (eMBI) to improve maternal mental health during pregnancy: Results from a randomized controlled trial.

Prevalence rates of peripartum depression and anxiety are high and correlate with adverse maternal and neonatal outcomes. Mindfulness-based interventions (MBI) have been shown to reduce mental distress during pregnancy. A multicenter, randomized controlled study was conducted after screening for depressive symptoms. The intervention group (IG) was given access to an 8-week supervised eMBI between weeks 29 and 36 of pregnancy and followed up to 5 months postpartum. Psychometric data were collected using the Edinburgh Postnatal Depression Scale (EPDS), the State-Trait Anxiety Inventory (STAI), the Pregnancy-Related Anxiety Questionnaire (PRAQ-R), the Freiburg Mindfulness Inventory (FMI-14) as well as the Patient Health Questionnaire (PHQ). Out of 5299 pregnant women, 1153 scored >9 on the EPDS and N = 460 were included in the RCT. No significant interaction effects for depressive symptoms and anxiety were found. Pregnancy- and birth-related anxiety decreased significantly in the IG and 6 weeks after birth, the rate of women at risk for adverse mental outcome was significantly lower compared to the CG. Mindfulness scores improved significantly in the IG. The eMBI program did not show effective regarding general depressive or anxiety symptoms, however, positive results were demonstrated regarding pregnancy and birth-related anxiety and the prevention of postpartum depression.

Mindfulness and skills-based eHealth intervention to reduce distress in cancer-affected patients in the Reduct trial: Intervention protocol of the make it training optimized.

Introduction: Cancer-affected patients experience high distress due to various burdens. One way to expand psycho-oncological support is through digital interventions. This protocol describes the development and structure of a web-based psycho-oncological intervention, the Make It Training optimized. This intervention is currently evaluated in the Reduct trial, a multicenter randomized controlled trial. Methods: The Make It Training optimized was developed in six steps: A patient need and demand assessment, development and acceptability analysis of a prototype, the formation of a patient advisory council, the revision of the training, implementation into a web app, and the development of a motivation and evaluation plan. Results: Through a process of establishing cancer-affected patients' needs, prototype testing, and patient involvement, the Make It Training optimized was developed by a multidisciplinary team and implemented in a web app. It consists of 16 interactive self-guided modules which can be completed within 16 weeks. Discussion: Intervention protocols can increase transparency and increase the likelihood of developing effective web-based interventions. This protocol describes the process and results of developing a patient-oriented intervention. Future research should focus on the further personalization of web-based psycho-oncological interventions and the potential benefits of combining multiple psychotherapeutic approaches.

Acceptance, experiences, and needs of hospitalized pregnant women toward an electronic mindfulness-based intervention: A pilot mixed-methods study.

Background: Anxiety disorders and depression during pregnancy are highly prevalent. Hospitalized pregnant women with high maternal or fetal risk represent a particularly vulnerable population often excluded from research samples. Screening for mental health disorders is not routinely offered for this particular patient group. Electronic mindfulness-based interventions constitute an accessible, convenient, and cost-effective mental health resource but have not yet been evaluated for acceptance in inpatient settings. To date, little is known about the needs and perceptions of this group of women. Objective: The aim of this study was to examine whether a brief electronic mindfulness-based intervention (eMBI) is accepted among hospitalized high-risk pregnant women. We assessed personal motivation and barriers, experiences, usability requirements, and overall acceptance of the eMBI, as well the specific needs and demands of patients with high-risk pregnancies regarding mental health services. Methods: An exploratory pilot study with a mixed-methods study design was carried out among 30 women hospitalized with a high obstetric risk. The study participants were given access to an eMBI with a 1-week mindfulness program on how to deal with stress, anxiety, and depressive symptoms. Semi-structured interviews were conducted with the 30 participants and analyzed using systematic content analysis. In addition, acceptance and usability were assessed via questionnaires. Results: Study findings showed a high level of acceptance of the eMBI. Most of the respondents were satisfied with the usability and considered the eMBI program to be helpful. The greatest barriers to using the eMBI were a general negative attitude toward using apps, preference for personal contact, or no current need for psychotherapy. Participants criticized the lack of awareness of mental health issues during pregnancy and expressed a need for low-threshold treatment offers, especially during hospitalization. Conclusions: There is a strong need for mental health services in pregnancy care, especially for pregnant women with risk profiles. An eMBI offers an acceptable means of providing mental health support for hospitalized women with a severe obstetric risk.

Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct.

INTRODUCTION: Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint). METHODS AND ANALYSIS: The study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18-65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate. ETHICS AND DISSEMINATION: The Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations. TRIAL REGISTRATION NUMBER: German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.

Evaluation of the E-Mental Health Mindfulness-Based and Skills-Based "CoPE It" Intervention to Reduce Psychological Distress in Times of COVID-19: Results of a Bicentre Longitudinal Study.

Background: The SARS-CoV-2 pandemic poses immense challenges for health care systems and population-wide mental health. The e-mental health intervention "CoPE It" has been developed to offer standardized and manualized support to overcome psychological distress caused by the pandemic. The aim of this study was to assess the effectiveness of "CoPE It" in terms of reducing distress (primary outcome), depression and anxiety symptoms, and improving self-efficacy, and mindfulness (secondary outcomes). Furthermore, the intervention's usability, feasibility, and participants' satisfaction with "CoPE It" was evaluated (tertiary outcome). The study protocol has been published previously. Methods: A bicentre longitudinal study was conducted from April 27th 2020 to May 3rd 2021. N = 110 participants were included in the analyses. The intervention consisted of four modules featuring different media promoting evidence-based methods of cognitive behavioral therapy and mindfulness-based stress reduction. Difference in psychological distress between baseline (T0) and post-intervention (T1) were analyzed by repeated measure analysis of covariance. Mixed linear models were applied to assess moderating effects. Depressive symptoms, generalized anxiety symptoms, self-efficacy, and mindfulness were compared between baseline (T0) and post-intervention (T1) via t-tests. Usability of the "CoPE It" intervention and participants' satisfaction was evaluated by calculation means and frequencies. Results: Primary outcome: A significant effect of time on psychological distress at post-intervention (T1) after controlling for age, gender, education, mental illness and attitudes toward online interventions was found. Depressive and anxiety symptoms, and mindfulness were a significant moderators of the relationship between time and psychological distress for consistent wording. Secondary outcomes: There was a significant decrease in depressive symptoms and generalized anxiety, and a significant increase in self-efficacy and mindfulness between baseline (T0) and post-intervention (T1). Tertiary outcomes: 95.83% of the participants thought the "CoPE It" intervention was easy to use and 87.50% were satisfied with the "CoPE It" intervention in an overall, general sense. Conclusion: The e-mental health "CoPE It" intervention seems to be an effective approach in reducing psychological distress, anxiety and depressive symptoms, and in enhancing self-efficacy and mindfulness during the COVID-19 pandemic. Participants' satisfaction and the program's feasibility, and usability were proven to be high. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: DRKS00021301.

Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention (eMBI) on maternal mental health during pregnancy: the mindmom study protocol for a randomized controlled clinical trial.

BACKGROUND: Mental disorders are common during the peripartum period and may have far-reaching consequences for both mother and child. Unfortunately, most antenatal care systems do not provide any structured screening for maternal mental health. As a consequence, mental illnesses are often overlooked and not treated adequately. If correctly diagnosed, cognitive behavioral therapy is currently the treatment of choice for mental illnesses. In addition, mindfulness-based interventions (MBIs) seem to represent a promising treatment option for anxiety and depression during the peripartum period. Considering the internet's increasing omnipresence, MBIs can also be offered electronically via a (tablet) computer or smartphone (electronically based MBI = eMBI). OBJECTIVE: The current study aims to examine the clinical effectiveness and cost-effectiveness of an eMBI (the mindmom application) developed by an interdisciplinary team of gynecologists, psychologists, and midwives, teaching pregnant women how to deal with stress, pregnancy-related anxiety, and depressive symptoms. The study sample consists of pregnant women in their third trimester who screened positive for emotional distress. The mindmom study is a bicentric prospective randomized controlled trial (RCT), which is currently conducted at the University women's hospitals of Heidelberg and Tübingen, Germany. METHODS: Within the scope of the routine prenatal care, pregnant women attending routine pregnancy care in Baden-Wuerttemberg, Germany, are invited to participate in a screening for mental distress based on the Edinburgh Postnatal Depression Scale (EPDS). Women with an EPDS screening result > 9 will be referred to one of the mindmom coordinating study centers and are offered counseling either face-to-face or via videotelephony. After an initial psychological counseling, women are invited to participate in an eMBI in their last pregnancy trimester. The study will enroll N = 280 study participants (N = 140 per group), who are randomized 1:1 into the intervention (IG) or control group (treatment as usual = TAU). All participants are requested to complete a total of 7 digital assessments (5 visits pre- and 2 follow-up visits postpartum), involving self-report questionnaires, sociodemographic and medical data, physiological measures, and morning cortisol profiles. The primary outcome will be depressive and anxiety symptoms, measured by the Edinburgh Postnatal Depression Scale, the State Trait Anxiety Questionnaire, and the Pregnancy-Related Anxiety Questionnaire. Secondary outcomes include mindfulness, satisfaction with birth, quality of life, fetal attachment, bonding, mode of delivery, and cost-effectiveness. DISCUSSION: This is the first German RCT to examine the (cost-)effectiveness of an eMBI on maternal mental health during pregnancy. If successful, the mindmom app represents a low-threshold and cost-effective help for psychologically distressed women during pregnancy, thereby reducing the negative impact on perinatal health outcome. TRIAL REGISTRATION: Deutsches Register Klinischer Studien, German Clinical Trials Register DRKS00017210 . Registered on 13 January 2020. Retrospectively registered.

Effects of a Brief Electronic Mindfulness-Based Intervention on Relieving Prenatal Depression and Anxiety in Hospitalized High-Risk Pregnant Women: Exploratory Pilot Study.

BACKGROUND: Peripartum depression and anxiety disorders are highly prevalent and are correlated with adverse maternal and neonatal outcomes. Antenatal care in Germany does not yet include structured screening and effective low-threshold treatment options for women facing peripartum depression and anxiety disorders. Mindfulness-based interventions (MBIs) are increasingly becoming a focus of interest for the management of such patients. Studies have shown a decrease in pregnancy-related stress and anxiety in expectant mothers following mindfulness programs. OBJECTIVE: The aim of this study was to explore the clinical effectiveness of a 1-week electronic course of mindfulness on prenatal depression and anxiety in hospitalized, high-risk pregnant women. We hypothesized that participating in a 1-week electronic MBI (eMBI) could alleviate symptoms of depression and anxiety during the hospital stay. METHODS: A prospective pilot study with an explorative study design was conducted from January to May 2019 in a sample of 68 women hospitalized due to high-risk pregnancies. After enrolling into the study, the participants were given access to an eMBI app on how to deal with stress, anxiety, and symptoms of depression. Psychometric parameters were assessed via electronic questionnaires comprising the Edinburgh Postnatal Depression Scale (EPDS), State-Trait Anxiety Inventory (STAI-S), and abridged version of the Pregnancy-Related Anxiety Questionnaire (PRAQ-R). RESULTS: We observed a high prevalence of peripartum depression and anxiety among hospitalized high-risk pregnant women: 39% (26/67) of the study participants in the first assessment and 41% (16/39) of the participants in the second assessment achieved EPDS scores above the cutoff value for minor/major depression. The number of participants with anxiety levels above the cutoff value (66% [45/68] of the participants in the first assessment and 67% [26/39] of the participants in the second assessment) was significantly more than that of the participants with anxiety levels below the cutoff value, as measured with the STAI-S. After completing the 1-week electronic course on mindfulness, the participants showed a significant reduction in the mean state anxiety levels (P<.03). Regarding pregnancy-related anxiety, participants who completed more than 50% of the 1-week course showed lower scores in PRAQ-R in the second assessment (P<.05). No significant changes in the EPDS scores were found after completing the intervention. CONCLUSIONS: Peripartum anxiety and depression represent a relevant health issue in hospitalized pregnant patients. Short-term eMBIs could have the potential to reduce anxiety levels and pregnancy-related anxiety. However, we observed that compliance to eMBI seems to be related to lower symptoms of pregnancy-related stress among high-risk patients. eMBIs represent accessible mental health resources at reduced costs and can be adapted for hospitalized patients during pregnancy.

Web-based MINDfulness and Skills-based distress reduction in cancer (MINDS): study protocol for a multicentre observational healthcare study.

INTRODUCTION: Although a high percentage of patients with cancer experience severe psychological distress, few of them receive psycho-oncological care, largely due to barriers on the side of patients and healthcare providers that pose great challenges to delivering such care. In response, low-threshold, self-guided eHealth interventions can enable patients with cancer to deal independently and effectively with disease-related challenges and distress. Mindfulness and Skills-Based Distress Reduction in Oncology Training, nicknamed Make It Training, is one such innovative, self-guided eHealth intervention. In our study, we propose to assess different characteristics of such patients in order to define target populations for Make It Training, evaluate the intervention in terms of its usability, feasibility and sustainability and gather longitudinal data concerning the intervention's efficacy. METHODS AND ANALYSIS: Self-guided and web-based Make It Training consists of eight 30 min modules involving the use of techniques of mindfulness therapy, cognitive-behavioural therapy and acceptance and commitment therapy to be completed in a 4-month period. In our observational study, adult patients with cancer who possess adequate German language skills and provide their informed consent will be recruited at Essen, Erlangen and Tübingen University Hospitals at outpatient oncological institutions and via online channels. Patients will undergo a baseline online assessment (T0), an assessment directly after completing the intervention (T1) and assessments 3 and 6 months later (T2 and T3, respectively). With the results of those assessments, we will perform descriptive analyses of their sociodemographic and medical data, compare means and conduct regression analyses. ETHICS AND DISSEMINATION: The Ethics Committees of the University Hospitals Essen, Erlangen and Tübingen have approved the study (19-8643-BO, 27_19 B, 293/2018BO1). Results will be published in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: DRKS00017119.

E-mental health mindfulness-based and skills-based 'CoPE It' intervention to reduce psychological distress in times of COVID-19: study protocol for a bicentre longitudinal study.

INTRODUCTION: The SARS-CoV-2 (COVID-19) pandemic poses immense challenges for national and international healthcare systems. Especially in times of social isolation and governmental restrictions, mental health should not be neglected. Innovative approaches are required to support psychologically burdened people. The e-mental health intervention 'CoPE It' has been developed to offer manualised and evidence-based psychotherapeutic support adapted to COVID-19-related issues in order to overcome psychological distress. In our study, we aim to assess the efficacy of the e-mental health intervention 'CoPE It' in terms of reducing distress (primary outcome), depression and anxiety symptoms as well as improving self-efficacy, quality of life and mindfulness (secondary outcomes). Furthermore, we want to evaluate the programme's usability, feasibility and participants' satisfaction with 'CoPE It' (tertiary outcome). METHODS AND ANALYSIS: The e-mental health intervention 'CoPE It' consists of four 30 min modules, conducted every other day, involving psychotherapeutic techniques of mindfulness-based stress reduction and cognitive-behavioural therapy. The widely applied and previously established content has been adapted to the context of the COVID-19 pandemic by experts in psychosomatic medicine and stress prevention. In our longitudinal study, adult participants-with adequate German language and computer skills, and who have provided informed consent-will be recruited via emergency support hotlines in Germany. Flyers will be distributed, and online channels will be used. Participants will complete a baseline assessment (T0), a postintervention assessment (T1) and assessments 1 and 3 months later (T2 and T3, respectively). We will perform repeated measures analysis of covariance, mixed linear models, standard analyses of variance and regression, and correlation coefficients. In case of binary outcome variables, either mixed logistic regression or χ² tests will be used. ETHICS AND DISSEMINATION: The Ethics Committees of the University of Duisburg-Essen (20-9243-BO) and University of Tübingen (469/2020BO) approved the study. Results will be published in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: DRKS00021301.