Identification of depression and anxiety during pregnancy: A systematic review and meta-analysis of test accuracy.

INTRODUCTION: Depression and anxiety are significant contributors to maternal perinatal morbidity and a range of negative child outcomes. This systematic review and meta-analysis aimed to review and assess the diagnostic test accuracy of selected screening tools (Edinburgh Postnatal Depression Scale [EPDS], EPDS-3A, Patient Health Questionnaire [PHQ-9]-, PHQ-2, Matthey Generic Mood Question [MGMQ], Generalized Anxiety Disorder scale [GAD-7], GAD-2, and the Whooley questions) used to identify women with antenatal depression or anxiety in Western countries. MATERIAL AND METHODS: On January 16, 2023, we searched 10 databases (CINAHL, Cochrane Library, CRD Database, Embase, Epistemonikos, International HTA Database, KSR Evidence, Ovid MEDLINE, PROSPERO and PsycINFO); the references of included studies were also screened. We included studies of any design that compared case-identification with a relevant screening tool to the outcome of a diagnostic interview based on the Diagnostic and Statistical Manual of Mental Disorders, fourth or fifth edition (DSM-IV or DSM-5), or the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10). Diagnoses of interest were major depressive disorder and anxiety disorders. Two authors independently screened abstracts and full-texts for relevance and evaluated the risk of bias using QUADAS-2. Data extraction was performed by one person and checked by another team member for accuracy. For synthesis, a bivariate model was used. The certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). REGISTRATION: PROSPERO CRD42021236333. RESULTS: We screened 8276 records for eligibility and included 16 original articles reporting on diagnostic test accuracy: 12 for the EPDS, one article each for the GAD-2, MGMQ, PHQ-9, PHQ-2, and Whooley questions, and no articles for the EPDS-3A or GAD-7. Most of the studies had moderate to high risk of bias. Ten of the EPDS articles provided data for synthesis at cutoffs ≥10 to ≥14 for diagnosing major depressive disorder. Cutoff ≥10 gave the optimal combined sensitivity (0.84, 95% confidence interval [CI]: 0.75-0.90) and specificity (0.87, 95% CI: 0.79-0.92). CONCLUSIONS: Findings from the meta-analysis suggest that the EPDS alone is not perfectly suitable for detection of major depressive disorder during pregnancy. Few studies have evaluated the other instruments, therefore, their usefulness for identification of women with depression and anxiety during pregnancy remains very uncertain. At present, case-identification with any tool may best serve as a complement to a broader dialogue between healthcare professionals and their patients.

Validity and reliability of the WHOQOL-BREF in a pregnant population.

BACKGROUND: Physical end emotional changes during pregnancy may not only affect pregnant womens' quality of life, but also how instruments assessing quality of life perform in such populations. To date, there is insufficient evidence on psychometric properties for both generic and condition-specific instruments measuring quality of life during pregnancy. The aim of this study was thus to examine the structural validity, internal consistency, and construct validity of the WHOQOL-BREF in a sample of pregnant women. METHODS: A convenience sample of 1015 pregnant women in Sweden completed the WHOQOL-BREF online. We examined the psychometric properties of the instrument using principal component analysis (PCA), confirmatory factor analysis (CFA), Cronbach's alpha, item-domain correlations, correlations with overall QOL and general health, and multiple linear regression with items on overall QOL and general health as outcomes. RESULTS: Principal Component Analysis in a random subsample (n = 502) supported a four-factor model, encompassing the domains physical, psychological, social and environmental quality of life, but with four of the items originally in the environmental domain relocated to the other domains. The proposed domain structure showed good fit in confirmatory factor analysis in the other random subsample (n = 513). The physical and psychological domains showed good internal consistency (Cronbach's alpha = 0.885 and 0.826 respectively), while the social and environmental domains were weaker in this regard. All domains showed significant positive correlations with items on overall QOL and general health. The physical and psychological domains were the most evident predictors in the regression models. CONCLUSIONS: We find the Swedish version of the WHOQOL-BREF to have good psychometric properties to be used in samples of pregnant women, and propose an alternative domain structure that might be even more useful for assessing quality of life during pregnancy. The physical and psychological domains showed good internal consistency and construct validity.

An online tiered screening procedure to identify mental health problems among refugees.

BACKGROUND: Many refugees suffer from mental health problems due to stressful and traumatic events before, during, and after migration. However, refugees are facing a wide variety of barriers, limiting their access to mental health care. Internet-based tools, available in several languages, could be one way to increase the availability of mental health services for refugees. The present study aimed to develop and test a screening tool to screen for clinically relevant symptoms of psychiatric disorders common among refugees (i.e. Depression, Anxiety, Post-traumatic stress disorder, and Insomnia). We, designed, translated, and adapted an internet-based tiered screening procedure suitable for use with the largest refugee populations residing in Sweden. The tool aims to accurately identify symptoms of mental distress (Tier 1), differentiate between symptoms of specific psychiatric disorders (Tier 2), and assess symptom severity (Tier 3). We tested the overall efficiency of using a tiered screening procedure. METHODS: Seven hundred fifty-seven refugees residing in Sweden, speaking any of the languages Arabic, Dari, Farsi, English, or Swedish, completed an online questionnaire following a three-tiered procedure with screening instruments for each tier. In this study, the Tier 3 scales were used as reference standards for clinically relevant symptoms, to evaluate screening efficiency in terms of accuracy and reduction of item burden in previous tiers. RESULTS: The results show that the tiered procedure could reduce the item burden while maintaining high accuracy, with up to 86% correctly assessed symptoms and few false negatives with moderate symptoms and above (at most 9%), and very few with severe symptoms (at most 1.3%). DISCUSSION: This study generated an accurate screening tool that efficiently identifies clinically relevant symptoms of common psychiatric disorders among refugees. Using an adapted online tiered procedure to screen for multiple mental health issues among refugees has the potential to facilitate screening and increase access to mental health services for refugees. We discuss the utility of the screening tool and the necessity of further evaluation.

The factor structure of the cardiac anxiety questionnaire, and validation in a post-MI population.

BACKGROUND: CVD-patients with higher levels of cardiac anxiety suffer psychologically, as well as being at increased risk for cardiac morbidity and mortality. Therefore it is important to be able to assess CA in a clinical setting. It is currently measured with the Cardiac Anxiety Questionnaire, which has conflicting findings regarding its factor structure, and it has not been validated in a Swedish population. This study aimed to examine the factor structure of CAQ and its psychometric properties in a Swedish CVD-population. METHODS: Nine hundred thirty patients post-MI were recruited at different Swedish hospitals and completed the CAQ, along with several other questionnaires. Exploratory factor analysis and confirmatory factor analysis were conducted to explore factor structure and to inspect various factor solutions from previous research. Standard psychometric tests were performed for the CAQ to test its validity and reliability. RESULTS: The exploratory analysis found a model with the factors Fear/Worry, Avoidance and Attention. The confirmatory factor analysis indicated that a 3-factor solution best fitted the data, but with certain items removed. Additionally, psychometric properties turned out acceptable in a Swedish post-MI population. CONCLUSIONS: We conclude that the original 3-factor structure of the CAQ is valid, but that the questionnaire could be revised in regard to some items. A shorter 10-items version could also be considered. We also confirm that the CAQ is a valid instrument to measure CA in a Swedish MI-population. TRIAL REGISTRATION: The study was registered on ClinicalTrials.gov on 05/01/2012 (NCT01504191).

Preconception fear of childbirth: experiences and needs of women fearing childbirth before first pregnancy.

BACKGROUND: Although early case studies have indicated that fear of childbirth can predate a woman's first pregnancy, the concept of preconception fear of childbirth is largely unexplored. The few studies reporting on the prevalence of preconception fear of childbirth found higher levels than most prevalence estimates in pregnant populations. However, little is known about women's fear of childbirth before becoming pregnant. The aim of this qualitative study was to give voice to the experiences of this often-neglected group of women. METHODS: To address the experiences and needs of women who do not dare become pregnant due to fear of childbirth, we conducted nine qualitative interviews and analyzed these using reflexive thematic analysis. RESULTS: The women perceived childbirth as an extremely risky event and doubted their abilities to cope with it. With increasing age, the fear became more real. It was associated with thoughts of becoming too old to be able to conceive. The women did their best to cope with fear on their own by seeking information, trying not to think about it, and using multiple strategies to avoid becoming pregnant. Despite expressing a strong wish for professional support, they all described very limited opportunities to receive support from maternal care services. They felt abandoned, left on their own in a stressful and constantly ongoing negotiation with themselves, feeling the pressure to decide whether to dare become pregnant or not. CONCLUSION: In this study, women expressed having experienced fear of childbirth long before a first pregnancy. They felt abandoned as they had to deal with their fear by themselves, without support from maternal care services. The results point to the necessity of an increased awareness of preconception fear of childbirth. We encourage maternal care services to consider their opportunities to support these women.

Designing a Web-Based Psychological Intervention for Patients With Myocardial Infarction With Nonobstructive Coronary Arteries: User-Centered Design Approach.

BACKGROUND: The involvement of patient research partners (PRPs) in research aims to safeguard the needs of patient groups and produce new interventions that are developed based on patient input. Myocardial infarction with nonobstructive coronary arteries (MINOCA), unlike acute myocardial infarction (MI) with obstructive coronary arteries, is presented with no significant obstructive coronary artery disease. Patients with this diagnosis are a subset of those diagnosed with traditional MI and often need more psychological support, something that is presently not established in the current treatment scheme in Swedish health care or elsewhere, to our knowledge. An internet-delivered intervention might offer patients with MINOCA the opportunity to access a psychological treatment that is tailored to their specific needs after MINOCA and could therefore supplement the existing medical care in an easily accessible format. OBJECTIVE: This paper aims to describe the development of a therapist-guided, internet-delivered psychological intervention designed specifically for patients with MINOCA. METHODS: The study used a participatory design that involved 7 PRPs diagnosed with MINOCA who collaborated with a team consisting of researchers, cardiologists, and psychologists. Intervention content was developed iteratively and presented to the PRPs across several prototypes, each continually adjusted and redesigned according to the feedback received. The intervention and experience of it were discussed by PRPs in a final meeting and then presented to a panel of 2 clinical psychologists and a cardiologist for further input. RESULTS: The outcome of the collaboration between PRPs and the research group produced a web-based psychological 9-step program focusing on stress, worry, and valued action. The input from PRPs contributed substantially to the therapy content, homework tasks, interactive activities, multimedia, and design presentation. CONCLUSIONS: Working with PRPs to develop an intervention for people with MINOCA produced a web-based intervention that can be further evaluated with the goal of offering a new psychological treatment option to a patient group currently without one. Direct contribution from PRPs enabled us to obtain relevant, insightful, and valuable feedback that was put towards the overall design and content of the intervention.

Potential mechanisms in fear of birth: The role of pain catastrophizing and intolerance of uncertainty.

BACKGROUND: Although many pregnant women experience fear, worry, or anxiety relating to the upcoming birth, little is known regarding the psychological mechanisms contributing to these experiences. In this study, we wanted to take a first step in trying to identify mechanisms of potential interest. The objective of this cross-sectional study was thus to investigate pain catastrophizing, intolerance of uncertainty, positive worry beliefs, and cognitive avoidance as potential mechanisms predicting fear of birth among pregnant women. METHODS: A sample of 499 pregnant women, recruited in antenatal health care settings in 2 Swedish regions, completed the Fear of Birth Scale, along with measurements of the mechanisms of interest. Linear and logistic hierarchical regression analyses were used to investigate the extent to which pain catastrophizing, intolerance of uncertainty, positive worry beliefs, and cognitive avoidance predicted fear of birth, both as a continuous and a dichotomous measure. RESULTS: Logistic regression analysis showed high levels of pain catastrophizing and intolerance of uncertainty to be the best predictors of fear of birth, OR 3.49 (95% CI 2.17-5.61) and OR 3.25 (95% CI 2.00-5.27), respectively. Positive beliefs about worry and cognitive avoidance were both correlated with fear of birth as a continuous measure, but did not contribute to the logistic regression model. CONCLUSIONS: Pain catastrophizing and intolerance of uncertainty were the most evident predictors of fear of birth. Although preliminary, the findings suggest that interventions targeting catastrophic cognitions and intolerance of uncertainty might be relevant to psychological treatment for fear, worry, or anxiety relating to giving birth.

Heterogeneity in childbirth related fear or anxiety.

Many pregnant women experience fear, worry or anxiety relating to the upcoming childbirth. The aim of this cross-sectional study was to investigate possible subgroups in a sample of 206 pregnant women (mean age 29.4 years), reporting fear of birth in mid-pregnancy. Comparisons were made between nulliparous and parous women. In a series of cluster analyses, validated psychological instruments were used to cluster women based on their psychological profiles. A five-cluster solution was suggested, with the clusters characterized by: overall low symptom load, general high symptom load, medium symptom load with high performance-based self-esteem, blood- and injection phobic anxiety, and specific anxiety symptoms. Nulliparous women were more likely to report clinically relevant levels of blood- and injection phobia (OR = 2.57, 95% CI 1.09-6.01), while parous women more often reported previous negative experiences in health care (OR 1.93, 95% CI 1.09-3.39) or previous trauma (OR 2.90, 95% CI 1.58-5.32). The results indicate that women reporting fear of birth are a heterogeneous group. In order to individualize treatment, psychological characteristics may be of greater importance than parity in identifying relevant subgroups.

Association of Anxiety and Recurrent Cardiovascular Events: Investigating Different Aspects of Anxiety.

AIMS: While elevated levels of anxiety are associated with worse prognosis of cardiovascular disease (CVD), this association may vary between different aspects of anxiety. The aim of this study was to analyse self-reported behavioural, physiological, affective, and cognitive aspects of anxiety and their relation to the risk of recurrent CV events. METHODS AND RESULTS: This prospective cohort study utilized data from the U-CARE Heart trial. Participants (N = 935, post myocardial infarction) answered the Hospital Anxiety and Depression Scale (HADS: Anxiety subscale) and the Cardiac Anxiety Questionnaire (CAQ: Fear, Avoidance & Attention subscales). HADS Anxiety reflected physiological aspects, CAQ Fear reflected cognitive and affective aspects, CAQ Avoidance reflected behavioural aspects, and CAQ Attention reflected cognitive aspects of anxiety. Cox Regression was used to estimate the risk between anxiety and recurrent major adverse cardiac event (MACE). During the follow-up period (mean 2.9 years), 124 individuals (13%) experienced a specified MACE endpoint. HADS Anxiety and CAQ Total were both associated with increased risk of MACE (HR = 1.52, 95% CI: 1.15-2.02 and HR = 1.30, 95% CI: 1.04-1.64, respectively). Among the CAQ subscales, there was support for an association between Avoidance and risk of MACE (HR = 1.37, 95% CI 1.15-1.64), but not for Attention and Fear. CONCLUSION: The results support that anxiety is associated with an increased risk of recurrent MACE in post-MI patients. The association between anxiety and risk was strong for the aspects of anxiety relating to behaviour and physiology, while the support for an association with cognitive and affective aspects was lacking.

Feasibility of a randomised trial of Teaching Recovery Techniques (TRT) with refugee youth: results from a pilot of the Swedish UnaccomPanied yOuth Refugee Trial (SUPpORT).

BACKGROUND: Although post-traumatic stress is prevalent among unaccompanied refugee minors (URM), there are few evidence-based psychological interventions for this group. Teaching Recovery Techniques (TRT) is a brief, manualised intervention for trauma-exposed youth, which has shown promising results in exploratory studies. The aim of the present study was to assess the feasibility of conducting a randomised controlled trial (RCT) evaluating the use of TRT among URM by investigating key uncertainties relating to recruitment, randomisation, intervention delivery and data collection. METHODS: A 3-month long non-blinded internal randomised pilot trial with a parallel-group design assessed the feasibility of a planned nationwide multi-site RCT. URM with or without granted asylum were eligible if they were 14 to 20 years old, had arrived in Sweden within the last 5 years and had screened positive for symptoms of post-traumatic stress disorder (PTSD). Quantitative data were collected pre- and post-intervention, and 18 weeks after randomisation. On-site individual randomisation (1:1) followed directly after pre-intervention assessment. Participants allocated to the intervention were offered seven weekly group-based TRT sessions. Quantitative pilot outcomes were analysed using descriptive statistics. Qualitative information was gathered through on-site observations and follow-up dialogue with group facilitators. A process for Decision-making after Pilot and feasibility Trials (ADePT) was used to support systematic decision-making in moving forward with the trial. RESULTS: Fifteen URM (mean age 17.73 years) with PTSD symptoms were recruited at two sites. Three of the youths were successfully randomised to either TRT or waitlist control (TRT n = 2, waitlist n = 1). Fourteen participants were offered TRT for ethical reasons, despite not being randomised. Six (43%) attended ≥ 4 of the seven sessions. Seventy-three percent of the participants completed at least two assessments, with a response rate of 53% at both post-intervention and follow-up. CONCLUSIONS: The findings demonstrated a need for amendments to the protocol, especially with regard to the procedures for recruitment and randomisation. Upon refinement of the study protocol and strategies, an adequately powered RCT was pursued, with data from this pilot study excluded. TRIAL REGISTRATION: ISRCTN47820795 , prospectively registered on 20 December 2018.

Reducing stress and anxiety in patients with myocardial infarction with non-obstructive coronary arteries or Takotsubo syndrome: A non-randomized feasibility study.

Background and aim: In the aftermath of a myocardial infarction with non-obstructive coronary arteries (MINOCA) or Takotsubo syndrome (TS), patients commonly express high levels of stress and anxiety. Current treatment alternatives rarely address these issues. The planned E-health Treatment of Stress and Anxiety in Stockholm Myocardial Infarction With Non-obstructive Coronaries Study (e-SMINC) aims to evaluate the effects of an internet-based intervention, building on cognitive behavioral therapy (CBT) by comparison with treatment as usual using an RCT approach. This was a small-scale single arm study designed to test the feasibility of the RCT, addressing uncertainties regarding recruitment, data collection, and intervention delivery. Methods: Participant recruitment and screening took place before discharge from the coronary care unit at a large Swedish hospital. Eligible patients were invited to a nine-step psychologist guided, internet-based CBT intervention. The sample size was set in advance to 10 participants completing the intervention. The recruitment and flow of participants were documented and evaluated in relation to seven pre-defined progression criteria. Self-reports of anxiety (HADS-A), stress (PSS-14), cardiac anxiety (CAQ), posttraumatic stress (IES-6) and quality of life (Rand-36), collected at screening, pre-intervention and post-intervention, were analysed descriptively and by effect sizes (Cohen's d). Individual interviews targeting participant experiences were conducted. Results: Six out of seven progression criteria yielded no concerns. Out of 49 patients with a working diagnosis of MINOCA or TS, 31 were eligible for screening, 26 consented to participate, and 14 were eligible with regard to symptoms of stress and/or anxiety. Eleven completed the pre-assessment and were given access the intervention, and 9 completed the intervention. Only the number of patients screened prior to eligibility assessment was slightly lower than expected, indicating possible concerns. Self-reports of anxiety, stress, cardiac anxiety, posttraumatic stress, and quality of life all indicated symptom reduction from pre- to post-intervention, generally showing large effect sizes (d = 0.6-2.6). The general consensus among participants was that the programme was helpful and relevant, and that the personal contact with the psychologist was highly valued. Setting aside time to complete assignments was found critical. Conclusion: Conducting a full scale RCT was found feasible. Inclusion of more study sites and minor amendments to the protocol and intervention were decided to improve feasibility further. Trial registration: Clinicaltrials.govNCT04178434.

The e-mental health treatment in Stockholm myocardial infarction with non-obstructive coronaries or Takotsubo syndrome study (E-SMINC): a study protocol for a randomised controlled trial.

BACKGROUND: In the aftermath of a myocardial infarction with non-obstructive coronary arteries (MINOCA) or Takotsubo syndrome (TS), patients commonly express high levels of stress and anxiety. Current treatment alternatives rarely address these issues. METHODS: The study is a randomised controlled trial, where 90 patients with a discharge diagnosis of MINOCA or TS who also report symptoms of stress or anxiety will be randomised 2-6 weeks after their cardiac event. The treatment consists of 10 weeks of Internet-based cognitive behaviour therapy (CBT) and starts immediately after randomisation for the treatment group. The control group receives usual care. Main outcomes are symptoms of anxiety measured with the Hospital Anxiety and Depression scale, anxiety subscale, and perceived stress measured with the Perceived Stress Scale, 14-item version, 10 weeks after randomisation. Secondary measures include cardiac specific anxiety, symptoms of post-traumatic stress, quality of life, cortisol measured in hair and physiological stress responses (heart rate variability, blood pressure and saliva cortisol) during a stress procedure. Ten weeks after randomisation, the control group will also receive treatment. Long-term follow-up in the self-report measures mentioned above will be conducted 20 and 50 weeks after randomisation where the total group's development over time is followed, and the groups receiving intervention early versus late compared. DISCUSSION: At present, there are no randomised studies evaluating psychological treatment for patients with MINOCA or TS. There is an urgent need for treatment alternatives aiming at relieving stress and anxiety considering the high mental stress and anxiety levels observed in MINOCA and TS, leading to decreased quality of life. CBT aiming at reducing mental stress has been shown to be effective regarding prognosis in patients with coronary artery disease. The current protocol describes a randomised open-label controlled trial evaluating an Internet-based CBT program for reduction of stress and anxiety in patients with increased mental stress and/or anxiety with a discharge diagnosis of either MINOCA or TS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04178434 . Registered on 26 November 2019.

Symptoms of Depression and Anxiety During the Early Phase of the COVID-19 Pandemic in Sweden.

In this cross-sectional study we aimed to assess symptoms of depression and anxiety at an early stage of the COVID-19 pandemic, and to explore factors predictive of these mental health outcomes. A sample of 1,503 participants, recruited from the general Swedish population, completed an online survey distributed through social media. In this sample, 22.2% reported clinically significant levels of depressive symptoms (PHQ-9 ≥ 10) and 10.9% indicated possible major depression using the PHQ-9 algorithm. Moreover, 28.3% reported clinically significant levels of anxiety (GAD-7 ≥ 8) and 9.7% severe anxiety and possible GAD (GAD-7 ≥ 15). Multiple linear regression analyses identified some common predictors for both outcomes. Age, having a stable income, and sufficient social stimulation, sleep, and recovery showed negative associations, whereas worry about the economy and overall burden showed positive associations. These results suggest an impact on mental health already at an early stage of the COVID-19 pandemic.

Evaluation of the teaching recovery techniques community-based intervention for accompanied refugee children experiencing post-traumatic stress symptoms (Accompanied refugeeS In Sweden Trial; ASsIST): study protocol for a cluster randomised controlled trial.

BACKGROUND: Refugee children have often experienced traumas and are at significant risk of developing mental health problems, such as symptoms of post-traumatic stress disorder (PTSD), depression and anxiety, which can continue for years after resettlement. The Accompanied refugeeS In Sweden Trial (ASsIST) aims to evaluate a community-based intervention, called 'Teaching Recovery Techniques' (TRT), for accompanied refugee minors experiencing PTSD symptoms. METHODS/DESIGN: A cluster randomised controlled trial will be conducted in which participants will be randomly allocated to one of the two possible arms: the intervention arm (n=113) will be offered the TRT programme and the waitlist-control arm (n=113) will receive services as usual, followed by the TRT programme around 20 weeks later. Outcome data will be collected at three points: pre-intervention (T1), post-intervention (T2; c.8 weeks after randomisation) and follow-up (T3; c.20 weeks after randomisation). ETHICS AND DISSEMINATION: Ethical approval was granted by the Regional Ethical Review Board in Uppsala (Ref. 2018/382) (24th February 2019). Results will be published in scientific journals. TRIAL REGISTRATION DETAILS: ISRCTN17754931. Prospectively registered on 4th June 2019.

Evaluation of the Teaching Recovery Techniques community-based intervention for unaccompanied refugee youth experiencing post-traumatic stress symptoms (Swedish UnaccomPanied yOuth Refugee Trial; SUPpORT): study protocol for a randomised controlled trial.

BACKGROUND: In 2015, 162,877 persons sought asylum in Sweden, 35,369 of whom were unaccompanied refugee minors (URMs). Refugee children, especially URMs, have often experienced traumas and are at significant risk of developing mental health problems, such as symptoms of post-traumatic stress disorder (PTSD), depression and anxiety, which can continue years after resettlement. The Swedish UnaccomPanied yOuth Refugee Trial (SUPpORT) aims to evaluate a community-based intervention, called Teaching Recovery Techniques (TRT), for refugee youth experiencing PTSD symptoms. METHODS/DESIGN: A randomised controlled trial will be conducted in which participants will be randomly allocated to one of two possible arms: the intervention arm (n = 109) will be offered the TRT programme, and the waitlist-control arm (n = 109) will receive services as usual, followed by the TRT programme around 20 weeks later. Outcome data will be collected at three points: pre-intervention (T1), post-intervention (T2; about 8 weeks after randomisation) and follow-up (T3; about 20 weeks after randomisation). DISCUSSION: This study will provide knowledge about the effect and efficiency of a group intervention for URMs reporting symptoms of PTSD in Sweden. TRIAL REGISTRATION: ISRCTN, ISRCTN47820795. Prospectively registered on 20 December 2018.

Comparing Internet-Based Cognitive Behavioral Therapy With Standard Care for Women With Fear of Birth: Randomized Controlled Trial.

BACKGROUND: Although many pregnant women report fear related to the approaching birth, no consensus exists on how fear of birth should be handled in clinical care. OBJECTIVE: This randomized controlled trial aimed to compare the efficacy of a guided internet-based self-help program based on cognitive behavioral therapy (guided ICBT) with standard care on the levels of fear of birth in a sample of pregnant women reporting fear of birth. METHODS: This nonblinded, multicenter randomized controlled trial with a parallel design was conducted at three study centers (hospitals) in Sweden. Recruitment commenced at the ultrasound screening examination during gestational weeks 17-20. The therapist-guided ICBT intervention was inspired by the Unified protocol for transdiagnostic treatment of emotional disorders and consisted of 8 treatment modules and 1 module for postpartum follow-up. The aim was to help participants observe and understand their fear of birth and find new ways of coping with difficult thoughts and emotions. Standard care was offered in the three different study regions. The primary outcome was self-assessed levels of fear of birth, measured using the Fear of Birth Scale. RESULTS: We included 258 pregnant women reporting clinically significant levels of fear of birth (guided ICBT group, 127; standard care group, 131). Of the 127 women randomized to the guided ICBT group, 103 (81%) commenced treatment, 60 (47%) moved on to the second module, and only 13 (10%) finished ≥4 modules. The levels of fear of birth did not differ between the intervention groups postintervention. At 1-year postpartum follow-up, participants in the guided ICBT group exhibited significantly lower levels of fear of birth (U=3674.00, z=-1.97, P=.049, Cohen d=0.28, 95% CI -0.01 to 0.57). Using the linear mixed models analysis, an overall decrease in the levels of fear of birth over time was found (P≤ .001), along with a significant interaction between time and intervention, showing a larger reduction in fear of birth in the guided ICBT group over time (F1,192.538=4.96, P=.03). CONCLUSIONS: Fear of birth decreased over time in both intervention groups; while the decrease was slightly larger in the guided ICBT group, the main effect of time alone, regardless of treatment allocation, was most evident. Poor treatment adherence to guided ICBT implies low feasibility and acceptance of this treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT02306434; https://clinicaltrials.gov/ct2/show/NCT02306434 (Archived by WebCite at http://www.webcitation.org/70sj83qat).

A randomized controlled study comparing internet-based cognitive behavioral therapy and counselling by standard care for fear of birth - A study protocol.

Fear of birth is a concern that requires evidence based treatment. The aim of this study is to present the protocol of a randomized controlled multi-center trial to compare internet-based cognitive therapy with counseling as standard care for pregnant women reporting fear of birth. Participants will be recruited in mid-pregnancy. Women who score 60 or above on the Fear of Birth Scale will be offered to participate in this study. Data will be collected by questionnaires including validated instruments at baseline and follow-ups at gestational weeks 30 and 36, two months and one year after birth. The primary outcome will be level of fear of birth measured with the Fear of Birth Scale at 36 weeks of gestation. Secondary outcome measures are level of fear of birth at two months and one year after giving birth, preferences for mode of birth, requests for elective cesarean section, compliance and satisfaction with treatment and birth outcomes. A power calculation based on a 20% reduction of fear implies that approximately 200 will be included in the trial. The study outlined in this protocol will be the first randomized controlled trial comparing internet-based cognitive therapy with counseling for women reporting fear of birth. An effective treatment may result in better overall health for women with fear of birth and a reduction in cesarean sections for non-medical reasons. Evidence regarding treatment options of fear of birth will also provide a greater choice for women.

Psychological perspectives on fear of childbirth.

The objective of this narrative review was to examine the literature on fear of childbirth from a psychological perspective, addressing the specificity of childbirth fear, the pathways of fear acquisition, and the physiological, cognitive and behavioral aspects of fear. Systematic procedures for literature search, inclusion and exclusion left 86 original research papers for analysis. Findings summarize the body of knowledge for each area of interest, as well as the number of studies addressing each theme. Overall, few studies adopt a clear-cut psychological perspective, leaving the psychological mechanisms of childbirth fear largely unexplored. Although methodological limitations make conclusions difficult, results give a hint of etiological diversity and possible psychological mechanisms commonly described as transdiagnostic features in anxiety. Systematic investigations of psychological mechanisms, longitudinal studies exploring possible vicious circles of fear, and studies comparing psychological characteristics within the group of women fearing childbirth are identified as research areas of high priority.