Background: Pregnant women with symptoms of depression or anxiety often do not receive adequate treatment. In view of the high incidence of these symptoms in pregnancy and their impact on pregnancy outcomes, getting treatment is of the utmost importance. A guided internet self-help intervention may help to provide more women with appropriate treatment. Objective: This study aimed to examine the effectiveness of a guided internet intervention (MamaKits online) for pregnant women with moderate to severe symptoms of anxiety or depression. Assessments took place before randomization (T0), post intervention (T1), at 36 weeks of pregnancy (T2), and 6 weeks postpartum (T3). We also explored effects on perinatal child outcomes 6 weeks postpartum. Methods: This randomized controlled trial included pregnant women (16) or anxiety above threshold (ie, Hospital Anxiety and Depression Scale-Anxiety subscale [HADS-A] >8) or both of them. Participants were recruited via general media and flyers in prenatal care waiting rooms or via obstetricians and midwives. After initial assessment, women were randomized to (1) MamaKits online in addition to treatment as usual or (2) treatment as usual (control condition). MamaKits online is a 5-week guided internet intervention based on problem solving treatment. Guidance was was provided by trained students pursuing a Master's in Psychology. Outcomes were based on a Web-based self-report. Women in the control condition were allowed to receive the intervention after the last assessment (6 weeks postpartum). Results: Of the 159 included women, 79 were randomized to MamaKits online, 47% (79/37) of whom completed the intervention. Both groups showed a substantial decrease in affective symptoms on the CES-D, HADS-A, and Edinburgh Postnatal Depression Scale over time. In the intervention group, affective symptoms decreased more than that in the control group, but between-group effect sizes were small to medium (Cohen d at T3=0.45, 0.21, and 0.23 for the 3 questionnaires, respectively) and statistically not significant. Negative perinatal child outcomes did not differ between the 2 groups (χ21=0.1; P=.78). Completer analysis revealed no differences in outcome between the treatment completers and the control group. The trial was terminated early for reasons of futility based on the results of an interim analysis, which we performed because of inclusion problems. Conclusions: Our study did show a significant reduction in affective symptoms in both groups, but the differences in reduction of affective symptoms between the intervention and control groups were not significant. There were also no differences in perinatal child outcomes. Future research should examine for which women these interventions might be effective or if changes in the internet intervention might make the intervention more effective. Trial Registration: Netherlands Trial Register NL4162; https://tinyurl.com/sdckjek

Depression and anxiety occur frequently in pregnancy and may have unfavourable consequences for mother and child. Therefore, adequate symptom measurement seems important. Commonly used instruments are the Center for Epidemiologic Studies Depression Scale (CES-D), the Edinburgh Postpartum Depression Scale (EPDS), and the Hospital Anxiety and Depression Scale, anxiety subscale (HADS-A). We compared the (1) structural and (2) longitudinal validity of these instruments. The data originated from a study on the effectiveness of an Internet intervention for pregnant women with affective symptoms. (1) A confirmatory factor analysis was used to estimate the construct validity. The theoretical factorial structure that was defined in earlier studies of the CES-D and the EPDS, but not the HADS-A, could be sufficiently replicated with acceptable CFI and RMSEA values. (2) Since there were two measurements in time, the hypotheses concerning plausible directions of the change scores of subscales that were (un)related to each other could be formulated and tested. In this way, longitudinal validity in the form of responsiveness was estimated. Ten of sixteen hypotheses were confirmed, corroborating the longitudinal validity of all constructs, except anhedonia, probably due to inconsistent conceptualization. The HADS-A seems less suitable to screen for anxiety in pregnancy. Anhedonia needs better conceptualisation to assess the change of symptoms over time with the CES-D and the EPDS.

Objective: Previous studies reported less prenatal healthcare consumption and more perinatal complications in women with a migrant background. Hence, we investigated in a country with free healthcare access whether women with a migrant background differed with respect to pregnancy complications, healthcare consumption and in terms of associations with psychological distress in comparison to native Dutch. Methods: We included 324 native Dutch and 303 women with a migrant background, who visited two hospitals in Amsterdam for antenatal care between 2014 and 2015. Participants completed the Edinburgh Postnatal Depression Scale, the Hospital Depression and Anxiety Scale, and sociodemographic questions. Complications and healthcare consumption during pregnancy were extracted from medical records. Regression analyses were used with adjustment for covariates. Results: Except for gestational diabetes [adjusted OR = 3.09; 95% CI = (1.51, 6.32)], no differences were found between groups in perinatal complications [OR = 1.15; 95% CI = (0.80, 1.64)], nor in healthcare consumption [OR = 0.87; 95% CI = (0.63, 1.19)]. Women with a migrant background reported more depressive symptoms [Cohen’s d = 0.25; 95% CI = (0.10, 0.41)], even after adjustment for socio-economic factors. Psychological distress was associated with more hospital admissions during pregnancy. When experiencing depressive symptoms, women with a migrant background had an increased risk to be admitted [OR = 1.11; 95% CI = (1.01, 1.21)]. Conclusions for Practice: This cohort study found no differences in pregnancy-related complications, except for diabetes, nor different healthcare consumption, in women with a migrant background versus native Dutch, in a country with free health care access. However, women with a migrant background experienced more depressive symptoms, and when depressed their risk for hospital admission increased. Additional research is warranted to improve healthcare for this population.

BACKGROUND Catatonia is a severe psychomotor syndrome predominantly associated with depressive, bipolar, and psychotic disorders. Untreated catatonia has a 10% mortality rate and may lead to complications such as renal failure, rhabdomyolysis, pneumonia, embolism, and contractures. High doses of the benzodiazepine lorazepam, a gamma-aminobutyric acid (GABA)-A receptor modulator, are the primary pharmacological treatment, enhancing GABA’s inhibitory effect, potentially reducing symptoms of catatonia. However, lorazepam is ineffective in about 25% of cases, leaving electroconvulsive therapy (ECT) as the only well-investigated alternative. Although often effective, ECT may have severe side effects and is not easily accepted among patients and caregivers. Therefore, there is an urgent need for novel therapies for catatonia. Sodium oxybate, a GABA precursor and GABA-B receptor agonist, is a promising alternative treatment based on observational data, but its efficacy has never been thoroughly investigated. OBJECTIVE This study aims to evaluate the efficacy and safety of sodium oxybate in treating catatonia unresponsive to lorazepam, while also capturing the natural course and determinants of catatonia through an observational cohort. METHODS The Laborit trial consists of a cohort study and an embedded single-blind randomized controlled trial (RCT). Patients with catatonia admitted to a psychiatric ward may join the study’s cohort, where their clinical characteristics are recorded. Standard care, including lorazepam up to 24 mg/day, will be administered. On day 4, the Bush Francis Catatonia Rating Scale (BFCRS) will be used to measure symptom response. Patients with ≤50% improvement on the BFCRS, compared to the score at start, will be eligible for the trial. A total of 42 patients will be randomly assigned to either the sodium oxybate group, after a 2-day lorazepam reduction period, or the continuation of lorazepam. The primary endpoint is response, measured by the BFCRS score change after 4 days of treatment. A ≥50% reduction in BFCRS will define a responder, who will continue allocated treatment for an additional 10 days, with a secondary endpoint at 14 days. Data will be analyzed using intention-to-treat and per-protocol methods, with chi-square and logistic regression tests to compare group response and remission rates. RESULTS This study was funded by the Dutch Brain Foundation (Hersenstichting) in December 2020. The study protocol was approved by the Amsterdam UMC Ethics Board on May 22, 2023. As of March 2025, the first 4 participants have been included in the cohort, with no trial participants enrolled yet. CONCLUSIONS If positive, the results of this RCT may pave the way for international catatonia researchers and clinicians to introduce a new pharmacological treatment option for catatonia. Implementation could potentially benefit patients who endure this severe syndrome and present health care professionals with an additional treatment option. CLINICALTRIAL ISRCTN ISRCTN11236443; https://tinyurl.com/4px5s4aa INTERNATIONAL REGISTERED REPORT PRR1-10.2196/68356

Background: Catatonia is a severe psychomotor syndrome predominantly associated with depressive, bipolar, and psychotic disorders. Untreated catatonia has a 10% mortality rate and may lead to complications such as renal failure, rhabdomyolysis, pneumonia, embolism, and contractures. High doses of the benzodiazepine lorazepam, a gamma-aminobutyric acid (GABA)-A receptor modulator, are the primary pharmacological treatment, enhancing GABA’s inhibitory effect, potentially reducing symptoms of catatonia. However, lorazepam is ineffective in about 25% of cases, leaving electroconvulsive therapy (ECT) as the only well-investigated alternative. Although often effective, ECT may have severe side effects and is not easily accepted among patients and caregivers. Therefore, there is an urgent need for novel therapies for catatonia. Sodium oxybate, a GABA precursor and GABA-B receptor agonist, is a promising alternative treatment based on observational data, but its efficacy has never been thoroughly investigated. Objective: This study aims to evaluate the efficacy and safety of sodium oxybate in treating catatonia unresponsive to lorazepam, while also capturing the natural course and determinants of catatonia through an observational cohort. Methods: The Laborit trial consists of a cohort study and an embedded single-blind randomized controlled trial (RCT). Patients with catatonia admitted to a psychiatric ward may join the study’s cohort, where their clinical characteristics are recorded. Standard care, including lorazepam up to 24 mg/day, will be administered. On day 4, the Bush Francis Catatonia Rating Scale (BFCRS) will be used to measure symptom response. Patients with ≤50% improvement on the BFCRS, compared to the score at start, will be eligible for the trial. A total of 42 patients will be randomly assigned to either the sodium oxybate group, after a 2-day lorazepam reduction period, or the continuation of lorazepam. The primary endpoint is response, measured by the BFCRS score change after 4 days of treatment. A ≥50% reduction in BFCRS will define a responder, who will continue allocated treatment for an additional 10 days, with a secondary endpoint at 14 days. Data will be analyzed using intention-to-treat and per-protocol methods, with chi-square and logistic regression tests to compare group response and remission rates. Results: This study was funded by the Dutch Brain Foundation (Hersenstichting) in December 2020. The study protocol was approved by the Amsterdam UMC Ethics Board on May 22, 2023. As of March 2025, the first 4 participants have been included in the cohort, with no trial participants enrolled yet. Conclusions: If positive, the results of this RCT may pave the way for international catatonia researchers and clinicians to introduce a new pharmacological treatment option for catatonia. Implementation could potentially benefit patients who endure this severe syndrome and present health care professionals with an additional treatment option. Trial Registration: ISRCTN ISRCTN11236443; https://tinyurl.com/4px5s4aa International Registered Report Identifier (IRRID): PRR1-10.2196/68356

BACKGROUND Pregnant women with symptoms of depression or anxiety often do not receive adequate treatment. In view of the high incidence of these symptoms in pregnancy and their impact on pregnancy outcomes, getting treatment is of the utmost importance. A guided internet self-help intervention may help to provide more women with appropriate treatment. OBJECTIVE This study aimed to examine the effectiveness of a guided internet intervention (MamaKits online) for pregnant women with moderate to severe symptoms of anxiety or depression. Assessments took place before randomization (T0), post intervention (T1), at 36 weeks of pregnancy (T2), and 6 weeks postpartum (T3). We also explored effects on perinatal child outcomes 6 weeks postpartum. METHODS This randomized controlled trial included pregnant women (16) or anxiety above threshold (ie, Hospital Anxiety and Depression Scale-Anxiety subscale [HADS-A] >8) or both of them. Participants were recruited via general media and flyers in prenatal care waiting rooms or via obstetricians and midwives. After initial assessment, women were randomized to (1) MamaKits online in addition to treatment as usual or (2) treatment as usual (control condition). MamaKits online is a 5-week guided internet intervention based on problem solving treatment. Guidance was was provided by trained students pursuing a Master's in Psychology. Outcomes were based on a Web-based self-report. Women in the control condition were allowed to receive the intervention after the last assessment (6 weeks postpartum). RESULTS Of the 159 included women, 79 were randomized to MamaKits online, 47% (79/37) of whom completed the intervention. Both groups showed a substantial decrease in affective symptoms on the CES-D, HADS-A, and Edinburgh Postnatal Depression Scale over time. In the intervention group, affective symptoms decreased more than that in the control group, but between-group effect sizes were small to medium (Cohen d at T3=0.45, 0.21, and 0.23 for the 3 questionnaires, respectively) and statistically not significant. Negative perinatal child outcomes did not differ between the 2 groups (χ21=0.1; P=.78). Completer analysis revealed no differences in outcome between the treatment completers and the control group. The trial was terminated early for reasons of futility based on the results of an interim analysis, which we performed because of inclusion problems. CONCLUSIONS Our study did show a significant reduction in affective symptoms in both groups, but the differences in reduction of affective symptoms between the intervention and control groups were not significant. There were also no differences in perinatal child outcomes. Future research should examine for which women these interventions might be effective or if changes in the internet intervention might make the intervention more effective. CLINICALTRIAL Netherlands Trial Register NL4162; https://tinyurl.com/sdckjek