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Perinatal Depression clinical trials

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NCT ID: NCT05196152 Not yet recruiting - Clinical trials for Postpartum Depression

MomMoodBooster VA Program

Perinatal MMB
Start date: January 10, 2022
Phase: N/A
Study type: Interventional

The MomMoodBooster intervention is an empirically validated treatment for postpartum depression symptoms. The intervention was created by Brian Danaher and Milagra Tyler, who have continued to update the intervention technology and content. The intervention is now available for pregnant and postpartum Veterans, and it is accessible on browsers via computer, tablet, or mobile phone. The intervention contains six cognitive-behavioral modules that span six weeks, and it includes identification of pleasant activities, tracking mood and thoughts, and identification of goals. The current trial is an expansion of a nationwide service delivery project that has been ongoing for six years with the goal of offering the intervention to postpartum Veterans nationwide. Within that study, Veterans completed the online modules in concert with weekly phone coaching calls wherein coaches applied the content to the Veteran's current life. In addition, two booster modules and associated coaching calls were developed to continue application of the skills beyond the six-week intervention period. The present study seeks to investigate the incremental utility of the phone coaching component of the intervention by randomizing pregnant and postpartum Veterans to the MomMoodBooster intervention or the MomMoodBooster intervention plus phone coaching. Primary outcomes will include depressive symptoms, behavioral activation, and negative automatic thoughts.

NCT ID: NCT05186272 Not yet recruiting - Clinical trials for Perinatal Depression

Healthy Mama and Baby Study

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Postpartum depression (PPD) is associated with significant health consequences for mothers and children, and the current COVID-19 pandemic has had a major impact on the mental health of particularly vulnerable populations including pregnant Black and Latina women. There is an urgent need for evidence-based, accessible, and scalable mental health care options for these high-risk, vulnerable women. This study aims to: (a) examine the effectiveness of a digitally-delivered self-paced mindfulness program in pregnant Black and Latina women at increased risk of PPD; and (b) examine barriers and facilitators to implementation within a large healthcare system.

NCT ID: NCT05175755 Not yet recruiting - Clinical trials for Perinatal Depression

Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women

PsyCOVIDUMGEN
Start date: January 15, 2022
Phase: N/A
Study type: Interventional

In December 2019, infection with a novel coronavirus SARS-CoV-2 emerged in China and has since spread throughout the world. Forms of varying severity of COVID-19, a disease induced by this emerging virus, have been described in pregnant women. In addition to the direct effects of the virus on the pregnant woman and the fetus, the pandemic context itself is likely to act as a psychological risk factor and to alter the protective factors for mental disorders. This pandemic context is in itself anxiety-provoking, even traumatogenic, particularly because of the potentially lethal infectious risk that it carries, all the more so in psychologically vulnerable populations. In addition to the fear of viral contamination, in the perinatal period, the fear of childbirth also includes a more or less important part of anxiety-producing uncertainty. This addition of stress factors is likely to increase the prevalence of perinatal anxiety disorders, particularly psychotraumatic experiences of childbirth and peri-traumatic dissociative states. Health and social measures, such as confinement, restriction of access of accompanying persons to maternity services, or contagious isolation of mothers suspected of being infected or infected, which may furthermore impose a mother-infant separation, are also likely to have psychopathological consequences. Studies specifically concerning the psychological effects of the COVID-19 pandemic context have been published. Among them, the French COVIPREV study, carried out in the general population during the first and second week of the containment period (beginning mid-March 2020), reported a prevalence of anxiety of 26.7% and 21.5% respectively. These prevalences are significantly higher than the usual prevalence estimated at 13.5% in the same population. Many international studies show an increase in the prevalence of postnatal depression in the current pandemic context. In the population of pregnant women, an Italian study on the psychological impact of the COVID-19 pandemic in 100 women in pregnancy, with no psychiatric history, in Naples during the second half of March 2020, found a positive score on the Impact of Event Scale-Revised (IES-R) for more than half of the women and a positive anxiety score on the State-Trait Anxiety Inventory (STAI-S) for 68% of the women The same observation was made in Quebec where two cohorts of pregnant women (between 4 and 41 weeks of amenorrhea) subjected to self-questionnaires evaluating different dimensions of their mental health, a first one recruited before the pandemic phase of 496 women and a second one of 1258 women recruited online between April 2 and 13, 2020, have been analyzed. Women in the second cohort had significantly higher levels of depressive and anxiety symptoms, more dissociative symptoms and post-traumatic stress symptoms. In China, a multicenter study in 25 hospitals in 10 provinces across the country that included 4124 women in the third trimester of pregnancy from January 1 to February 9, 2020, when the epidemic was publicly announced on January 20, 2020, again reported increased levels of anxiety and depressive symptoms on the Edinburgh Postnatal Depression Scale (EPDS) in pregnant women after the announcement compared to before. Finally, similar results are reported by Turkish researchers showing again a high prevalence of depressive symptoms during pregnancy (35.4%) during the COVID-19 pandemic. In the perinatal context, it has been documented that post-traumatic stress disorder is strongly associated with the risk of perinatal depression. In the context of the COVID-19 pandemic, three maternity units of the PREMA University Hospital Federation (FHU PREMA), the Paris Saint-Joseph Hospital Group (GhPSJ), the Louis Mourier Hospital (APHP) and the Port-Royal Maternity Unit (APHP), in partnership with the Boulevard Brune Psychopathology Center (CPBB) and the Psychiatry Department of the Louis Mourier Hospital (APHP), have set up, as of June 2020 a care protocol consisting of a screening offered systematically to women in postpartum at D1 of their delivery, intended to identify those presenting anxiety and depressive perinatal symptoms using the Edinburgh Postnatal Depression Scale (EPDS). Thus, the PsyCOVIDUM project to estimate the prevalence of depressive symptoms in the immediate postpartum period just after delivery at different times during the pandemic episode was initiated in the three FHU PREMA maternity hospitals. This study aims at the constitution of a DNA and serum biobank in voluntary women presenting or not a depression with an antenatal onset identified at the maternity hospital. This collection would eventually allow the evaluation of the role of inflammatory and genetic biological factors in the occurrence of antenatal onset depression on an independent cohort.

NCT ID: NCT05119062 Recruiting - Parenting Clinical Trials

The Feasibility of an Online Intergenerational Co-parenting Program

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

This is a feasibility study with pilot randomized controlled trial design. A convenience sample of 60 intergenerational co-parenting family units, including 60 first-time parents (60 mothers and 60 fathers) and 60 grandmothers (mother-in-law of mothers) will be recruited from the obstetric clinics in the outpatient department of the study hospital, with 30 family units of each in the intervention group and control group respectively. Participants who are recruited will be randomly assigned to the intervention or control group by a research assistant based on the sequential enrollment list. Participants in the control group will receive usual care. Those who are randomized to the intervention group will receive the intergenerational co-parenting program in addition to the usual care.

NCT ID: NCT05056454 Recruiting - Depression Clinical Trials

New Moms Mood Tracking & Wellbeing

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

New moms can be at risk for perinatal depression (PND). The New Moms Mood Tracking and Wellbeing study is investigating mood changes, risk factors for depression and anxiety and treatment response around the time of delivery. Participants will be asked to complete three sets of online surveys between week 28 gestation and week 20 after delivery, in addition to downloading an app to collect data using their smartphone sensors and brief symptom surveys every other week. Women with elevated symptoms can participate in treatment. Women will be randomized to one of two conditions - Perinatal Psychiatric Care or Screening and Treatment for Anxiety and Depression (STAND). In Perinatal Psychiatric Care, participants will receive appointments with psychiatry clinicians. In STAND, participants will be further allocated to Online therapy with Coaching or Clinical Care, which includes both psychotherapy and psychiatry appointments. Treatment can last up to 6 months and there will be treatment related assessments for the duration of the 6 months, in addition to brief symptom surveys on a regular basis. Therefore, participation can last between 24 and 52 weeks, as both time of delivery and treatment enrollment timepoint cannot be scheduled in advance.

NCT ID: NCT04914299 Not yet recruiting - Clinical trials for Perinatal Depression

Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

The primary aim of the study is to investigate whether a novel mobile App-based behavioral intervention in pregnant women can: (1) prevent and/or decrease the incidence of perinatal mood disorders (2) decrease the severity and/or duration of perinatal mood disorders in affected participants (3) increase access of pregnant women to behavioral intervention and support tools (4) increase the satisfaction of pregnant women with their prenatal care.

NCT ID: NCT04846504 Recruiting - Clinical trials for Perinatal Depression

Accelerating Implementation of Mindful Mood Balance for Moms

MMB4Moms
Start date: September 27, 2021
Phase: N/A
Study type: Interventional

The Mindful Mood Balance for Moms (MMBFM) study examines whether using an internet program called Mindful Mood Balance for Moms to deliver Mindfulness Based Cognitive Therapy (MBCT) over an 8-week time period, is effective for reducing depression symptoms among pregnant women with a history of prior depression, and studies the effects of implementation strategies on the reach of the MMBFM program. This study will enroll 470 women from Kaiser Permanente Colorado, Southern California, Georgia. The investigators will compare clinical outcomes between those that receive mental health clinician coaching and those that receive peer coaching throughout the 8-week program. Survey data will be collected at 4 time points throughout the study (baseline, 12 weeks, 3rd trimester, and 3 months postpartum). The cost-effectiveness of both the clinical and peer coaching models at each health care system will be evaluated. For the implementation portion of the study, 30 OB clinics across the 4 health systems will be randomized in equal numbers to provide clinician facing implementation strategies (e.g., recruitment flyers, script pads, electronic medical record prompts) to encourage engagement in the MMBFM program or to usual care where women are only recruited by the study team with no clinician involvement. The primary outcome for testing clinician facing implementation strategies is reach, the percentage of women outreached who initially engage in the MMBFM program.

NCT ID: NCT04844138 Recruiting - Clinical trials for Perinatal Depression

Evaluating Overcoming Anxiety in Pregnancy and Postpartum as an Online Self-Directed Program

Start date: April 30, 2021
Phase: N/A
Study type: Interventional

The pregnancy and postpartum periods can be joyous times in life; however, they can also be filled with challenging physical, emotional, and lifestyle changes. These changes may lead to feelings of stress, anxiety, and depression amongst new and expecting mothers, which can have negative effects on fetal and infant development (Beijers et al., 2010; Goodman et al., 2016). The impacts of increased worry about health and safety due to COVID-19 as well as future-related uncertainties, paired with social (physical) distancing, may be felt especially strongly in this population. Of concern, pregnant and postpartum women have low rates of mental health service use even prior to the pandemic (Fonseca et al., 2015). E-health (Internet) and m-health (mobile application) psychological interventions are accessible, available at reduced cost, and can be accessed within users' homes, a factor that is particularly important during the pandemic (Andrews & Titov, 2010). In this study, the investigators will disseminate a free, online, self-directed Cognitive Behavioural Therapy program to women experiencing symptoms of anxiety during pregnancy and postpartum. This program has shown to be effective at improving symptoms of anxiety and depression when delivered in an in-person group format, and has high acceptability (Furer & Reynolds, 2015). The investigators will transfer this program into an online format so that pregnant and postpartum users can navigate the sessions on their own, without the support of a clinician. This program contains six modules which include topics such as coping with negative thoughts, unpacking the myth of the supermom, and managing expectations during pregnancy and postpartum. Additionally, material related to COVID-19 has been added to the program to target any pandemic-related stress participants may be experiencing. The investigators will collect information about the program's feasibility, acceptability, and effectiveness, which will inform future improvements to the program. This program is expected to reduce participants' feelings of stress, anxiety, and depression, in addition to improving maternal attachment. It is anticipated that these gains will be maintained when the investigators follow-up with participants one month after program completion. This program has the potential to provide accessible and affordable mental health services to pregnant and postpartum women struggling during the pandemic.

NCT ID: NCT04838210 Enrolling by invitation - Pregnancy Related Clinical Trials

Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care

EleVATE GC
Start date: May 21, 2021
Phase: N/A
Study type: Interventional

This study will provide high-quality, representative data on the capacity of Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care (EleVATE GC) to reduce perinatal depression, preterm birth, and low birthweight in African-American women. If findings from this study indicate that EleVATE GC is feasible and effective, this model could be implemented nationwide to help achieve mental and obstetric health parity for low-income women of color in the United States.

NCT ID: NCT04819711 Not yet recruiting - Clinical trials for Perinatal Depression

Addressing Perinatal Depression in Deprived Areas of Istanbul, Turkey

Start date: April 2021
Phase: N/A
Study type: Interventional

In Turkey, the prevalence rate of perinatal depression has been estimated between 20%-40%, reflecting the global average of 25%. Untreated perinatal depression is of concern not only because of its effect on maternal health but also from the effect that impaired maternal role fulfilment has on the mother-infant bonding and child care and the long-term impact on the infant's physical and cognitive development. Thinking Healthy Programme (THP) is an evidence-based intervention incorporated into the World Health Organization's flagship Mental Health Gap Action Programme, tailored to the perinatal period that has been shown to be effective for depressed or stressed mothers. Turkey prioritize antenatal care, and this provides an opportunity to integrate mental health care into an existing antenatal care programme. Public hospitals operate 'antenatal pregnancy schools' where women are invited to attend 5 weekly group sessions that incorporate education about pregnancy and newborn care. We have developed an on-line group version of the Thinking Healthy Programme which has been designed to be integrated into the routine on-line antenatal pregnancy classes. The intervention has been designed so it is suitable for all women (universal) rather than depressed mothers only (targeted). The aim of this study is to pilot this adapted on-line group intervention in selected hospitals' pregnancy schools. The study will be a two-arm pilot individual randomised controlled trial comparing the Thinking Healthy group intervention integrated into antenatal pregnancy school classes with antenatal pregnancy school classes alone. Our sample size of 60 pregnant women (that is 30 participants in each arm of the pilot trial), who are over 18 years old, between 12-30 weeks' gestation, and intend to attend all 5 sessions of the online antenatal classes. Participants in both arms will be assessed for depression and anxiety symptoms, levels of disability, quality of sleep, perceived social support, coping skills, and relationship with partner. All one hundred and twenty women will get a detailed assessment initially and 4-6 weeks after the intervention. Some of the study participants and antenatal nurses delivering these sessions will be approached for in-depth qualitative interviews to explore the acceptability, feasibility and perceptions of the study participants' receiving the intervention sessions.