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Perinatal Depression clinical trials

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NCT ID: NCT06001021 Not yet recruiting - Clinical trials for Perinatal Depression

Cognitive Behavioral Couple Therapy for Perinatal Distress

Start date: August 15, 2023
Phase: N/A
Study type: Interventional

The hypotheses of the study are - There will be differences in perceived distress, dyadic coping strategies, social support, quality of life, and well-being in couples at Pre- and Post-Test Levels during the perinatal period in couples. - There will be differences in psychopharmacology on total scores of perceived distress, dyadic coping strategies, social support, quality of life, and well-being between the experimental and wait list-placebo control groups. - There will be differences in CBCT (condition: without Zikr) on total scores of perceived distress, dyadic coping strategies, social support, quality of life, and well-being between the experimental and wait list control group. - There will be differences in CBCT (condition: with Zikr) on total scores of perceived distress, dyadic coping strategies, social support, quality of life, and well-being between the experimental and wait list-placebo control groups. - There will be differences for combined psychopharmacology, and CBT (conditions: with Zikr, without Zikr ) dimensions on total scores of perceived distress, dyadic coping strategies, social support, quality of life, and well-being between experimental and wait list-placebo control group.

NCT ID: NCT06000449 Not yet recruiting - Clinical trials for Perinatal Depression

Center M: Digital Health Innovation Pilot

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Center M is a digital health solution to Perinatal Depression (PD) which provides an alternative to Mindfulness Based Cognitive Therapy - Perinatal Depression (MBCT-PD). Center M shifts treatment to a telehealth model, reduces the number of sessions, and transitions home practice materials to a digital format. This study will include a clinical trial in which participants will be randomized to the Center M treatment with smartphone app delivery of homework compared to treatment as usual (TAU).

NCT ID: NCT05951738 Recruiting - Clinical trials for Perinatal Depression

Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies

PRESeNT
Start date: February 11, 2022
Phase: N/A
Study type: Interventional

The study aims at identifying: 1. specific biological and molecular alterations associated with development of depression in pregnancy or risk of it. 2. specific biological and molecular alterations due to exposure to maternal depression in utero that are still present in the offspring, that could possibly mediate the development of negative outcomes, and which are the possible clinical moderators of the associated risk; 3. whether antidepressant therapies prescribed by personal physician and the use of digital tools can have a preventive effect in the transmission of the risk from mothers to babies and in the development of depressive symptoms in high-risk pregnant women; In order to achieve these, 80 pregnant women with depression, 80 at high-risk and 80 controls will be recruited and clinically monitored over pregnancy and postpartum along with their babies, specifically at these timepoints: 25th and 32nd weeks of gestation, 1 week postpartum, 4 weeks postpartum, 8 weeks postpartum, 12 months postpartum. Women, based on their clinician choice, will receive antidepressants and will be provided with a smartphone app to monitor them, using a combination of personalised, daily self-reported assessments and sensors for passive data collection to cover mental and physical health. Blood and saliva samples from pregnant women will be collected at the 25th and 32nd week of gestation to perform biological analyses. Saliva samples from babies will be collected at 8 weeks and 12 months postpartum to perform biological analyses. Clinical and psychological data will be collected from women at all timepoints.

NCT ID: NCT05897619 Recruiting - Clinical trials for Perinatal Depression

Feasibility and Acceptability of a Novel Cognitive Behavioral Skills Mobile App for Pregnant and Postpartum Individuals

Start date: September 19, 2023
Phase: N/A
Study type: Interventional

This study aims to assess the feasibility and acceptability of the Maya Perinatal Cognitive Behavioral Skills App, a novel app for pregnant and postpartum individuals experiencing difficulties with mood, anxiety, or stress. Participants will complete the 12-module app to learn evidence-based strategies previously shown to help manage mood and anxiety. Assessments will include app feedback questionnaires, feedback interviews, a daily symptom tracker, and symptom measures. The study investigators hypothesizes that participants will find content to be helpful in developing skills to manage anxiety and mood difficulties during the perinatal period, and that the app interface, session structure, and pacing will be acceptable and feasible for this population. It is further hypothesized that increased Maya Perinatal Cognitive Behavioral Skills App use, engagement, and satisfaction will be associated with lower self-reported anxiety and mood symptoms.

NCT ID: NCT05832424 Not yet recruiting - Substance Use Clinical Trials

Feasibility and Acceptability of a Telehealth Intervention Among Women With Perinatal Mental Health

Start date: March 15, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot feasibility/acceptability study is to evaluate the effectiveness of a telehealth approach to increase access to services and reduce depression/anxiety symptoms and risk of substance use in a population of women with perinatal depression/anxiety and elevated substance use risk. The main questions it aims to answer are: - Assess the acceptability and feasibility of a telehealth approach to deliver an 8-week evidence-based group intervention to women with perinatal depression/anxiety and mild to moderate substance use risk. - Obtain preliminary data on treatment response to a telehealth 8-week evidence-based group intervention. Participants will participate in an 8-week evidence-based group intervention and complete the study questionnaire including depression severity, treatment adherence, and substance use risk which will be evaluated at baseline, post-intervention, and 2-month follow-up.

NCT ID: NCT05800509 Not yet recruiting - Clinical trials for Postpartum Depression

Gestational Diabetes and Perinatal Depression: an Intervention Program

Start date: April 2023
Phase: N/A
Study type: Interventional

Background: The gestational diabetes mellitus and perinatal depression are both global public health issues with high prevalence. Non-perinatal diabetes mellitus and depression are confirmed to have reciprocal influence, which is bidirectional relationship. However, there are still no any confirmations of relationship in the perinatal period. The reason could be that these kinds of studies mostly had been done for postpartum depression, they had rarely been discussed with a clearly sequential influence between gestational diabetes mellitus and perinatal depression. Additionally, there have not been so many Asian countries which been done this kind of studies, therefore, this study will focus on the relationship of primiparous gestational diabetes mellitus and perinatal depression. Purpose: This study will discuss the bidirectional relationship of gestational diabetes mellitus and perinatal depression. In the other words, the prenatal depression influences on gestational diabetes mellitus, and vice versa. Those changeable factors, such as social support, health behavior, prenatal body index, weight gain during pregnancy, perinatal complications…etc, will be tested for whether they could be regulators or not between the gestational diabetes mellitus and perinatal depression.Afterwards, a part of participants with diagnosis of gestational diabetes mellitus will receive the intervention of health education to influence the health behavior, then depression and other obstetrics and gynecological results will be tested for effects.

NCT ID: NCT05795114 Recruiting - Clinical trials for Perinatal Depression

Perinatal Depression and Adverse Childhood Experiences: Prevention Trial

PPD-ACE
Start date: July 20, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the development of perinatal depression. Participants will be randomized to either enhanced treatment as usual or the ROSE intervention, delivered by a care manager within a perinatal collaborative care program. They will complete self-reported surveys of their depression symptoms every 4 weeks to inform their symptom trajectories. They will also complete clinical interviews to establish any incident diagnoses of a major depressive episode.

NCT ID: NCT05714956 Active, not recruiting - Clinical trials for Perinatal Depression

Pilot Study of Mothers and Babies Online in Home Visiting

eMB
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The investigators propose a pilot randomized controlled trial (RCT) that examines how the redesigned version of Mothers and Babies Online (eMB) can be delivered in the context of home visiting (HV) programs that serve pregnant individuals and new mothers across the United States. The PI, Dr. Darius Tandon (Northwestern University), has conducted extensive research on the in-person Mothers and Babies (MB) intervention with HV programs and has received interest from one of the largest HV models-Parents as Teachers (PAT)-to explore the use of eMB with pregnant individuals that they serve.

NCT ID: NCT05710991 Not yet recruiting - Sleep Disturbance Clinical Trials

Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy

Start date: February 2023
Phase: N/A
Study type: Interventional

Pregnant and postpartum individuals often have difficulty sleeping and these sleep problems can negatively impact both the parent and infant. Research suggests that pregnant individuals prefer non-medication-based treatment for their sleep difficulties but there is a lack of research on the success of sleep treatment during pregnancy. Currently, there are two main non-medical treatments for sleep difficulties available. The first, cognitive behavioural therapy (CBT), is the first treatment recommended for insomnia and has been found to successfully treat insomnia during pregnancy and the postpartum period. In addition, shortened sessions of CBT for insomnia have also been found to successfully reduce sleep difficulties. The second option is sleep hygiene education which is the most commonly offered treatment for sleep difficulties and has been found to improve sleep problems. The present study will compare the effectiveness of a CBT for insomnia group workshop to a Sleep Hygiene group workshop.

NCT ID: NCT05654987 Recruiting - Clinical trials for Perinatal Depression

Perinatal Mental Health for Refugee Women

PMH-RW
Start date: December 1, 2022
Phase:
Study type: Observational [Patient Registry]

Since February 24th, 2022, the beginning of Russia's aggression against Ukraine, more than 80,000 women were expected to give birth. Therefore, understanding the impact of war on the perinatal health of women is an important requisite to improve perinatal care.