Anxiety Clinical Trial - eMBC for Perinatal Depression & Anxiety

Status Active, not recruiting

Clinical Trial Summary

Depression and anxiety that occur around the time of pregnancy can adversely impact a person's health and well-being, and their child's health and development. Fewer than 20% of affected people are adequately treated, often because of under-use of medications. Measurement based care (MBC) is a model of care where psychiatric symptoms are routinely tracked and reviewed together by a patient and their doctor to better manage symptoms. It has not been systematically evaluated for perinatal depression and anxiety. The overall objective of this study is to test the feasibility of MBC in this population to inform a future large randomized controlled trial for definitive evaluation. In order to avoid known barriers to MBC, electronic MBC (eMBC) will be used. With eMBC, patients can enter their symptoms into their electronic medical records before their appointment so that they can be evaluated by their doctor during the appointment. In this pilot study, the feasibility of recruitment for a future efficacy trial, including feasibility of recruitment, and retention, acceptability and adherence to a trial protocol will be evaluated.

Clinical Trial Description

A parallel group randomized controlled trial (RCT) will be conducted. Eligible and consenting patients with depression and/or anxiety will be randomized in a 1:1 ratio to either the eMBC condition or a control condition. The study will be stratified by diagnosis (major depressive disorder vs generalized anxiety disorder). 80 patient participants will be recruited from the Reproductive Life Stages (RLS) Program at Women's College Hospital. The active treatment phase of the study is 12 weeks. Outcomes will be measured online and by phone at 4-, 8-, and 12- weeks post-randomization. Following the completion of the study, some participants will be asked to participate in follow-up interviews. RLS psychiatrists whose patients participated in the study will participate in a focus group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04836585
Study type	Interventional
Source	Women's College Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 4, 2022
Completion date	June 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05777044` - The Effect of Hatha Yoga on Mental Health	N/A
Recruiting	`NCT04680611` - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed	`NCT04512768` - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy	N/A
Completed	`NCT04748367` - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care	N/A
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT04579354` - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia	N/A
Completed	`NCT03457714` - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Completed	`NCT03535805` - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances	N/A
Recruiting	`NCT05956912` - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting	`NCT05302167` - Molehill Mountain Feasibility Study.	N/A
Completed	`NCT05588622` - Meru Health Program for Cancer Patients With Depression and Anxiety	N/A
Completed	`NCT05881681` - A Mindfulness Approach to UA for Afro-descendants	N/A
Active, not recruiting	`NCT04961112` - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits	N/A
Terminated	`NCT04612491` - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Completed	`NCT05980845` - The Effect Nature Sounds and Music on Hemodialysis Patients	N/A
Recruiting	`NCT05449002` - Digital Single Session Intervention for Youth Mental Health	N/A
Completed	`NCT05585749` - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients	N/A
Terminated	`NCT03272555` - WILD 5 Wellness: A 30-Day Intervention	N/A
Recruiting	`NCT05997849` - Development of a Multiplatform Mental Health Mobile Tool	N/A
Completed	`NCT06421233` - The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

eMBC for Perinatal Depression and Anxiety — eMBC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms