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Treatment of Anxiety in Pregnancy Study

NCT05064254 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-04-17

No results posted yet for this study

Summary

Anxiety Disorders or Depressive Disorders with anxiety, affect about 3/5 pregnancies. It is known that if left untreated, these disorders are associated with poor delivery outcomes, ongoing mental illness, and negative effects on the child. The COVID-19 pandemic has created heightened anxiety in many people especially the most vulnerable. As a result, the investigators have seen that pregnant women report even higher rates of anxiety than in the past. Talk therapy is recommended but is underused in part because it takes a long time to learn and use. The COVID crisis has added another layer of complexity in that in-person treatment is not routinely available. The investigator team has adapted a talk therapy treatment, "Mindful adaptive practice in pregnancy (MAPP)" where women are taught skills to reduce anxiety. This treatment is done virtually over the internet in a synchronous group format. The overall objective of this study is to assess the feasibility, acceptability, and adherence to the clinical trial protocol evaluating MAPP on anxiety symptoms among pregnant women. This synchronous virtual treatment is novel and has the potential to change clinical practice as it will effectively reduce anxiety, takes a short time to learn and women will have access to it regardless of living in rural or remote areas. The results of this study will guide the development of a larger multi-site randomized controlled trial (RCT).

Conditions

Interventions

OTHER

Treatment as usual (TAU)

TAU may include self-help methods, physician visit, provision of resources etc.

OTHER

Mindful Adaptive Practice in Pregnancy Therapy

MAP teaches: a) recognition of personal maladaptive/ distressing patterns driving anxiety; b) how to relate differently; and c) cultivation of more adaptive ways of dealing with anxiety and learning how to effectively control it rapidly which allows re-engagement with life in more flexible ways.

Sponsors & Collaborators

  • Sunnybrook Research Institute

    collaborator OTHER

  • Women's College Hospital

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Sophie Grigoriadis, MD, PhD · Sunnybrook Health Sciences Center

  • Steven Selchen, MD, FRCPC · Sunnybrook Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2022-07-01
Completion
2022-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064254 on ClinicalTrials.gov