PROJECT HIGHLIGHTS

Governance Organization

SHS – Sunnybrook Medical Services Alternative Funding Plan Association

Project Title

SHS-21-007 – Evaluating an ultra brief intervention for the treatment of COVID-19 related anxiety in pregnant women.

Project Highlights

Our team has created, “Mindful adaptive practice in pregnancy (MAPP)”, a talk therapy treatment adapted for pregnancy and for virtual delivery over the Internet. Anxious pregnant women are taught skills to reduce anxiety in only 4 weeks in a synchronous group format. There is evidence to support the original treatments’ effectiveness in adults but given the urgency in treating anxiety in pregnancy during the COVID-19 pandemic, our team endeavored to fill the gap by making modifications for pregnancy and assess virtual delivery. The pandemic facilitated virtual health care delivery but we must be confident this modality is effective. The overall objective of this study is to assess the feasibility, acceptability and adherence to our 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 development of a larger multi-site randomized controlled trial (RCT).

To date we have had investigator meetings and worked collaboratively to finalize our processes as well as with our therapists. Our team has been successful in securing REB approval from the Sunnybrook and Women’s College Research Ethics Boards, our two sites. Consent materials, protocols (study and safety), scripts, questionnaires and case forms have all been created and reviewed. In an amendment, we created a way to simultaneously validate a new diagnostic questionnaire with no increase to participant’s time (we want to ensure we can capture diagnostic information without having the participants undergo a diagnostic clinical interview). We have worked with the Centre for Clinical Trial Support of the Sunnybrook Research Institute to program the questionnaires into REDCap, a secure web application for on-line data capture and to randomize our participants. These on-line questionnaires have been tested and timed during completion to align with our protocol. The treatment manual of MAPP has been created but will be revised by the results of our pilot. There will be 2 study therapists delivering MAPP and they have been trained.

We have designed, created and launched our trial website (https://Sunnybrook.ca/TAPS) including with links to REDcap. Advertisements (posters, social media posts, brochures, videos, and logos) have been created and are on-line with the website. Sunnybrook Communications approved our website and advertisements. We are at the final stages of creating Facebook and Instagram advertisements in collaboration with Sunnybrook Communications. We have also put together a list of possible on-line recruitment venues. Although we have launched the website and are testing recruitment strategies (on-line, clinics, others), we set the first group therapy session to start running at the beginning of January 2022. Participating physicians have been made aware of the study at this point by email only but we plan to attend the appropriate clinics in person to inform staff and be available if more information is required. We anticipate we will have enough participants recruited to run the first group in January. If necessary we can run therapy groups concurrently.

Our study is on track with the proposed timeline.

Theme

Virtual Health Care

Primary Project Lead for Contact

Dr. Sophie Grigoriadis

Email

Sophie.Grigoriadis@sunnybrook.ca

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