Treatment of Anxiety in Pregnancy Study

NCT ID: NCT05064254

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-21
• Study Completion Date: 2022-09-01

Brief 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).

Detailed Description

Antenatal mental illness is common. About 3/5 of women have antenatal anxiety or depression with anxiety which are both linked to adverse delivery outcomes and negative effects on child development. Often these conditions remain undetected/untreated, perpetuating the cycle of mental illness. A Canadian survey of pregnant women (~2000, April 2020) found >50% endorsed anxiety and > 2/3 elevated anxiety specific to pregnancy during the COVID-19 pandemic. This is on a background of elevated rates of antenatal mental illness. Psychotherapeutic interventions are preferred antenatally but barriers prevent their initiation and adherence (i.e., time duration). With the pandemic and the spike in anxiety, these vulnerable women are at risk to continue being ill and their child at risk for negative delivery/ longer-term outcomes. It is imperative these women receive rapid treatment to reduce acute anxiety to prevent mental health deterioration and the potential adverse effects. The pandemic has also forced clinicians to deliver healthcare in creative ways such as providing psychiatric care virtually despite their not knowing if the therapy can be effectively provided in this way and must be evaluated.

Mindful Adaptive Practice in Pregnancy (MAPP) is a novel ultra-brief psychotherapy developed by the investigator team to reduce anxiety. Prior work (nonclinical samples) suggested high recruitment and retention, significant distress reduction, and enhancement of wellbeing at rates comparable to gold standard therapies of longer duration. The work with clinical samples has shown it to have a large effect size. The investigators have adapted the technique to pregnant women to address the urgent clinical need for a brief, effective targeted intervention. As the investigators were challenged to offer health care services creatively, they adapted MAPP for virtual delivery, in a group format using the Ontario Telemedicine Network for example.

The overall objective of this study is to determine the feasibility, acceptability, and adherence to a clinical trial protocol evaluating the MAPP intervention on anxiety symptoms among pregnant women. The results of this pilot work will guide the development of a larger multi-site randomized controlled trial (RCT) to definitively evaluate the effectiveness of MAPP. As a secondary outcome, the investigators will assess the effect of MAPP in reducing anxious symptoms; this preliminary data on MAPP's effect will inform an effect size for the larger trial power analysis.

Pregnant participants from obstetrics, family practice, midwifery, and reproductive psychiatry clinics, as well as self-referral from social media, will be recruited. Sixty women will be randomized to the control group (standard care) or the intervention group (standard care plus MAPP). Outcomes will be captured electronically right after therapy ends, 3 months post-therapy, and 6 months post-therapy. Results of this work will be used for the larger trial which will have the potential to change clinical practice. Subsequent knowledge translation activities will foster knowledge uptake of the pilot results and once the final RCT is completed, the intervention will be widely disseminated.

Conditions

Anxiety; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Treatment as usual

All participants allocated to the control group will have access to standard care.

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: OTHER

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

Mindful Adaptive Practice in Pregnancy Therapy

Participants allocated to the intervention group will have access to treatment as usual in addition to synchronous virtual MAPP.

MAPP draws upon existing integrative principles of structured psychotherapies (mindfulness-based, cognitive, behavioural and relational psychotherapy)

Group Type: EXPERIMENTAL

Treatment as usual (TAU)

Intervention Type: OTHER

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

Mindful Adaptive Practice in Pregnancy Therapy

Intervention Type: OTHER

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.

Interventions

Treatment as usual (TAU)

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

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

MAPP

Eligibility Criteria

Inclusion Criteria

• Pregnant
• >18 years of age
• At 12-30weeks gestation
• Score > 7 on the GAD-7
• Have internet access with camera, microphone, and ability to run the necessary software.
• Fluent in written and spoken English
• Willing to provide the name and contact details of their primary health care provider / other contact who would know person's whereabouts.

Exclusion Criteria

• Current substance use
• Current psychotic/manic symptoms
• Active suicidal ideation
• Current use of psychotropic medication with dose change within 4 weeks of recruitment
• Currently receiving psychotherapy
• Unwilling to be randomized.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Research Institute

OTHER

Sponsor Role: collaborator

Women's College Hospital

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Grigoriadis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Center

Steven Selchen, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Center

Locations

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Site Status: RECRUITING

Women's College Hospital

Toronto, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Sophie Grigoriadis, MD, PhD

Role: CONTACT

sophie.grigoriadis@sunnybrook.ca

416 480 5677

Morgan Sterling, BAH

Role: CONTACT

morgan.sterling@sunnybrook.ca

4164806100 ext. 685217

Facility Contacts

Sophie Grigoriadis, MD, PhD

Role: primary

sophie.grigoriadis@sunnybrook.ca

416 480 5677

Simone Vigod, MD, FRCPC

Role: primary

simone.vigod@wchospital.ca

416-323-6400 ext. 4080

Other Identifiers

TAPS

Identifier Type: -

Identifier Source: org_study_id