Clinical trial NCT05064254: Treatment of Anxiety in Pregnancy Study
Official title: Evaluating an Ultra-Brief Intervention for The Treatment Of COVID-19 Related Anxiety in Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Pregnancy
Keywords: anxiety
pregnancy
pilot
brief psychotherapy
Mindfulness
virtual
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Sunnybrook Research Institute
name: Women's College Hospital
First posted: 2021-10-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind randomized controlled design. Pregnant women with anxiety symptoms will be randomly allocated 1:1 to either a control group (treatment as usual) or intervention group (treatment as usual plus MAPP intervention).
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: The number of participants screened positive for anxiety by the GAD-7 who are eligible for the study.
timeFrame: 11 months
measure: The rate of recruitment as assessed by the number of participants recruited
timeFrame: 11 months
measure: Reasons for non-participation as recorded by participants
timeFrame: 11 months
measure: Participant acceptability of treatment as measured by the Treatment Acceptability Scale
timeFrame: 6 weeks
measure: Participant acceptability of treatment as measured by the Acceptability of Internet Delivery (AID)/ Experiences of Therapy Questionnaire
timeFrame: 6 weeks
measure: Therapist acceptability of treatment as measured by the Acceptability of Intervention Measures
timeFrame: 6 weeks
measure: Therapist acceptability of treatment as measured by questions on the Intervention Appropriateness Measure (IAM)
timeFrame: 6 weeks
measure: Therapist acceptability of treatment as measured by the Feasibility of Intervention Measure (FIM) Questionnaire
timeFrame: 6 weeks
measure: Participant Adherence to therapy as measured by proportion of participants who attend each session of therapy
timeFrame: 4 weeks
measure: Participant Adherence to therapy as measured by proportion of participants who attend all sessions of therapy
timeFrame: 4 weeks
measure: Participant Adherence to therapy as measured by the number completing follow-up questionnaires at 6, 12, and 24 weeks
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
measure: Participant Adherence to therapy as measured by recorded reasons for dropout
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
measure: Therapist Adherence to Therapy as assessed by therapist adherence checklists
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
Secondary outcomes:
measure: Anxiety symptoms as measured by the GAD-7
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
Other outcomes:
measure: Clinician rated anxiety as assessed by the Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
measure: Coronavirus anxiety as assessed by the COVID Anxiety Scale (CAS)
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
measure: Participant Depression as assessed by the Edinburgh Postnatal Depression Scale The Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
measure: Participant experiences of pregnancy as assessed by The Pregnancy Experiences Scale-Brief Version (PES-B)
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
measure: Participant Healthcare Usage as assessed by the Edinburgh Health Care Utilization (HCU)
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
measure: Participant Coping as assessed by the The Warwick Edinburgh Mental Well-being Scale (WMWS)
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
measure: What is the effect of MAPP on pregnancy specific stressors
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
measure: What is the effect of MAPP on life stressors The Life Stress Inventory (LSI; Holmes & Rahe) general life stressors. The inventory is a well-known tool of 43 life events measuring stress load.
timeFrame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
measure: Adverse effects
timeFrame: 6 weeks
measure: Demographics
timeFrame: Baseline
measure: Diagnoses
timeFrame: Baseline
measure: Therapists' activities log-intervention activities
timeFrame: 4 weeks
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Center
name: Sophie Grigoriadis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Center
name: Steven Selchen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: