- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05064254
Treatment of Anxiety in Pregnancy Study (TAPS)
Evaluating an Ultra-Brief Intervention for The Treatment Of COVID-19 Related Anxiety in Pregnant Women
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sophie Grigoriadis, MD, PhD
- Phone Number: 416 480 5677
- Email: sophie.grigoriadis@sunnybrook.ca
Study Contact Backup
- Name: Morgan Sterling, BAH
- Phone Number: 685217 4164806100
- Email: morgan.sterling@sunnybrook.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Center
-
Contact:
- Sophie Grigoriadis, MD, PhD
- Phone Number: 416 480 5677
- Email: sophie.grigoriadis@sunnybrook.ca
-
Toronto, Ontario, Canada, M5S 1B2
- Not yet recruiting
- Women's College Hospital
-
Contact:
- Simone Vigod, MD, FRCPC
- Phone Number: 4080 416-323-6400
- Email: simone.vigod@wchospital.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment as usual
All participants allocated to the control group will have access to standard care.
|
TAU may include self-help methods, physician visit, provision of resources etc.
|
Experimental: 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) |
TAU may include self-help methods, physician visit, provision of resources etc.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of participants screened positive for anxiety by the GAD-7 who are eligible for the study.
Time Frame: 11 months
|
Among pregnant women who screen positive for anxiety, what is the rate of eligibility?
The rate of eligibility will be determined as a raw percentage of the total number eligible over the total pool of participants entering the site.
|
11 months
|
The rate of recruitment as assessed by the number of participants recruited
Time Frame: 11 months
|
Among eligible pregnant women who screen positive for anxiety, what is the rate of recruitment? The rate of recruitment will be determined as a raw percentage of the number recruited over the number eligible. |
11 months
|
Reasons for non-participation as recorded by participants
Time Frame: 11 months
|
Among pregnant women who screen positive for anxiety, what are the reasons for non-participation? Reasons for nonparticipation will also be calculated as a proportion. |
11 months
|
Participant acceptability of treatment as measured by the Treatment Acceptability Scale
Time Frame: 6 weeks
|
What are participants' level of perceived acceptability of the MAPP intervention? The Treatment Acceptability Scale (TAAS) will be used to assess participant acceptability of the intervention. It is a 10 item self report questionnaire where items were developed based on several factors including credibility, expectancy and perceived gaps specifically in the anxiety disorders literature. A 7-point Likert scale is used where higher scores indicate higher acceptability and anticipation to adhere to the intervention. The scale has good psychometric properties and is recommended for evaluating anxiety interventions. |
6 weeks
|
Participant acceptability of treatment as measured by the Acceptability of Internet Delivery (AID)/ Experiences of Therapy Questionnaire
Time Frame: 6 weeks
|
What are participants' level of perceived acceptability of the synchronous virtual group format? For the acceptability of internet delivery (AID), we will use questions that rate the importance of advantages and disadvantages of internet therapy in making a decision regarding using versus rejecting it. |
6 weeks
|
Therapist acceptability of treatment as measured by the Acceptability of Intervention Measures
Time Frame: 6 weeks
|
What are the therapists' perceptions of providing the MAPP intervention in a synchronous group format?
For the acceptance of the virtual format, the therapists will complete the Acceptability of Intervention Measure (AIM) a four-item implementation measure that has been referred to as the "leading indicators" of successful implementation with shown psychometric strength and completion time being less than 1 minute.
|
6 weeks
|
Therapist acceptability of treatment as measured by questions on the Intervention Appropriateness Measure (IAM)
Time Frame: 6 weeks
|
What are the therapists' perceptions of providing the MAPP intervention in a synchronous group format?
For the acceptance of the virtual format, the therapists will complete the Intervention Appropriateness Measure (IAM), a four-item implementation measure that has been referred to as the "leading indicators" of successful implementation with shown psychometric strength and completion time being less than 1 minute.
|
6 weeks
|
Therapist acceptability of treatment as measured by the Feasibility of Intervention Measure (FIM) Questionnaire
Time Frame: 6 weeks
|
What are the therapists' perceptions of providing the MAPP intervention in a synchronous group format?
For the acceptance of the virtual format, the therapists will complete the Feasibility of Intervention Measure (FIM) a four-item implementation measure that has been referred to as the "leading indicators" of successful implementation with shown psychometric strength and completion time being less than 1 minute.
|
6 weeks
|
Participant Adherence to therapy as measured by proportion of participants who attend each session of therapy
Time Frame: 4 weeks
|
What proportion of participants attend each session of therapy Proportion of participants completing each session over all participants for the session |
4 weeks
|
Participant Adherence to therapy as measured by proportion of participants who attend all sessions of therapy
Time Frame: 4 weeks
|
What proportion of participants all therapy session Proportion of participants completing all sessions over all participants |
4 weeks
|
Participant Adherence to therapy as measured by the number completing follow-up questionnaires at 6, 12, and 24 weeks
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
What number complete all questionnaires at 6,12 and 24 weeks Proportion of participants over all at each time point |
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
Participant Adherence to therapy as measured by recorded reasons for dropout
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
What are the reasons for drop out? Participants who drop out will be asked why and their answers will be recorded |
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
Therapist Adherence to Therapy as assessed by therapist adherence checklists
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
What are the therapists' rate of adherence to the intervention?
We will rate the therapists' adherence to the trial protocol by having independent assessors rate adherence by completing a checklist devised for the study intervention based on a previous successfully used framework.
Comparisons will be made between therapists and their adherence rates
|
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety symptoms as measured by the GAD-7
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
What is the effect of MAPP on anxiety symptoms compared to the control group at 6 weeks post randomization?
The results from this question will be used to generate preliminary data on MAPP's effect on symptoms of anxiety compared to the control condition to inform an effect size for the larger trial power analysis.
We will also assess at 12 and 24 weeks The GAD-7 is a 7-item anxiety scale with a min value of 0 and a maximum value of 21, with a higher score indicating higher levels of anxiety.
|
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician rated anxiety as assessed by the Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
Hamilton Anxiety Rating Scale (HAM-A) will be used as an objective measure of anxiety (to circumvent contamination of expectation) and completed prior to the other measures.
The HAM-A is a 14-item, clinician-rated scale used to assess the severity of anxiety symptoms.
Each item is rated on a 5-point likert scale where the total score ranges from 0 to 56.
This scale shows good reliability, validity and sensitivity to change.
Research staff blind to group will rate the items virtually.
|
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
Coronavirus anxiety as assessed by the COVID Anxiety Scale (CAS)
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
The COVID anxiety scale Assesses dysfunctional anxiety associated with the COVID-19 crisis.
It has 5 items rated on a 0-4 Likert scale.
|
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
Participant Depression as assessed by the Edinburgh Postnatal Depression Scale The Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
The Edinburgh Postnatal Depression Scale (EPDS) is an internationally recommended measure for depression symptoms in the perinatal period with well documented psychometric properties for pregnancy.
Thirteen items are rated and a cutoff score > 12 will be used as recommended to identify depression.
|
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
Participant experiences of pregnancy as assessed by The Pregnancy Experiences Scale-Brief Version (PES-B)
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
The Pregnancy Experiences Scale-Brief Version (PES-B) will be used to measure overall pregnancy experience.
It is made up of 10-items with positive and negative stressors specific to pregnancy rated from 0(not at all) to 3(great deal).
Each item is rated on one dimension ("hassle or uplift").
We will calculate the intensity of hassles and uplifts (sum of scale scores (1-3)/hassles or uplift frequency.
It has good reliability and validity for measuring positive and negative experiences.
|
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
Participant Healthcare Usage as assessed by the Edinburgh Health Care Utilization (HCU)
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
The Edinburgh Health Care Utilization (HCU) will be monitored to determine co-intervention or contamination.
We will ask participants the number of visits they had with their psychiatrist, family physician for mental health reasons, and start of any treatments during the study period including medication.
It has been used successfully in our previous studies with perinatal samples.
|
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
Participant Coping as assessed by the The Warwick Edinburgh Mental Well-being Scale (WMWS)
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
The Warwick Edinburgh Mental Well-being Scale (WMWS) will be used to measure coping skills.
It consists of 14 positively worded items on scale of 0 to 5. Total scores range from 14 to 70 and it is psychometrically robust and used in pregnant women.
|
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
What is the effect of MAPP on pregnancy specific stressors
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
What is the effect of MAPP on pregnancy specific stressors The Pregnancy Related Anxiety Questionnaire R2 (PRAQ-R2) will capture pregnancy specific stressors. The 11 items of the PRAQ-R2 have strong evidence as pregnancy stressors. |
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
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.
Time Frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
What is the effect of MAPP on life stressors
|
After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
|
Adverse effects
Time Frame: 6 weeks
|
We will capture potential adverse effects by using a form made for the trial (Adverse effects form).
|
6 weeks
|
Demographics
Time Frame: Baseline
|
Demographic information will be collected using a Socio-demographic questionnaire
|
Baseline
|
Diagnoses
Time Frame: Baseline
|
In order to better describe the sample, especially to be able to classify according to diagnosis, major psychiatric diagnoses will be captured with the Psychiatric Diagnostic Screening Questionnaire (PDSQ).
It was developed to be a diagnostic aid in clinical practice and with current psychiatric nomenclature.
It is self-report and assesses the most common major psychiatric diagnoses seen in outpatient mental health settings.
It has good reliability and validity.
While half of participants will randomly receive the PDSQ, the other half will be randomized to receive the Mini International Neuropsychiatric Interview (MINI) anxiety and depression modules.
The purpose of using both questionnaires is to validate the PDSQ as an equivalent measurement to the MINI diagnostic inventory in our patient population and will use only the PDSQ for our future large
|
Baseline
|
Therapists' activities log-intervention activities
Time Frame: 4 weeks
|
Therapists' activities (session completed / date, telephone discussions if any, missed sessions etc.) will be documented.
|
4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sophie Grigoriadis, MD, PhD, Sunnybrook Health Sciences Center
- Principal Investigator: Steven Selchen, MD, FRCPC, Sunnybrook Health Sciences Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAPS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompletedProlonged PregnancyFrance
-
University Hospital, ToursCompleted
-
Technische Universität DresdenWithdrawnPregnancy Trimester, Second | Pregnancy Trimester, First | Pregnancy Trimester, ThirdGermany
-
Universitair Ziekenhuis BrusselMerck Serono International SAUnknownPregnancy | Pregnancy LossBelgium
-
Turku University HospitalUniversity of TurkuCompleted
-
Centre Hospitalier René DubosCompletedDeciduitis; Complicating Pregnancy
Clinical Trials on Treatment as usual (TAU)
-
Centro Mente Aberta de MindfulnessUnknown
-
Academisch Medisch Centrum - Universiteit van Amsterdam...KU Leuven; ZonMw: The Netherlands Organisation for Health Research and Development and other collaboratorsRecruiting
-
Hospital Universitari Vall d'Hebron Research InstituteParc Sanitari Sant Joan de Déu; Universitat Autonoma de BarcelonaCompleted
-
Centre for Addiction and Mental HealthCompleted
-
Nova Scotia Health AuthorityCompletedEating DisordersCanada
-
Virginia Commonwealth UniversityCompletedSubstance Use Disorders | Substance Abuse | Drug Abuse | Drug Addiction | Drug Dependence | Drug Use Disorders | Substance AddictionUnited States
-
Hospital Universitari Vall d'Hebron Research InstituteActive, not recruiting
-
University of BariUniversity of Dublin, Trinity CollegeCompletedRecovery | Mental Disorder | Schizophrenia and Related Disorders | Intellectual Disability, Mild to Moderate | Personality Disorders and Disturbances in Behavior | Personality Disorders, AntisocialItaly
-
Fundació Sant Joan de DéuUniversitat Autonoma de BarcelonaRecruiting
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedSubstance AbuseUnited States