Treatment of Anxiety in Pregnancy Study

NCT05064254 | Completed DMC

• 1 other identifier: TAPS
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

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).

Conditions

Anxiety; Pregnancy

Keywords

anxiety; pregnancy; pilot; brief psychotherapy; Mindfulness; virtual

Outcome Measures

Primary Outcomes (13)

• The number of participants screened positive for anxiety by the GAD-7 who are eligible for the study.

  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

  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

  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

  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

  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

  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)

  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

  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

  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

  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

  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

  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

  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 Outcomes (1)

• Anxiety symptoms as measured by the GAD-7

  After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy

Other Outcomes (12)

• Clinician rated anxiety as assessed by the Hamilton Anxiety Rating Scale (HAM-A)

  After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy

• Coronavirus anxiety as assessed by the COVID Anxiety Scale (CAS)

  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)

  After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

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

Other: Treatment as usual (TAU)

Mindful Adaptive Practice in Pregnancy Therapy

EXPERIMENTAL

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)

Other: Treatment as usual (TAU); Other: Mindful Adaptive Practice in Pregnancy Therapy

Interventions

Treatment as usual (TAU) OTHER

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

Mindful Adaptive Practice in Pregnancy Therapy; Treatment as usual

Mindful Adaptive Practice in Pregnancy Therapy 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.

Also known as: MAPP

Mindful Adaptive Practice in Pregnancy Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Sunnybrook Research Institute: collaborator
• Women's College Hospital: collaborator

Study Sites (2)

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sophie Grigoriadis, MD, PhD

  Sunnybrook Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Steven Selchen, MD, FRCPC

  Sunnybrook Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: October 1, 2021
• Study Start: November 17, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 30, 2022
• Last Updated: April 17, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)