AnxietyTAPSNCT05064254
Treatment of Anxiety in Pregnancy Study
A study testing Treatment as usual (TAU) and Mindful Adaptive Practice in Pregnancy Therapy in people with Anxiety and Pregnancy, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Treatment as usual (TAU) and Mindful Adaptive Practice in Pregnancy Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesCanada
- Study dates
- 17 Nov 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
Women's College Hospital
Toronto, Ontario, M5S 1B2
About this study
Official title: Evaluating an Ultra-Brief Intervention for The Treatment Of COVID-19 Related Anxiety in Pregnant Women
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).
Read the 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.
- Being tested
- Treatment as usual (TAU), Mindful Adaptive Practice in Pregnancy Therapy
- Keywords
- anxiety, pregnancy, pilot, brief psychotherapy, Mindfulness, virtual
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAU may include self-help methods, physician visit, provision of resources etc.
Mindful Adaptive Practice in Pregnancy TherapyOther
Also called MAPP
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | All participants allocated to the control group will have access to standard care. Receives: 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) Receives: Other: Treatment as usual (TAU); Other: Mindful Adaptive Practice in Pregnancy Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
Secondary outcomes (1)
Anxiety symptoms as measured by the GAD-7
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.
Measured: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start17 Nov 2021
- Primary completion1 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute, Women's College Hospital
- Responsible party
- Sponsor
- Investigators
- Sophie Grigoriadis, MD, PhD, Principal investigator, Sunnybrook Health Sciences CentreSteven Selchen, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064254
- Sponsor's protocol ID
- TAPS
- Acronym
- TAPS
- Status last verified
- May 2025
- First submitted
- 23 Jul 2021
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Ultra-Brief Intervention for The Treatment Of COVID-19 Related Anxiety in Pregnant Women
- ClinicalTrials.gov ID
- NCT05064254
- Acronym / sponsor ID
- TAPS / TAPS
- Keywords
- anxiety, pregnancy, pilot, brief psychotherapy, Mindfulness, virtual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute, Women's College Hospital
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Other: Treatment as usual (TAU)All participants allocated to the control group will have access to standard care. |
| Mindful Adaptive Practice in Pregnancy Therapy | Experimental | Other: Treatment as usual (TAU), Other: Mindful Adaptive Practice in Pregnancy TherapyParticipants 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usual (TAU)TAU may include self-help methods, physician visit, provision of resources etc. | Other | Mindful Adaptive Practice in Pregnancy Therapy, Treatment as usual |
| Mindful Adaptive Practice in Pregnancy TherapyAlso: MAPPMAP 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 | Mindful Adaptive Practice in Pregnancy Therapy |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
1 secondary outcome
Anxiety symptoms as measured by the GAD-7
Time frame: After therapy (4 weeks), 3 months post-therapy, and 6 months post-therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Grigoriadis, MD, PhD principal investigator
Sunnybrook Health Sciences Centre
Steven Selchen, MD, FRCPC principal investigator
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual (TAU) and Mindful Adaptive Practice in Pregnancy Therapy in people with Anxiety and Pregnancy, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants screened positive for anxiety by the GAD-7 who are eligible for the study. (time frame: 11 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.