Postpartum AnxietyNCT05691140
Prevention of Postpartum Anxiety in High-Risk Women
A study testing Cognitive Behavioural Therapy in people with Postpartum Anxiety, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
The primary aim of this study is to evaluate whether a CBT group designed to target IU (CBT-IU) in pregnant women with heightened levels of IU, prevents postpartum anxiety. The investigators hypothesize that women with clinically significant IU during pregnancy will exhibit both significant reductions in IU, as well… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Anxiety
- What is being tested?
- Cognitive Behavioural Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2022to 1 Oct 2024
- 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 women (up to 30 weeks pregnant to allow for completion of the CBT-IU protocol before child delivery)
- 18 years or older
- Baseline score of ≥64 on the IUS (Furtado et al., 2021)
- No psychotropic medication or, if taking medication, no change in dose or type for a minimum of 6 weeks prior to baseline
- No concurrent psychological treatment
- Fluent in English and able to consent for treatment
- Located in Ontario, Canada
Who cannot join
- A current diagnosed DSM-5 anxiety disorder, as assessed by the Mini International Neuropsychiatric Interview (version 7.0.2)
- Active suicidal ideation
- Current psychosis or substance use disorder
- For those enrolled on a stable dosage of a psychotropic medication, if a change in medication is required during the psychological therapy trial, the participant will continue with the therapy but will be excluded from the analysis.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Sheryl M Green, PhD, CPsych
About this study
Official title: Prevention of Postpartum Anxiety in High-Risk Women: A Proof-of-Concept Randomized Clinical Trial
The primary aim of this study is to evaluate whether a CBT group designed to target IU (CBT-IU) in pregnant women with heightened levels of IU, prevents postpartum anxiety. The investigators hypothesize that women with clinically significant IU during pregnancy will exhibit both significant reductions in IU, as well as a decrease in anxiety symptoms postpartum, compared to a treatment as usual control group. The secondary aim of this study is to evaluate whether CBT-IU significantly improves and/or prevents depression symptoms, worry symptom severity, and difficulties with emotion regulation. The investigators hypothesize that CBT-IU will lead to significant improvements in symptom severity compared to the treatment as usual control group.
Read the detailed description
Anxiety disorders are a serious mental health concern, affecting as many as 15-24% of women during the perinatal period. Despite the high prevalence of anxiety during the perinatal period and its associated impact, fewer than 15% of women receive treatment often due to difficulties in timely and accurate symptom detection. Our group conducted a longitudinal study that investigated the psychosocial and biological risk factors of postpartum anxiety worsening in a sample of high-risk pregnant women with pre-existing anxiety and depressive disorders. In this study, intolerance of uncertainty (IU) was identified as the strongest predictor. IU is a cardinal trait of anxiety and has been implicated in predicting treatment response in non-perinatal populations. However, despite the relevance of IU in anxiety disorders, our study was the first to assess IU in the perinatal population. As improving symptom detection through identification of significant risk factors, such as IU, can aid in the development of preventative and treatment measures, our group recently validated the Intolerance of Uncertainty Scale (IUS) in a perinatal population for the detection of anxiety disorders. In this study of 198 perinatal women, the IUS demonstrated excellent internal consistency and an optimal clinical cut-off score of 64 or greater was established, yielding a sensitivity of 89%. The IUS also demonstrated very good positive (79%) and negative (80%) predictive values. These findings suggest that the IUS represents a clinically useful screening tool to be used as an aid for the early and accurate detection of anxiety disorders during the perinatal period. Cognitive Behavioural Therapy (CBT) is considered a first-line treatment for perinatal anxiety disorders and CBT programs targeting IU have revealed promising findings in non-perinatal populations.It is therefore imperative to investigate whether a treatment program specifically designed to target IU during pregnancy can prevent postpartum anxiety.
- Conditions
- Postpartum Anxiety
- Being tested
- Cognitive Behavioural Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyOther
Cognitive Behavioural Therapy targeting Intolerance of Uncertainty
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy | Experimental | Not described Receives: Other: Cognitive Behavioural Therapy |
| Treatment as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with principal anxiety disorder (as per DSM-5)
Postpartum anxiety prevention will be defined as whether participants meet provisional DSM-5 diagnostic criteria for an anxiety disorder at the post-treatment assessments.
Measured: 6-12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Oct 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postpartum AnxietyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheryl Green, St. Joseph's Healthcare Hamilton
- Investigators
- Sheryl M Green, PhD, CPsych, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691140
- Sponsor's protocol ID
- 13902
- Status last verified
- Apr 2023
- First submitted
- 10 Jan 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dennis CL, Falah-Hassani K, Shiri R. Prevalence of antenatal and postnatal anxiety: systematic review and meta-analysis. Br J Psychiatry. 2017 May;210(5):315-323. doi: 10.1192/bjp.bp.116.187179. Epub 2017 Mar 16.
PubMed 28302701Furtado M, Frey BN, Green SM. Validation of the intolerance of uncertainty scale as a screening tool for perinatal anxiety. BMC Pregnancy Childbirth. 2021 Dec 14;21(1):829. doi: 10.1186/s12884-021-04296-1.
PubMed 34903196Smith MV, Shao L, Howell H, Wang H, Poschman K, Yonkers KA. Success of mental health referral among pregnant and postpartum women with psychiatric distress. Gen Hosp Psychiatry. 2009 Mar-Apr;31(2):155-62. doi: 10.1016/j.genhosppsych.2008.10.002. Epub 2008 Dec 3.
PubMed 19269536Furtado M, Van Lieshout RJ, Van Ameringen M, Green SM, Frey BN. Biological and psychosocial predictors of anxiety worsening in the postpartum period: A longitudinal study. J Affect Disord. 2019 May 1;250:218-225. doi: 10.1016/j.jad.2019.02.064. Epub 2019 Mar 1.
PubMed 30870771Dugas MJ, Ladouceur R. Treatment of GAD. Targeting intolerance of uncertainty in two types of worry. Behav Modif. 2000 Oct;24(5):635-57. doi: 10.1177/0145445500245002.
PubMed 11036732van der Heiden C, Muris P, van der Molen HT. Randomized controlled trial on the effectiveness of metacognitive therapy and intolerance-of-uncertainty therapy for generalized anxiety disorder. Behav Res Ther. 2012 Feb;50(2):100-9. doi: 10.1016/j.brat.2011.12.005. Epub 2011 Dec 21.
PubMed 22222208Furtado M, Frey BN, Inness BE, McCabe RE, Green SM. Targeting Intolerance of Uncertainty During Pregnancy: A Randomized Controlled Trial to Prevent Postpartum Anxiety Disorders. J Clin Psychiatry. 2025 Nov 5;87(1):25m15979. doi: 10.4088/JCP.25m15979.
PubMed 41190888Furtado M, Frey BN, Inness BE, McCabe RE, Green SM. Cognitive behavioural therapy for intolerance of uncertainty: A study protocol for the prevention of postpartum anxiety. J Reprod Infant Psychol. 2025 Apr 29:1-20. doi: 10.1080/02646838.2025.2495928. Online ahead of print.
PubMed 40297898
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postpartum Anxiety in High-Risk Women: A Proof-of-Concept Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05691140
- Acronym / sponsor ID
- 13902
- Conditions
- Postpartum Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 19 Jan 2023 (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.
The primary aim of this study is to evaluate whether a CBT group designed to target IU (CBT-IU) in pregnant women with heightened levels of IU, prevents postpartum anxiety. The investigators hypothesize that women with clinically significant IU during pregnancy will exhibit both significant reductions in IU, as well as a decrease in anxiety symptoms postpartum, compared to a treatment as usual control group. The secondary aim of this study is to evaluate whether CBT-IU significantly improves and/or prevents depression symptoms, worry symptom severity, and difficulties with emotion regulation. The investigators hypothesize that CBT-IU will lead to significant improvements in symptom severity compared to the treatment as usual control group.
Detailed description
Anxiety disorders are a serious mental health concern, affecting as many as 15-24% of women during the perinatal period. Despite the high prevalence of anxiety during the perinatal period and its associated impact, fewer than 15% of women receive treatment often due to difficulties in timely and accurate symptom detection. Our group conducted a longitudinal study that investigated the psychosocial and biological risk factors of postpartum anxiety worsening in a sample of high-risk pregnant women with pre-existing anxiety and depressive disorders. In this study, intolerance of uncertainty (IU) was identified as the strongest predictor. IU is a cardinal trait of anxiety and has been implicated in predicting treatment response in non-perinatal populations. However, despite the relevance of IU in anxiety disorders, our study was the first to assess IU in the perinatal population. As improving symptom detection through identification of significant risk factors, such as IU, can aid in the development of preventative and treatment measures, our group recently validated the Intolerance of Uncertainty Scale (IUS) in a perinatal population for the detection of anxiety disorders. In this study of 198 perinatal women, the IUS demonstrated excellent internal consistency and an optimal clinical cut-off score of 64 or greater was established, yielding a sensitivity of 89%. The IUS also demonstrated very good positive (79%) and negative (80%) predictive values. These findings suggest that the IUS represents a clinically useful screening tool to be used as an aid for the early and accurate detection of anxiety disorders during the perinatal period. Cognitive Behavioural Therapy (CBT) is considered a first-line treatment for perinatal anxiety disorders and CBT programs targeting IU have revealed promising findings in non-perinatal populations.It is therefore imperative to investigate whether a treatment program specifically designed to target IU during pregnancy can prevent postpartum anxiety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy | Experimental | Other: Cognitive Behavioural Therapy |
| Treatment as Usual | No intervention | – |
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 women (up to 30 weeks pregnant to allow for completion of the CBT-IU protocol before child delivery)
- 18 years or older
- Baseline score of ≥64 on the IUS (Furtado et al., 2021)
- No psychotropic medication or, if taking medication, no change in dose or type for a minimum of 6 weeks prior to baseline
- No concurrent psychological treatment
Key exclusion criteria (4 listed)
- A current diagnosed DSM-5 anxiety disorder, as assessed by the Mini International Neuropsychiatric Interview (version 7.0.2)
- Active suicidal ideation
- Current psychosis or substance use disorder
- For those enrolled on a stable dosage of a psychotropic medication, if a change in medication is required during the psychological therapy trial, the participant will continue with the therapy but will be excluded from the analysis.
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 |
|---|---|---|
| Cognitive Behavioural TherapyCognitive Behavioural Therapy targeting Intolerance of Uncertainty | Other | Cognitive Behavioural Therapy |
Primary outcome
Number of participants with principal anxiety disorder (as per DSM-5)
Time frame: 6-12 weeks postpartum
Postpartum anxiety prevention will be defined as whether participants meet provisional DSM-5 diagnostic criteria for an anxiety disorder at the post-treatment assessments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 28302701Dennis CL, Falah-Hassani K, Shiri R. Prevalence of antenatal and postnatal anxiety: systematic review and meta-analysis. Br J Psychiatry. 2017 May;210(5):315-323. doi: 10.1192/bjp.bp.116.187179. Epub 2017 Mar 16.
- Background: PubMed 34903196Furtado M, Frey BN, Green SM. Validation of the intolerance of uncertainty scale as a screening tool for perinatal anxiety. BMC Pregnancy Childbirth. 2021 Dec 14;21(1):829. doi: 10.1186/s12884-021-04296-1.
- Background: PubMed 19269536Smith MV, Shao L, Howell H, Wang H, Poschman K, Yonkers KA. Success of mental health referral among pregnant and postpartum women with psychiatric distress. Gen Hosp Psychiatry. 2009 Mar-Apr;31(2):155-62. doi: 10.1016/j.genhosppsych.2008.10.002. Epub 2008 Dec 3.
- Background: PubMed 30870771Furtado M, Van Lieshout RJ, Van Ameringen M, Green SM, Frey BN. Biological and psychosocial predictors of anxiety worsening in the postpartum period: A longitudinal study. J Affect Disord. 2019 May 1;250:218-225. doi: 10.1016/j.jad.2019.02.064. Epub 2019 Mar 1.
- Background: PubMed 11036732Dugas MJ, Ladouceur R. Treatment of GAD. Targeting intolerance of uncertainty in two types of worry. Behav Modif. 2000 Oct;24(5):635-57. doi: 10.1177/0145445500245002.
- Background: PubMed 22222208van der Heiden C, Muris P, van der Molen HT. Randomized controlled trial on the effectiveness of metacognitive therapy and intolerance-of-uncertainty therapy for generalized anxiety disorder. Behav Res Ther. 2012 Feb;50(2):100-9. doi: 10.1016/j.brat.2011.12.005. Epub 2011 Dec 21.
- Derived from this study: PubMed 41190888Furtado M, Frey BN, Inness BE, McCabe RE, Green SM. Targeting Intolerance of Uncertainty During Pregnancy: A Randomized Controlled Trial to Prevent Postpartum Anxiety Disorders. J Clin Psychiatry. 2025 Nov 5;87(1):25m15979. doi: 10.4088/JCP.25m15979.
- Derived from this study: PubMed 40297898Furtado M, Frey BN, Inness BE, McCabe RE, Green SM. Cognitive behavioural therapy for intolerance of uncertainty: A study protocol for the prevention of postpartum anxiety. J Reprod Infant Psychol. 2025 Apr 29:1-20. doi: 10.1080/02646838.2025.2495928. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Sheryl M Green, PhD, CPsych principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy in people with Postpartum Anxiety, run by St. Joseph's Healthcare Hamilton at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Furtado, MSc, PhD (candidate) (905-522-1155 ext. 36369, mfurtado@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with principal anxiety disorder (as per DSM-5) (time frame: 6-12 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05691140, which also lists 8 linked publications.
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 14 Apr 2023.