Perinatal AnxietyPhase 3NCT05510752
Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety
A Phase 3 study testing Cognitive Behavioural Group Therapy and Psychoeducation in people with Perinatal Anxiety, run by St. Joseph's Healthcare Hamilton.
Trial summary
Anxiety during pregnancy and the postpartum (perinatal) period is very common and is associated with adverse consequences for mothers and their infants. Currently, medication is the most commonly prescribed treatment for perinatal anxiety and the lack of nonmedication-based interventions for perinatal anxiety is a… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Perinatal Anxiety
- What is being tested?
- Cognitive Behavioural Group Therapy and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Sep 2026
- Phase
- Phase 3
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18 and older that are pregnant or between 0-12 months postpartum;
- Principal diagnosis of an anxiety disorder as per the Mini International Neuropsychiatric Interview for DSM-5 (version 7.0.2) with or without comorbid depression;
- No concurrent psychological treatment;
- Not taking psychoactive medication or a) medications are stable in dose and type for at least 8 weeks prior to the study (as per Canadian psychiatric guidelines; and b) medications remain stable throughout the study;
- Fluent in English, minimal grade 8 reading level.
Who cannot join
- Severe depression/suicidality requiring acute intervention;
- Women with psychotic or current substance use disorders,
- medication changes in dose or type or less than 5/6 sessions complete (will continue with treatment but be excluded from the study).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety: A Randomized Controlled Trial
Anxiety during pregnancy and the postpartum (perinatal) period is very common and is associated with adverse consequences for mothers and their infants. Currently, medication is the most commonly prescribed treatment for perinatal anxiety and the lack of nonmedication-based interventions for perinatal anxiety is a barrier to receiving effective treatment for many women. As such, the present single-blind, randomized controlled trial seeks to evaluate whether group-based cognitive behavioural therapy, the gold-standard psychological treatment for anxiety disorders in the general population, effectively treats perinatal anxiety symptoms when compared to a psychoeducation group, which is currently the most commonly prescribed non-medication-based treatment for perinatal distress.
- Conditions
- Perinatal Anxiety
- Being tested
- Cognitive Behavioural Group Therapy, Psychoeducation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Group TherapyBehavioural
CBGT is a 6-week group that meets weekly for 2-hours per week, where participants learn cognitive and behavioural techniques to enhance coping skills for their everyday anxieties.
PsychoeducationBehavioural
Psychoeducation is the most common non-pharmacological treatment for perinatal distress, where participants learn about healthy infant milestones and how to implement self-care in their daily lives, which in turn reduces distress during the perinatal period.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation Group | Active comparator | Psychoeducation is the most commonly offered non-pharmacological treatment for perinatal distress, with the assumption that an understanding of perinatal distress, self-care and infant milestones will improve mental health outcomes. Psychoeducation has been shown to be effective in reducing the severity of perinatal anxiety and depression. Receives: Behavioral: Psychoeducation |
| Cognitive Behavioural Group Therapy | Experimental | Cognitive Behavioural Group Therapy (CBGT) is a well-established psychological treatment for anxiety and other mental health disorders. CBGT treatment for perinatal anxiety has shown significant reductions in anxiety (primary outcome), worry and depression from pre- to post-treatment when compared to a waitlist control condition. However, to be considered well-established, a treatment must be at least as effective as other active interventions. As such, the present study will compare CBGT to what is most commonly offered to perinatal women with a principal anxiety disorder (i.e., psychoeducation). Receives: Behavioral: Cognitive Behavioural Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
The STICSA is a 21-item self-report scale that assesses cognitive and somatic components of anxiety. The STICSA is comprised of a state scale that measures individuals' current anxiety symptoms, and a trait scale that assesses one's proneness to anxiety, more generally. In the present study, only the trait scale of the STICSA will be used. Items are scored on a 4-point scale ranging from 1 ('not at all') to 4 ('very much so'). The STICSA has demonstrated excellent validity and reliability. A cut-off score of 43 or higher on the STICSA has been suggested for detecting a probable anxiety disorder. The STICSA has been validated for use in clinical samples of adults with anxiety disorders, although not explicitly in perinatal samples.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Secondary outcomes (14)
Penn State Worry Questionnaire (PSWQ)
The PSWQ is a 16-item self-report measure that assesses the tendency to worry. Items are scored on a 5-point scale ranging from 1 ('not typical at all') to 5 ('very typical'), with higher scores reflecting greater pathological worry. A cut-off score of 62 or higher has been suggested for determining a probable GAD diagnosis. The PSWQ has demonstrated excellent internal consistency and validity across various populations and has been validated for use in perinatal samples.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Generalized Anxiety Disorder 7 (GAD-7)
The GAD-7 is a 7-item self-report measure that assesses anxiety symptom severity over a previous two-week period. Items are measured on a 4-point scale ranging from 0 ('not at all') to 3 ('nearly every day'). A cut-off score of 10 or higher with sensitivity of 89% and specificity of 82% has been suggested for detecting a probable diagnosis of Generalized Anxiety Disorder. The GAD-7 has also been validated for use in perinatal samples.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Edinburgh Postnatal Depression Scale (EPDS)
The EPDS is a 10-item self-report measure that assesses symptoms of depression during the perinatal period. Items are scored on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater depressive symptomatology. The EPDS has demonstrated good sensitivity and specificity for a diagnosis of Major Depressive Disorder (MDD). Cut-off scores of 15 and 13 or higher have been suggested for detecting a probable diagnosis of MDD during pregnancy and the postpartum period, respectively.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Worry Behaviors Inventory Perinatal Revised (WBI-P)
The WBI-PR is adapted from the Worry Behaviours Inventory, which assesses the frequency of problematic behaviours associated with generalized anxiety disorder. The WBI-PR is a 10-item self-report measure that is designed to measure problematic GAD behaviours during the perinatal period. Items are measured on a 5-point Likert scale, ranging from 0 to 4 and includes two subscales: Avoidance and Safety Behaviours. In its initial validation, the WBI-PR demonstrated acceptable internal consistency and convergent and discriminant validity.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Intolerance of Uncertainty Scale (IUS)
The IUS is a 27-item self-report questionnaire assessing one's beliefs and reactions to uncertainty. Items are scored on a 5-point scale ranging from 1 ('not at all characteristic of me') to 5 ('entirely characteristic of me'), with higher scores reflecting greater intolerance of uncertainty. The IUS has demonstrated excellent internal consistency and test-retest reliability in the general population, and excellent convergent validity with measures of worry and GAD in perinatal populations. A cut-off score of 64 of greater with sensitivity of 89% and specificity of 65% has been determined for detection of an anxiety disorder within the perinatal period.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Perceived Stress Scale (PSS).
The PSS is the most widely used psychological instrument for measuring the perception of stress. The PSS is a 10-item self-report measure designed to assess the degree to which situations in one's life are appraised as stressful. Items are scored on a 5-point scale ranging from 0 ('never) to 4 ('fairly often') with higher scores reflecting greater perceived stress. The PSS has demonstrated good psychometric properties.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Difficulties in Emotion Regulation Scale (DERS)
The DERS is a 36-item self-report scale designed to assess difficulties with emotion regulation. The DERS contains six subscales that measure: non-acceptance goals, impulse, awareness, strategies, and clarity. Items are rated on a 5-point Likert scale, ranging from 1 (almost never, 0-10%) to 5 (almost always, 91-100%), with higher scores reflecting greater difficulties regulating emotions. The DERS has demonstrated good internal consistency (α=0.86) and test-retest reliability (0.74).
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Insomnia Severity Index (ISI).
The ISI is a 7-item self-report questionnaire that assesses the nature, severity, and impact of insomnia. Items are scored on a 5-point Likert scale ranging from 0 ('no problem') to 4 ('very severe problem') with higher scores reflecting greater insomnia severity. Total scores between 0-7 indicate an absence of insomnia; scores between 8-14 suggest subthreshold insomnia; scores between 15-21 indicate moderate insomnia; and scores between 22-28 suggest severe insomnia. The ISI has demonstrated good psychometric properties.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Anxiety Sensitivity Index (ASI-3)
The ASI-3 is an 18-item self-report measures that assesses anxiety sensitivity related to physical, cognitive and social concerns. Items are scored on a 5-point scale ranging from 0 ('very little') to 4 ('very much'), with higher scores reflecting greater anxiety sensitivity. The ASI-3 has demonstrated good reliability and validity.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Abbreviated Dyadic Adjustment Scale (ADAS)
The ADAS is a 7-item self-report scale assessing relationship satisfaction and adjustment in couples. Six of the items are scored on a 6-point Likert Scale, with higher scores reflecting greater relationship satisfaction. Item seven provides a global 'overall happiness' rating and is scored on 7- point Likert Scale ranging from 0 (extremely unhappy) to 6 (perfect). The ADAS has demonstrated good internal consistency, validity, and responsivity to change.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Social Provisions Scale (SPS)
The SPS is a 24-item self-report scale that assesses perceived social support received within social relationships. Items are scored on a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating higher levels of perceived social support. The SPS has 6 subscales assessing dimensions of attachment, social integration, reassurance of worth, guidance, nurturance, and reliance.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Illness Intrusiveness Rating Scale (IIRS).
The IIRS is a 13-item self-report measure designed to assess the extent to which a particular problem causes impairment in different aspects of one's life including health, diet, work, recreation, finances, social and romantic relationships, sex life, self- and religious-expression, and community/civic involvement. Items are scores on a 7-point scale ranging from 1 ('not very much') to 7 ('very much'), with higher scores reflecting greater intrusiveness. The IIRS has shown good reliability and validity.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
World Health Organization Quality of Life Scale (WHOQoL-BREF).
The WHOQoL-BREF is a 26-item self-report measure that assesses quality of life across four domains, including physical health, psychological health, social relationships, and environment (WHOQoL group, 1998). Items are scored on a 5-point Likert scale ranging from 1 to 5, with higher scores indicating greater quality of life. The WHOQoLBREF has demonstrated good discriminant validity, content validity, internal consistency, and test-retest reliability.
Measured: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Client Satisfaction Questionnaire (CSQ)
The CSQ is an 8-item self-report scale designed to measure satisfaction with health services. Items are scored on a 4-point scale from 1 to 4, with higher scores indicating higher levels of satisfaction with services. This scale demonstrates good psychometric properties with high internal consistency (Cronbach's alpha ranging from 0.92 to 0.93). In terms of construct validity, tests of global improvement correlated with client satisfaction (r = 0.53).
Measured: One week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510752
- Sponsor's protocol ID
- CBT-Psychoed-RCT
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05510752
- Acronym / sponsor ID
- CBT-Psychoed-RCT
- Conditions
- Perinatal Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Aug 2022 (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 during pregnancy and the postpartum (perinatal) period is very common and is associated with adverse consequences for mothers and their infants. Currently, medication is the most commonly prescribed treatment for perinatal anxiety and the lack of nonmedication-based interventions for perinatal anxiety is a barrier to receiving effective treatment for many women. As such, the present single-blind, randomized controlled trial seeks to evaluate whether group-based cognitive behavioural therapy, the gold-standard psychological treatment for anxiety disorders in the general population, effectively treats perinatal anxiety symptoms when compared to a psychoeducation group, which is currently the most commonly prescribed non-medication-based treatment for perinatal distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation Group | Active comparator | Behavioral: PsychoeducationPsychoeducation is the most commonly offered non-pharmacological treatment for perinatal distress, with the assumption that an understanding of perinatal distress, self-care and infant milestones will improve mental health outcomes. Psychoeducation has been shown to be effective in reducing the severity of perinatal anxiety and depression. |
| Cognitive Behavioural Group Therapy | Experimental | Behavioral: Cognitive Behavioural Group TherapyCognitive Behavioural Group Therapy (CBGT) is a well-established psychological treatment for anxiety and other mental health disorders. CBGT treatment for perinatal anxiety has shown significant reductions in anxiety (primary outcome), worry and depression from pre- to post-treatment when compared to a waitlist control condition. However, to be considered well-established, a treatment must be at least as effective as other active interventions. As such, the present study will compare CBGT to what is most commonly offered to perinatal women with a principal anxiety disorder (i.e., psychoeducation). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women 18 and older that are pregnant or between 0-12 months postpartum;
- Principal diagnosis of an anxiety disorder as per the Mini International Neuropsychiatric Interview for DSM-5 (version 7.0.2) with or without comorbid depression;
- No concurrent psychological treatment;
- Not taking psychoactive medication or a) medications are stable in dose and type for at least 8 weeks prior to the study (as per Canadian psychiatric guidelines; and b) medications remain stable throughout the study;
- Fluent in English, minimal grade 8 reading level.
Key exclusion criteria (3 listed)
- Severe depression/suicidality requiring acute intervention;
- Women with psychotic or current substance use disorders,
- medication changes in dose or type or less than 5/6 sessions complete (will continue with treatment but be excluded from the study).
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 Group TherapyCBGT is a 6-week group that meets weekly for 2-hours per week, where participants learn cognitive and behavioural techniques to enhance coping skills for their everyday anxieties. | Behavioural | Cognitive Behavioural Group Therapy |
| PsychoeducationPsychoeducation is the most common non-pharmacological treatment for perinatal distress, where participants learn about healthy infant milestones and how to implement self-care in their daily lives, which in turn reduces distress during the perinatal period. | Behavioural | Psychoeducation Group |
Primary outcome
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
The STICSA is a 21-item self-report scale that assesses cognitive and somatic components of anxiety. The STICSA is comprised of a state scale that measures individuals' current anxiety symptoms, and a trait scale that assesses one's proneness to anxiety, more generally. In the present study, only the trait scale of the STICSA will be used. Items are scored on a 4-point scale ranging from 1 ('not at all') to 4 ('very much so'). The STICSA has demonstrated excellent validity and reliability. A cut-off score of 43 or higher on the STICSA has been suggested for detecting a probable anxiety disorder. The STICSA has been validated for use in clinical samples of adults with anxiety disorders, although not explicitly in perinatal samples.
14 secondary outcomes
Penn State Worry Questionnaire (PSWQ)
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Generalized Anxiety Disorder 7 (GAD-7)
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Worry Behaviors Inventory Perinatal Revised (WBI-P)
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Intolerance of Uncertainty Scale (IUS)
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Perceived Stress Scale (PSS).
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Insomnia Severity Index (ISI).
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Anxiety Sensitivity Index (ASI-3)
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Abbreviated Dyadic Adjustment Scale (ADAS)
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Social Provisions Scale (SPS)
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Illness Intrusiveness Rating Scale (IIRS).
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
World Health Organization Quality of Life Scale (WHOQoL-BREF).
Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Client Satisfaction Questionnaire (CSQ)
Time frame: One week post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Behavioural Group Therapy and Psychoeducation in people with Perinatal Anxiety, run by St. Joseph's Healthcare Hamilton.
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 5 inclusion and 3 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 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sheryl M Green, C.Psych (905-522-1155 ext. 33672, sgreen@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) (time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.). 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 22 Aug 2022.