Postpartum DepressionNCT06597448
Public Health Nurse-Peer Co-Led Group Cognitive Behavioral Therapy for Postpartum Depression
A study testing Cognitive Behavioral Therapy for Postpartum Depression (PPD) in people with Postpartum Depression, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effectiveness of an online 9-week group Cognitive Behavioural Therapy (CBT; a type of talking therapy) intervention that is co-led by public health nurses (PHNs) and individuals who have previously recovered (i.e., lay peers) from postpartum depression (PPD) for treating… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Cognitive Behavioral Therapy for Postpartum Depression (PPD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2024to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Mothers or birthing parents, 18 years old, have an infant under 12 months of age at recruitment, fluent in written/spoken English, have a Edinburgh Postnatal Depression Scale (EPDS) score ≥10 and live in Ontario, Canada.
Who cannot join
- Bipolar, psychotic, or current substance use disorders and borderline personality disorder as assessed during screening when study coordinator administers the Mini International Neuropsychiatric Interview (MINI).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Public Health Nurse-Peer Co-Delivered Group Cognitive Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial
The purpose of this study is to determine the effectiveness of an online 9-week group Cognitive Behavioural Therapy (CBT; a type of talking therapy) intervention that is co-led by public health nurses (PHNs) and individuals who have previously recovered (i.e., lay peers) from postpartum depression (PPD) for treating PPD when delivered in addition to treatment as usual (TAU) compared to TAU alone. The study will also assess the impact of the intervention on common comorbidities (anxiety) and complications (parenting stress, mother-infant relationship, social support, and infant temperament) of PPD and whether it is cost-effective.
Read the detailed description
The primary objective of the Randomized Controlled Trial (RCT) is to determine if a 9-week group Cognitive Behavioral Therapy (CBT) intervention delivered online and co-led by public health nurses (PHNs) and peers added to treatment as usual (TAU) can improve postpartum depression (PPD) more than TAU alone. Peers are individuals who have previously recovered from PPD and received training to deliver the intervention. The secondary objective of the RCT is to determine if the intervention can effectively treat its common comorbidities (anxiety) and complications (parenting stress, social support, mother-infant relationship, and infant temperament) and whether the intervention is cost-effective. 170 mothers/birthing parents will take part in the study with 50% being randomly assigned to the intervention group. All participants complete online questionnaires at 3 time points: baseline (T1), 9 weeks later (T2-immediately post-intervention in the experimental group to assess effectiveness) and 6 months later (T3-intervention durability).
- Conditions
- Postpartum Depression
- Being tested
- Cognitive Behavioral Therapy for Postpartum Depression (PPD)
- Keywords
- Postpartum depression, PPD, Cognitive Behavioural Therapy, Public Health Nurse, Peer
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Postpartum Depression (PPD)Behavioural
Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). The intervention consists of 9- 2hr sessions, the first half involves teaching and practice of CBT skills (cognitive restructuring, thinking errors, problem solving etc) followed by one hour of unstructured discussion around topics relevant to participants with Postpartum Depression (PPD) (sleep, supports, transitions, etc). Each group will be delivered by one randomly selected PHN and one randomly selected peer using our intervention manual.
| Study group | Role | What they receive |
|---|---|---|
| Online CBT Group | Experimental | Participants randomized to the Intervention group will attend a 9-week online CBT group co-led by a Public Health Nurse and a Peer (individual who has recovered from PPD and received training to deliver the intervention) in addition to receiving usual care. Receives: Behavioral: Cognitive Behavioral Therapy for Postpartum Depression (PPD) |
| Treatment as Usual | No intervention | Participants randomized to the No Intervention group will continue to receive treatment as usual (standard postnatal care). A list of resources will be emailed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Depression
PPD is best conceptualized as a continuous construct with its impact operating across a continuum of severity. The primary outcome is change in PPD symptoms at 9 weeks (i.e., immediately post-treatment). This will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a gold standard measure of PPD symptoms used commonly in research and clinical settings. The EPDS has 10 items scored on a scale 0-3. Scores range from 0-30, with higher scores indicating more severe depression symptoms. The EPDS will be examined as a continuous outcome. Changes in score of 4 or more points is considered clinically meaningful improvement.
Measured: 9 weeks (post treatment/intervention)
Major Depressive Disorder
We will compare DSM-5-defined major depressive disorder (MDD) using the Mini International Neuropsychiatric Interview (MINI). This interview will be administered by telephone at T2-T3. Symptoms must be present every day or nearly every day for a period of at least 2 weeks and include at least one of: depressed mood most of the day, markedly diminished interest or pleasure in all or almost all activities. There must be a total of five symptoms including the previous two criteria and the following five criteria: significant unintentional weight change or appetite change; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue; feelings of worthlessness or inappropriate or excessive guilt; decreased ability to concentrate or make decisions; recurrent thoughts of death or suicidal ideation.
Measured: 9 weeks (post treatment/intervention)
Major Depressive Disorder
We will compare DSM-5-defined major depressive disorder (MDD) using the Mini International Neuropsychiatric Interview (MINI). This interview will be administered by telephone at T2-T3. Symptoms must be present every day or nearly every day for a period of at least 2 weeks and include at least one of: depressed mood most of the day, markedly diminished interest or pleasure in all or almost all activities. There must be a total of five symptoms including the previous two criteria and the following five criteria: significant unintentional weight change or appetite change; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue; feelings of worthlessness or inappropriate or excessive guilt; decreased ability to concentrate or make decisions; recurrent thoughts of death or suicidal ideation.
Measured: 6 months (durability of intervention effects)
Postpartum Depression
PPD is best conceptualized as a continuous construct with its impact operating across a continuum of severity. The primary outcome is change in PPD symptoms 6 months later (i.e., to assess durability of intervention effects). This will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a gold standard measure of PPD symptoms used commonly in research and clinical settings. The EPDS has 10 items scored on a scale 0-3. Scores range from 0-30, with higher scores indicating more severe depression symptoms. The EPDS will be examined as a continuous outcome. Changes in score of 4 or more points is considered clinically meaningful improvement.
Measured: 6 months (durability of intervention effects)
Secondary outcomes (18)
Parenting Stress
The PSI-SF (Parenting Stress Index-Short Form ) is a 36-item self-scoring measure of parenting stress. It has 3 subscales: Parental distress, parent-child dysfunctional interaction and difficult child. Items are scored on a 5-point Likert scale. Higher scores indicate higher parental stress.
Measured: 9 weeks (post treatment/intervention)
Parenting Stress
The PSI-SF (Parenting Stress Index-Short Form ) is a 36-item self-scoring measure of parenting stress. It has 3 subscales: Parental distress, parent-child dysfunctional interaction and difficult child. Items are scored on a 5-point Likert scale. Higher scores indicate higher parental stress.
Measured: 6 months (durability of intervention effects)
Healthcare Resource Utilization Questionnaire
Healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period based on the Canadian Community Health Survey and Service Use and Resources Form. Participants will be asked to provide information on health care resource use including diagnosis and procedures, medications, hospital stays, physician and ER visits and the use of all other services (including those related to mental health). The investigators will measure resources consumed from the perspective of public health care payer and corresponding unit costs will be calculated using provincial billing rates.
Measured: 9 weeks (post treatment/intervention)
Healthcare Resource Utilization Questionnaire
Healthcare resource utilization data will be collected using a questionnaire used in prior work and adapted for the postpartum period based on the Canadian Community Health Survey and Service Use and Resources Form. Participants will be asked to provide information on health care resource use including diagnosis and procedures, medications, hospital stays, physician and ER visits and the use of all other services (including those related to mental health). The investigators will measure resources consumed from the perspective of public health care payer and corresponding unit costs will be calculated using provincial billing rates.
Measured: 6 months (durability of intervention effects)
Other Psychiatric Disorders
The Mini International Neuropsychiatric Interview (MINI) will be administered at T2 and T3 to provide information on the presence or absence of the major Axis 1 psychiatric disorders in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM 5) at these time points. This will be administered by phone by a research assistant and will include the following modules: Major Depressive Episode; Major Depressive Disorder; Panic Disorder; Agoraphobia; Social Anxiety Disorder (Social Phobia); Obsessive-Compulsive Disorder; Posttraumatic Stress Disorder; Alcohol Use Disorder; Substance Use Disorder (Non-alcohol); Generalized Anxiety Disorder with extra screening questions for Psychosis.
Measured: 9 weeks (post treatment/intervention)
Other Psychiatric Disorders
The Mini International Neuropsychiatric Interview (MINI) will be administered at T2 and T3 to provide information on the presence or absence of the major Axis 1 psychiatric disorders in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM 5) at these time points. This will be administered by phone by a research assistant and will include the following modules: Major Depressive Episode; Major Depressive Disorder; Panic Disorder; Agoraphobia; Social Anxiety Disorder (Social Phobia); Obsessive-Compulsive Disorder; Posttraumatic Stress Disorder; Alcohol Use Disorder; Substance Use Disorder (Non-alcohol); Generalized Anxiety Disorder with extra screening questions for Psychosis.
Measured: 6 months (durability of intervention effects)
Postpartum Anxiety
The GAD-7 (General Anxiety Disorder-7) is a reliable and valid 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common PPD comorbidity. Total score for the seven items ranges from 0-21 with a higher score indicating more severe anxiety symptoms.
Measured: 9 weeks (post treatment/intervention)
Postpartum Anxiety
The GAD-7 (General Anxiety Disorder-7) is a reliable and valid 7-item self-report scale that assesses the symptoms of generalized anxiety disorder, the most common PPD comorbidity. Total score for the seven items ranges from 0-21 with a higher score indicating more severe anxiety symptoms.
Measured: 6 months (durability of intervention effects)
Social Support
The MSPSS (Multidimensional Scale of Perceived Social Support) is a 12-item self-report scale designed to measure perceived social support from three sources: family, friends and partner. Each item is rated 1-7 with 1 very strongly disagree and 7 very strongly agree. Higher scores could be considered as having higher levels of support.
Measured: 9 weeks (post treatment/intervention)
Social Support
The MSPSS (Multidimensional Scale of Perceived Social Support) is a 12-item self-report scale designed to measure perceived social support from three sources: family, friends and partner. Each item is rated 1-7 with 1 very strongly disagree and 7 very strongly agree. Higher scores could be considered as having higher levels of support.
Measured: 6 months (durability of intervention effects)
Infant Temperament
The Infant Behavior Questionnaire - Revised (Very Short Form) is a parent report measure of infant temperament. The IBQ-R (Very Short Form) consists of 37 items answered on a 7-point scale (1-7) and assess 3 factors: Positive Affectivity/Surgency with 13 items, Negative Emotionality with 12 items and Orienting/Regulatory Capacity with 12 items. Higher scores indicate greater alignment with the domain.
Measured: 6 months (durability of intervention effects)
Infant Temperament
The Infant Behavior Questionnaire - Revised (Very Short Form) is a parent report measure of infant temperament. The IBQ-R (Very Short Form) consists of 37 items answered on a 7-point scale (1-7) and assess 3 factors: Positive Affectivity/Surgency with 13 items, Negative Emotionality with 12 items and Orienting/Regulatory Capacity with 12 items. Higher scores indicate greater alignment with the domain.
Measured: 9 weeks (post treatment/intervention)
Mother-Infant Relationship
The PBQ (Postpartum Bonding Questionnaire) is a 25-item maternal report measure that assesses four aspects of maternal-infant relations: (1) bonding, (2) rejection and anger towards the infant, (3) infant-focused anxiety and (4) incipient abuse. Subscales 1-3 will be explored as a continuous outcome using subscale total score. Respondents respond to each statement based on a 6-point scale, with total scale scores ranging from 0-125, with a higher cumulative score indicating more severe bonding disturbances. Each item is scored on a scale of 0-5 with higher scores suggestive of more problems. Mother-infant bonding will be measured as a continuous and dichotomous outcome, using cut-off scores for each subscale indicting bonding disorders. Cutoff values of 12 for the bonding subscale, 17 for rejection and anger, and 10 for infant-focused anxiety have been proposed to define bonding disorders in each category.
Measured: 9 weeks (post treatment/intervention)
Mother-Infant Relationship
The PBQ (Postpartum Bonding Questionnaire) is a 25-item maternal report measure that assesses four aspects of maternal-infant relations: (1) bonding, (2) rejection and anger towards the infant, (3) infant-focused anxiety and (4) incipient abuse. Subscales 1-3 will be explored as a continuous outcome using subscale total score. Respondents respond to each statement based on a 6-point scale, with total scale scores ranging from 0-125, with a higher cumulative score indicating more severe bonding disturbances. Each item is scored on a scale of 0-5 with higher scores suggestive of more problems. Mother-infant bonding will be measured as a continuous and dichotomous outcome, using cut-off scores for each subscale indicting bonding disorders. Cutoff values of 12 for the bonding subscale, 17 for rejection and anger, and 10 for infant-focused anxiety have been proposed to define bonding disorders in each category.
Measured: 6 months (durability of intervention effects)
Postpartum Anxiety
Postpartum Anxiety as a maternal comorbidity is a secondary outcome measure and the DSM-5 defined generalized anxiety disorder (GAD) will be compared using the Mini International Neuropsychiatric Interview (MINI). The GAD module will be part of the full MINI administered during screening and then administered again at T2 and T3 by phone by a research assistant. Excessive worry/anxiety about several routine things must be present most days in the preceding 6 months, anxiety/worry must be difficult to control as well as significantly disrupt social, work or relationship functions or cause significant distress. In order to meet the criteria for a Generalized Anxiety Disorder (current) to be present, three or more of the following must also be present in previous 6 months in addition to the previous three criteria: feel restless, keyed up or on edge; muscle tension; difficulties concentrating; irritability; sleep difficulties.
Measured: 9 weeks (post treatment/intervention)
Postpartum Anxiety
Postpartum Anxiety as a maternal comorbidity is a secondary outcome measure and the DSM-5 defined generalized anxiety disorder (GAD) will be compared using the Mini International Neuropsychiatric Interview (MINI). The GAD module will be part of the full MINI administered during screening and then administered again at T2 and T3 by phone by a research assistant. Excessive worry/anxiety about several routine things must be present most days in the preceding 6 months, anxiety/worry must be difficult to control as well as significantly disrupt social, work or relationship functions or cause significant distress. In order to meet the criteria for a Generalized Anxiety Disorder (current) to be present, three or more of the following must also be present in previous 6 months in addition to the previous three criteria: feel restless, keyed up or on edge; muscle tension; difficulties concentrating; irritability; sleep difficulties.
Measured: 6 months (durability of intervention effects)
EQ-5D-5L
A utility-based health-related quality of life self-report instrument consisting of five questions (scale of 1-5) covering mobility, self-care, usual activities, pain/discomfort and depression/anxiety. Lower scores indicate less problems. Quality of Life will be calculated using the Canadian scoring algorithm by multiplying the health utility for the corresponding time period (ie. area under the curve approach)
Measured: 9-week (post treatment/intervention)
EQ-5D-5L
A utility-based health-related quality of life self-report instrument consisting of five questions (scale of 1-5) covering mobility, self-care, usual activities, pain/discomfort and depression/anxiety. Lower scores indicate less problems. Quality of Life will be calculated using the Canadian scoring algorithm by multiplying the health utility for the corresponding time period (ie. area under the curve approach)
Measured: 6-month (durability of intervention effects)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Sep 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (108)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who have met the eligibility requirements and signed the consent form are randomized and allocated in a 1:1 ratio to one of two groups: Intervention (those who participate in the 9-week CBT group along with treatment as usual) and Control (continue with treatment as usual alone). Control group participants receive a list of mental health resources. Both groups complete online questionnaires at 3 timepoints: enrollment (T1), 9 weeks later (T2-post intervention for those in the intervention group) and 6 months later (T3).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Niagara Region Public Health
- Responsible party
- Principal investigator, Ryan Van Lieshout, MD, PhD, McMaster University
- Investigators
- Ryan J Van Lieshout, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597448
- Sponsor's protocol ID
- PHN-Peer Co-Led CBT for PPD
- Status last verified
- Dec 2025
- First submitted
- 11 Sep 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be available to other researchers
Publications
Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.
PubMed 16260528Lanes A, Kuk JL, Tamim H. Prevalence and characteristics of postpartum depression symptomatology among Canadian women: a cross-sectional study. BMC Public Health. 2011 May 11;11:302. doi: 10.1186/1471-2458-11-302.
PubMed 21569372Zanardo V, Manghina V, Giliberti L, Vettore M, Severino L, Straface G. Psychological impact of COVID-19 quarantine measures in northeastern Italy on mothers in the immediate postpartum period. Int J Gynaecol Obstet. 2020 Aug;150(2):184-188. doi: 10.1002/ijgo.13249. Epub 2020 Jun 16.
PubMed 32474910Lakshmin P. Experts Fear Increase in Postpartum Mood and Anxiety Disorders. The New York Times [Internet]. 2020 https://wwwnytimes.com/2020/05/27/parenting/coronavirus-postpartum-depressionanxiety.html?smid=tw-share
Goodman SH, Rouse MH, Connell AM, Broth MR, Hall CM, Heyward D. Maternal depression and child psychopathology: a meta-analytic review. Clin Child Fam Psychol Rev. 2011 Mar;14(1):1-27. doi: 10.1007/s10567-010-0080-1.
PubMed 21052833Lovejoy MC, Graczyk PA, O'Hare E, Neuman G. Maternal depression and parenting behavior: a meta-analytic review. Clin Psychol Rev. 2000 Aug;20(5):561-92. doi: 10.1016/s0272-7358(98)00100-7.
PubMed 10860167Barry TJ, Murray L, Fearon RM, Moutsiana C, Cooper P, Goodyer IM, Herbert J, Halligan SL. Maternal postnatal depression predicts altered offspring biological stress reactivity in adulthood. Psychoneuroendocrinology. 2015 Feb;52:251-60. doi: 10.1016/j.psyneuen.2014.12.003. Epub 2014 Dec 9.
PubMed 25544737Murray L, Fearon P, Cooper P. Postnatal Depression, Mother-Infant Interactions, and Child Development. Identifying Perinatal Depression and Anxiety. John Wiley & Sons, Ltd; 2015:139-164. doi:10.1002/9781118509722.ch9
Burke L. The impact of maternal depression on familial relationships. Int Rev Psychiatry. 2003 Aug;15(3):243-55. doi: 10.1080/0954026031000136866.
PubMed 15276963Grace SL, Evindar A, Stewart DE. The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Womens Ment Health. 2003 Nov;6(4):263-74. doi: 10.1007/s00737-003-0024-6.
PubMed 14628179Halligan SL, Murray L, Martins C, Cooper PJ. Maternal depression and psychiatric outcomes in adolescent offspring: a 13-year longitudinal study. J Affect Disord. 2007 Jan;97(1-3):145-54. doi: 10.1016/j.jad.2006.06.010. Epub 2006 Jul 24.
PubMed 16863660O'Hara MW, McCabe JE. Postpartum depression: current status and future directions. Annu Rev Clin Psychol. 2013;9:379-407. doi: 10.1146/annurev-clinpsy-050212-185612. Epub 2013 Feb 1.
PubMed 23394227Bauer A, Knapp M, Adelaja B. Best practice for perinatal mental health care: the economic case. PSSRU Rep. 2016.
Krzeczkowski JE, Schmidt LA, Van Lieshout RJ. Changes in infant emotion regulation following maternal cognitive behavioral therapy for postpartum depression. Depress Anxiety. 2021 Apr;38(4):412-421. doi: 10.1002/da.23130. Epub 2021 Jan 19.
PubMed 33464686Letourneau NL, Dennis CL, Cosic N, Linder J. The effect of perinatal depression treatment for mothers on parenting and child development: A systematic review. Depress Anxiety. 2017 Oct;34(10):928-966. doi: 10.1002/da.22687. Epub 2017 Sep 29.
PubMed 28962068
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Public Health Nurse-Peer Co-Delivered Group Cognitive Behavioral Therapy for Postpartum Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06597448
- Acronym / sponsor ID
- PHN-Peer Co-Led CBT for PPD
- Conditions
- Postpartum Depression
- Keywords
- Postpartum depression, PPD, Cognitive Behavioural Therapy, Public Health Nurse, Peer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Niagara Region Public Health
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 19 Sep 2024 (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 purpose of this study is to determine the effectiveness of an online 9-week group Cognitive Behavioural Therapy (CBT; a type of talking therapy) intervention that is co-led by public health nurses (PHNs) and individuals who have previously recovered (i.e., lay peers) from postpartum depression (PPD) for treating PPD when delivered in addition to treatment as usual (TAU) compared to TAU alone. The study will also assess the impact of the intervention on common comorbidities (anxiety) and complications (parenting stress, mother-infant relationship, social support, and infant temperament) of PPD and whether it is cost-effective.
Detailed description
The primary objective of the Randomized Controlled Trial (RCT) is to determine if a 9-week group Cognitive Behavioral Therapy (CBT) intervention delivered online and co-led by public health nurses (PHNs) and peers added to treatment as usual (TAU) can improve postpartum depression (PPD) more than TAU alone. Peers are individuals who have previously recovered from PPD and received training to deliver the intervention. The secondary objective of the RCT is to determine if the intervention can effectively treat its common comorbidities (anxiety) and complications (parenting stress, social support, mother-infant relationship, and infant temperament) and whether the intervention is cost-effective. 170 mothers/birthing parents will take part in the study with 50% being randomly assigned to the intervention group. All participants complete online questionnaires at 3 time points: baseline (T1), 9 weeks later (T2-immediately post-intervention in the experimental group to assess effectiveness) and 6 months later (T3-intervention durability).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants who have met the eligibility requirements and signed the consent form are randomized and allocated in a 1:1 ratio to one of two groups: Intervention (those who participate in the 9-week CBT group along with treatment as usual) and Control (continue with treatment as usual alone). Control group participants receive a list of mental health resources. Both groups complete online questionnaires at 3 timepoints: enrollment (T1), 9 weeks later (T2-post intervention for those in the intervention group) and 6 months later (T3).
| Arm | Type | Receives |
|---|---|---|
| Online CBT Group | Experimental | Behavioral: Cognitive Behavioral Therapy for Postpartum Depression (PPD)Participants randomized to the Intervention group will attend a 9-week online CBT group co-led by a Public Health Nurse and a Peer (individual who has recovered from PPD and received training to deliver the intervention) in addition to receiving usual care. |
| Treatment as Usual | No intervention | –Participants randomized to the No Intervention group will continue to receive treatment as usual (standard postnatal care). A list of resources will be emailed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers or birthing parents, 18 years old, have an infant under 12 months of age at recruitment, fluent in written/spoken English, have a Edinburgh Postnatal Depression Scale (EPDS) score ≥10 and live in Ontario, Canada.
Key exclusion criteria (1 listed)
- Bipolar, psychotic, or current substance use disorders and borderline personality disorder as assessed during screening when study coordinator administers the Mini International Neuropsychiatric Interview (MINI).
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 Behavioral Therapy for Postpartum Depression (PPD)Cognitive Behavioral Therapy (CBT) is a type of psychotherapy (talk therapy). The intervention consists of 9- 2hr sessions, the first half involves teaching and practice of CBT skills (cognitive restructuring, thinking errors, problem solving etc) followed by one hour of unstructured discussion around topics relevant to participants with Postpartum Depression (PPD) (sleep, supports, transitions, etc). Each group will be delivered by one randomly selected PHN and one randomly selected peer using our intervention manual. | Behavioural | Online CBT Group |
Primary outcome
Postpartum Depression
Time frame: 9 weeks (post treatment/intervention)
PPD is best conceptualized as a continuous construct with its impact operating across a continuum of severity. The primary outcome is change in PPD symptoms at 9 weeks (i.e., immediately post-treatment). This will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a gold standard measure of PPD symptoms used commonly in research and clinical settings. The EPDS has 10 items scored on a scale 0-3. Scores range from 0-30, with higher scores indicating more severe depression symptoms. The EPDS will be examined as a continuous outcome. Changes in score of 4 or more points is considered clinically meaningful improvement.
Major Depressive Disorder
Time frame: 9 weeks (post treatment/intervention)
We will compare DSM-5-defined major depressive disorder (MDD) using the Mini International Neuropsychiatric Interview (MINI). This interview will be administered by telephone at T2-T3. Symptoms must be present every day or nearly every day for a period of at least 2 weeks and include at least one of: depressed mood most of the day, markedly diminished interest or pleasure in all or almost all activities. There must be a total of five symptoms including the previous two criteria and the following five criteria: significant unintentional weight change or appetite change; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue; feelings of worthlessness or inappropriate or excessive guilt; decreased ability to concentrate or make decisions; recurrent thoughts of death or suicidal ideation.
Major Depressive Disorder
Time frame: 6 months (durability of intervention effects)
We will compare DSM-5-defined major depressive disorder (MDD) using the Mini International Neuropsychiatric Interview (MINI). This interview will be administered by telephone at T2-T3. Symptoms must be present every day or nearly every day for a period of at least 2 weeks and include at least one of: depressed mood most of the day, markedly diminished interest or pleasure in all or almost all activities. There must be a total of five symptoms including the previous two criteria and the following five criteria: significant unintentional weight change or appetite change; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue; feelings of worthlessness or inappropriate or excessive guilt; decreased ability to concentrate or make decisions; recurrent thoughts of death or suicidal ideation.
Postpartum Depression
Time frame: 6 months (durability of intervention effects)
PPD is best conceptualized as a continuous construct with its impact operating across a continuum of severity. The primary outcome is change in PPD symptoms 6 months later (i.e., to assess durability of intervention effects). This will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a gold standard measure of PPD symptoms used commonly in research and clinical settings. The EPDS has 10 items scored on a scale 0-3. Scores range from 0-30, with higher scores indicating more severe depression symptoms. The EPDS will be examined as a continuous outcome. Changes in score of 4 or more points is considered clinically meaningful improvement.
18 secondary outcomes
Parenting Stress
Time frame: 9 weeks (post treatment/intervention)
Parenting Stress
Time frame: 6 months (durability of intervention effects)
Healthcare Resource Utilization Questionnaire
Time frame: 9 weeks (post treatment/intervention)
Healthcare Resource Utilization Questionnaire
Time frame: 6 months (durability of intervention effects)
Other Psychiatric Disorders
Time frame: 9 weeks (post treatment/intervention)
Other Psychiatric Disorders
Time frame: 6 months (durability of intervention effects)
Postpartum Anxiety
Time frame: 9 weeks (post treatment/intervention)
Postpartum Anxiety
Time frame: 6 months (durability of intervention effects)
Social Support
Time frame: 9 weeks (post treatment/intervention)
Social Support
Time frame: 6 months (durability of intervention effects)
Infant Temperament
Time frame: 6 months (durability of intervention effects)
Infant Temperament
Time frame: 9 weeks (post treatment/intervention)
Mother-Infant Relationship
Time frame: 9 weeks (post treatment/intervention)
Mother-Infant Relationship
Time frame: 6 months (durability of intervention effects)
Postpartum Anxiety
Time frame: 9 weeks (post treatment/intervention)
Postpartum Anxiety
Time frame: 6 months (durability of intervention effects)
EQ-5D-5L
Time frame: 9-week (post treatment/intervention)
EQ-5D-5L
Time frame: 6-month (durability of intervention effects)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Background: PubMed 16260528Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1071-83. doi: 10.1097/01.AOG.0000183597.31630.db.
- Background: PubMed 21569372Lanes A, Kuk JL, Tamim H. Prevalence and characteristics of postpartum depression symptomatology among Canadian women: a cross-sectional study. BMC Public Health. 2011 May 11;11:302. doi: 10.1186/1471-2458-11-302.
- Background: PubMed 32474910Zanardo V, Manghina V, Giliberti L, Vettore M, Severino L, Straface G. Psychological impact of COVID-19 quarantine measures in northeastern Italy on mothers in the immediate postpartum period. Int J Gynaecol Obstet. 2020 Aug;150(2):184-188. doi: 10.1002/ijgo.13249. Epub 2020 Jun 16.
- BackgroundLakshmin P. Experts Fear Increase in Postpartum Mood and Anxiety Disorders. The New York Times [Internet]. 2020 https://wwwnytimes.com/2020/05/27/parenting/coronavirus-postpartum-depressionanxiety.html?smid=tw-share
- Background: PubMed 21052833Goodman SH, Rouse MH, Connell AM, Broth MR, Hall CM, Heyward D. Maternal depression and child psychopathology: a meta-analytic review. Clin Child Fam Psychol Rev. 2011 Mar;14(1):1-27. doi: 10.1007/s10567-010-0080-1.
- Background: PubMed 10860167Lovejoy MC, Graczyk PA, O'Hare E, Neuman G. Maternal depression and parenting behavior: a meta-analytic review. Clin Psychol Rev. 2000 Aug;20(5):561-92. doi: 10.1016/s0272-7358(98)00100-7.
- Background: PubMed 25544737Barry TJ, Murray L, Fearon RM, Moutsiana C, Cooper P, Goodyer IM, Herbert J, Halligan SL. Maternal postnatal depression predicts altered offspring biological stress reactivity in adulthood. Psychoneuroendocrinology. 2015 Feb;52:251-60. doi: 10.1016/j.psyneuen.2014.12.003. Epub 2014 Dec 9.
- BackgroundMurray L, Fearon P, Cooper P. Postnatal Depression, Mother-Infant Interactions, and Child Development. Identifying Perinatal Depression and Anxiety. John Wiley & Sons, Ltd; 2015:139-164. doi:10.1002/9781118509722.ch9
- Background: PubMed 15276963Burke L. The impact of maternal depression on familial relationships. Int Rev Psychiatry. 2003 Aug;15(3):243-55. doi: 10.1080/0954026031000136866.
- Background: PubMed 14628179Grace SL, Evindar A, Stewart DE. The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Womens Ment Health. 2003 Nov;6(4):263-74. doi: 10.1007/s00737-003-0024-6.
- Background: PubMed 16863660Halligan SL, Murray L, Martins C, Cooper PJ. Maternal depression and psychiatric outcomes in adolescent offspring: a 13-year longitudinal study. J Affect Disord. 2007 Jan;97(1-3):145-54. doi: 10.1016/j.jad.2006.06.010. Epub 2006 Jul 24.
- Background: PubMed 23394227O'Hara MW, McCabe JE. Postpartum depression: current status and future directions. Annu Rev Clin Psychol. 2013;9:379-407. doi: 10.1146/annurev-clinpsy-050212-185612. Epub 2013 Feb 1.
- Individual participant dataSharing planned: No. No individual participant data will be available to other researchers
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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.
Ryan J Van Lieshout, MD, PhD principal investigator
McMaster University
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 Behavioral Therapy for Postpartum Depression (PPD) in people with Postpartum Depression, run by McMaster University 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Postpartum Depression (time frame: 9 weeks (post treatment/intervention)). The study lists 4 primary outcomes in all. 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 NCT06597448, which also lists 108 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 9 Dec 2025.