Postpartum DepressionNCT05040581
1 Day Workshops for Preventing PPD: A Pilot Study
A study testing 1-Day CBT-Based Workshop for Preventing PPD in people with Postpartum Depression, run by McMaster University at 1 site in Canada.
Trial summary
The aim of this pilot study is to (1) develop a treatment manual for a 1-Day CBT-Based Workshop for preventing postpartum depression that is acceptable to women; (2) recruit 15 women into a pilot workshop and seek their feedback on content, delivery and assessment procedures; and (3) conduct a small pilot randomized… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- 1-Day CBT-Based Workshop for Preventing PPD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 31 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- >28 weeks pregnant
- do not meet diagnostic criteria for a current major depressive episode (determined using the Mini International Neuropsychiatric Interview (MINI))
- Presence of one or more of the following risk factors for PPD:
- Past history of major depressive disorder or generalized anxiety disorder (Mini International Neuropsychiatric Interview (MINI))
- Low SES (Canadian Household Low Income Cut-Off (LICOs) Before Tax)
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- Single marital status (Antenatal (Psychosocial) Risk Questionnaire (ANRQ))
- Major life stress in past 12 months (Antenatal (Psychosocial) Risk Questionnaire (ANRQ))
- Major life stress in past 12 months (Antenatal (Psychosocial) Risk Questionnaire (ANRQ))
- History of physical and/or sexual abuse (Antenatal (Psychosocial) Risk Questionnaire (ANRQ))
- Perceived low social support (Antenatal (Psychosocial) Risk Questionnaire (ANRQ))
Who cannot join
- Bipolar, psychotic and/or current substance use disorders (determined using the Mini International Neuropsychiatric Interview (MINI))
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online 1-Day Cognitive Behavioural Therapy-Based Workshops for Preventing Postpartum Depression: A Pilot Study
The aim of this pilot study is to (1) develop a treatment manual for a 1-Day CBT-Based Workshop for preventing postpartum depression that is acceptable to women; (2) recruit 15 women into a pilot workshop and seek their feedback on content, delivery and assessment procedures; and (3) conduct a small pilot randomized controlled trial (n=60) examining the impact of these workshops on rates of PPD when added to care as usual (CAU) more than CAU alone in addition to a 90-minute information session on PPD.
Read the detailed description
Postpartum depression affects up to 1 in 5 mothers, however just 15% receive evidence-based treatment. It is associated with negative consequences for women and their families with enormous costs to the healthcare system. Postpartum depression is an ideal candidate for prevention because it is common, the window of opportunity to intervene is clear (pregnancy), and its risk factors are well-established and easily identifiable. Furthermore, women are in frequent contact with the healthcare system during pregnancy and are more motivated to improve their health during this time than at any other time in their lives. Given high rates of PPD and its adverse effects on mothers and their families, and the relative lack of efficient, effective psychotherapeutic interventions for preventing PPD, safe, novel, and efficient preventive interventions are needed. Since large 1-day workshops appear to successfully treat depression, given the widespread interest and investment of public health units across Canada in maternal and child health, Online 1-Day CBT-Based Workshops for Preventing PPD should be developed and tested for their ability to prevent PPD in Canadian women.
Based on longstanding clinical work with women at high risk for PPD, the development of a successful 1-Day CBT-Based Treatment Workshop for PPD and its delivery in-person and online, and an extensive review of the PPD prevention literature, the investigators will develop the content for our prevention workshop as well as an accompanying script and intervention manual for participants (Objective 1). They will then advertise and assess the feasibility of recruiting 15 women into a pilot workshop and seek their feedback on its content, delivery and assessment procedures (Objective 2). Using these data, the workshop will be revised, and the investigators will conduct a small pilot randomized controlled trial (n=60) examining the impact of these workshops on rates of PPD when added to care as usual (CAU) more than CAU alone in addition to a 90-minute information session on PPD (Objective 3).
These objectives will enable us to develop and deliver this intervention, assess the feasibility of our recruitment strategy, determine recruitment and retention rates, assess study personnel needs, refine the study protocol and estimate effect sizes for group differences in support of a larger, full-scale trial aimed as assessing the effectiveness of these workshops at reducing the likelihood of developing PPD in women at risk.
The pilot study will be considered successful and proceed to a larger trial in the future if:
- The treatment manual for the workshop is acceptable to women
- 15 women are recruited into a pilot workshop within three months and have 70% complete their follow-up measures
- Recruit and randomize 60 women over six months into two separate workshop/info sessions (each consisting of 15 in the workshop and 15 into the control information session) and:
- 70% of eligible sign-ups enroll in the study
- 75% of participants assigned to experimental group complete intervention
- 70% of participants complete all follow-up measures
- Estimate a treatment effect and variance (measured using Mini International Neuropsychiatric Interview Major Depressive Disorder Module and the Edinburgh Postnatal Depression Scale)
- Conditions
- Postpartum Depression
- Being tested
- 1-Day CBT-Based Workshop for Preventing PPD
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Day CBT-Based Workshop for Preventing PPDBehavioural
The intervention is a 6-hour long CBT-based workshop. The intervention will be delivered in in modules and contain content on PPD etiology (with a focus on modifiable risk factors), the development of cognitive skills including cognitive restructuring, behavioural skills such as problem solving, sleep strategies, behavioural activation, assertiveness, and self-care, and the final module will involve goal setting and action planning.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group - 1 Day CBT | Experimental | The intervention is a 6-hour long CBT-based workshop. Cognitive behavioural therapy is a structured psychotherapy based on the cognitive theory of depression that posits that negative thoughts about the self, others and the future can lead to and perpetuate depressed mood states. CBT equips participants with skills that enable them to identify and modify distortions in their thinking that lead to depressed mood and maladaptive behavioural responses.
The intervention will be delivered in in modules and contain content on PPD etiology (with a focus on modifiable risk factors), the development of cognitive skills including cognitive restructuring, behavioural skills such as problem solving, sleep strategies, behavioural activation, assertiveness, and self-care, and the final module will involve goal setting and action planning. Receives: Behavioral: 1-Day CBT-Based Workshop for Preventing PPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of developed treatment manual
this outcome will be assessed using open-ended questions in an electronic survey to elicit participant feedback
Measured: 6 months
Feasibility of recruiting 15 mothers into a pilot workshop
counts will be used to determine the number of participants recruited into the pilot workshop
Measured: 6 months
Feasibility of recruiting 60 participants into pilot RCT in 6 months
counts will be used to determine the number of participants recruited into the pilot RCT
Measured: 6 months
Proportion of eligible participants who enroll in study
counts will be used to determine the proportion of eligible participants who enroll in the study
Measured: 6 months
Proportion of participants in experimental arm who complete intervention
counts will be used to determine the proportion of participants who complete the intervention
Measured: 6 months
Proportion of participants who complete all outcome measures
Counts will be used to determine the number of participants who complete the outcome measures
Measured: 6 months
Secondary outcomes (2)
Estimate of treatment effect and variance of primary outcome for later RCT - Major Depressive Disorder
Measured using Mini International Neuropsychiatric Interview Major Depressive Disorder Module to determine if participants meet diagnostic criteria for PPD
Measured: measured at 1, 2, and 3 months postpartum
Estimate of treatment effect and variance of primary outcome for later RCT - Depressive Symptoms
Measured using the Edinburgh Postnatal Depression Scale (EPDS) to assess level of depressive symptoms. The EPDS is a self-report measure that produces scores ranging from 0-30, with higher scores indicating higher levels of depressive symptoms. Scores of 13 or more suggest probable PPD.
Measured: measured at 1, 2, and 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Objective 2 will be addressed using a single-group pre-post design (n=15).
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Van Lieshout, MD, PhD, McMaster University
- Investigators
- Ryan Van Lieshout, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040581
- Sponsor's protocol ID
- 1DayPrev
- Status last verified
- Feb 2023
- First submitted
- 9 Jun 2021
- Last updated
- 2 Mar 2023
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online 1-Day Cognitive Behavioural Therapy-Based Workshops for Preventing Postpartum Depression: A Pilot Study
- ClinicalTrials.gov ID
- NCT05040581
- Acronym / sponsor ID
- 1DayPrev
- Conditions
- Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Sep 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.
The aim of this pilot study is to (1) develop a treatment manual for a 1-Day CBT-Based Workshop for preventing postpartum depression that is acceptable to women; (2) recruit 15 women into a pilot workshop and seek their feedback on content, delivery and assessment procedures; and (3) conduct a small pilot randomized controlled trial (n=60) examining the impact of these workshops on rates of PPD when added to care as usual (CAU) more than CAU alone in addition to a 90-minute information session on PPD.
Detailed description
Postpartum depression affects up to 1 in 5 mothers, however just 15% receive evidence-based treatment. It is associated with negative consequences for women and their families with enormous costs to the healthcare system. Postpartum depression is an ideal candidate for prevention because it is common, the window of opportunity to intervene is clear (pregnancy), and its risk factors are well-established and easily identifiable. Furthermore, women are in frequent contact with the healthcare system during pregnancy and are more motivated to improve their health during this time than at any other time in their lives. Given high rates of PPD and its adverse effects on mothers and their families, and the relative lack of efficient, effective psychotherapeutic interventions for preventing PPD, safe, novel, and efficient preventive interventions are needed. Since large 1-day workshops appear to successfully treat depression, given the widespread interest and investment of public health units across Canada in maternal and child health, Online 1-Day CBT-Based Workshops for Preventing PPD should be developed and tested for their ability to prevent PPD in Canadian women.
Based on longstanding clinical work with women at high risk for PPD, the development of a successful 1-Day CBT-Based Treatment Workshop for PPD and its delivery in-person and online, and an extensive review of the PPD prevention literature, the investigators will develop the content for our prevention workshop as well as an accompanying script and intervention manual for participants (Objective 1). They will then advertise and assess the feasibility of recruiting 15 women into a pilot workshop and seek their feedback on its content, delivery and assessment procedures (Objective 2). Using these data, the workshop will be revised, and the investigators will conduct a small pilot randomized controlled trial (n=60) examining the impact of these workshops on rates of PPD when added to care as usual (CAU) more than CAU alone in addition to a 90-minute information session on PPD (Objective 3).
These objectives will enable us to develop and deliver this intervention, assess the feasibility of our recruitment strategy, determine recruitment and retention rates, assess study personnel needs, refine the study protocol and estimate effect sizes for group differences in support of a larger, full-scale trial aimed as assessing the effectiveness of these workshops at reducing the likelihood of developing PPD in women at risk.
The pilot study will be considered successful and proceed to a larger trial in the future if:
- The treatment manual for the workshop is acceptable to women
- 15 women are recruited into a pilot workshop within three months and have 70% complete their follow-up measures
- Recruit and randomize 60 women over six months into two separate workshop/info sessions (each consisting of 15 in the workshop and 15 into the control information session) and:
- 70% of eligible sign-ups enroll in the study
- 75% of participants assigned to experimental group complete intervention
- 70% of participants complete all follow-up measures
- Estimate a treatment effect and variance (measured using Mini International Neuropsychiatric Interview Major Depressive Disorder Module and the Edinburgh Postnatal Depression Scale)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Objective 2 will be addressed using a single-group pre-post design (n=15).
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - 1 Day CBT | Experimental | Behavioral: 1-Day CBT-Based Workshop for Preventing PPDThe intervention is a 6-hour long CBT-based workshop. Cognitive behavioural therapy is a structured psychotherapy based on the cognitive theory of depression that posits that negative thoughts about the self, others and the future can lead to and perpetuate depressed mood states. CBT equips participants with skills that enable them to identify and modify distortions in their thinking that lead to depressed mood and maladaptive behavioural responses. The intervention will be delivered in in modules and contain content on PPD etiology (with a focus on modifiable risk factors), the development of cognitive skills including cognitive restructuring, behavioural skills such as problem solving, sleep strategies, behavioural activation, assertiveness, and self-care, and the final module will involve goal setting and action planning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years of age or older
- >28 weeks pregnant
- do not meet diagnostic criteria for a current major depressive episode (determined using the Mini International Neuropsychiatric Interview (MINI))
- Presence of one or more of the following risk factors for PPD:
- Past history of major depressive disorder or generalized anxiety disorder (Mini International Neuropsychiatric Interview (MINI))
Key exclusion criteria (1 listed)
- Bipolar, psychotic and/or current substance use disorders (determined using 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 |
|---|---|---|
| 1-Day CBT-Based Workshop for Preventing PPDThe intervention is a 6-hour long CBT-based workshop. The intervention will be delivered in in modules and contain content on PPD etiology (with a focus on modifiable risk factors), the development of cognitive skills including cognitive restructuring, behavioural skills such as problem solving, sleep strategies, behavioural activation, assertiveness, and self-care, and the final module will involve goal setting and action planning. | Behavioural | Experimental Group - 1 Day CBT |
Primary outcome
Acceptability of developed treatment manual
Time frame: 6 months
this outcome will be assessed using open-ended questions in an electronic survey to elicit participant feedback
Feasibility of recruiting 15 mothers into a pilot workshop
Time frame: 6 months
counts will be used to determine the number of participants recruited into the pilot workshop
Feasibility of recruiting 60 participants into pilot RCT in 6 months
Time frame: 6 months
counts will be used to determine the number of participants recruited into the pilot RCT
Proportion of eligible participants who enroll in study
Time frame: 6 months
counts will be used to determine the proportion of eligible participants who enroll in the study
Proportion of participants in experimental arm who complete intervention
Time frame: 6 months
counts will be used to determine the proportion of participants who complete the intervention
Proportion of participants who complete all outcome measures
Time frame: 6 months
Counts will be used to determine the number of participants who complete the outcome measures
2 secondary outcomes
Estimate of treatment effect and variance of primary outcome for later RCT - Major Depressive Disorder
Time frame: measured at 1, 2, and 3 months postpartum
Estimate of treatment effect and variance of primary outcome for later RCT - Depressive Symptoms
Time frame: measured at 1, 2, and 3 months postpartum
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 2 Mar 2023.
- 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.
Ryan 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 1-Day CBT-Based Workshop for Preventing 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 11 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: finished, as of the sponsor's last update on 2 Mar 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?
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?
Acceptability of developed treatment manual (time frame: 6 months). The study lists 6 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 2 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.