Postpartum DepressionNCT04073043
Telephone Coaching Intervention for Postpartum Depression and Anxiety
A study testing Telephone Coaching in people with Postpartum Depression and Anxiety, run by McGill University at 1 site in Canada.
Trial summary
Mental health problems affect up to 20% of women at some point during the perinatal period (i.e., from pregnancy to one year postpartum. Perinatal mental health (PMH) problems have been associated with many negative obstetric outcomes, such as higher elective caesarean section, premature delivery, pre-eclampsia, lower… 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, Anxiety
- What is being tested?
- Telephone Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 12 Aug 2019to 26 Apr 2021
- 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
- Age 18+ (at birth)
- Ability to speak English or French
- Livebirth
- Access to the internet and email
- Score on either EPDS 10 - 19 or GAD-7 of 10+. Women with a GAD-7 score of 15+ will be referred to the mental health nurse and will be included in the study.
- Baby at home
Who cannot join
- Women currently undergoing psychological treatment and /or having a history of bipolar disorder or psychosis will be excluded
- Severe symptoms (Score of 20 or more on the EPDS, will be excluded Any anti-depressant and/or psychological treatment will be managed by the participant's own physician and not by the research team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Trial of a Telephone Coaching Intervention for Postpartum Depression and Anxiety
Mental health problems affect up to 20% of women at some point during the perinatal period (i.e., from pregnancy to one year postpartum. Perinatal mental health (PMH) problems have been associated with many negative obstetric outcomes, such as higher elective caesarean section, premature delivery, pre-eclampsia, lower fertility rates, and longer postpartum hospital stay.
This research study is a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and potential benefits of a low cost sustainable web-based intervention (WBI) with telephone coaching for women with mild to moderate symptomatology of postpartum depression and anxiety.
Read more
The intervention contains modules that will help postpartum mothers:
- Learning new information to better understand their condition. This can help mothers feel that they are not alone, and that their experience is not abnormal. It gives a better understanding that can help them feel more confident in their communications with health care professionals and can make it easier to share their experience with family and friends.
- Learning and practicing new skills. This can help mothers feel confident that they can engage in the behaviours that have been shown to be beneficial for mood and to improve stress. This can include learning to plan activities like physical exercise, practice proper sleep hygiene or learning to use a new way of thinking about problems to help you find solutions.
This trial represents a first step to implement a sustainable intervention for PMH problems in order to better serve women's PMH needs and preferences for support. This will help inform the current gap in low cost web-based interventions for PMH.Specific deliverables (in both French and English) include: a manual detailing coaching procedures; reports for decision makers and short summaries for stakeholder groups
Read the detailed description
Among women who present with symptoms of depression or anxiety within 5 - 12 weeks of giving birth, the following research questions will be considered:
- Feasibility and Acceptability of the two intervention components - WBI and coaching:
- Among women in the coached and non-coached groups: i) What are participant perceptions of the usability of the WBI with regard to the layout, navigation and functionality at 3 months following randomization? ii) What are the rates of satisfaction with the intervention at 6 months? b) Among women in the coached group: i) What are rates of completion of the planned telephone contacts? ii) What are participant perceptions of the acceptability of the coaching at 6 months? iii) What are coach perceptions of acceptability of coaching intervention?
- Effectiveness: The EPDS is the primary outcome measure for depression and the GAD-7 is the primary outcome measure for anxiety i) Primary outcomes: What is the effect of coaching on the severity of depression and/or anxiety symptoms at the 3 and 6 month follow-up? ii). Secondary outcomes: What is the effect of coaching at 3 and 6 months on maternal functioning, parental stress and at 6 months on use of mental health services, and barriers to use of these services?
Hypothesis: The investigators expect a decrease in scores in the EPDS and GAD-7 in the group with coaching when compared to the group without coaching at 6 months.
The investigators will conduct a pilot single -blind randomized control trial with lay telephone coaching with two groups of women, one assigned to the WBI with coaching and the other to the self-guided WBI. This RCT would consist of the following steps:
- Recruiting a sample of women immediately post-birth(24 hrs) at SMHC and obtaining consent to contact them again within 5 - 12 weeks postpartum
- 5-12 weeks postpartum: Screen women for eligibility for RCT;
- Request informed consent to RCT
- Baseline measures (T0);
- Follow up at 3 months (T1) and
- Follow-up at 6 months (T2). Women who deliver elsewhere in the CIUSSS can be referred to the study at 5-12 weeks postpartum. These women then follow steps 2-6
The participants will be asked to answer online questionnaires at each time point as mentioned above and use web-based resources for information and support after giving birth. The intervention group will receive telephone support from coaches to help answer questions and navigate the website material.
- Conditions
- Postpartum Depression, Anxiety
- Being tested
- Telephone Coaching
- Keywords
- Support, Self-management, Resources
- Medical subject headings
- Depression, Postpartum, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CoachingBehavioural
Access to Telephone Coaching for a period of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will have access to the web-based intervention along with telephone coaching. Participants in the intervention will receive 7 coach calls over a period of 12 weeks. Receives: Behavioral: Telephone Coaching |
| Control Group | No intervention | The control group will have access only to the web-based intervention without telephone support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale (EPDS)
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure, with a four point response scale, and is designed to screen participants for depressive symptoms in the last seven days. The EPDS includes one question (Item 10) about thoughts of self-harm. Sum scores for the 10 items are used to generate a total score. This measure has optimal sensitivity and specificity using a cut-off score of 12. For the purposes of this study, a cut off score of 10+ is used to identify participants with potentially clinically significant depressive symptoms . Women who score 20 or over on the EPDS will be excluded and is considered to be in the range of severe symptoms. A score of 10-19 will be included in the study and is considered to be mild to moderate symptoms. An increase in these scores in either category would be consdiered as an increase in symptoms of depression
Measured: Screening, 3 months & 6 months
Generalized Anxiety Disorder-7 (GAD-7)
The seven-item, self-report Generalized Anxiety Disorder (GAD-7) questionnaire, designed to screen for and measure the level of anxiety symptoms during the last seven days. An identified cut point of 10 is used for this study. Women who have a GAD-7 of greater than 15 will be considered as showing symptoms of anxiety in the severe range. a score of 10 - 15 will be considered mild to moderate symptoms of anxiety.
Measured: Screening,3 months & 6 months
Secondary outcomes (8)
Questions on usability & acceptability
All participants will complete a survey at 3 months after randomization to assess usability (layout, navigation, functionality) and acceptability (overall usefulness, usefulness of specific topics, utility of the site for improving mood and engaging in healthy behaviours, credibility and program length/duration). System usage data will complement users' self-reports and include frequency and duration of user log in, number of modules viewed. Given that a mean adherence rate of about 50% (defined as number of modules completed) has been observed in e-mental health interventions showing significant changes in outcomes, this cut-off has been selected as an acceptable usage metric.
Measured: 3 months
Barkin Index of Maternal Functioning (BIMF)
The Barkin Index of Maternal Functioning (BIMF) is designed to measure maternal functioning in new mothers. It is known for its comprehensibility, patient-centered assessment style, and psychometric profile. The 20 item BIMF is based on the experiences of women experiencing new motherhood and has a possible range of 0 to 120 with a total score of 120 indicating optimal maternal functioning.
Measured: Baseline, 3 months & 6 months
Parental Stress Questionnaire (PARSS)
The Parental Stress Questionnaire (PARSS) is an 18 item questionnaire designed to measure the positive aspects of parenting as well as the negative stressful aspects. The self-report five point scale helps parents rate how they feel about the relationship with their child by agreeing or disagreeing on various themes of parenting. The tool is used to assess the change in level of stress and would inform the level of support or services need to improve parenting capacity. The 8 positive items are reverse scored so that possible scores on the scale can range between 18-90. Higher scores on the scale indicate greater stress.
Measured: Baseline, 3 months & 6 months
Client Satisfaction Questionnaire (CSQ-8)
Satisfaction with the intervention will be measured with an 8-item open-ended questions that will ask participants what they liked most about the intervention and what could be improved.
Measured: 6 months
Questionnaire on Use of services for mental health problems
This measure uses questions adapted from the Canadian Community Mental Health Questionnaire (CCMHS). These questions ask about visits to psychiatrists, psychologists, family doctors, nurse, social workers, self-help groups, and other community services for mental health problems since they entered the study. The questions will identify the percentage of women who have used these services since the time they entered the study.
Measured: Baseline & 6 months
Acceptability of Coaching Questionnaire
The intervention group will receive an additional questionnaire at 6 months on the usefulness (positive and negative aspects) of having support and guidance from the coach
Measured: 6 months
Coach logs and records
Adherence to the coaching will be tracked in coach logs that record attempted and completed, duration of contacts, topics covered, modules that were recommended and/or used, goals set, and problems that arose. Contacts will be tape-recorded for fidelity monitoring.
Measured: 6 months
Coach exit interview
At the end of the study, the coach will participate in a semi structured exit interview regarding their experiences, the challenges that arose in delivering this form of support, and how the intervention could be improved.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start12 Aug 2019
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is a secure psychoeducational e-health platform. Participants will be randomized into two groups - Intervention and Control and will be provided with access to self-guided learning modules such as emotional health, healthy living, mental fitness tools and parenting. The Intervention group will also be given telephone coaching by a trained lay coach who will guide participants through the materials, provide positive reinforcement and help to answer questions. The coach will schedule 7 contacts over the 12 week intervention period with an average of 10 - 15 minutes for each call. A suggested script with specific objectives is provided as well as training based on the drafted coach manual. Coach supervision meetings will take place where difficulties/questions will be reviewed including coach logs, recorded contacts periodically and feedback to the coach. The control group will be provided with the intervention materials but will not receive telephone support.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane McCusker, MD DrPH, McGill University
- Investigators
- Hannah Schwartz, MDCM, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073043
- Sponsor's protocol ID
- SMHC-18-25
- Status last verified
- Apr 2022
- First submitted
- 17 Apr 2019
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial of a Telephone Coaching Intervention for Postpartum Depression and Anxiety
- ClinicalTrials.gov ID
- NCT04073043
- Acronym / sponsor ID
- SMHC-18-25
- Conditions
- Postpartum Depression, Anxiety
- Keywords
- Support, Self-management, Resources
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 28 Aug 2019 (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.
Mental health problems affect up to 20% of women at some point during the perinatal period (i.e., from pregnancy to one year postpartum. Perinatal mental health (PMH) problems have been associated with many negative obstetric outcomes, such as higher elective caesarean section, premature delivery, pre-eclampsia, lower fertility rates, and longer postpartum hospital stay.
This research study is a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and potential benefits of a low cost sustainable web-based intervention (WBI) with telephone coaching for women with mild to moderate symptomatology of postpartum depression and anxiety.
The intervention contains modules that will help postpartum mothers:
- Learning new information to better understand their condition. This can help mothers feel that they are not alone, and that their experience is not abnormal. It gives a better understanding that can help them feel more confident in their communications with health care professionals and can make it easier to share their experience with family and friends.
- Learning and practicing new skills. This can help mothers feel confident that they can engage in the behaviours that have been shown to be beneficial for mood and to improve stress. This can include learning to plan activities like physical exercise, practice proper sleep hygiene or learning to use a new way of thinking about problems to help you find solutions.
This trial represents a first step to implement a sustainable intervention for PMH problems in order to better serve women's PMH needs and preferences for support. This will help inform the current gap in low cost web-based interventions for PMH.Specific deliverables (in both French and English) include: a manual detailing coaching procedures; reports for decision makers and short summaries for stakeholder groups
Detailed description
Among women who present with symptoms of depression or anxiety within 5 - 12 weeks of giving birth, the following research questions will be considered:
- Feasibility and Acceptability of the two intervention components - WBI and coaching:
- Among women in the coached and non-coached groups: i) What are participant perceptions of the usability of the WBI with regard to the layout, navigation and functionality at 3 months following randomization? ii) What are the rates of satisfaction with the intervention at 6 months? b) Among women in the coached group: i) What are rates of completion of the planned telephone contacts? ii) What are participant perceptions of the acceptability of the coaching at 6 months? iii) What are coach perceptions of acceptability of coaching intervention?
- Effectiveness: The EPDS is the primary outcome measure for depression and the GAD-7 is the primary outcome measure for anxiety i) Primary outcomes: What is the effect of coaching on the severity of depression and/or anxiety symptoms at the 3 and 6 month follow-up? ii). Secondary outcomes: What is the effect of coaching at 3 and 6 months on maternal functioning, parental stress and at 6 months on use of mental health services, and barriers to use of these services?
Hypothesis: The investigators expect a decrease in scores in the EPDS and GAD-7 in the group with coaching when compared to the group without coaching at 6 months.
The investigators will conduct a pilot single -blind randomized control trial with lay telephone coaching with two groups of women, one assigned to the WBI with coaching and the other to the self-guided WBI. This RCT would consist of the following steps:
- Recruiting a sample of women immediately post-birth(24 hrs) at SMHC and obtaining consent to contact them again within 5 - 12 weeks postpartum
- 5-12 weeks postpartum: Screen women for eligibility for RCT;
- Request informed consent to RCT
- Baseline measures (T0);
- Follow up at 3 months (T1) and
- Follow-up at 6 months (T2). Women who deliver elsewhere in the CIUSSS can be referred to the study at 5-12 weeks postpartum. These women then follow steps 2-6
The participants will be asked to answer online questionnaires at each time point as mentioned above and use web-based resources for information and support after giving birth. The intervention group will receive telephone support from coaches to help answer questions and navigate the website material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The intervention is a secure psychoeducational e-health platform. Participants will be randomized into two groups - Intervention and Control and will be provided with access to self-guided learning modules such as emotional health, healthy living, mental fitness tools and parenting. The Intervention group will also be given telephone coaching by a trained lay coach who will guide participants through the materials, provide positive reinforcement and help to answer questions. The coach will schedule 7 contacts over the 12 week intervention period with an average of 10 - 15 minutes for each call. A suggested script with specific objectives is provided as well as training based on the drafted coach manual. Coach supervision meetings will take place where difficulties/questions will be reviewed including coach logs, recorded contacts periodically and feedback to the coach. The control group will be provided with the intervention materials but will not receive telephone support.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Telephone CoachingThe intervention group will have access to the web-based intervention along with telephone coaching. Participants in the intervention will receive 7 coach calls over a period of 12 weeks. |
| Control Group | No intervention | –The control group will have access only to the web-based intervention without telephone support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18+ (at birth)
- Ability to speak English or French
- Livebirth
- Access to the internet and email
- Score on either EPDS 10 - 19 or GAD-7 of 10+. Women with a GAD-7 score of 15+ will be referred to the mental health nurse and will be included in the study.
Key exclusion criteria (2 listed)
- Women currently undergoing psychological treatment and /or having a history of bipolar disorder or psychosis will be excluded
- Severe symptoms (Score of 20 or more on the EPDS, will be excluded Any anti-depressant and/or psychological treatment will be managed by the participant's own physician and not by the research team.
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 |
|---|---|---|
| Telephone CoachingAccess to Telephone Coaching for a period of 12 weeks | Behavioural | Intervention Group |
Primary outcome
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Screening, 3 months & 6 months
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report measure, with a four point response scale, and is designed to screen participants for depressive symptoms in the last seven days. The EPDS includes one question (Item 10) about thoughts of self-harm. Sum scores for the 10 items are used to generate a total score. This measure has optimal sensitivity and specificity using a cut-off score of 12. For the purposes of this study, a cut off score of 10+ is used to identify participants with potentially clinically significant depressive symptoms . Women who score 20 or over on the EPDS will be excluded and is considered to be in the range of severe symptoms. A score of 10-19 will be included in the study and is considered to be mild to moderate symptoms. An increase in these scores in either category would be consdiered as an increase in symptoms of depression
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Screening,3 months & 6 months
The seven-item, self-report Generalized Anxiety Disorder (GAD-7) questionnaire, designed to screen for and measure the level of anxiety symptoms during the last seven days. An identified cut point of 10 is used for this study. Women who have a GAD-7 of greater than 15 will be considered as showing symptoms of anxiety in the severe range. a score of 10 - 15 will be considered mild to moderate symptoms of anxiety.
8 secondary outcomes
Questions on usability & acceptability
Time frame: 3 months
Barkin Index of Maternal Functioning (BIMF)
Time frame: Baseline, 3 months & 6 months
Parental Stress Questionnaire (PARSS)
Time frame: Baseline, 3 months & 6 months
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 6 months
Questionnaire on Use of services for mental health problems
Time frame: Baseline & 6 months
Acceptability of Coaching Questionnaire
Time frame: 6 months
Coach logs and records
Time frame: 6 months
Coach exit interview
Time frame: 6 months
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 6 Apr 2022.
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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.
Hannah Schwartz, MDCM principal investigator
McGill 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 Telephone Coaching in people with Postpartum Depression and Anxiety, run by McGill 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 6 inclusion and 2 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 6 Apr 2022. 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?
Edinburgh Postnatal Depression Scale (EPDS) (time frame: Screening, 3 months & 6 months). The study lists 2 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 6 Apr 2022.