To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk
Primary Purpose
Depression, Postpartum
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telephone support
Sponsored by
About this trial
This is an interventional prevention trial for Depression, Postpartum
Eligibility Criteria
Inclusion Criteria:
- Pregnant women (12-25 weeks' gestation)
- subclinical and clinical levels of depression (Edinburgh Postnatal Depression Scale (EPDS) scores 8-16)
- ability to read and understand French.
Exclusion Criteria:
- EPDS score in the clinical range (≥ 17) or no symptoms (EPDS < 8)
- Positive screening of psychotic symptoms using the Psychosis Screening Questionnaire (PSQ)
- self-reported substance abuse problems.
Sites / Locations
- St. Justine hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Access to an online cognitive behavioural intervention without telephone support
Cognitive-Behavioral Therapy (CBT) and interpersonal counseling with telephone support.
Arm Description
The control group will receive a fully automated version of the virtual intervention without telephone support
The experimental group will receive an online cognitive behavioural intervention with weekly telephone support
Outcomes
Primary Outcome Measures
Change from baseline at 3 month postpartum depressive symptoms: The Edinburgh Perinatal/Postnatal Depression Scale (EPDS)
The Edinburgh Perinatal/Postnatal Depression Scale (EPDS) assesses a score between 0 and 30. A score less than 8 means depression is unlikely. A score from 9 to 11 means depression is possible. A score from 12 to 13 means high possibility of depression. A score of 14 and higher means probable depression.
Secondary Outcome Measures
Depressive symptoms: The Edinburgh Postnatal Depression Scale (EPDS)
The Edinburgh Perinatal/Postnatal Depression Scale (EPDS) assesses a score between 0 and 30. A score less than 8 means depression is unlikely. A score from 9 to 11 means depression is possible. A score from 12 to 13 means high possibility of depression. A score of 14 and higher means probable depression.
Change from baseline in Generalized Anxiety Disorder questionnaire (GAD-7) score
Brief questionnaire about problems felt during the last 2 weeks, derived from the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptom criteria for GAD for a total score ranging from 0-21. Minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21) severity ranges have been identified, with a clinical cutoff score of 8 indicating probable diagnosis of GAD
Anxiety related to pregnancy: Pregnancy-specific anxiety scale (PRAQ-R2)
The 10-item Pregnancy-specific anxiety scale revisited-2 (PRAQ-R2) by Van den Bergh to assess and identify pregnancy-specific anxiety in nulliparous women. Scores on each item are ranged from 1 (definitely not true) to 5 (definitely true). The items are divided into three subscales. The 1st subscale - Fear of giving birth, consists of three items. The 2nd subscale - Worries about bearing a physically or mentally handicapped child, consists of 4 items. The 3rd subscale -Concern about own appearance, consists of 3 items.
Stress: Perceived Stress Scale (PSS)
The Perceived Stress Scale is a 14-items questionnaire to measure the degree to which respondents find their lives unpredictable, uncontrollable and overloading. Individual scores on the PSS can range from 0 to 40, with higher scores indicating higher perceived stress.
Well-being: WHO-5 (World Health Organization) index
The 5-item WHO-5 well-being index is used to assess subjective psychological well-being.
Self-efficacy: General Self-Efficacy scale (GSE)
The 10-items General Self-Efficacy scale was created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events.The minimum score is ten points and the maximum score is forty points for this scale.
Self-compassion: Self-Compassion Scale (SCS)
We used the corresponding items from the short SCS in the 26-item French questionnaire, to use a 10-item French questionnaire. For each item (e.g.; I'm kind to myself when I'm experiencing suffering), respondents are asked to indicate how often they behave in the stated manner. Each statement is rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always).
Sleep: Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI), a 19-items self-report questionnaire measuring sleep quality over a one-month interval.
Social Adjustment: Social Adjustment Scale - Self-report (SAS-SR)
The Screener version of the Social Adjustment Scale (SAS-SR) is a self-reported 14-item questionnaire derived from the Social Adjustment Scale interview. The questions measure expressive and instrumental performance over the past 2 weeks in six roles areas: work (paid or unpaid), social and leisure activities, relationships with extended family, role as marital partner, role as parent, and role within the family unit. Each area covers four expressive and instrumental categories: performance at expected tasks; the amount of friction with people; finer aspects of interpersonal relations; and feelings and satisfactions. Questions are rated on a five-point scale from which role area means and an overall mean can be obtained, with higher scores meaning greater impairment. The investigators used only the work subscale for this study
Marital satisfaction: Short Form of the Dyadic Adjustment Scale (DAS-7)
The 7-item Dyadic Adjustment Scale (DAS-7) is a shortened version of the original 32-item scale was created to assess multidimensional subjective satisfaction of marriage or similar dyads (93). In the shortened version, six items are rated on a six-point Likert-type scales (from "always agree" to "always disagree" or "all the time" to "never") and the seventh is rated on a seven-point scale (from "extremely unhappy" to "perfectly happy"). A 16-item version of the scale was translated in French and validated. We extracted the 7 items corresponding to DAS-7 from the 16-item French questionnaire.
Co-parenting: Co-parenting Relationship Scale (CRS)
The Co-parenting Relationship Scale multi-domain measure of the co-parenting relationship in dual parent families. The self-reported questionnaire contains 35 items and 7 subscales: Co-parenting Agreement, Co-parenting Closeness, Exposure, Conflict, Co-parenting Support, Co-parenting Undermining, Endorse Partner Parenting, and Division of Labor. Answers have a 7-point response scale ranging from "not true of us" to "very true of us"
Social support: Social Provisions
The initial 10-items Social Provisions Scale (SPS) was developed based on Weiss's model of social provisions. The model focus on five social need that can be fulfilled through relationships: guidance, reliable alliance, reassurance of worth, attachment and social integration. Each of the 5 subscales are represented by 2 positively worded statements and rated on a 4-point Likert scale from "1=strongly disagree" to "4=strongly agree"
Parenting practices: Parenting Cognitions and Behaviors Scale
The Parenting Cognitions and Behaviors Scale assesses parents' cognitions and behavioral tendencies that reflect the quality of their parental involvement with the infant. The scale has 32 items, measured on a Likert scale with scores ranging from 0 ("Not at all") to 10 ("Exactly"). The instrument has 6 dimensions: sense of parental efficacy, perceived impact of parenting, tendency to coerce, tendency to overprotect, parental affection, and parent's perception of the child's general qualities.
Change from 3 months post-partum at 6 month post partum child social, emotional and cognitive development: Ages and stages questionnaire 3rd edition (ASQ-3)
The Ages and Stages Questionnaire is a parent-reported scale designed to screen for developmental delays in children. The scale comprises 21 age-specific questionnaires, covering 1 through 66 months of age, each with six items in each of five developmental domains: communication, problem-solving, personal-social, gross motor, and fine motor skills. Answers to each item are "yes," "sometimes," or "not yet", corresponding to scores of 10,5 and 0.
Child's temperament: Difficult Temperament Scale
The 7 items of the difficult temperament scale are taken from the Infant Characteristics Questionnaire (ICQ) of Bates, Freeland and Lounsbury, which is designed to measure the degree of difficulty a child presents to his or her parents. Parents are asked to indicate on a scale of 1 (easy) to 7 (difficult) how they perceive their baby's behavior when compared with that of an "average" or "typical" baby.
Personality disorders symptoms: Personality Inventory for DSM-5 Brief Form (PID-5 BF)
The brief form of the Personality Inventory for DSM-5 is a 25-item self-report questionnaire that measures the severity of the DSM-5-proposed personality pathology constructs of negative affectivity, detachment, antagonism, disinhibition, and psychoticism.
Gender roles: Bem Sex Role Inventory (BSRI)
The BEM Sex Role Inventory (BSRI) is a 30-items self-reported scale designed to evaluate gender. The items in the masculine subscale measure socially desirable masculine characteristics, with the central characteristic being "cognitive focus on getting the job done". The items in the feminine subscale are intended to measure socially desirable feminine characteristics, with the central characteristic being "affective concern for the welfare of others
Full Information
NCT ID
NCT05110456
First Posted
October 13, 2021
Last Updated
April 11, 2023
Sponsor
St. Justine's Hospital
Collaborators
Canadian Medical Association, Hewitt Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05110456
Brief Title
To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk
Official Title
Starting Before Birth to Prevent Maternal Mental Health Problems: "Parents and Babies" Program (Programme "Toi, Moi, Bébé")
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital
Collaborators
Canadian Medical Association, Hewitt Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Women's perinatal mental health problems can create a cascade of short- and long-term negative influences for the mother, child, and the family as a whole. To prevent these impacts, preventive online and telephone interventions exist, but need to be tested and improved to develop this type of support to women in Quebec. The Parents & Babies program, which is a distance learning course, followed during pregnancy and accompanied by telephone follow-up, aims to improve the mental health of future parents.The investigators seek to evaluate the effect of the intervention of the Parents & Babies program offered with telephone support compared to the course offered without telephone follow-up.
Detailed Description
The Parents & Babies intervention to be evaluated is an adaptation of the existing, evidence-based Mothers & Babies program which has shown efficacy in four clinical trials for the prevention of postpartum depression through in-person (group or individual) counseling
The Parents & Babies program was adapted to be virtual and include: 1) specific modules for the mother-partner dyad; 2) third-wave cognitive behavioral therapy (CBT) strategies targeting well-being, relaxation, mindfulness, self-compassion, and gratitude; 3) confinement and social distancing related material. Participants follow the program online or with a paper workbook and are called weekly by a member of the intervention team.
Participants will fill out three questionnaires (online or by telephone) at 12-25 weeks' gestation, 3 months' postpartum and 6-months postpartum to assess baseline values and trial outcomes, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
510 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Access to an online cognitive behavioural intervention without telephone support
Arm Type
No Intervention
Arm Description
The control group will receive a fully automated version of the virtual intervention without telephone support
Arm Title
Cognitive-Behavioral Therapy (CBT) and interpersonal counseling with telephone support.
Arm Type
Experimental
Arm Description
The experimental group will receive an online cognitive behavioural intervention with weekly telephone support
Intervention Type
Behavioral
Intervention Name(s)
Telephone support
Intervention Description
Participants will receive 10 telephone counseling calls by trained coaches: 9 during pregnancy (one call/week) and 1 at 6 weeks postpartum. We have included individual telephone calls by a trained coaches aimed to :
encourage the use of online material;
identify strategies for overcoming obstacles;
help apply content to real-life settings; and
underscore the participants' success in using effective coping strategies
Primary Outcome Measure Information:
Title
Change from baseline at 3 month postpartum depressive symptoms: The Edinburgh Perinatal/Postnatal Depression Scale (EPDS)
Description
The Edinburgh Perinatal/Postnatal Depression Scale (EPDS) assesses a score between 0 and 30. A score less than 8 means depression is unlikely. A score from 9 to 11 means depression is possible. A score from 12 to 13 means high possibility of depression. A score of 14 and higher means probable depression.
Time Frame
baseline (between gestational weeks 12-25) , 3 months postpartum
Secondary Outcome Measure Information:
Title
Depressive symptoms: The Edinburgh Postnatal Depression Scale (EPDS)
Description
The Edinburgh Perinatal/Postnatal Depression Scale (EPDS) assesses a score between 0 and 30. A score less than 8 means depression is unlikely. A score from 9 to 11 means depression is possible. A score from 12 to 13 means high possibility of depression. A score of 14 and higher means probable depression.
Time Frame
6 months postpartum
Title
Change from baseline in Generalized Anxiety Disorder questionnaire (GAD-7) score
Description
Brief questionnaire about problems felt during the last 2 weeks, derived from the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptom criteria for GAD for a total score ranging from 0-21. Minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21) severity ranges have been identified, with a clinical cutoff score of 8 indicating probable diagnosis of GAD
Time Frame
baseline (between gestational weeks 12-25) , 3 and 6 months postpartum
Title
Anxiety related to pregnancy: Pregnancy-specific anxiety scale (PRAQ-R2)
Description
The 10-item Pregnancy-specific anxiety scale revisited-2 (PRAQ-R2) by Van den Bergh to assess and identify pregnancy-specific anxiety in nulliparous women. Scores on each item are ranged from 1 (definitely not true) to 5 (definitely true). The items are divided into three subscales. The 1st subscale - Fear of giving birth, consists of three items. The 2nd subscale - Worries about bearing a physically or mentally handicapped child, consists of 4 items. The 3rd subscale -Concern about own appearance, consists of 3 items.
Time Frame
baseline (between gestational weeks 12-25)
Title
Stress: Perceived Stress Scale (PSS)
Description
The Perceived Stress Scale is a 14-items questionnaire to measure the degree to which respondents find their lives unpredictable, uncontrollable and overloading. Individual scores on the PSS can range from 0 to 40, with higher scores indicating higher perceived stress.
Time Frame
6 months postpartum
Title
Well-being: WHO-5 (World Health Organization) index
Description
The 5-item WHO-5 well-being index is used to assess subjective psychological well-being.
Time Frame
3 months postpartum
Title
Self-efficacy: General Self-Efficacy scale (GSE)
Description
The 10-items General Self-Efficacy scale was created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events.The minimum score is ten points and the maximum score is forty points for this scale.
Time Frame
3 months postpartum
Title
Self-compassion: Self-Compassion Scale (SCS)
Description
We used the corresponding items from the short SCS in the 26-item French questionnaire, to use a 10-item French questionnaire. For each item (e.g.; I'm kind to myself when I'm experiencing suffering), respondents are asked to indicate how often they behave in the stated manner. Each statement is rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always).
Time Frame
3 months postpartum
Title
Sleep: Pittsburgh Sleep Quality Index (PSQI)
Description
The Pittsburgh Sleep Quality Index (PSQI), a 19-items self-report questionnaire measuring sleep quality over a one-month interval.
Time Frame
3 months postpartum
Title
Social Adjustment: Social Adjustment Scale - Self-report (SAS-SR)
Description
The Screener version of the Social Adjustment Scale (SAS-SR) is a self-reported 14-item questionnaire derived from the Social Adjustment Scale interview. The questions measure expressive and instrumental performance over the past 2 weeks in six roles areas: work (paid or unpaid), social and leisure activities, relationships with extended family, role as marital partner, role as parent, and role within the family unit. Each area covers four expressive and instrumental categories: performance at expected tasks; the amount of friction with people; finer aspects of interpersonal relations; and feelings and satisfactions. Questions are rated on a five-point scale from which role area means and an overall mean can be obtained, with higher scores meaning greater impairment. The investigators used only the work subscale for this study
Time Frame
3 months postpartum
Title
Marital satisfaction: Short Form of the Dyadic Adjustment Scale (DAS-7)
Description
The 7-item Dyadic Adjustment Scale (DAS-7) is a shortened version of the original 32-item scale was created to assess multidimensional subjective satisfaction of marriage or similar dyads (93). In the shortened version, six items are rated on a six-point Likert-type scales (from "always agree" to "always disagree" or "all the time" to "never") and the seventh is rated on a seven-point scale (from "extremely unhappy" to "perfectly happy"). A 16-item version of the scale was translated in French and validated. We extracted the 7 items corresponding to DAS-7 from the 16-item French questionnaire.
Time Frame
3 months postpartum
Title
Co-parenting: Co-parenting Relationship Scale (CRS)
Description
The Co-parenting Relationship Scale multi-domain measure of the co-parenting relationship in dual parent families. The self-reported questionnaire contains 35 items and 7 subscales: Co-parenting Agreement, Co-parenting Closeness, Exposure, Conflict, Co-parenting Support, Co-parenting Undermining, Endorse Partner Parenting, and Division of Labor. Answers have a 7-point response scale ranging from "not true of us" to "very true of us"
Time Frame
3 months postpartum
Title
Social support: Social Provisions
Description
The initial 10-items Social Provisions Scale (SPS) was developed based on Weiss's model of social provisions. The model focus on five social need that can be fulfilled through relationships: guidance, reliable alliance, reassurance of worth, attachment and social integration. Each of the 5 subscales are represented by 2 positively worded statements and rated on a 4-point Likert scale from "1=strongly disagree" to "4=strongly agree"
Time Frame
6 months postpartum
Title
Parenting practices: Parenting Cognitions and Behaviors Scale
Description
The Parenting Cognitions and Behaviors Scale assesses parents' cognitions and behavioral tendencies that reflect the quality of their parental involvement with the infant. The scale has 32 items, measured on a Likert scale with scores ranging from 0 ("Not at all") to 10 ("Exactly"). The instrument has 6 dimensions: sense of parental efficacy, perceived impact of parenting, tendency to coerce, tendency to overprotect, parental affection, and parent's perception of the child's general qualities.
Time Frame
6 months postpartum
Title
Change from 3 months post-partum at 6 month post partum child social, emotional and cognitive development: Ages and stages questionnaire 3rd edition (ASQ-3)
Description
The Ages and Stages Questionnaire is a parent-reported scale designed to screen for developmental delays in children. The scale comprises 21 age-specific questionnaires, covering 1 through 66 months of age, each with six items in each of five developmental domains: communication, problem-solving, personal-social, gross motor, and fine motor skills. Answers to each item are "yes," "sometimes," or "not yet", corresponding to scores of 10,5 and 0.
Time Frame
3 and 6 months postpartum
Title
Child's temperament: Difficult Temperament Scale
Description
The 7 items of the difficult temperament scale are taken from the Infant Characteristics Questionnaire (ICQ) of Bates, Freeland and Lounsbury, which is designed to measure the degree of difficulty a child presents to his or her parents. Parents are asked to indicate on a scale of 1 (easy) to 7 (difficult) how they perceive their baby's behavior when compared with that of an "average" or "typical" baby.
Time Frame
6 months postpartum
Title
Personality disorders symptoms: Personality Inventory for DSM-5 Brief Form (PID-5 BF)
Description
The brief form of the Personality Inventory for DSM-5 is a 25-item self-report questionnaire that measures the severity of the DSM-5-proposed personality pathology constructs of negative affectivity, detachment, antagonism, disinhibition, and psychoticism.
Time Frame
baseline (between gestational weeks 12-25)
Title
Gender roles: Bem Sex Role Inventory (BSRI)
Description
The BEM Sex Role Inventory (BSRI) is a 30-items self-reported scale designed to evaluate gender. The items in the masculine subscale measure socially desirable masculine characteristics, with the central characteristic being "cognitive focus on getting the job done". The items in the feminine subscale are intended to measure socially desirable feminine characteristics, with the central characteristic being "affective concern for the welfare of others
Time Frame
6 months postpartum
Other Pre-specified Outcome Measures:
Title
Health Service Utilization and Cost of Care Questionnaire
Description
We reduced the questionnaire to 24 questions and translated it in French.
Time Frame
6 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women (12-25 weeks' gestation)
subclinical and clinical levels of depression (Edinburgh Postnatal Depression Scale (EPDS) scores 8-16)
ability to read and understand French.
Exclusion Criteria:
EPDS score in the clinical range (≥ 17) or no symptoms (EPDS < 8)
Positive screening of psychotic symptoms using the Psychosis Screening Questionnaire (PSQ)
self-reported substance abuse problems.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie Carpentier, Master
Phone
4385060910
Email
melanie.carpentier.hsj@ssss.gouv.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvana Côté
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Justine hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mélanie Carpentier, Master
Phone
4385060910
Email
melanie.carpentier.hsj@ssss.gouv.qc.ca
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Effectiveness of a Virtual and Telephone Intervention for the Prevention of Postpartum Depression in Women at Risk
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