Background
Prenatal mental health problems
The cycle of under detection and under treatment of prenatal depression, anxiety, and stress
Integrated perinatal mental healthcare
Standardized psychosocial assessment
Cognitive behavioral therapy
Cost-effectiveness
Mechanisms of integrated psychosocial care
Maternal-child outcomes
The need for a trial
Research questions
Gap | objective | Research question | Testable hypotheses |
---|---|---|---|
1
| To compare the clinical effectiveness of integrated psychosocial assessment-care-referral versus usual prenatal care on prenatal depression, anxiety, and stress symptoms | What is the effect of integrated, online psychosocial care delivered in pregnancy to women with low or moderate psychosocial risk on the presence and severity of prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks post-randomization compared to usual prenatal care? | Presence of symptoms: Compared to women in the control group, fewer women in the intervention group will have depression, anxiety, and stress symptoms (for example, be above the established cut-off for the DASS21 and EPDS). |
Severity of symptoms: Women in the intervention group will have lower severity of depression, anxiety, and stress (that is, they will have lower mean scores on the depression, anxiety, and stress subscales) compared to those in the control group. |
Gap | objective | Research question | Testable hypotheses |
---|---|---|---|
1-2
| To compare the clinical effectiveness of integrated psychosocial assessment-care-referral versus usual prenatal care on postnatal mental health, psychosocial resources, infant health, and family health | Compared to usual care, what is the effect of integrated, online psychosocial care delivered in pregnancy on: | Compared to women in the control group, those in the intervention will have significantly: |
-decreased presence and severity of depression, anxiety, and stress symptoms at 12 weeks postpartum; | |||
…..prenatal and postpartum mental health? | -increased psychosocial resources (self-efficacy, mastery, self-esteem, coping); improved sleep quality; and higher relationship quality at 6 to 8 weeks postrandomization and 3, 6, and 12 months postpartum. | ||
…infant health? | Infants of women in the intervention group will have significantly higher: 1) 5-minute Apgar scores, 2) birth weight, 3) gestational age, 4) maternal-child attachment, and 5) significantly reduced ‘dysfunctional’ infant behavior compared to the intervention group. | ||
…family health? | The intervention group will have significantly higher parenting competence and partner relationship quality and significantly lower parenting stress compared to the control group. | ||
To evaluate process outcomes of integrated psychosocial care | Is integrated psychosocial care more efficient, feasible, and acceptable than usual prenatal care? |
Efficiency: Compared to the control group, a significantly higher percentage of women in the intervention group will have a psychosocial assessment and receive treatment. The intervention group will have significantly lower percentage of women receiving emergency mental healthcare compared to the control group. | |
Feasibility: ≥ 90% of providers and women report psychosocial assessment is easily done as a component of routine prenatal care, ≥ 95% of intervention group women will access cognitive behavior therapy modules (CBT) within 2 weeks of psychosocial assessment, ≥ 80% of intervention group will access the CBT modules every 1-2 weeks, ≥75% intervention group will complete all CBT exercises, and intervention group will complete 80-100% modules within 6 to 8 weeks. | |||
Acceptability: ≥ 90% of intervention group women and providers will report tablet-based psychosocial assessment during prenatal care acceptable, > 90% women will report that they could provide ‘honest’ responses, and ≥ 90% of intervention group women and providers will find the CBT modules acceptable. | |||
Utility: ≥ 85% of intervention group will report that the CBT homework exercises were useful, and ≥ 90% of intervention group will report each module as useful. | |||
Usability: ≥ 90% of intervention group will report that the exercises and modules were clear, easy to understand, and easy to navigate around. | |||
(Note. Targets are based on meta-analyses of adherence and satisfaction rates [44]). | |||
3
| To describe mechanisms of integrated care | What are the mediators and moderators of the intervention effect? | Psychosocial resources (self-efficacy, mastery, self-esteem, coping), sleep, and relationship quality will mediate the impact of the intervention on maternal, child, and family outcomes; and participant characteristics will moderate the effect (for example, demographics, use of antidepressants). |
4
| To compare the cost-effectiveness of integrated psychosocial care compared to usual care | Is the integrated psychosocial care model cost-effective when compared to usual prenatal care? | The expected incremental cost effectiveness of integrated psychosocial assessment, referral, and targeted cognitive behavioral therapy is cost effective at values of health considered acceptable in the Canadian healthcare system. |
Methods/Design
Design
Randomized controlled trial
Setting and recruitment procedures
Participant eligibility
Based on baseline DASS21/EPDS | Based on ‘unsuitability’ for CBT (intervention group) |
---|---|
Women with ‘severe’ or ‘extremely severe’ psychological distress based on one or more of the following criteria: | Women in intervention group with three or more of the following criteria: |
1. Depression subscale ≥21 and/or | 1. ANRQ-R positive for childhood emotional neglect, childhood emotional abuse, or childhood sexual or physical abuse and/or |
2. Anxiety subscale ≥15 and/or | 2. ANRQ-R positive for multiple major stressors (for example, major financial issues, bereavement, or separation) |
3. Stress subscale ≥26 | 3. Current substance use or domestic violence |
4. EPDS positive Q10 (1, 2, or 3) | 4. EPDS positive Q10 or total EPDS score >15 |
Prerandomization
Postrandomization
Randomization and allocation procedures
Sample size estimation
N = 2(0.84 + 1.96)2 * (σ/§)2
| ||
---|---|---|
σ = standard deviation of the primary outcome (Depression, Anxiety, Stress subscales of DASS21) | ||
§ = minimal clinically important difference | ||
Depression subscale | Anxiety subscale | Stress subscale |
N = 2(0.84 + 1.96)2 * (σ/§)2
| N = 2(0.84 + 1.96)2 * (σ/§)2
| N = 2(0.84 + 1.96)2 * (σ/§)2
|
N = 2(0.84 + 1.96)2 * (5.4/4)2
| N = 2(0.84 + 1.96)2 *(10.2/4)2
| N = 2(0.84 + 1.96)2 * (8.6/4)2
|
N = 28.6 per group | N = 102 per groupa
| N = 72.5 per group |
Intervention
Online psychosocial assessment
Referral
Online cognitive behavior therapy
Comparator: usual prenatal care
Definition and measurement of outcomes
Primary outcome
Variable (Measure) | Timing of measures | ||||
---|---|---|---|---|---|
Baseline | 6 to 8 weeks post-randomization (pregnancy) | 3 months postpartum | 6 months postpartum | 12 months postpartum | |
PHASE I | |||||
Demographics (education, income, maternal age at recruitment, ethnicity) (Items from Maternity Experiences Survey, bMES [120]) |
X
| ||||
Obstetric and medical history (parity, chronic and pregnancy complications, type of delivery, weight - pre-pregnancy, delivery, 6 weeks postpartum) (Items from MES) |
X
|
X
| |||
Mental health history (history of depression, anxiety, stress; age of onset of previous episodes of mental health problems) (Items from MES) |
X
| ||||
Pharmacologic therapy for depression/anxiety (past; current) (Items from Canadian Community Health Survey, CCHS) |
X
|
X
|
X
|
X
|
X
|
Social support (Interpersonal Support Evaluation List, ISEL [121]) |
X
|
X
|
X
|
X
|
X
|
Prenatal depression, anxiety, stress symptoms (Depression, Anxiety, and Stress Scale, DASS-21 [107] - presence (percent above cut-off point) and severity (mean score, standard deviation) |
X
|
X
| |||
Postnatal depression, anxiety, stress symptoms (Depression, Anxiety, and Stress Scale, DASS-21 [107] - presence (percent above cut-off point) and severity (mean score, standard deviation) |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
| |
Depression (Edinburgh Postnatal Depression Scale, EPDS) [111] |
X
|
X
|
X
|
X
|
X
|
aANRQ-R acceptability |
X
| ||||
Mastery (Pearlin’s Mastery Scale) [122] |
X
|
X
|
X
|
X
|
X
|
Self-efficacy (Generalized Self-Efficacy Scale) [123] |
X
|
X
|
X
|
X
|
X
|
Self-esteem [124] |
X
|
X
|
X
|
X
|
X
|
Resilience (Connor-Davidson Resilience Scale) [91] |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
| |
Parenting competence (Parenting Sense of Competence Scale, PSCS; subscales Efficacy, Interest, Satisfaction) [127] |
X
|
X
|
X
| ||
Parenting stress (Parental Stress Scale) [128] |
X
|
X
|
X
| ||
X
|
X
|
X
|
X
|
X
| |
Coping (Brief Cope) [130] |
X
|
X
|
X
|
X
|
X
|
Maternal-infant attachment (Condon and Corkindale) [131] |
X
|
X
|
X
| ||
Infant behavior (Infant Behavior Questionnaire) [132] |
X
|
X
|
X
| ||
X
|
X
|
X
| |||
Birth weight (medical record) |
X
| ||||
Gestational age (medical record) |
X
| ||||
5-minute Apgar score (medical record) |
X
| ||||
Other factors related to infant outcomes: feeding method (medical record and parent-report); neonatal/infant health (medical record and parent-report) (Parent report items from the All Our Babies birth cohort studyc) |
X
|
X
|
X
| ||
Patient diaries [134] (For economic analysis - including health service use, medication use, productivity loss, personal cost) |
X
|
X
|
X
|
X
|
X
|
Quality of life (For economic analysis - SF-36,SF-6D to calculate QALY) [135] |
X
|
X
|
X
|
X
|
X
|
Efficiency of intervention (percent of women with psychosocial assessment, referral, and care in IG versus CG; self-report and medical record) |
X
|
X
|
X
| ||
Utility of intervention (one question asked at the end of each cognitive behavior therapy (CBT) homework exercise: This exercise was useful to me with four response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly agree; one question asked at the end of each CBT module: The information in this module was useful to me with same response options) |
X
| ||||
Usability of intervention (one question asked at the end of each CBT homework exercise: This exercise was clear and easy to understand with response options; 2 questions asked at the end of each module: 1) The information in this module was clear and easy to understand; 2) It was easy to work through the module (for example, it was easy for me to get from one part to the other, easy to find what I needed) with same response options) |
X
| ||||
Acceptability: Tablet-based psychosocial assessment (one question at end of completing ANRQ-R: I would recommend a tablet-based approach to asking about emotional health to a pregnant friend with four response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly agree) |
X
| ||||
Acceptability: CBT (one question at end of each CBT module: I would recommend this module to a pregnant friend who was struggling with stress, depression, or anxiety with 4 response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly agree) |
X
| ||||
Overall assessment (two open-ended questions at the end of every CBT module: 1) The thing I liked most about this module was….; 2) The thing I liked least about this module was….) |
X
| ||||
Log of interactions with participants (completed by research nurse) |
X
|
X
|
X
| ||
PHASE 2 | |||||
Efficiency (Providers’ views of the efficiency of the process of clinic-based online psychosocial assessment) |
X
| ||||
Utility (Women’s views of how useful the modules in were in meeting their needs) | |||||
Usability (Women’s views of how easy/difficult the modules were to navigate) |
X
| ||||
Feasibility (providers’ views of feasibility of conducting integrated intervention in their setting; women’s views of the feasibility of doing the modules; Google Analytics for example, percent of women accessing CBT within 2 weeks postassessment; percent of women accessing each CBT module within 1 to 2 weeks; percent completion of all six CBT modules; percent completion of CBT modules within 8 weeks) |
X
| ||||
Acceptability (women’s and providers’ views of acceptability/ability to promote disclosure) |
X
| ||||
Mechanisms (women’s views of why and how the intervention did/did not improve outcomes; how the intervention benefitted/did not benefit them) |
X
|
Secondary outcomes
Data collection
Procedures
Enrollment | Allocation | CBT Suitability | Post-randomization | |||||
---|---|---|---|---|---|---|---|---|
TIME POINT |
-t
1
| 0 | 0 |
T
1
(Baseline)
|
T
2
(6 to 8 weeks postrandomization)
|
T
3
(3 months postpartum)
|
T
4
(6 months postpartum)
|
T
5
(12 months postpartum)
|
ENROLLMENT: | ||||||||
Eligibility screen (based on DASS21 and EPDS) | X | |||||||
Informed consent | X | |||||||
Allocation | X | |||||||
Determination of suitability for CBT (based on ANRQ-R) | X | |||||||
INTERVENTIONS:
| ||||||||
Psychosocial assessment (ANRQ-R) | X | |||||||
Referral | X | |||||||
Online cognitive behavior therapy | X | X | ||||||
ASSESSMENTS:
| ||||||||
Baseline variablesa
| X | |||||||
Primary outcome: Depression, anxiety, stress symptoms | X | X | X | |||||
Secondary outcomes -maternalb
| X | X | ||||||
Secondary outcomes -maternal and infantc
| X | X | X | |||||
Utility, usability, acceptability of intervention | X | |||||||
Phase 2: Qualitative interviews | X | X | X |