Anxiety, Depression
Conditions
Keywords
Anxiety, Depression, CBT
Brief summary
We hypothesize that the intervention will: (1) offer a feasible approach for providing mental healthcare to pregnant women and have a high level of acceptability by pregnant women and healthcare providers; (2) reduce symptoms of depression, stress, anxiety, and parenting stress; improve parenting competence, coping, and relationship adjustment compared to usual care; and (3) reduce the risk of poor maternal-infant attachment. As such, this early intervention holds promise for reducing maternal mental health morbidity and its negative influences on infants, children, and families.
Detailed description
One of the main reasons that women do not receive treatment is that their mood and anxiety problems are not detected. Despite recommendations and high rates of acceptance by providers and women, only a minority of providers conduct psychosocial assessments as part of routine prenatal care. Computer-based 'screening' is an acceptable and feasible approach to assessment of sensitive issues including prenatal and postnatal intimate partner violence, mental health problems, and postpartum depression by patients and providers. It is well-suited for busy clinical settings and is advantageous in that it offers a consistent approach to assessment, is resource-sparing, can be tailored to meet the specific needs of patients, can be used with audio/video for low literacy, provides a real-time summary for patients/providers,achieves similar or higher rates of disclosure of violence and mental health problems, and is preferred by patients because they perceive it as more anonymous compared to interviews or questionnaires. However, psychosocial assessment on its own is ineffective in preventing or treating mood disorders and unethical in the absence of treatment options. As such, many providers do not assess pregnant women for mood disorders because non-pharmacological treatments are frequently unavailable and pregnant women prefer them. Cognitive behavioural therapy (CBT) is a highly effective, non-pharmacological treatment for depression and anxiety and is recommended by perinatal national Australian guidelines as a potentially effective EARLY intervention for reducing the risk of maternal-child outcomes.
Interventions
BEHAVIORALCognitive Behavioral Therapy
Cognitive Behavioral Therapy- an effective, non-pharmacological treatment for depression and anxiety.
Sponsors
Norlien Foundation
Women and Children's Health Research Institute, Canada
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Pregnant women will be eligible for Phase 2 if they are: 1. \< 28 weeks gestation (to provide the opportunity to complete 6 modules and follow-up questionnaires prior to delivery) 2. able to speak/read English; and (3) willing to complete email questionnaires
Exclusion criteria
1. \>28 weeks gestation 2. unable to speak/read English 3. unable to complete email questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components. | 6 weeks post randomization | Feasibility/acceptability of the intervention will be assessed through individual face-to-face or telephone-based semi-structured qualitative interviews of both clinic staff and women in the intervention group. The field does not allow for all questions to be provided. Sample question for clinic staff is 'What aspects made it easy/challenging to use the tablet for prenatal assessment as part of routine prenatal care?' Sample questions for intervention group participants: 1)How did you feel about answering these kinds of questions on a tablet?; 2)Please describe any concerns you had about answering these questions on a tablet; 3)How would you prefer the results to be shared with you |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal coping | on recruitment, 6 weeks post-randomization and 3 months postpartum | The Brief Cope Self-reported by mother on emailed questionnaire |
| Relationship Adjustment | on recruitment, 6 weeks post-randomization and 3 months postpartum | Scale: Dyadic Adjustment Scale, DAS-7 Self-reported by mother on emailed questionnaire |
| Parenting Stress | 3 months postpartum | Parenting Stress Scale Self-reported by mother |
| Maternal depression, anxiety, stress | on recruitment, 6 weeks post randomization and 3 months postpartum | Depression, Anxiety, and Stress Scale (DASS-21) Self-reported by mother on emailed questionnaire |
| Maternal-infant attachment | 3 months postpartum | Maternal Attachment Inventory (MAI) Self-reported by mother on emailed questionnaire |
| Trait anxiety | on recruitment, 6 weeks postrandomization, 3 months postpartum | State Trait Anxiety Inventory (STAI) Self-reported by mother on emailed questionnaire |
| Parenting competence | 3 months postpartum | Parenting Sense of Competence Scale Self-reported by mother on emailed questionnaire |
Countries
Canada
Outcome results
None listed