Clinical trial NCT04073043: Telephone Coaching Intervention for Postpartum Depression and Anxiety
Official title: A Pilot Randomized Trial of a Telephone Coaching Intervention for Postpartum Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Anxiety
Keywords: Support
Self-management
Resources
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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:

1. 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.
2. 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:

1. Feasibility and Acceptability of the two intervention components - WBI and coaching:

   a) 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?
2. 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:

1. Recruiting a sample of women immediately post-birth(24 hrs) at SMHC and obtaining consent to contact them again within 5 - 12 weeks postpartum
2. 5-12 weeks postpartum: Screen women for eligibility for RCT;
3. Request informed consent to RCT
4. Baseline measures (T0);
5. Follow up at 3 months (T1) and
6. 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.

Eligibility criteria: Inclusion Criteria:

* Age 18+ (at birth)
* Ability to speak English or French
* Livebirth
* Access to the internet and email

Inclusion criteria (at step 2):

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Screening, 3 months & 6 months
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Screening,3 months & 6 months
Secondary outcomes:
measure: Questions on usability & acceptability
timeFrame: 3 months
measure: Barkin Index of Maternal Functioning (BIMF)
timeFrame: Baseline, 3 months & 6 months
measure: Parental Stress Questionnaire (PARSS)
timeFrame: Baseline, 3 months & 6 months
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 6 months
measure: Questionnaire on Use of services for mental health problems
timeFrame: Baseline & 6 months
measure: Acceptability of Coaching Questionnaire
timeFrame: 6 months
measure: Coach logs and records
timeFrame: 6 months
measure: Coach exit interview
timeFrame: 6 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: St. Mary's Hospital Centre
state: Quebec
Study officials:
affiliation: McGill University
name: Hannah Schwartz, MDCM
role: PRINCIPAL_INVESTIGATOR
References: