Telephone Coaching Intervention for Postpartum Depression and Anxiety

NCT04073043 | Completed

• 1 other identifier: SMHC-18-25
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Postpartum Depression; Anxiety

Keywords

Support; Self-management; Resources

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Screening,3 months & 6 months

Secondary Outcomes (8)

• Questions on usability & acceptability

  3 months

• Barkin Index of Maternal Functioning (BIMF)

  Baseline, 3 months & 6 months

• Parental Stress Questionnaire (PARSS)

  Baseline, 3 months & 6 months

• Client Satisfaction Questionnaire (CSQ-8)

  6 months

• Questionnaire on Use of services for mental health problems

  Baseline & 6 months

Study Arms (2)

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.

Behavioral: Telephone Coaching

Control Group

NO INTERVENTION

The control group will have access only to the web-based intervention without telephone support

Interventions

Telephone Coaching BEHAVIORAL

Access to Telephone Coaching for a period of 12 weeks

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

St. Mary's Hospital Centre

Montreal, Quebec, H3T 1M5, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Hannah Schwartz, MDCM

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Scientist, St. Mary's Research Centre

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: August 28, 2019
• Study Start: August 12, 2019
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

CA (1)