Telephone Support for Postpartum Depression

Overseen By Mélanie Carpentier, Master

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Psychosis, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

510 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Telephone support, Telephone-based Behavioral Activation, Telehealth Behavioral Activation, Tele-BA for Postpartum Depression?

Research shows that behavioral activation, which is part of the telephone-based treatment, is effective in reducing depression. Studies on teletherapy for depression and anxiety have shown positive changes in symptoms, suggesting that similar telephone-based approaches could help with postpartum depression. ^{1 2 3 4 5}

Is telephone support for postpartum depression safe for humans?

The research does not provide specific safety data for telephone support for postpartum depression, but behavioral activation, which is a similar approach, is generally considered safe for treating depression and anxiety. ^{1 2 6 7 8}

How does telephone support differ from other treatments for postpartum depression?

Telephone support for postpartum depression is unique because it provides direct, real-time communication and emotional support over the phone, which can be more accessible for new mothers who may have time constraints or fear judgment. This approach can be particularly beneficial for those in rural areas or with limited access to traditional in-person therapy. ^{9 10 11 12 13}

Research Team

Sylvana Côté

Principal Investigator

St. Justine's Hospital

Eligibility Criteria

This trial is for French-speaking pregnant women between 12-25 weeks' gestation who are at risk of postpartum depression, with mild to moderate depressive symptoms. Women with severe depression, psychosis, or substance abuse issues cannot participate.

Inclusion Criteria

I am pregnant and between 12 to 25 weeks along.

My depression score is between 8 and 16.

I can read and understand French.

Exclusion Criteria

Self-reported substance abuse problems.

Positive screening of psychotic symptoms using the Psychosis Screening Questionnaire (PSQ)

My depression score is either high (17 or above) or very low (below 8).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants follow the Parents & Babies program online or with a paper workbook, accompanied by weekly telephone support

Until 3 months postpartum

Weekly telephone calls

Follow-up

Participants are monitored for mental health outcomes and other measures postpartum

6 months postpartum

Questionnaires at 3 and 6 months postpartum

Treatment Details

Interventions

• Telephone support

Trial Overview The study tests the Parents & Babies program's effectiveness in preventing postpartum depression when accompanied by telephone support versus without it. The intervention includes a distance learning course during pregnancy.

Participant Groups

Group I: Cognitive-Behavioral Therapy (CBT) and interpersonal counseling with telephone support. Experimental Treatment 1 Intervention

The experimental group will receive an online cognitive behavioural intervention with weekly telephone support

Group II: Access to an online cognitive behavioural intervention without telephone support Active Control 1 Intervention

The control group will receive a fully automated version of the virtual intervention without telephone support

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Hewitt Foundation

Collaborator

Trials

2

Recruited

1,700+

Canadian Medical Association

Collaborator

Trials

1

Recruited

510+

St. Justine Foundation

Collaborator

Trials

1

Recruited

510+

Findings from Research

Internet-based behavioral activation (iBA) significantly reduces depressive symptoms compared to inactive control groups, with a moderate effect size based on a systematic review of 12 randomized controlled trials involving 3274 participants.

iBA also leads to reductions in anxiety and improvements in quality of life and activation, although no significant effects on depressive symptoms were observed at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis. Alber, CS., Krämer, LV., Rosar, SM., et al.[2023]

In a study of 130 low-income primary care patients receiving brief behavioral activation teletherapy for depression and anxiety, those who completed 4 or more sessions showed significantly lower depression and anxiety scores compared to those who completed fewer sessions.

The majority of patients achieved and maintained remission from depression, indicating that BA teletherapy is a feasible and effective treatment option for improving mental health outcomes in low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Behavioral Activation Teletherapy Intervention to Treat Depression and Anxiety in Primary Care VitalSign6 Program. Trombello, JM., South, C., Cecil, A., et al.[2022]

A study involving seven patients with bipolar depression analyzed 2,480 hours of self-reported activities, revealing that movement-related activities were linked to the highest pleasure scores, suggesting that physical activity may enhance mood.

The research demonstrated the feasibility of using a data-driven approach to identify behavioral patterns, which could inform therapists and lead to the development of digital solutions for behavioral activation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. Rohani, DA., Tuxen, N., Quemada Lopategui, A., et al.[2020]

A systematic review of nine randomized controlled trials involving 2157 adult participants found that guided Internet-based behavioral activation (BA) is effective in reducing depression and anxiety, showing promising results compared to other treatments like physical activity and psychoeducation.

While Internet-based BA demonstrated non-inferior efficacy to other behavioral therapies and mindfulness, the overall quality of evidence was low to moderate, indicating a need for more rigorous studies to confirm its effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. Huguet, A., Miller, A., Kisely, S., et al.[2019]

In a 9-week randomized controlled trial involving 78 patients with major depression, the study found that both expected mastery and pleasure from behavioral activation tasks were strongly correlated with improvements in depression severity.

The results suggest that the anticipation of pleasure from planned activities may be more important for the effectiveness of behavioral activation than the actual pleasure experienced, highlighting the role of meaningful engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? Furukawa, TA., Imai, H., Horikoshi, M., et al.[2019]

Behavioral activation (BA) is an effective treatment for depression, but many patients still experience treatment failure due to various factors, such as difficulty understanding the treatment rationale and behavioral noncompliance.

A case study of a depressed breast cancer patient highlights these challenges and suggests that improving patient awareness of life values and enhancing contingency management could help reduce failure rates in BA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment failure in behavior therapy: focus on behavioral activation for depression. Hopko, DR., Magidson, JF., Lejuez, CW.[2022]

A one-day online workshop utilizing cognitive behavioral therapy significantly improved symptoms of postpartum depression and anxiety, as well as enhancing social support and the mother-infant relationship.

This approach offers an efficient way to increase access to treatment for postpartum depression, suggesting it could be a valuable addition to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Day Workshop Beneficial for Postpartum Depression. Rosenberg, K.[2022]

A case study of a first-time mother with postpartum depression showed that therapist-assisted internet-delivered cognitive behavior therapy (ICBT) led to significant symptom reduction over 12 weeks, indicating its potential efficacy for treating PPD.

The participant reported high treatment satisfaction and a strong therapeutic alliance with her therapist, suggesting that this approach could be a valuable option for clinicians working with women experiencing PPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet therapy for postpartum depression: a case illustration of emailed therapeutic assistance. Pugh, NE., Hadjistavropoulos, HD., Fuchs, CM.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Internet-Based Behavioral Activation for Depression: Systematic Review and Meta-Analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a Behavioral Activation Teletherapy Intervention to Treat Depression and Anxiety in Primary Care VitalSign6 Program. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Reasons for refusing referrals and challenges to effectual engagement in tele-treatment for depression among low-income homebound older adults. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Six-month postintervention depression and disability outcomes of in-home telehealth problem-solving therapy for depressed, low-income homebound older adults. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Data-Driven Learning in High-Resolution Activity Sampling From Patients With Bipolar Depression: Mixed-Methods Study. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Treatment failure in behavior therapy: focus on behavioral activation for depression. [2022]

9. India pubmed.ncbi.nlm.nih.gov

The effectiveness of mobile phone text massaging support for mothers with postpartum depression: A clinical before and after study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Telephone-Administered Interpersonal Psychotherapy by Nurse-Midwives for Postpartum Depression. [2017]

11. Iran pubmed.ncbi.nlm.nih.gov

The effect of telephone support on postpartum depression: a randomized controlled trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

One-Day Workshop Beneficial for Postpartum Depression. [2022]

13. Austria pubmed.ncbi.nlm.nih.gov

Internet therapy for postpartum depression: a case illustration of emailed therapeutic assistance. [2022]