Telephone Support for Postpartum Depression

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance mental health support for pregnant women in Quebec by testing an online course with phone support, known as telephone-based behavioral activation. It compares two groups: one receives counseling and weekly phone check-ins, while the other follows the course without phone support. Pregnant women between 12 to 25 weeks along, experiencing mild to moderate depression symptoms, are suitable candidates for this study. Participants should be able to read and understand French.

As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health solutions for pregnant women.

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 prior data suggests that telephone support is safe for postpartum depression interventions?

Research has shown that phone support, combined with online therapy, can safely assist new mothers with postpartum depression. One study found that remote behavioral activation therapy reduced suicidal thoughts in women with depression during and after pregnancy. This therapy was effective both in person and remotely.

Phone support is commonly used in mental health care and is generally well-received. Reports have not indicated any serious safety issues with this kind of support. It offers a convenient way for people to receive help without needing to travel. Overall, phone support combined with online therapy appears to be a safe option for those facing mental health challenges during and after pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of adding telephone support to online cognitive-behavioral therapy (CBT) for postpartum depression. Unlike standard treatments that might include in-person therapy or medication, this approach combines the convenience of a virtual platform with the personalized touch of weekly phone support. This method could make mental health support more accessible for new moms who might struggle with time constraints or geographical barriers. Additionally, the incorporation of interpersonal counseling via phone could enhance the effectiveness of the therapy, providing a more comprehensive support system.

What evidence suggests that telephone support is effective for postpartum depression?

Research has shown that telehealth services, such as phone support, can assist with postpartum depression. In this trial, one group will receive an online cognitive-behavioral intervention with weekly telephone support. One study found that digital tools, including phone support, improved mental health for new mothers. This method encourages positive activities and provides emotional support. Similar programs have successfully reduced anxiety and depression in low-income patients. These findings suggest that adding phone support to online therapy could enhance mental health for new mothers. ^{1 2 5 6 7}

Who Is on the Research Team?

Sylvana Côté

Principal Investigator

St. Justine's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8532017/

Effectiveness of Telehealth Interventions for Women With ... Postpartum depression (PPD) is a prevalent mental health problem with serious adverse consequences for affected women and their infants.

3. psychiatrist.com psychiatrist.com/pcc/behavioral-activation-teletherapy-for-depression-and-anxiety/

Efficacy of a Behavioral Activation Teletherapy Intervention ... Among low-income real-world primary care patients receiving a brief BA teletherapy program for depression and anxiety, we analyzed descriptive ...

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-021-03767-9

Internet-based behavioural activation to improve depressive ... Child abuse and postnatal depression are two public health problems that often co-occur, with rates of childhood maltreatment highest during ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10015349/

Digital Behavioral Activation Interventions During the Perinatal ... Depression symptoms during pregnancy, in particular, are among the main predictors of postpartum depression [8]. From a clinical viewpoint, depression during ...

6. womensmentalhealth.org womensmentalhealth.org/posts/behavioral-activation-reduces-suicidal-ideation-in-perinatal-depression/

Behavioral Activation Reduces Suicidal Ideation in Women ... Behavioral activation significantly reduced suicidal ideation in women with perinatal depression, showing effectiveness whether delivered in-person or ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07077-7

Effect of Remote Peer-Counsellor- delivered Behavioral ... Antenatal depression (AD) is the most common complication of pregnancy in developed countries and increases the risk of preterm birth (PTB).