Online Cognitive Behavioural Therapy for Postpartum Depression

(postnataIiCBT Trial)

Recruiting at 4 trial locations

Overseen By Alexandra Chapdelaine, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must not be taking: Benzodiazepines

Disqualifiers: Schizophrenia, Bipolar, Substance abuse, others

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

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

226 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This research project aims to examine the acceptability and efficacy of a French-Canadian adaptation of a postnatal anxiety and depression program. The main question it aims to answer is: \[1\] When the adapted postnatal Internet-delivered cognitive behavioral therapy (iCBT) is added to treatment as usual (TAU) in community-based care for women with anxiety and depressive symptoms, is the iCBT+TAU condition more effective to reduce symptoms than TAU alone? Participants will: postnatal iCBT group -\> Answer questionnaires before, after (week 6) and 4 weeks after the intervention (week 10); do the 6-week non-guided iCBT program for anxiety and depressive symptoms during the postnatal period. Waitlist, TAU group -\> Answer questionnaires at enrolment, at week 6 and week 10. Participants will have access to the intervention after they complete their last questionnaires.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have started new medication for depression or anxiety within the last 8 weeks. It also excludes those currently using benzodiazepines.

Is online cognitive behavioral therapy safe for postpartum depression?

Research on online cognitive behavioral therapy (iCBT) for postpartum depression shows it is generally safe, with participants reporting satisfaction and a strong connection with their therapists. While specific safety data is limited, the studies suggest no significant safety concerns for this treatment. ^{1 2 3 4 5}

How is the online cognitive behavioral therapy treatment for postpartum depression different from other treatments?

This treatment is unique because it is delivered online, making it more accessible for new mothers who may struggle to attend in-person sessions. It involves therapist-assisted communication through emails, which helps maintain a therapeutic relationship and provides personalized support. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment for postpartum depression?

Research shows that internet-delivered cognitive behavioral therapy (iCBT) can help reduce symptoms of postpartum depression and anxiety. In one study, a mother who used therapist-assisted iCBT reported symptom reduction and high satisfaction with the treatment. Another study found that an online one-day workshop based on cognitive behavioral therapy improved postpartum depression and anxiety. ^{1 2 3 4 6}

Who Is on the Research Team?

Pasquale Roberge, PhD

Principal Investigator

Université de Sherbrooke

Helen-Maria Vasiliadis, PhD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

This trial is for postnatal women experiencing mixed anxiety and depressive symptoms. Participants should be comfortable with French-Canadian language as the program is adapted to this variant. There are no specific inclusion or exclusion criteria provided, but typically participants would need access to the internet and have some level of comfort with using online tools.

Inclusion Criteria

I am fluent in both speaking and writing French.

Access to a computer/tablet and internet connection

Being within 12 months postpartum

Exclusion Criteria

I started treatment for depression or anxiety less than 8 weeks ago.

I am currently taking benzodiazepines.

Severe depression (EPDS score ≥ 23) or active suicidal intentions (EPDS question 10 = 3, yes quite often)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the postnatal iCBT group complete a 6-week non-guided iCBT program for anxiety and depressive symptoms

6 weeks

Questionnaires at week 0, week 6

Follow-up

Participants are monitored for safety and effectiveness after treatment, with questionnaires at week 10

4 weeks

Questionnaires at week 10

Waitlist Control

Participants in the TAU group complete questionnaires and have delayed access to the iCBT program after the follow-up phase

10 weeks

Questionnaires at week 0, week 6, week 10

What Are the Treatments Tested in This Trial?

Interventions

• Postnatal anxiety and depression iCBT program

Trial Overview The study tests a French-Canadian version of an internet-delivered cognitive behavioral therapy (iCBT) program designed for postnatal women with anxiety and depression. It compares the effectiveness of iCBT plus usual care versus usual care alone over a period of 10 weeks, including follow-up assessments.

How Is the Trial Designed?

Group I: The postnatal anxiety and depression iCBTprogram + TAU Experimental Treatment 1 Intervention

Women will have access to the postnatal iCBT program (self-directed) and will have to complete the program over six weeks. They still can have contacts with the healthcare system.

Group II: Treatment-as-usual Active Control 1 Intervention

No restrictions will be imposed regarding usual care. To reflect heterogeneity of health seeking behaviour and mental health practices for anxiety and depressive symptoms in the community during the postpartum period, participants will not be constrained to a prespecified usual care treatment for external validity or have contacts with the healthcare system. Data will be collected on throughout the trial. This group will have a delayed access to the program after they complete their four-week follow-up questionnaire.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Centre intégré de santé et services sociaux de la Montérégie-Centre

Collaborator

Trials

1

Recruited

230+

Centre intégré de santé et services sociaux de la Montérégie-Ouest

Collaborator

Trials

1

Recruited

230+

Centre intégré de santé et services sociaux de la Montérégie-Est

Collaborator

Trials

1

Recruited

230+

Champlain Local Health Integration Network

Collaborator

Trials

2

Recruited

340+

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke

Collaborator

Trials

1

Recruited

230+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

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]

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]

Citations

1. Austria pubmed.ncbi.nlm.nih.gov

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

2. Canada pubmed.ncbi.nlm.nih.gov

Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy for Symptoms of Postpartum Anxiety and Depression: Feasibility Randomized Controlled Trial. [2022]

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

A Randomised Controlled Trial of Therapist-Assisted, Internet-Delivered Cognitive Behavior Therapy for Women with Maternal Depression. [2022]

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

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

5. Australia pubmed.ncbi.nlm.nih.gov

The preventive effect of internet-based cognitive behavioral therapy for prevention of depression during pregnancy and in the postpartum period (iPDP): a large scale randomized controlled trial. [2023]

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

Online cognitive behaviour therapy for maternal antenatal and postnatal anxiety and depression in routine care. [2023]