Cognitive Behavioral Therapy for Depression During Pregnancy

Overseen By Shahirose Premji, PhD, NP

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Shahirose Sadrudin Premji

Must not be taking: Antidepressants

Disqualifiers: Treated mental conditions

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

Approved in 8 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help Chinese immigrant pregnant women in Canada manage depression. It aims to determine if these women find the app useful and if they will use it. The trial also evaluates the effectiveness of recruiting and retaining participants. The app provides THP: cognitive behavior therapy and behavioral activation, known as the Thinking Healthy Programme. Women who are at least 22 weeks pregnant, speak Mandarin, and have a smartphone with internet access may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative mental health solutions tailored to their community.

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 excludes women currently being treated for mental conditions, including depression.

What prior data suggests that this intervention is safe for pregnant women?

Research has shown that the Thinking Healthy Program (THP), which includes cognitive behavioral therapy (CBT) and behavioral activation, is generally safe during pregnancy. A large study found that THP significantly lowered depression rates compared to usual care, with no major safety issues reported. Another analysis found that behavioral activation, a component of THP, slightly reduced depressive symptoms in pregnant women. These findings suggest that the treatment is well-tolerated and poses no known risks for pregnant women. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this new approach to treating depression during pregnancy because it harnesses the power of technology and accessibility. Unlike traditional in-person therapy sessions, this treatment uses an Android-based app to deliver cognitive behavioral therapy and behavioral activation, allowing pregnant women to access therapy modules anytime, anywhere. This digital method not only provides flexibility but also integrates specific tasks and healthy thinking steps tailored to the perinatal period, potentially enhancing both maternal and fetal well-being. By offering therapy through a mobile app, this treatment could reach more people and provide support in a more convenient format than standard face-to-face therapy sessions.

What evidence suggests that this intervention is effective for depression during pregnancy?

Research has shown that the Thinking Healthy Programme (THP), a type of talk therapy, effectively treats depression during and after pregnancy, particularly in resource-limited areas. One study found that a similar therapy reduced the risk of postpartum depression by 81% when delivered by trained non-specialists. This suggests that THP can improve mental health for pregnant women. In this trial, participants will engage with the Adapted THP group, which employs a "task-shared" approach, allowing delivery by individuals without specialized mental health training, thus increasing accessibility. Studies indicate that THP works by altering negative thoughts and promoting healthier habits, making it recommended for depression during and after pregnancy. ^{1 6 7 8 9}

Who Is on the Research Team?

Shahirose Premji, PhD, NP

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

This trial is for Chinese immigrant pregnant women over 18 years old, living in Canada, who are at least 22 weeks pregnant and speak Mandarin. It's not suitable for those who don't meet these specific criteria.

Inclusion Criteria

I am willing to use the study's mobile app for therapy sessions.

I am pregnant and have reached or passed 22 weeks of gestation.

First or second-generation Chinese immigrants residing in Canada (who identify as someone with East Asian cultural and ethnic background born outside of Canada or have at least one parent born outside of Canada)

Exclusion Criteria

Women currently being treated for mental conditions, including depression

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Intervention

Participants use the Thinking Healthy Program (THP) mobile app for mental health support

3-4 weeks

App-based engagement

Follow-up

Participants complete questionnaires and are monitored for mental well-being

6-8 weeks postpartum

2 visits (virtual)

Qualitative Interviews

A subset of participants participate in individual semi-structured telephone interviews

1-2 weeks

1 visit (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• THP: cognitive behavior therapy and behavioral activation

Trial Overview

The study tests a mobile app delivering the Thinking Healthy Program (THP), which uses cognitive behavior therapy and behavioral activation to support mental well-being during and after pregnancy.

How Is the Trial Designed?

Group I: Adapted THP group Experimental Treatment 1 Intervention

Participants will be invited to complete three modules relevant to the health and well-being of mothers and fetus/infants during the perinatal period, through an Android based app on their mobile device. In addition, each section incorporates the three healthy thinking steps to help the mother negotiate each of the three areas. After the introductory session, each session involves four tasks that mothers are required to complete. The tasks include 1) a review of the key message from the previous section, 2) a review of the mood chart, 3) engaging in the three steps to thinking healthy on the designated area for the section, and 4) practicing suggested activities between sessions.

THP: cognitive behavior therapy and behavioral activation is already approved in India, China, Canada for the following indications:

Approved in India as Thinking Healthy Programme for:

• Perinatal depression

Approved in China as Thinking Healthy Programme for:

• Perinatal depression

Approved in Canada as Thinking Healthy Programme for:

• Perinatal depression

Who Is Running the Clinical Trial?

Shahirose Sadrudin Premji

Lead Sponsor

Trials

1

Recruited

50+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Kingston Health Sciences Centre

Lead Sponsor

Trials

312

Recruited

112,000+

Queen's University

Lead Sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

The Thinking Healthy Programme (THP) is being evaluated in a study involving perinatal women in four cities in Anhui Province, China, using a mobile application called Mom's Good Mood (MGM) to manage perinatal depression (PND).

This study aims to assess the effectiveness of THP as a psychosocial intervention and to identify barriers and facilitators to its implementation in primary healthcare, which is crucial for improving mental health support for new mothers in low/middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mom's Good Mood: screening and management of perinatal depression within primary healthcare system in China-protocol for an effectiveness-implementation design study. Lu, M., Jiang, M., Gu, Y., et al.[2023]

Cognitive behavioral therapy (CBT) for antenatal depression showed significant long-term benefits, with the woman's mood improving dramatically after treatment and remaining stable in the mild to moderate range for up to 7 years postpartum.

The child's development was generally age-appropriate, suggesting that effective treatment of maternal depression may have protective effects on child development, although some areas like communication and processing speed showed relative weaknesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 7-year follow-up of antenatal depression treatment with cognitive behavioral therapy: A case report of maternal and child outcomes. Bleker, LS., Milgrom, J., Gemmill, AW., et al.[2020]

The Learning through Play Plus (LTP Plus) program, which combines parenting support with Cognitive Behaviour Therapy, significantly reduced maternal depression symptoms in 247 women over a 6-month period, as measured by the Edinburgh Postnatal Depression Scale.

Participants in the LTP Plus program not only experienced lower depression scores but also reported less parental distress and improved knowledge about child development, indicating the program's effectiveness in enhancing both maternal mental health and parenting skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of maternal depression in urban slums of Karachi, Pakistan: A randomized controlled trial (RCT) of an integrated maternal psychological and early child development intervention. Husain, N., Zulqernain, F., Carter, LA., et al.[2018]

Cognitive Behavioral Therapy (CBT) initiated during pregnancy has been shown to effectively reduce the risk of postpartum depression and anxiety, according to an overview of seven systematic reviews.

Five of the reviews indicated that CBT was more effective than usual care or no intervention in lowering depression rates, while one review confirmed that psychotherapy, including CBT, significantly reduced anxiety in perinatal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy in perinatal mental health: An overview of systematic reviews. Okatsau, A., Aoyama, S., Yamaji, N., et al.[2022]

Behavioral activation (BA) significantly reduced depressive symptoms in pregnant women compared to treatment as usual (TAU), with a notable remission rate of 56.3% in the BA group versus 30.3% in TAU.

Participants in the BA group also experienced improvements in anxiety and perceived stress, and reported higher levels of activation and environmental reward, which were linked to better depression outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pragmatic randomized clinical trial of behavioral activation for depressed pregnant women. Dimidjian, S., Goodman, SH., Sherwood, NE., et al.[2018]

The Thinking Healthy program (THP) significantly reduced perinatal depression symptoms in women, with a median PHQ-9 score decrease from 8 to 2 in the pre-pandemic cohort and from 7 to 2 in the pandemic cohort, indicating its efficacy in both settings.

The program was effective regardless of delivery method, as even women who participated in a remote module showed significant improvements, highlighting the flexibility and accessibility of THP during challenging times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal depression and implementation of the "Thinking Healthy program" support intervention in an impoverished setting of Lima, Peru: Assessment before and during the COVID-19 pandemic. Aguilar, M., Contreras, C., Raviola, G., et al.[2023]

Over 13% of pregnant women in the U.S. are prescribed antidepressants, but the safety and effectiveness of these medications may be overstated, while the benefits of psychotherapy are often overlooked.

Cognitive-behavioral therapy enhanced with hypnosis is highlighted as a highly effective treatment for perinatal depression, offering excellent results without the risks associated with antidepressant medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When the bough breaks: rethinking treatment strategies for perinatal depression. Rosenquist, SE.[2018]

The Thinking Healthy Programme (THPP) significantly increased the remission rate of perinatal depression among participants, with 73% of women in the THPP group achieving remission compared to 60% in the control group, indicating its effectiveness as an intervention.

THPP was found to be cost-effective, providing a moderate impact on mental health without significant differences in symptom severity or serious adverse events, making it a viable option for community health workers in India.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering the Thinking Healthy Programme for perinatal depression through peers: an individually randomised controlled trial in India. Fuhr, DC., Weobong, B., Lazarus, A., et al.[2023]

Depression during pregnancy is a major public health issue that can negatively affect both mothers and their children, yet it remains largely untreated due to preferences for non-drug therapies.

The review highlights various effective psychotherapeutic approaches, such as interpersonal therapy and cognitive-behavioral therapy, and emphasizes the importance of collaborative decision-making to enhance treatment uptake among pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapeutic Treatments for Depression During Pregnancy. Genovez, M., Vanderkruik, R., Lemon, E., et al.[2019]

The Thinking Healthy Programme (THP) delivered by peer volunteers did not significantly reduce the severity of perinatal depression or increase remission rates compared to enhanced usual care alone, based on a study involving 570 women in Rawalpindi, Pakistan.

Despite the lack of significant differences in primary outcomes, THP was found to be cost-effective and may help utilize community resources to address the treatment gap in perinatal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering the Thinking Healthy Programme for perinatal depression through volunteer peers: a cluster randomised controlled trial in Pakistan. Sikander, S., Ahmad, I., Atif, N., et al.[2022]

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