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

Trial Summary

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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Depression During Pregnancy?

Research shows that the Thinking Healthy Programme (THP), which is based on cognitive behavioral therapy, effectively reduces depression in pregnant women. Studies in Pakistan and Peru found significant decreases in depression scores among women who participated in THP sessions. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy safe for treating depression during pregnancy?

Cognitive Behavioral Therapy (CBT), including the Thinking Healthy Programme (THP), is generally considered safe for treating depression during pregnancy. It is a non-drug approach that avoids the risks associated with medications, making it a preferred choice for many pregnant women. ^{4 5 6 7 8}

How is the treatment for depression during pregnancy using cognitive behavioral therapy and behavioral activation different from other treatments?

This treatment is unique because it combines cognitive behavioral therapy (CBT), which helps change negative thought patterns, with behavioral activation (BA), which encourages engaging in positive activities, making it a non-drug option preferred by many pregnant women. It is designed to be scalable and aligns with the preference for nonpharmacological interventions during pregnancy. ^{1 2 8 9 10}

What is the purpose of this trial?

The goal of this study is to determine the feasibility of using a psychosocial intervention culturally adapted in China to support perinatal mental well-being of Chinese immigrant pregnant women in Canada. The intervention is adapted from the Thinking Healthy Program (THP), available through a mobile application, and will be offered to Chinese immigrant pregnant women (22 weeks' gestation or greater) residing in Canada, who are over the age of 18, and speak Mandarin. The main questions this study aims to answer are: * Will the Chinese version of the THP be acceptable to Chinese immigrant pregnant women residing in Canada and will they use the program which is delivered through a mobile App? * How well does the process of recruiting, keeping participants in the study and helping them complete the activities work, so it can be used for a future larger study? Women interested in the study and who meet the study criteria will complete a questionnaire at the start of the study, then use the THP for three weeks, complete questionnaires 3-4 weeks after completing the intervention and 6-8 weeks after having their baby(ies). Some may be asked to participate in an individual interview.

Research Team

Shahirose Premji, PhD, NP

Principal Investigator

Queen's University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

A pragmatic randomized clinical trial of behavioral activation for depressed pregnant women. [2018]

2. Japan pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy in perinatal mental health: An overview of systematic reviews. [2022]

3. England 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. [2023]

4. England 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Delivering the Thinking Healthy Programme for perinatal depression through volunteer peers: a cluster randomised controlled trial in Pakistan. [2022]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Delivering the Thinking Healthy Programme for perinatal depression through peers: an individually randomised controlled trial in India. [2023]

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

Psychotherapeutic Treatments for Depression During Pregnancy. [2019]

9. England 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. [2020]

10. Netherlands 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. [2018]