Internet-Delivered Cognitive Behavioural Therapy for Depression and Anxiety

Overseen By Heather Hadjistavropoulos, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Severe psychiatric condition, Living outside Saskatchewan, others

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

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online therapy program designed to help new and expecting parents manage anxiety and depression. The program uses cognitive behavioral therapy (CBT), which teaches skills for managing mental health challenges. Over 8 weeks, participants will work through online lessons that focus on identifying symptoms, managing thoughts, and preventing relapse. This program suits parents or guardians of a new infant, or those expecting one, who experience anxiety or depression and wish to learn self-management skills. As an unphased trial, this study offers participants a unique opportunity to gain valuable skills and contribute to research that could benefit future parents.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that this internet-delivered cognitive behavioral therapy is safe for perinatal parents?

Research shows that Internet-Delivered Cognitive Behavioral Therapy (ICBT) is generally safe for treating depression and anxiety. Studies have found that ICBT can effectively help with various mental health issues, including perinatal depression, which affects new and expecting parents.

Most people tolerate ICBT well. This online therapy involves reading materials and practicing ways to manage symptoms. No reports of serious side effects exist because it doesn't use medication or involve physical procedures.

In one study, people with depression showed significant improvement without major problems. The online format makes it easy to access and convenient, allowing participants to learn at their own pace. Overall, ICBT is a safe option for managing anxiety and depression, especially during the perinatal period. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Internet-Delivered Cognitive Behavioural Therapy (ICBT) for depression and anxiety because it offers a unique delivery method that can reach people who might not have access to traditional face-to-face therapy. Unlike standard treatments that often require in-person visits, ICBT provides flexibility and convenience, allowing new and expecting parents to engage with therapy from the comfort of their homes. Additionally, ICBT incorporates structured lessons focusing on symptom identification, thought monitoring, and relapse prevention, which are tailored specifically for perinatal parents. This approach not only makes therapy more accessible but also targets the specific challenges faced during the perinatal period, potentially improving mental health outcomes for this group.

What evidence suggests that internet-delivered cognitive behavioural therapy is effective for depression and anxiety?

Research has shown that online cognitive behavioral therapy (ICBT) effectively reduces symptoms of depression and anxiety. Studies have found that ICBT helps individuals recognize and change negative thinking patterns. In this trial, new and expecting parents, who face unique emotional challenges, will participate in a Wellbeing Course specifically designed for them. This course offers easy access to therapy, which is especially useful for busy parents. Overall, ICBT presents a promising method to improve mental health during the perinatal period. ^{1 3 4 5 6}

Who Is on the Research Team?

Heather Hadjistavropoulos, PhD

Principal Investigator

University of Regina

Are You a Good Fit for This Trial?

This trial is for perinatal parents experiencing symptoms of depression or anxiety. Participants should be comfortable with internet use, as the therapy is delivered online. They must commit to an 8-week course and complete questionnaires assessing their mental health over time.

Inclusion Criteria

Willingness to learn information and skills to self-manage mental health difficulties, consent to course and associated research

Become the guardian of an infant in the last 24 months by birth or adoption/fostering or are expecting the birth of an infant as a birthing parent or partner

I struggle with depression or anxiety.

Exclusion Criteria

Living outside of Saskatchewan

Unable to read and understand English (All content is provided in English and staff is English speaking; it is cost prohibitive at this time to provide the complete service in languages other than English)

I do not have a severe medical or psychiatric condition needing immediate treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (telephone)

Treatment

Participants complete 5 ICBT lessons over 8 weeks with therapist support, focusing on depression and anxiety symptoms

8 weeks

Online course with therapist support

Follow-up

Participants are monitored for changes in depression and anxiety symptoms, and feedback is gathered through a semi-structured interview

12 weeks

Questionnaires at weeks 8 and 20, semi-structured interview after week 8

What Are the Treatments Tested in This Trial?

Interventions

• Internet-Delivered Cognitive Behaviour Therapy

Trial Overview The effectiveness of the Wellbeing Course for New and Expecting Parents (WCNEP), which is an internet-delivered cognitive behavioral therapy program designed to reduce anxiety and depression in perinatal parents, will be tested within a routine care setting.

How Is the Trial Designed?

Group I: Wellbeing Course for New and Expecting Parents Experimental Treatment 1 Intervention

Participants in the current study will be perinatal parents experiencing symptoms of depression and/or anxiety. All participants will have access to 5 ICBT lessons released gradually over 8 weeks. The 5 ICBT lessons target challenges and symptoms of anxiety and depression in perinatal parents and focus on: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are text-based with visual images, and are presented as slideshows, stories, homework reflections, and additional resources.

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Government of Saskatchewan, Ministry of Health

Collaborator

Trials

1

Recruited

60+

Macquarie University, Australia

Collaborator

Trials

27

Recruited

27,100+

Published Research Related to This Trial

In a study of 96 clients undergoing internet-delivered cognitive behaviour therapy (ICBT), 61.5% reported experiencing at least one negative effect during treatment, highlighting the importance of monitoring these effects in real-time rather than relying solely on post-treatment reports.

Common negative effects included technical difficulties and negative emotional states, but serious adverse events like symptom deterioration were not reported, suggesting that while ICBT is generally effective, there are still challenges that need to be addressed to improve client experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative effects associated with internet-delivered cognitive behaviour therapy: An analysis of client emails. Gullickson, KM., Hadjistavropoulos, HD., Dear, BF., et al.[2020]

Internet delivered cognitive behaviour therapy (ICBT) has been shown to be effective for treating anxiety and depression, with large clinical improvements and high patient satisfaction reported across clinics in Sweden, Denmark, Norway, Canada, and Australia.

ICBT services, which include therapist support and rigorous governance for quality and safety, can reach more patients, especially those in remote areas, compared to traditional face-to-face assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ICBT in routine care: A descriptive analysis of successful clinics in five countries. Titov, N., Dear, B., Nielssen, O., et al.[2023]

A digital mental health program providing internet-based cognitive behavioral therapy (iCBT) was successfully implemented in primary care, with 2,228 patients prescribed the program and nearly 49% enrolling, indicating good acceptance among patients.

Patients who engaged with the iCBT program showed significant clinical improvements, with a 23% reduction in depression scores (PHQ-9) and a 26% reduction in anxiety scores (GAD-7), demonstrating the efficacy of digital tools in treating mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. Sharif-Sidi, Z., Shen, C., Wong, W., et al.[2021]

In a study of 241 participants who completed internet-delivered cognitive-behavioral therapy (iCBT) for anxiety and depression, 70.8% remained in remission at 9 months post-treatment, while 29.2% experienced a relapse during that period.

Key predictors of relapse included younger age, having a long-term condition, and residual anxiety symptoms at the end of treatment, highlighting factors that may influence the durability of iCBT outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability of treatment effects following internet-delivered cognitive behavioural therapy for depression and anxiety delivered within a routine care setting. Palacios, JE., Enrique, A., Mooney, O., et al.[2022]

The iCBT program Tranquility demonstrated a high fidelity to cognitive behavioral therapy principles, with a mean rating of 91% from CBT experts, indicating it effectively follows established therapeutic guidelines.

Usability ratings for Tranquility were also high, with 88% of participants recommending the program, suggesting it is user-friendly and has potential for broader adoption in treating anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Cognitive Behavioral Therapy Program for Anxiety and Depression (Tranquility): Adaptation Co-design and Fidelity Evaluation Study. Patterson, VC., Rossi, MA., Pencer, A., et al.[2022]

A systematic review of 76 randomized controlled trials involving 11,704 participants found that behavioral activation in internet cognitive behavioral therapy (iCBT) may significantly reduce depression severity, while relaxation techniques could potentially be harmful.

Combining human and automated encouragement in iCBT programs was shown to decrease dropout rates, suggesting that support mechanisms are crucial for maintaining engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data. Furukawa, TA., Suganuma, A., Ostinelli, EG., et al.[2022]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06881693

Internet-Delivered Cognitive Behaviour Therapy for ... Study Overview. Brief Summary. This study evaluates the effectiveness of the Wellbeing Course for New and Expecting Parents (WCNEP), an internet ...

3. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-04547-9

Effectiveness of cognitive behavioural therapy-based ... Although existing evidence suggests cognitive behavioral therapy (CBT) based interventions are effective for perinatal depression, less is known ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8040152/

Effectiveness of digital psychotherapeutic intervention among ... The perinatal period is a challenging time of substantial emotional, physiological, social, and relational changes. Depression, anxiety ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165032717301295

Internet delivered cognitive behavior therapy for antenatal ... Internet delivered CBT with brief therapist guidance (ICBT) is effective for a variety of psychiatric disorders including depression (Andersson ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8956202/

Perinatal internet‐based cognitive behavioural therapy for ... Postnatal depression (PND) is one of the most common complications of pregnancy (Wang 2021). The main symptoms of PND include sadness, emotional instability, ...