60 Participants Needed

Internet-Delivered Cognitive Behavioural Therapy for Depression and Anxiety

MN
HH
Overseen ByHeather Hadjistavropoulos, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Regina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the effectiveness of the Wellbeing Course for New and Expecting Parents (WCNEP), an internet-delivered cognitive behavioral therapy (ICBT) intervention, in reducing symptoms of anxiety and depression in perinatal parents, within a routine care online therapy clinic (the Online Therapy Unit). The study aims to assess treatment uptake, perceptions, feasibility, and effectiveness of the WCNEP in routine care among birthing and non-birthing parents. Over the duration of 8 weeks, participants will review course materials online and respond to questionnaires aimed at assessing changes in various outcomes over time.

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.

Is Internet-Delivered Cognitive Behavioural Therapy (ICBT) safe for humans?

ICBT is generally considered safe, with most negative effects being minor issues like technical difficulties or feeling temporarily upset. Serious problems like worsening symptoms or new severe issues were not found in the studies reviewed.12345

How is Internet-Delivered Cognitive Behavioural Therapy different from other treatments for depression and anxiety?

Internet-Delivered Cognitive Behavioural Therapy (iCBT) is unique because it provides structured therapy programs online, making it accessible for people with mobility issues or those living in remote areas. It allows patients to engage in therapy at their own pace and convenience, without the need for in-person sessions, and has been shown to effectively reduce symptoms of depression and anxiety.56789

What data supports the effectiveness of the treatment Internet-Delivered Cognitive Behaviour Therapy for depression and anxiety?

Research shows that internet-delivered cognitive behavioural therapy (CBT) is effective for reducing symptoms of depression and anxiety, with studies reporting large clinical improvements and high patient satisfaction. Additionally, patients using this treatment in routine care settings have shown significant reductions in depression and anxiety scores.25101112

Who Is on the Research Team?

HH

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.
See 1 more

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?
1Treatment groups
Experimental Treatment
Group I: Wellbeing Course for New and Expecting ParentsExperimental Treatment1 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.

Find a Clinic Near You

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

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.
ICBT in routine care: A descriptive analysis of successful clinics in five countries.Titov, N., Dear, B., Nielssen, O., et al.[2023]
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.
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]
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.
Addressing depression and behavioral health needs through a digital program at scale.Sharif-Sidi, Z., Shen, C., Wong, W., et al.[2021]

Citations

Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. [2022]
ICBT in routine care: A descriptive analysis of successful clinics in five countries. [2023]
Durability of treatment effects following internet-delivered cognitive behavioural therapy for depression and anxiety delivered within a routine care setting. [2022]
Addressing depression and behavioral health needs through a digital program at scale. [2021]
Effectiveness of eHealth-based cognitive behavioural therapy on depression: A systematic review and meta-analysis. [2022]
Negative effects associated with internet-delivered cognitive behaviour therapy: An analysis of client emails. [2020]
Using the Internet to provide cognitive behaviour therapy. [2022]
Treating anxiety and depression in young adults: A randomised controlled trial comparing clinician-guided versus self-guided Internet-delivered cognitive behavioural therapy. [2019]
Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data. [2022]
Internet-based cognitive behaviour therapy for depression and anxiety. [2018]
Efficacy of cognitive behavioural therapy delivered over the Internet for depressive symptoms: A systematic review and meta-analysis. [2023]
An Internet-Based Cognitive Behavioral Therapy Program for Anxiety and Depression (Tranquility): Adaptation Co-design and Fidelity Evaluation Study. [2022]
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