Completed

Examining The Acceptability and Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy for Symptoms of Postpartum Anxiety and Depression: A Randomized Controlled Trial

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What is being tested

Therapist-assisted ICBT

Behavioral
Who is being recruted

Urogenital Diseases+9

+ Anxiety Disorders

+ Behavior

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2019
See protocol details

Summary

Principal SponsorUniversity of Regina
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 30, 2019

Actual date on which the first participant was enrolled.

In the proposed study, the investigators will examine the efficacy of transdiagnostic, Internet-delivered cognitive behaviour therapy (ICBT) in the treatment of postpartum anxiety and depression. Half of participants will receive the treatment immediately, and half of the participants will be assigned to a treatment-as-usual control condition. Participants assigned to the control condition will be offered the treatment after a 12-week waiting period, although data from this portion will not be included in the current study. All participants will complete questionnaires prior to the start of the treatment, following treatment (or corresponding 8-week waiting period), at 1-months follow-up (or corresponding 12-week waiting period), and at 6-months follow-up (in those assigned to the treatment condition). Further, those who receive the treatment will complete questionnaires on a weekly basis. The primary outcome measures include anxiety and depression. As part of the battery of questionnaires administered after the completion of the program, participants will be asked to rate the program content, the overall service, and their satisfaction with the program.

Official TitleExamining The Acceptability and Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy for Symptoms of Postpartum Anxiety and Depression: A Randomized Controlled Trial
NCT04012580
Principal SponsorUniversity of Regina
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAnxiety DisordersBehaviorMental DisordersBehavioral SymptomsDepressionDepressive DisorderFemale Urogenital Diseases and Pregnancy ComplicationsPregnancy ComplicationsPuerperal DisordersDepression, PostpartumMood Disorders

Criteria

8 inclusion criteria required to participate
18 years of age or older

female

have given birth and have a child under one year of age

score of 10 or above on EPDS or a score of 9 or above on the GAD-7

Show More Criteria

11 exclusion criteria prevent from participating
younger than 18 years

not female

have not given birth to a child less than one year of age

are experiencing minimal to no symptoms of anxiety and/or depression

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. In addition to the program, participants will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact provided on a weekly basis.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Online Therapy Unit, University of Regina

Regina, CanadaOpen Online Therapy Unit, University of Regina in Google Maps
CompletedOne Study Center
Examining The Acceptability and Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy for Symptoms of Postpartum Anxiety and Depression: A Randomized Controlled Trial | PatLynk