Clinical trial NCT04012580: Examining the Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy in New Mothers Experiencing Anxiety and Depression
Official title: Examining The Acceptability and Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy for Symptoms of Postpartum Anxiety and Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Anxiety
Keywords: postpartum
depression
anxiety
internet-delivered cognitive behaviour therapy
randomized controlled trial
therapist-assistance
Lead sponsor: University of Regina
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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
* be a resident of Saskatchewan
* have access to a secure computer and the Internet, and be comfortable using technology
* be available to work through treatment each week
* be willing to provide a medical contact as an emergency contact

Exclusion Criteria:

* 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
* are not a resident of Saskatchewan
* have been hospitalized within the last year for mental health and/or suicide risk concerns;
* have unmanaged problems with alcohol, drugs, psychosis or mania, or are at increased suicide risk (specific plans and intent reflected by the Suicide Behaviors Questionnaire-Revised)
* started a new psychotropic medication within the past month
* do not have access to a secure computer and the Internet or is not comfortable using technology
* are not available to work through treatment each week
* are not willing to provide a medical contact as an emergency contact

Primary outcomes:
measure: Change in postpartum depression
timeFrame: Baseline, weeks 1-9, 13, and 37
measure: Change in anxiety
timeFrame: Baseline, weeks 1-9, 13, and 37
Secondary outcomes:
measure: Change in depression
timeFrame: Baseline, weeks 1-9, 13, and 37
measure: Change in depression, anxiety, stress
timeFrame: Baseline, 8 weeks, 1 month, and 6 months
measure: Mother-infant bonding
timeFrame: Baseline, weeks 9, 13, and 37
measure: Relationship satisfaction
timeFrame: Baseline, weeks 9, 13, and 37
measure: Treatment credibility
timeFrame: Baseline and week 9
measure: Therapeutic alliance
timeFrame: 9 weeks following baseline
measure: Treatment satisfaction
timeFrame: 9 weeks following baseline
measure: Adverse effects
timeFrame: 9 weeks following baseline
measure: Service utilization
timeFrame: Weeks 9, 13, and 37
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit, University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Marcie Nugent, MSW
role: STUDY_DIRECTOR
References:
citation: Suchan V, Peynenburg V, Thiessen D, Nugent M, Dear B, Titov N, Hadjistavropoulos H. Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy for Symptoms of Postpartum Anxiety and Depression: Feasibility Randomized Controlled Trial. JMIR Form Res. 2022 Sep 6;6(9):e37216. doi: 10.2196/37216.