Examining the Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy in New Mothers Experiencing Anxiety and Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Depression, Postpartum; Anxiety
• Intervention / Treatment: Behavioral: Therapist-assisted ICBT

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S 0A2
      • Online Therapy Unit, University of Regina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Therapist-assisted ICBT; 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.	Behavioral: Therapist-assisted ICBT; An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students will provide support by email once a week.
NO_INTERVENTION: Treatment as usual control; Participants will not receive access to the transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) program for 12-weeks. Participants will be permitted to access community resources (e.g., support groups). After 12-weeks, participants will be offered the program although their treatment data will not be included in the current study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postpartum depression	Measured by the Edinburgh Postnatal Depression Scale (EPDS). 10 items are summed into a total score ranging from 0 to 30, with higher scores indicating more severe depression.	Baseline, weeks 1-9, 13, and 37
Change in anxiety	Measured by the Generalized Anxiety Disorder Scale 7-Item (GAD-7). 7 items are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.	Baseline, weeks 1-9, 13, and 37

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression	Measured by the Patient Health Questionnaire 9-Item (PHQ-9). 9 items are summed into a total score, with scores ranging from 0 to 27. Higher scores are associated with higher depression severity.	Baseline, weeks 1-9, 13, and 37
Change in depression, anxiety, stress	Measured by the Depression and Anxiety Stress Scales (DASS-21). 21 items are summed into a total score ranging from 0 to 42, with higher scores indicating more severe symptoms with respect to the depression, anxiety, and stress subscales.	Baseline, 8 weeks, 1 month, and 6 months
Mother-infant bonding	Measured by the Postnatal Bonding Questionnaire (PBQ). 25 items are summed into a total score ranging from 0 to 125, with higher scores indicating more reported difficulties bonding with one's baby.	Baseline, weeks 9, 13, and 37
Relationship satisfaction	Measured by the Dyadic Adjustment Scale-7 item (DAS-7). 7 items are summed into a total score ranging from 0 to 32, with higher scores indicating greater perceived relationship quality.	Baseline, weeks 9, 13, and 37
Treatment credibility	Measured by the Credibility/Expectancy Questionnaire (CEQ). 6 items are summed into a total score and two subscales (credibility and expectancy). Total scores can range from 3 to 27, with higher scores representing greater perceptions of ICBT credibility.	Baseline and week 9
Therapeutic alliance	Measured by the Working Alliance Inventory-Short Revised (WAI-SR). Scores are summed into three sub-total scores, which respectively assess various domains of the therapeutic relationship (i.e., goal, task, and bond). Sub-total scores each range between 5 and 20, with higher scores representing better therapeutic relationship in each of the three domains assessed.	9 weeks following baseline
Treatment satisfaction	Measured by the Treatment Satisfaction Questionnaire (TSQ). 6 items are scored using various scales. Descriptive statistics are produced for each item.	9 weeks following baseline
Adverse effects	Measured by questions assessing whether participants encountered any adverse effects of treatment, developed any new psychological symptoms, or experienced any unexpected events over the course of treatment	9 weeks following baseline
Service utilization	Measured by a series of questions asking participants whether they accessed additional services or support	Weeks 9, 13, and 37

Collaborators and Investigators

• Sponsor: University of Regina
• Investigators: Study Director: Marcie Nugent, MSW, University of Regina

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2019
• Primary Completion (ACTUAL): November 27, 2020
• Study Completion (ACTUAL): November 27, 2020

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (ACTUAL): July 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: randomized controlled trial; depression; anxiety; postpartum; internet-delivered cognitive behaviour therapy; therapist-assistance
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Anxiety Disorders; Depression, Postpartum
• Other Study ID Numbers: 2019-077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No