Back to resultsExamining the Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy in New Mothers Experiencing Anxiety and Depression
Primary Purpose
Depression, Postpartum, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Therapist-assisted ICBT
Sponsored by
About this trial
This is an interventional treatment trial for Depression, Postpartum focused on measuring postpartum, depression, anxiety, internet-delivered cognitive behaviour therapy, randomized controlled trial, therapist-assistance
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
Sites / Locations
- Online Therapy Unit, University of Regina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Therapist-assisted ICBT
Treatment as usual control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Treatment satisfaction
Measured by the Treatment Satisfaction Questionnaire (TSQ). 6 items are scored using various scales. Descriptive statistics are produced for each item.
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
Service utilization
Measured by a series of questions asking participants whether they accessed additional services or support
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04012580
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
November 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum, Anxiety
Keywords
postpartum, depression, anxiety, internet-delivered cognitive behaviour therapy, randomized controlled trial, therapist-assistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapist-assisted ICBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapist-assisted ICBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in postpartum depression
Description
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.
Time Frame
Baseline, weeks 1-9, 13, and 37
Title
Change in anxiety
Description
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.
Time Frame
Baseline, weeks 1-9, 13, and 37
Secondary Outcome Measure Information:
Title
Change in depression
Description
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.
Time Frame
Baseline, weeks 1-9, 13, and 37
Title
Change in depression, anxiety, stress
Description
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.
Time Frame
Baseline, 8 weeks, 1 month, and 6 months
Title
Mother-infant bonding
Description
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.
Time Frame
Baseline, weeks 9, 13, and 37
Title
Relationship satisfaction
Description
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.
Time Frame
Baseline, weeks 9, 13, and 37
Title
Treatment credibility
Description
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.
Time Frame
Baseline and week 9
Title
Therapeutic alliance
Description
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.
Time Frame
9 weeks following baseline
Title
Treatment satisfaction
Description
Measured by the Treatment Satisfaction Questionnaire (TSQ). 6 items are scored using various scales. Descriptive statistics are produced for each item.
Time Frame
9 weeks following baseline
Title
Adverse effects
Description
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
Time Frame
9 weeks following baseline
Title
Service utilization
Description
Measured by a series of questions asking participants whether they accessed additional services or support
Time Frame
Weeks 9, 13, and 37
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcie Nugent, MSW
Organizational Affiliation
University of Regina
Official's Role
Study Director
Facility Information:
Facility Name
Online Therapy Unit, University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36066958
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.
Results Reference
derived
Learn more about this trial
Examining the Effectiveness of Transdiagnostic, Internet-Delivered Cognitive Behaviour Therapy in New Mothers Experiencing Anxiety and Depression
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