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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapist-assisted ICBT | 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. |
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| Treatment as usual control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapist-assisted ICBT | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcie Nugent, MSW | University of Regina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Online Therapy Unit, University of Regina | Regina | Saskatchewan | S4S 0A2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36066958 | Derived | 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. |
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|
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 |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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