Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Mother Infant Bonding Scale (MIBS) |
The MIBS consists of 8 one-word items describing an emotional response, such as ''loving'', "resentful", and ''disappointed" and is designed to assess the feelings of a mother toward her new baby. Mothers rate the degree to which they feel each of the 8 emotional responses toward their infant using a 4-point Likert scale from very much (0) to not at all (3). Five items describe negative emotional responses and are reverse scored. Total scores can range from 0 to 24, with lower scores indicating better bonding. |
Change from Baseline to End of Treatment at 8 weeks |
|
| Other |
Working Alliance Inventory (WAI-SR) |
A validated 12-item instrument that measures therapeutic alliance. The instrument consists of a composite score and three subscales assessing key aspects of the therapeutic alliance: 1) agreement between the client and therapist on the tasks of therapy (e.g., "As a result of these sessions I am clearer as to how I might be able to change"); 2) agreement between the client and therapist on the goals of therapy (e.g., "Woebot and I collaborate on setting goals for my therapy"), and 3) the development and strength of an affective bond between the client and therapist (e.g., "Woebot and I respect each other"). The WAI-SR will be tailored to the current intervention, replacing the term "therapist" with "Woebot". |
Day 3 and End of Treatment at 8 weeks |
|
| Other |
Feasibility, acceptability, perceptions of stigma as a barrier to mental health care, and mood outcomes across key sociodemographic variables of race and ethnicity, age, and level of education |
Named outcome measures will be descriptively characterized and results will be stratified according to race and ethnicity, age group, and level of education. |
Baseline, Day 3 and End of Treatment at 8 weeks |
|
| Primary |
Usage Rating Profile Intervention (URPI)-Feasibility |
Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention feasibility. |
End of Treatment (8 weeks from baseline) |
|
| Primary |
Usage Rating Profile Intervention (URPI)-Acceptability |
Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability. |
End of Treatment (8 weeks from baseline) |
|
| Primary |
Client Satisfaction Questionnaire (CSQ-8) |
An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale (1 = "very dissatisfied" to 4 = "very satisfied"). Example questions include, "How would you rate the quality of service you received"? and "Did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with the W-PPMA mobile application. |
End of Treatment (8 weeks from baseline) |
|
| Primary |
Number of active days in the W-PPMA application |
Application engagement in the total number of active days using the application will be collected during the study to provide quantitative data regarding application utilization. |
Throughout treatment (from baseline to end of treatment at 8 weeks) |
|
| Primary |
Number of messages sent per week in the W-PPMA application |
Application engagement in the number of messages sent each week within the application will be collected during the study to provide quantitative data regarding application utilization. |
Throughout treatment (from baseline to end of treatment at 8 weeks) |
|
| Primary |
Number of modules completed in the W-PPMA application |
Application engagement in the number of modules completed within the application will be collected during the study to provide quantitative data regarding application content engagement. |
Throughout treatment (from baseline to end of treatment at 8 weeks) |
|
| Primary |
Content satisfaction ratings in the W-PPMA application |
Application content satisfaction ratings will be collected during the study to provide quantitative data regarding application content engagement. |
Throughout treatment (from baseline to end of treatment at 8 weeks) |
|
| Secondary |
Patient Health Questionnaire (PHQ-8) |
An 8-item abbreviated version of the PHQ-9 used to assess mood and anxiety symptoms respectively. The PHQ-8 excludes an item assessing suicidality. Total score between 0-27, where higher scores indicate greater levels of depression. |
Change from Baseline to End of Treatment at 8 weeks) |
|
| Secondary |
Edinburgh Prenatal Depression Scale (EPDS) |
A 10-item self-report questionnaire used as a screening tool to identify patients who are at risk for perinatal depression. The scale assesses depression criteria including anhedonia, worry, and sleep disturbance, in the past seven days. Each item has four ordinal response options, yielding a total score of 0 to 30 such that higher scores indicate more severe symptoms. |
Change from Baseline to End of Treatment at 8 weeks |
|
| Secondary |
Generalized Anxiety Disorder Questionnaire (GAD-7) |
A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety. |
Change from Baseline to End of Treatment at 8 weeks |
|
| Secondary |
Perceived Stress Scale (PSS-10) |
A 10-item self-reported questionnaire designed to measure the degree to which situations in one's life are appraised as stressful. Items comprising the PSS-10 assess the frequency of experiencing certain thoughts and feelings (e.g., feelings of upset, nervousness, a lack of control) over the past month. Each item is scored on a 5-point Likert scale from 0 (never) to 4 (very often); four positively stated items are reverse scored before summing all items to obtain the total score. Higher PSS scores indicate greater perceived stress. |
Change from Baseline to End of Treatment at 8 weeks |
|
