Trial Outcomes & Findings for [Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression] (NCT NCT05551195)

[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]

Measure of depression. This is a 6-item questionnaire, where total scores range from 0 to 22, with higher scores indicating greater severity of depression.

Measure of postpartum depression. A 10-item self-report questionnaire that assesses depression criteria and yields a total score from 0 to 30 where higher scores denote greater depression.

Measure of depression. A 9-item self-report questionnaire where total scores range from 0 to 27, with higher scores indicating greater levels of depression

Measure of anxiety. A 7-item brief self-report questionnaire, where total score range is between 0-21, with higher scores indicate greater levels of anxiety.

Measure of mother-infant bond. An 8-item self-report questionnaire, where total scores range from 0 to 24, with lower scores indicating good bonding.

Measure of overall severity of current clinical presentation and symptomatology. A single item, 7-point Likert scale on which the investigator will rate patients' severity of illness based on clinical interviews and assessments relative to their experience with other patients with the same diagnosis. Responses include 0 (not assessed) and range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill).

Measure of improvement. A single item, 7-point Likert scale that assesses the overall improvement in patients' condition at the end of treatment. The investigator will rate whether the participant's total improvement was due entirely to the intervention. Responses include 0 (not assessed) and range from 1 (very much improved) to 7 (very much worse).

Measure of change in clinical status. A single item scale based on the CGI and adapted to the patient that mainly measures change in clinical status (PGI-C) but can also measure disease severity (PGI-S) or disease improvement (PGI-I). PGI-S responses for current illness severity range from "I Feel Fine (1)" to "I Feel Extremely Ill (4)". PGI-C responses range from "Very Much Improved (1) to "Very Much Worse (7)" since starting the trial. For both scales, lower scores indicate better outcomes.

An 8-item measure used to assess client's satisfaction with treatment.Total scores range from 8-32, with high scores indicating greater satisfaction with the treatment.