Postpartum Depression Clinical Trial
Verified date | August 2017 |
Source | i4Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary aim of this study is to assess the relationship between personality style, self-compassion and depression during pregnancy, to identify psychological risk factors, particularly personality styles, that may contribute to the onset of PPD. Additionally, the study will provide support for the effectiveness of Internet-based Compassionate-Mind Training (iCMT) as a prevention intervention for Postpartum Depression (PPD) for women in the 2nd and 3rd trimester of pregnancy. The study will also assess differences along personality predictors and depression severity as they relate to intervention outcomes (i.e. depression in postpartum and self-compassion) and engagement. The researchers hypothesize that women both at high and low risk for PPD will receive benefits from the intervention, however, those who endorse more maladaptive personality traits will likely engage and benefit less than those who do not endorse these traits.
Status | Completed |
Enrollment | 228 |
Est. completion date | May 9, 2017 |
Est. primary completion date | May 9, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pregnant women in the second and third trimester Exclusion Criteria: - Under 18 years of age - Males - Women who are not pregnant - Pregnant women in the first trimester of pregnancy or over 36 weeks pregnant - Women who likely meet criteria for a Major Depressive Episode - Women currently in in-person psychological tx |
Country | Name | City | State |
---|---|---|---|
United States | Palo Alto University | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
i4Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Edinburgh Postnatal Depression Scale | Change from baseline depression at 6 and 12-weeks postpartum | ||
Primary | Vulnerable Personality Style Questionnaire | At baseline | ||
Primary | Self Compassion Scale | Change from baseline self-compassion at two weeks post-baseline, and 6 and 12-weeks postpartum | ||
Secondary | Mini-markers | Saucier's Mini-markers of the Big Five Personality Traits (extraversion, agreeableness, openness, conscientiousness, neuroticism) | At baseline | |
Secondary | Postpartum Depression Predictors Inventory - Revised | At baseline |
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