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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02813174
Other study ID # 16-018-H
Secondary ID
Status Completed
Phase N/A
First received June 15, 2016
Last updated August 16, 2017
Start date June 2016
Est. completion date May 9, 2017

Study information

Verified date August 2017
Source i4Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Compassionate Mind Training from Compassion-Focused Therapy


Locations

Country Name City State
United States Palo Alto University Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
i4Health

Country where clinical trial is conducted

United States, 

Outcome

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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