Personality Style and Self Compassion in Postpartum Depression: An Online Prevention Study
Primary Purpose
Postpartum Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compassionate Mind Training from Compassion-Focused Therapy
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Depression
Eligibility Criteria
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
Sites / Locations
- Palo Alto University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Automated online Compassionate Mind Training
Arm Description
Outcomes
Primary Outcome Measures
Edinburgh Postnatal Depression Scale
Vulnerable Personality Style Questionnaire
Self Compassion Scale
Secondary Outcome Measures
Mini-markers
Saucier's Mini-markers of the Big Five Personality Traits (extraversion, agreeableness, openness, conscientiousness, neuroticism)
Postpartum Depression Predictors Inventory - Revised
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02813174
Brief Title
Personality Style and Self Compassion in Postpartum Depression: An Online Prevention Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 9, 2017 (Actual)
Study Completion Date
May 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
i4Health
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Automated online Compassionate Mind Training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Compassionate Mind Training from Compassion-Focused Therapy
Primary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale
Time Frame
Change from baseline depression at 6 and 12-weeks postpartum
Title
Vulnerable Personality Style Questionnaire
Time Frame
At baseline
Title
Self Compassion Scale
Time Frame
Change from baseline self-compassion at two weeks post-baseline, and 6 and 12-weeks postpartum
Secondary Outcome Measure Information:
Title
Mini-markers
Description
Saucier's Mini-markers of the Big Five Personality Traits (extraversion, agreeableness, openness, conscientiousness, neuroticism)
Time Frame
At baseline
Title
Postpartum Depression Predictors Inventory - Revised
Time Frame
At baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Palo Alto University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Personality Style and Self Compassion in Postpartum Depression: An Online Prevention Study
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