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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
i4Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
June 15, 2016
Last Updated
August 16, 2017
Sponsor
i4Health
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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

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Personality Style and Self Compassion in Postpartum Depression: An Online Prevention Study

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