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

August 16, 2017 updated by: Meagan Stanley, i4Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Palo Alto University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Automated online Compassionate Mind Training
Behavioral: Compassionate Mind Training from Compassion-Focused Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Edinburgh Postnatal Depression Scale
Time Frame: Change from baseline depression at 6 and 12-weeks postpartum
Change from baseline depression at 6 and 12-weeks postpartum
Vulnerable Personality Style Questionnaire
Time Frame: At baseline
At baseline
Self Compassion Scale
Time Frame: Change from baseline self-compassion at two weeks post-baseline, and 6 and 12-weeks postpartum
Change from baseline self-compassion at two weeks post-baseline, and 6 and 12-weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-markers
Time Frame: At baseline
Saucier's Mini-markers of the Big Five Personality Traits (extraversion, agreeableness, openness, conscientiousness, neuroticism)
At baseline
Postpartum Depression Predictors Inventory - Revised
Time Frame: At baseline
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

i4Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

May 9, 2017

Study Completion (Actual)

May 9, 2017

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-018-H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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