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

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ClinicalTrials.gov Identifier: NCT02813174
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Meagan Stanley, i4Health

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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Behavioral: Compassionate Mind Training from Compassion-Focused Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2016
Actual Primary Completion Date : May 9, 2017
Actual Study Completion Date : May 9, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale [ Time Frame: Change from baseline depression at 6 and 12-weeks postpartum ]
  2. Vulnerable Personality Style Questionnaire [ Time Frame: At baseline ]
  3. Self Compassion Scale [ Time Frame: Change from baseline self-compassion at two weeks post-baseline, and 6 and 12-weeks postpartum ]

Secondary Outcome Measures :
  1. Mini-markers [ Time Frame: At baseline ]
    Saucier's Mini-markers of the Big Five Personality Traits (extraversion, agreeableness, openness, conscientiousness, neuroticism)

  2. Postpartum Depression Predictors Inventory - Revised [ Time Frame: At baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813174


Locations
United States, California
Palo Alto University
Palo Alto, California, United States, 94304
Sponsors and Collaborators
i4Health

Responsible Party: Meagan Stanley, Clinical Psychology PhD Candidate, i4Health
ClinicalTrials.gov Identifier: NCT02813174     History of Changes
Other Study ID Numbers: 16-018-H
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications