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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 15, 2016
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date August 21, 2017
Study Start Date  ICMJE June 2016
Actual Primary Completion Date May 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
  • Edinburgh Postnatal Depression Scale [ Time Frame: Change from baseline depression at 6 and 12-weeks postpartum ]
  • Vulnerable Personality Style Questionnaire [ Time Frame: At baseline ]
  • Self Compassion Scale [ Time Frame: Change from baseline self-compassion at two weeks post-baseline, and 6 and 12-weeks postpartum ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • Mini-markers [ Time Frame: At baseline ]
    Saucier's Mini-markers of the Big Five Personality Traits (extraversion, agreeableness, openness, conscientiousness, neuroticism)
  • Postpartum Depression Predictors Inventory - Revised [ Time Frame: At baseline ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
  • Mini-markers [ Time Frame: At baseline ]
  • Postpartum Depression Predictors Inventory - Revised [ Time Frame: At baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personality Style and Self Compassion in Postpartum Depression: An Online Prevention Study
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Postpartum Depression
Intervention  ICMJE Behavioral: Compassionate Mind Training from Compassion-Focused Therapy
Study Arms  ICMJE Experimental: Automated online Compassionate Mind Training
Intervention: Behavioral: Compassionate Mind Training from Compassion-Focused Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 16, 2017)
228
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2016)
150
Actual Study Completion Date  ICMJE May 9, 2017
Actual Primary Completion Date May 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02813174
Other Study ID Numbers  ICMJE 16-018-H
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Meagan Stanley, i4Health
Study Sponsor  ICMJE i4Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account i4Health
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP