NCT02813174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

June 15, 2016

Last Update Submit

August 16, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Edinburgh Postnatal Depression Scale

    Change from baseline depression at 6 and 12-weeks postpartum

  • Vulnerable Personality Style Questionnaire

    At baseline

  • Self Compassion Scale

    Change from baseline self-compassion at two weeks post-baseline, and 6 and 12-weeks postpartum

Secondary Outcomes (2)

  • Mini-markers

    At baseline

  • Postpartum Depression Predictors Inventory - Revised

    At baseline

Study Arms (1)

Automated online Compassionate Mind Training

EXPERIMENTAL
Behavioral: Compassionate Mind Training from Compassion-Focused Therapy

Interventions

Automated online Compassionate Mind Training

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women in the second and third trimester

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palo Alto University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychology PhD Candidate

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 24, 2016

Study Start

June 1, 2016

Primary Completion

May 9, 2017

Study Completion

May 9, 2017

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations