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

• Sponsor: i4Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02813174
• Collaborator: (none)
• Enrollment: 228
• Location: 1
• Arm: 1
• Duration (Months): 11.2
• Patients Per Site Per Month: 20.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Depression	Behavioral: Compassionate Mind Training from Compassion-Focused Therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 228 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: May 9, 2017
• Actual Study Completion Date: May 9, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Edinburgh Postnatal Depression Scale [Change from baseline depression at 6 and 12-weeks postpartum]

2. Vulnerable Personality Style Questionnaire [At baseline]

3. Self Compassion Scale [Change from baseline self-compassion at two weeks post-baseline, and 6 and 12-weeks postpartum]

Secondary Outcome Measures

1. Mini-markers [At baseline]

   Saucier's Mini-markers of the Big Five Personality Traits (extraversion, agreeableness, openness, conscientiousness, neuroticism)

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Alto University	Palo Alto	California	United States	94304

Sponsors and Collaborators

• i4Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Meagan Stanley, Clinical Psychology PhD Candidate, i4Health
• ClinicalTrials.gov Identifier: NCT02813174
• Other Study ID Numbers: 16-018-H
• First Posted: Jun 24, 2016
• Last Update Posted: Aug 21, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Depression, Postpartum; Depression; Depressive Disorder

Study Results

No Results Posted as of Aug 21, 2017