Postpartum DepressionNCT02813174
Personality Style and Self Compassion in Postpartum Depression: An Online Prevention Study
A study testing Compassionate Mind Training from Compassion-Focused Therapy in people with Postpartum Depression, run by i4Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Compassionate Mind Training from Compassion-Focused Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 9 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women in the second and third trimester
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postpartum Depression
- Being tested
- Compassionate Mind Training from Compassion-Focused Therapy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassionate Mind Training from Compassion-Focused TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Automated online Compassionate Mind Training | Experimental | Not described Receives: Behavioral: Compassionate Mind Training from Compassion-Focused Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale
Measured: Change from baseline depression at 6 and 12-weeks postpartum
Vulnerable Personality Style Questionnaire
Measured: At baseline
Self Compassion Scale
Measured: Change from baseline self-compassion at two weeks post-baseline, and 6 and 12-weeks postpartum
Secondary outcomes (2)
Mini-markers
Saucier's Mini-markers of the Big Five Personality Traits (extraversion, agreeableness, openness, conscientiousness, neuroticism)
Measured: At baseline
Postpartum Depression Predictors Inventory - Revised
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion9 May 2017
- Study completion9 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- i4Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meagan Stanley, i4Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813174
- Sponsor's protocol ID
- 16-018-H
- Status last verified
- Aug 2017
- First submitted
- 15 Jun 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality Style and Self Compassion in Postpartum Depression: An Online Prevention Study
- ClinicalTrials.gov ID
- NCT02813174
- Acronym / sponsor ID
- 16-018-H
- Conditions
- Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- i4HealthUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 9 May 2017 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Automated online Compassionate Mind Training | Experimental | Behavioral: Compassionate Mind Training from Compassion-Focused Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women in the second and third trimester
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassionate Mind Training from Compassion-Focused Therapy | Behavioural | Automated online Compassionate Mind Training |
Primary outcome
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
2 secondary outcomes
Mini-markers
Time frame: At baseline
Postpartum Depression Predictors Inventory - Revised
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassionate Mind Training from Compassion-Focused Therapy in people with Postpartum Depression, run by i4Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (time frame: Change from baseline depression at 6 and 12-weeks postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.