Postpartum DepressionNCT02387424
Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depressive Relapse/Recurrence
A study testing MBCT-PD and OAR in people with Postpartum Depression and Pregnancy, run by University of Colorado, Boulder at 4 sites in United States.
Trial summary
Pregnant women with histories of depression are at high risk of depressive relapse/recurrence during the perinatal period, and options for relapse/recurrence prevention are limited. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression, Pregnancy, Depression
- What is being tested?
- MBCT-PD and OAR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2010to May 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant up to 32 weeks gestation
- Meeting criteria for prior depression
- Failure to meet criteria for a diagnosis of MDD in the last two months
- Available for group intervention scheduled meetings
Who cannot join
- Presence of schizophrenia or schizoaffective disorder
- Presence of bipolar disorder or current psychosis
- Presence of organic mental disorder or pervasive developmental delay
- Presence of current eating disorder
- Presence of current substance abuse or dependence
- Presence of antisocial, borderline, or schizotypal personality disorder
Show all 9Show fewer
- Presence of imminent suicide or homicide risk
- Presence of any other axis I or II disorders that necessitate priority treatment not provided by the study protocol
- Women with any medical conditions that would preclude participation, including high-risk pregnancy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30322
Kaiser Permanente
Atlanta, Georgia, 30328
University of Colorado Boulder
Boulder, Colorado, 80309
Kaiser Permanente Colorado
Denver, Colorado, 80234
About this study
Official title: Phase Two: A Pilot Randomized Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depressive Relapse/Recurrence
Pregnant women with histories of depression are at high risk of depressive relapse/recurrence during the perinatal period, and options for relapse/recurrence prevention are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but has not been studied among at risk pregnant women.
This study is the second phase of a multi-phase project adapting MBCT for perinatal women (MBCT-PD).
Read the detailed description
Mindfulness-based cognitive therapy (MBCT) represents one of the most important recent developments in the effort to prevent recurrent depression. Explicitly designed to modify core underlying vulnerability factors among recovered individuals with histories of depression, MBCT may have high applicability to the prevention of perinatal depression (PD).
During this phase of the project the investigators will conduct a two-site pilot randomized clinical trial with pregnant women at high-risk of perinatal depression, comparing the efficacy of MBCT-PD to a control group in the prevention of depressive relapse and recurrence. Participants assigned to the control group will receive "ongoing assessment and referral" (OAR), consisting of routine screening and referral to behavioral health services within obstetric clinical settings within Kaiser Permanente (KP) in Colorado and Georgia. The investigators will randomly assign participants at each site to 8 weeks of MBCT-PD or OAR.
During this phase, the investigators will address the following aims:
- Specific Aim 1: To test the primary hypothesis that participants receiving MBCT-PD will experience improved depressive outcomes compared to participants receiving OAR, including lower rates of depressive relapse/recurrence and lower depressive symptom severity as compared to participants receiving OAR.
- Specific Aim 2: To explore the secondary hypotheses that participants receiving MBCT-PD will report improved functioning as compared to participants receiving OAR on a range of secondary outcomes, including indices of anxiety and stress and obstetrical complications.
- Specific Aim 3: To explore potential moderators and mediators of depression outcomes.
- Specific Aim 4: To train and evaluate the ability of behavioral health care providers to administer the MBCT-PD program with fidelity.
- Conditions
- Postpartum Depression, Pregnancy, Depression
- Being tested
- MBCT-PD, OAR
- Keywords
- depression, mindfulness, pregnancy, prevention, cognitive behavioral therapy
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCT-PDBehavioural
The 8-session MBCT protocol, with modifications for use in the context of pregnancy and in anticipation of the postpartum.
OARBehavioural
Ongoing Assessment and Referral (OAR) consists of routine screening and referral to behavioral health services within obstetric clinical settings within Kaiser Permanente (KP) in Colorado and Georgia.
| Study group | Role | What they receive |
|---|---|---|
| MBCT-PD | Experimental | Mindfulness-based cognitive therapy adapted for perinatal women (MBCT-PD) Receives: Behavioral: MBCT-PD |
| OAR | Active comparator | Ongoing Assessment and Referral (OAR) Receives: Behavioral: OAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement (class attendance)
Engagement is operationalized in-part as class attendance, with completion is defined as attendance at a minimum of four classes, and daily home practice recorded daily as the number of times of practice and type of practice, which are classified as either formal or informal practice.
Measured: Up to 8 weeks
Client Satisfaction (CSQ-8)
Participant satisfaction will be evaluated by the CSQ-8, which is designed to yield a homogeneous estimate of general satisfaction with services. An exit interview also will be completed at 6-months postpartum.
Measured: Up to 8 weeks
MBCT-PD Adherence Scale (MBCT-PD-AS)
Treatment fidelity will be assessed to provide checks on the adequacy of treatment implementation, using the MBCT-PD Adherence Scale.
Measured: Up to 8 weeks
Change in Depressive Relapse Status: Longitudinal Interval Follow-up Evaluation (LIFE)
Rate of depressive relapse and time to relapse will be assessed using the LIFE, which provides a retrospective assessment of relapse or recurrence based on a semi-structured interview according to DSM-IV-TR diagnostic criteria.
Measured: Up to 6 months postpartum
Change in Edinburgh Postpartum Depression Scale (EPDS)
Change in the severity of depressive symptoms will be evaluated by the Edinburgh Postpartum Depression Scale (EPDS), which is the most widely used self-report measure of antenatal and postpartum depression.
Measured: Up to 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startJul 2010
- Primary completionMay 2013
- Study completionMay 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sona Dimidjian, University of Colorado, Boulder
- Investigators
- Sona Dimidjian, PhD, Principal investigator, University of Colorado, BoulderSherryl Goodman, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387424
- Sponsor's protocol ID
- 13-0353-02
- Other IDs
- R34MH083866
- Status last verified
- Apr 2020
- First submitted
- 12 Feb 2015
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Two: A Pilot Randomized Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depressive Relapse/Recurrence
- ClinicalTrials.gov ID
- NCT02387424
- Acronym / sponsor ID
- 13-0353-02
- Conditions
- Postpartum Depression, Pregnancy, Depression
- Keywords
- depression, mindfulness, pregnancy, prevention, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- Emory University, Kaiser Permanente, National Institute of Mental Health (NIMH)
- Study start
- Jul 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Mar 2015 (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.
Pregnant women with histories of depression are at high risk of depressive relapse/recurrence during the perinatal period, and options for relapse/recurrence prevention are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but has not been studied among at risk pregnant women.
This study is the second phase of a multi-phase project adapting MBCT for perinatal women (MBCT-PD).
Detailed description
Mindfulness-based cognitive therapy (MBCT) represents one of the most important recent developments in the effort to prevent recurrent depression. Explicitly designed to modify core underlying vulnerability factors among recovered individuals with histories of depression, MBCT may have high applicability to the prevention of perinatal depression (PD).
During this phase of the project the investigators will conduct a two-site pilot randomized clinical trial with pregnant women at high-risk of perinatal depression, comparing the efficacy of MBCT-PD to a control group in the prevention of depressive relapse and recurrence. Participants assigned to the control group will receive "ongoing assessment and referral" (OAR), consisting of routine screening and referral to behavioral health services within obstetric clinical settings within Kaiser Permanente (KP) in Colorado and Georgia. The investigators will randomly assign participants at each site to 8 weeks of MBCT-PD or OAR.
During this phase, the investigators will address the following aims:
- Specific Aim 1: To test the primary hypothesis that participants receiving MBCT-PD will experience improved depressive outcomes compared to participants receiving OAR, including lower rates of depressive relapse/recurrence and lower depressive symptom severity as compared to participants receiving OAR.
- Specific Aim 2: To explore the secondary hypotheses that participants receiving MBCT-PD will report improved functioning as compared to participants receiving OAR on a range of secondary outcomes, including indices of anxiety and stress and obstetrical complications.
- Specific Aim 3: To explore potential moderators and mediators of depression outcomes.
- Specific Aim 4: To train and evaluate the ability of behavioral health care providers to administer the MBCT-PD program with fidelity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCT-PD | Experimental | Behavioral: MBCT-PDMindfulness-based cognitive therapy adapted for perinatal women (MBCT-PD) |
| OAR | Active comparator | Behavioral: OAROngoing Assessment and Referral (OAR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant up to 32 weeks gestation
- Meeting criteria for prior depression
- Failure to meet criteria for a diagnosis of MDD in the last two months
- Available for group intervention scheduled meetings
Key exclusion criteria (9 listed)
- Presence of schizophrenia or schizoaffective disorder
- Presence of bipolar disorder or current psychosis
- Presence of organic mental disorder or pervasive developmental delay
- Presence of current eating disorder
- Presence of current substance abuse or dependence
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 |
|---|---|---|
| MBCT-PDThe 8-session MBCT protocol, with modifications for use in the context of pregnancy and in anticipation of the postpartum. | Behavioural | MBCT-PD |
| OAROngoing Assessment and Referral (OAR) consists of routine screening and referral to behavioral health services within obstetric clinical settings within Kaiser Permanente (KP) in Colorado and Georgia. | Behavioural | OAR |
Primary outcome
Engagement (class attendance)
Time frame: Up to 8 weeks
Engagement is operationalized in-part as class attendance, with completion is defined as attendance at a minimum of four classes, and daily home practice recorded daily as the number of times of practice and type of practice, which are classified as either formal or informal practice.
Client Satisfaction (CSQ-8)
Time frame: Up to 8 weeks
Participant satisfaction will be evaluated by the CSQ-8, which is designed to yield a homogeneous estimate of general satisfaction with services. An exit interview also will be completed at 6-months postpartum.
MBCT-PD Adherence Scale (MBCT-PD-AS)
Time frame: Up to 8 weeks
Treatment fidelity will be assessed to provide checks on the adequacy of treatment implementation, using the MBCT-PD Adherence Scale.
Change in Depressive Relapse Status: Longitudinal Interval Follow-up Evaluation (LIFE)
Time frame: Up to 6 months postpartum
Rate of depressive relapse and time to relapse will be assessed using the LIFE, which provides a retrospective assessment of relapse or recurrence based on a semi-structured interview according to DSM-IV-TR diagnostic criteria.
Change in Edinburgh Postpartum Depression Scale (EPDS)
Time frame: Up to 6 months postpartum
Change in the severity of depressive symptoms will be evaluated by the Edinburgh Postpartum Depression Scale (EPDS), which is the most widely used self-report measure of antenatal and postpartum depression.
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 6 Apr 2020.
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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.
Sona Dimidjian, PhD principal investigator
University of Colorado, Boulder
Sherryl Goodman, PhD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCT-PD and OAR in people with Postpartum Depression and Pregnancy, run by University of Colorado, Boulder at 4 sites 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 4 inclusion and 9 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 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Engagement (class attendance) (time frame: Up to 8 weeks). The study lists 5 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 6 Apr 2020.