Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34MH083866 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Emory University | OTHER |
| Kaiser Permanente | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBCT-PD | Experimental | Mindfulness-based cognitive therapy adapted for perinatal women (MBCT-PD) |
|
| OAR | Active Comparator | Ongoing Assessment and Referral (OAR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBCT-PD | Behavioral | The 8-session MBCT protocol, with modifications for use in the context of pregnancy and in anticipation of the postpartum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Up to 6 months postpartum |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sona Dimidjian, PhD | University of Colorado, Boulder | Principal Investigator |
| Sherryl Goodman, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Boulder | Boulder | Colorado | 80309 | United States | ||
| Kaiser Permanente Colorado |
Not provided
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OAR | Behavioral | 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. |
|
| Denver |
| Colorado |
| 80234 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Kaiser Permanente | Atlanta | Georgia | 30328 | United States |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |