Depression Clinical Trial
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).
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.
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