The proposed study seeks to elucidate the mechanisms underlying Mindfulness-Based Cognitive Therapy in pregnancy to improve understanding of how and why this treatment modality enhances well-being, which can then be leveraged to optimize treatment for psychological distress emerging during this vulnerable period.
Pregnancy and postpartum is a period of vulnerability for new or worsening psychiatric symptoms. Mindfulness Based Cognitive Therapy (MBCT) is an effective approach to mitigate pregnancy-related worsening of psychological distress. However, prior research has focused predominantly on symptoms of depression and anxiety, and is it not clear how or why MBCT improves psychological health during the perinatal period. Thus, the goals of this project are to (1) examine whether MBCT improves psychological functioning among pregnant women and whether these improvements persist at three-months postpartum, (2) examine whether improved ability to regulate emotions and behavior accounts for the beneficial effects of MBCT, and (3) determine what demographic, socioeconomic, and psychosocial factors impact treatment engagement and effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
MBCT is an 8-week group-based treatment modality designed specifically to prevent recurrence of depressive symptoms. MBCT combines principles of cognitive behavioral therapy and mindfulness meditation to help participants change the way in which they relate to automatic negative thinking patterns that trigger symptom recurrence. Through awareness and acceptance of negative thoughts and emotions, participants learn how to dismiss negative thoughts and to tolerate distress and uncertainty.
TAU (the control group) provides participants with information about the benefits of mindfulness in pregnancy and offers referrals for psychotherapy in the community. Participants in TAU are contacted monthly via phone or videoconference call to maintain engagement.
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States
Change in presence and severity of depressive symptoms from baseline to 8 weeks
Change in the presence and severity of depressive symptoms from baseline to 8 weeks will be measured using the 10-item Edinburgh Postnatal Depression Scale (EPDS), a widely used instrument validated in pregnancy and the postpartum period. Questions 1, 2, 3, and 4 on the EPDS are scored 0, 1, 2, or 3 with the top box scored as 0 and the bottom box scored as 3. Questions 3 and 5-10 on the EPDS are reverse scored with the top box scored as 3 and the bottom box scored as 0. Total scores on the EPDS are calculated by summing the score for each question. Total scores on the EPDS range from 0-30, with a score of 10 or greater indicating possible depression and higher scores indicating greater severity of possible depression.
Time frame: baseline and 8 weeks
Change in presence and severity of depressive symptoms from 8 weeks to 3 months
Change in the presence and severity of depressive symptoms from baseline to 3 months will be measured using the 10-item Edinburgh Postnatal Depression Scale (EPDS), a widely used instrument validated in pregnancy and the postpartum period. Questions 1, 2, 3, and 4 on the EPDS are scored 0, 1, 2, or 3 with the top box scored as 0 and the bottom box scored as 3. Questions 3 and 5-10 on the EPDS are reverse scored with the top box scored as 3 and the bottom box scored as 0. Total scores on the EPDS are calculated by summing the score for each question. Total scores on the EPDS range from 0-30, with a score of 10 or greater indicating possible depression and higher scores indicating greater severity of possible depression.
Time frame: 8 weeks and 3 months
Change in perceptions of daily life stress from baseline to 8 weeks
Change in the perceptions of daily life stress from baseline to 8 weeks will be measured using the 10-item Perceived Stress Scale (PSS). Questions 1, 2, 3, 6, 9, and 10 on the PSS are scored 0, 1, 2, and 3. Questions 4, 5, 7, and 8 on the PSS are reverse scored 3, 2, 1, and 0. Total scores on the PSS are calculated by summing the score for each question. Total scores on the PSS range from 0-40, with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress, scores ranging from 14-26 would be considered moderate stress, and scores ranging from 27-40 would be considered high perceived stress.
Time frame: baseline and 8 weeks
Change in perceptions of daily life stress from 8 weeks to 3 months
Change in the perceptions of daily life stress from 8 weeks to 3 months will be measured using the 10-item Perceived Stress Scale (PSS). Questions 1, 2, 3, 6, 9, and 10 on the PSS are scored 0, 1, 2, and 3. Questions 4, 5, 7, and 8 on the PSS are reverse scored 3, 2, 1, and 0. Total scores on the PSS are calculated by summing the score for each question. Total scores on the PSS range from 0-40, with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress, scores ranging from 14-26 would be considered moderate stress, and scores ranging from 27-40 would be considered high perceived stress.
Time frame: 8 weeks and 3 months
Change in anxiety symptoms from baseline to 8 weeks
Change in anxiety symptoms from baseline to 8 weeks will be measured using the 16-item Penn State Worry Questionnaire (PSWQ). Questions 2, 4-7, 9, and 12-16 on the PSWQ are scored 1-5. Questions 1, 3, 8, 10, and 11 on the PSWQ are reverse scored 5-1. Total scores on the PSWQ are calculated by summing the score for each question. Total scores on the PSWQ range from 16-80, with higher scores indicating higher worry. Scores ranging from 16-39 would be considered low worry, scores ranging from 40-59 would be considered moderate worry, and scores ranging from 60-80 would be considered high worry.
Time frame: baseline and 8 weeks
Change in anxiety symptoms from 8 weeks to 3 months
Change in anxiety symptoms from 8 weeks to 3 months will be measured using the 16-item Penn State Worry Questionnaire (PSWQ). Questions 2, 4-7, 9, and 12-16 on the PSWQ are scored 1-5. Questions 1, 3, 8, 10, and 11 on the PSWQ are reverse scored 5-1. Total scores on the PSWQ are calculated by summing the score for each question. Total scores on the PSWQ range from 16-80, with higher scores indicating higher worry. Scores ranging from 16-39 would be considered low worry, scores ranging from 40-59 would be considered moderate worry, and scores ranging from 60-80 would be considered high worry.
Time frame: 8 weeks and 3 months
Change in rumination from baseline to 8 weeks
Change in rumination from baseline to 8 weeks will be measured using the 10-item Ruminative Response Scale (RRS-10). Questions 1-10 on the RRS-10 are scored 1-4. Total scores on the RRS-10 are calculated by summing the score for each question. Total scores on the RRS-10 range from 1-40, with higher scores indicating higher rumination.
Time frame: baseline and 8 weeks
Change in rumination from 8 weeks to 3 months
Change in rumination from 8 weeks to 3 months will be measured using the 10-item Ruminative Response Scale (RRS-10). Questions 1-10 on the RRS-10 are scored 1-4. Total scores on the RRS-10 are calculated by summing the score for each question. Total scores on the RRS-10 range from 1-40, with higher scores indicating higher rumination.
Time frame: 8 weeks and 3 months
Change in mindfulness from baseline to 8 weeks
Change in mindfulness from baseline to 8 weeks will be measured using the 39-item Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ consists of five subscales, which are calculated by summing the following questions, which are scored 1-5 (questions followed by "R" are reverse scored 5-1): observing = questions 1, 6, 11, 15, 20, 26, 31, and 36; describing = 2, 7, 12R, 16R, 22R, 27, 32, and 37; acting with awareness = 5R, 8R, 13R, 18R, 23R, 28R, 34R, and 38R; nonjudging of inner experience = 3R, 10R, 14R, 17R, 25R, 30R, 35R, and 39R; nonreactivity to inner experience = 4, 9, 19, 21, 24, 29, and 33. For the FFMQ subscales, scores can range from 8 to 40, except for non-reactivity to inner experience, which can range from 7 to 35. For the FFMQ subscales, higher scores represent higher subscale levels of mindfulness. Total scores are calculated by summing the subscale scores and range from 39-195, with higher scores indicating higher overall levels of mindfulness.
Time frame: baseline and 8 weeks
Change in mindfulness from 8 weeks to 3 months
Change in mindfulness from 8 weeks to 3 months will be measured using the 39-item Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ consists of five subscales, which are calculated by summing the following questions, which are scored 1-5 (questions followed by "R" are reverse scored 5-1): observing = questions 1, 6, 11, 15, 20, 26, 31, and 36; describing = 2, 7, 12R, 16R, 22R, 27, 32, and 37; acting with awareness = 5R, 8R, 13R, 18R, 23R, 28R, 34R, and 38R; nonjudging of inner experience = 3R, 10R, 14R, 17R, 25R, 30R, 35R, and 39R; nonreactivity to inner experience = 4, 9, 19, 21, 24, 29, and 33. For the FFMQ subscales, scores can range from 8 to 40, except for non-reactivity to inner experience, which can range from 7 to 35. For the FFMQ subscales, higher scores represent higher subscale levels of mindfulness. Total scores are calculated by summing the subscale scores and range from 39-195, with higher scores indicating higher overall levels of mindfulness.
Time frame: 8 weeks and 3 months
Change in rates of psychiatric diagnoses from baseline to 3 months
Change in rates of psychiatric diagnoses from baseline to 3 months will be measured using the Structured Clinical Interview for DSM-5 (SCID-5). The SCID-5 consists of a semistructured interview administered to participants by a clinician or trained mental health professional to determine participants' current and previous psychiatric diagnoses.
Time frame: baseline and 3 months
Change in disinhibition from baseline to 8 weeks
Change in disinhibition from baseline to 8 weeks will be assessed by the Go/No-Go task (GNG). The GNG task is administered on the computer and asks participants to respond to visual stimuli that is presented continuously. Participants must make a motor response for the "go" stimulus and withhold a motor response for the "no-go" stimulus. The proportion of no-go targets in which an individual successfully withholds a motor response will provide a measure of response inhibition, with fewer errors indicating better response inhibition and a higher error rate indicating a greater tendency towards disinhibited behavior.
Time frame: baseline and 8 weeks
Change in disinhibition from 8 weeks to 3 months
Change in disinhibition from 8 weeks to 3 months will be assessed by the Go/No-Go task (GNG). The GNG task is administered on the computer and asks participants to respond to visual stimuli that is presented continuously. Participants must make a motor response for the "go" stimulus and withhold a motor response for the "no-go" stimulus. The proportion of no-go targets in which an individual successfully withholds a motor response will provide a measure of response inhibition, with fewer errors indicating better response inhibition and a higher error rate indicating a greater tendency towards disinhibited behavior.
Time frame: 8 weeks and 3 months
Change in attention from baseline to 8 weeks
Change in attention from baseline to 8 weeks will be assessed by the Stroop Color-Word Test. The Stroop Color-Word Test is a computerized task in which participants are required to name the color of a written color word while inhibiting the impulse to read the word itself. The difference between mean response times of correct responses on incongruent and control trials is used to compute an interference score, which provides a measure of attention, with lower scores indicating greater attentional deficits.
Time frame: baseline and 8 weeks
Change in attention from 8 weeks to 3 months
Change in attention from 8 weeks to 3 months will be assessed by the Stroop Color-Word Test. The Stroop Color-Word Test is a computerized task in which participants are required to name the color of a written color word while inhibiting the impulse to read the word itself. The difference between mean response times of correct responses on incongruent and control trials is used to compute an interference score, which provides a measure of attention, with lower scores indicating greater attentional deficits.
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Time frame: 8 weeks to 3 months
Change in cognitive inflexibility from baseline to 8 weeks
Change in cognitive inflexibility from baseline to 8 weeks will be assessed by the Wisconsin Card Sorting Task (WCST). The WCST is a computerized task in which participants have to match a target card with one of four category cards under changing conditions. The number of incorrect responses that would have been correct for the preceding condition provides a measure of cognitive inflexibility, with higher scores indicating greater cognitive inflexibility.
Time frame: baseline to 8 weeks
Change in cognitive inflexibility from 8 weeks to 3 months
Change in cognitive inflexibility from 8 weeks to 3 months will be assessed by the Wisconsin Card Sorting Task (WCST). The WCST is a computerized task in which participants have to match a target card with one of four category cards under changing conditions. The number of incorrect responses that would have been correct for the preceding condition provides a measure of cognitive inflexibility, with higher scores indicating greater cognitive inflexibility.
Time frame: 8 weeks to 3 months
Change in emotion regulation from baseline to 8 weeks
Change in emotion regulation from baseline to 8 weeks will be measured using the 10-item Emotion Regulation Questionnaire (ERQ). The ERQ consists of two subscales, which are calculated by summing the following questions, which are scored 1-7 (none reverse scored): cognitive reappraisal = questions 1, 3, 5, 7, 8, and 10; expressive suppression = questions 2, 4, 6, and 9. For the ERQ subscales, scores can range from 1-42, with higher scores indicating higher use of that particular emotion regulation strategy and lower scores indicating less frequent use.
Time frame: baseline and 8 weeks
Change in emotion regulation from 8 weeks to 3 months
Change in emotion regulation from 8 weeks to 3 months will be measured using the 10-item Emotion Regulation Questionnaire (ERQ). The ERQ consists of two subscales, which are calculated by summing the following questions, which are scored 1-7 (none reverse scored): cognitive reappraisal = questions 1, 3, 5, 7, 8, and 10; expressive suppression = questions 2, 4, 6, and 9. For the ERQ subscales, scores can range from 1-42, with higher scores indicating higher use of that particular emotion regulation strategy and lower scores indicating less frequent use.
Time frame: 8 weeks and 3 months