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. 2023 May 4;2023(5):CD014874. doi: 10.1002/14651858.CD014874.pub2

Grote 2015.

Study characteristics
Methods

  • Study design: individual RCT (parallel groups)

  • Study aim/hypothesis: "It was hypothesised that compared to MSS‐Plus, the MOMCare collaborative care intervention would be associated with greater engagement in depression treatment, improved quality of depression care, and lower levels of perinatal depression severity" (Grote 2015, page 822).

  • Study setting: Seattle‐King County, USA. Data collection dates vary between studies, between 2009 and 2014

  • Trial registration number: NCT01045655
Participants

  • Inclusion criteria: ≥ 18 years, a likely diagnosis of major depression (PHQ‐9), or a likely diagnosis of dysthymia (MINI), 12‐32 weeks gestation, access to a telephone and English speaking

  • Exclusion criteria: acute suicidal behaviour or multiple (≥ 2) prior suicide attempts, lifetime history of schizophrenia or bipolar disorder I and II, substance abuse/dependence within the previous 3 months, current severe intimate partner violence, or currently in psychotherapy or seeing a psychiatrist

  • N referred and randomised: 1530 referred, 168 randomised

    • MOMCare: 83

    • MSS‐Plus: 85

  • N lost to follow‐up (post‐intervention): 17 (10.1%)

  • N analysed

    • Total sample: 164

    • Subsample used in meta‐analysis (unpublished data)

      • Baseline: MOMCare = 40, MSS‐Plus = 47

      • Post‐intervention: MOMCare = 40, MSS‐Plus = 38

      • 6‐month follow‐up: MOMCare = 40, MSS‐Plus = 41

      • 12‐month follow‐up: MOMCare = 39, MSS‐Plus = 41

      • 18‐month follow‐up: MOMCare = 39, MSS‐Plus = 40

  • Childhood maltreatment and/or complex trauma status: childhood maltreatment

  • Childhood maltreatment and/or trauma assessment: The Childhood Trauma Questionnaire. Mothers were classified using Bernstein's cut‐offs. Subsample consisted of mothers with one type of moderate to severe trauma exposure

  • Parenting stage: pregnancy to 6 weeks postpartum

  • Recruitment setting: public health centres, referrals from Maternity Support Services social works and nurses

  • Baseline characteristics

    • Mean parent age: 27.4 years

    • Mean child age: not reported

    • Parent gender: female participants

    • Parent co‐morbidity: majority of mothers experiencing mental health comorbidity (depression or dysthymia)

  • Progress+ coding: ethnic minority population
Interventions Intervention ‐ MOMCare + Maternity Support Services‐PLUS (MSS‐PLUS)

  • Category: psychological interventions (non‐trauma‐focused CBT‐based intervention)

  • Description: MOMCare consisted of brief interpersonal psychotherapy (IPT‐B) and/or pharmacotherapy for acute treatment. The MOMCare intervention was added onto MSS‐Plus.

  • Mode of delivery: blend of face‐to‐face and telephone, individually. Intervention services were provided in the public health centres, by phone, in community settings and infrequently at home

  • Dose: more than 10 hours

  • Length: other ‐ 3 to 6 months (treatment continued if adequate treatment response was not reached)

  • Frequency: weekly in acute phase and then variable

  • Protocol: yes

  • Provider: multidisciplinary team (depression care specialists, MOMCare study team)

  • Training: trainings included: (1) self‐study of the 4 study manuals ‐ engagement manual, brief IPT manual, pharmacotherapy manual and depression care by phone manual; (2) didactic orientation to perinatal medical complications by the team Ob/Gyn research physician; (3) training in the engagement session and motivational interviewing skills, e.g. reflective listening, affirming strengths, identifying and addressing treatment ambivalence, and problem‐solving barriers to care; (4) training in brief IPT, included readings, watching videos of skilled IPT therapists, role playing, and working with at least 2 to 3 training cases, which were audiotaped and evaluated to meet treatment fidelity; (5) training in cultural competence and implementing IPT‐B culturally relevant enhancements for socio‐economically disadvantaged patients; and (6) training in diagnosis and pharmacotherapy for depression and anxiety by the team psychiatrist

  • Implementation fidelity: the depression care specialists received weekly group supervision from the team psychiatrist and weekly individual supervision from the PI, who reviewed a majority of the audiotaped engagement and IPT‐B sessions, providing an opportunity for feedback and minimising treatment drift

  • Treatment adherence: 97.5% completed an initial IPT‐B or medication management treatment session, with a mean of 4.7 (SD 4.1) acute in‐person sessions and a mean of 4.8 (SD 4.3) acute telephone sessions completed, making a total of 9.5 (SD 4.0) acute treatment sessions completed. Almost all (95%) of the acute treatment sessions were completed within the 3‐month (75.5%) or 6‐month (19.1%) treatment window. Regarding maintenance, MOMCare patients received a mean total of 7.3 (SD 6.1) IPT maintenance and/or medication management sessions. "Seventy‐nine percent of MOMCare participants had at least one maintenance session through the 18‐month follow‐up" (Grote 2015, page 830)


Comparator ‐ Maternity Support Services‐PLUS (MSS‐PLUS)

  • Category: inactive comparator (enhanced treatment as usual)

  • Description: the usual standard of care in the public health system of Seattle‐King County for pregnant women on Medicaid. Goals of 'usual' MSS include offering services to promote healthy pregnancies and positive birth and parenting outcomes, providing case management services to meet basic needs, and facilitating regular contact with an OB provider. Pregnant women scoring PHQ‐9 & 10 were eligible for intensive MSS‐Plus services, entailing more frequent, longer visits from their multidisciplinary team

  • Mode of delivery: face‐to‐face

  • Dose: less than 1 hour

  • Length: other ‐ from pregnancy up to at least 2 months postpartum

  • Frequency: not reported

  • Protocol: not reported

  • Provider: multidisciplinary (public health social workers, nurses and nutritionists)

  • Training: not reported

  • Implementation fidelity: not reported

  • Uptake of standard care: the mean MSS‐PLUS visits in each unit of public health from baseline to 2 months postpartum was 11.35, with 35.2% engaging in an initial speciality mental health session
Outcomes Assessment time point(s)

  • Baseline (average 22 weeks pregnant)

  • Post‐intervention (< 3 months post‐intervention)

  • 6‐month follow‐up (3 to 12 months post‐intervention)

  • 12‐month follow‐up (3 to 12 months post‐intervention)

  • 18‐month follow‐up (> 12 month post‐intervention)


Note: at 3‐month follow‐up, 88% of mothers still pregnant; 6‐month follow‐up, 3 months postpartum; 12‐month follow‐up, mean 9 months postpartum; 18‐month follow‐up, mean 15 months postpartum
Primary outcome(s)
Parental complex trauma symptoms

  • PTSD symptom severity

    • Domain: parental psychological or socio‐emotional wellbeing

    • Measure: PTSD CheckList‐Civilian Version

    • Score range: 17 to 85

    • Direction of effect: higher scores = worse/more harm


Parental psychological wellbeing

  • Depression symptom severity

    • Domain: parental psychological or socio‐emotional wellbeing

    • Measure: Hopkins Symptom Checklist

    • Score range: 20 to 80

    • Direction of effect: higher scores = worse/more harm

  • Depression remission

    • Domain: parental psychological or socio‐emotional wellbeing

    • Measure: Hopkins Symptom Checklist (Score < 0.5)

    • Score range: 20 to 80

    • Direction of effect: higher scores = better/less harm

  • Probable Generalise Anxiety Disorder

    • Domain: parental psychological or socio‐emotional wellbeing

    • Measure: PRIME‐MD Patient Health Questionnaire

    • Score range: 0 to 29

    • Direction of effect: higher scores = worse/more harm

  • Functional impairment severity

    • Domain: parental psychological or socio‐emotional wellbeing

    • Measure: Work and Social Adjustment Scale

    • Score range: 0 to 40

    • Direction of effect: higher scores = worse/more harm


Secondary outcome(s)
Parent engagement

  • Dropout

    • Domain: parental intervention acceptability

    • Measure: dropout for any reason between randomisation and post‐intervention

    • Score range: not applicable

    • Direction of effect: higher events = more dropout


Cost or cost‐effectiveness

  • Depression free days

    • Domain: other outcomes

    • Measure: number of depression‐free days over 18 months, using a method adapted for the Hopkins Symptom Checklist–20 (SCL). SCL scores < 0.7 = depression free; SCL scores of 1.5 = fully symptomatic; SCL scores between 0.7 and 1.5 were assigned a proportional value

    • Score range: 20 to 80

    • Direction of effect: not applicable

  • Intervention costs

    • Domain: other outcomes

    • Measure: study staff salary and fringe benefit rates plus a 30% overhead rate

    • Score range: not applicable

    • Direction of effect: not applicable


Adverse outcome(s): none specified
Notes Comment(s)

  • Authors provided unpublished data for the subsample (87 participants) of mothers with moderate‐severe levels of maltreatment as assessed on the Childhood Trauma Questionnaire (for any of the 5 maltreatment types)

  • Baseline characteristics, Progress+ coding, enrolment/dropout details includes all participants in the study, unless otherwise specified

  • The data for the cost‐effectiveness outcome includes the total sample, including mothers with and without childhood maltreatment


Funding source: National Institute of Mental Health
Conflicts of interest: the authors declared that there were no conflicts of interest