Gjerdingen 2009.
| Methods | Study design: Pilot randomised controlled trial | |
| Participants | Setting: Primary care Diagnosis: Women who became positive on Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID) at 0 to 6 months postpartum. Participants were also given the opportunity to self‐diagnose depression through a 9‐month survey question with a yes/no answer: “Since your baby was born, have you been depressed or diagnosed with depression?” Inclusion criteria: Being a mother of a 0‐ to 1‐month‐old infant who was registered at one of the participating clinics, being English literate, and being greater than or equal to 12 years old Exclusion criteria: Not stated Age: Mean 27.6 years Gender: 100% female Ethnicity: 62% non‐white Country: United States Sample size (randomised): Total participants 39, intervention 19, control 20 |
|
| Interventions | Intervention: Stepped collaborative care Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary physician (PCP), nurse with MH experience (CM), psychiatrist (MH specialist) 2) a structured management plan: The stepped care intervention included (1) referral to the PCP for initial treatment (AD and/or psychotherapy referral); (2) regular telephone follow‐up with a CM; (3) decision support for PCPs (e.g. advice regarding specific ADs, additional treatment, or mental health referral); (4) consultation or referral to MH specialist for complex cases (e.g., psychiatrists conducted psychiatric evaluations and adjusted medications and therapists provided psychotherapy using CBT, interpersonal psychotherapy (IPT), or other therapies depending on patient need); and (5) patient education provided through the PCP, CM, and a mailed postpartum depression brochure. Telephone calls addressed depressive symptoms, mental health visits, treatment adherence and side effects, social support, suicidal ideation/plans, and lifestyle issues 3) scheduled patient follow‐ups: 18 calls, conducted every two weeks until symptom remission for up to 9 months 4) enhanced inter‐professional communication: The content of each call was documented on a form and a copy was faxed to the PCP. If a participant’s symptoms were not resolving as expected, this was specifically communicated Control: Treatment as usual enhanced as patients were informed of their depression diagnosis and referred to their PCP. The PCPs of some control patients were also PCPs of patients in the intervention arm |
|
| Outcomes | Depression (PHQ‐9): 1, 9 months Medication use: 9 months Quality of Life (mental and physical health): 1, 2, 9 months Satisfaction: 9 months |
|
| Notes | AD: antidepressant; CBT: cognitive behaviour therapy; CM: case manager; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire‐9 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated in blocks of 10 |
| Allocation concealment (selection bias) | Unclear risk | Standard block size. Insufficient information available to assess |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Short‐term loss to follow‐up based on primary depression outcome (PHQ‐9) was: overall 5/39 (13%), 3/19 (16%) intervention and 2/20 (10%) control. Reasons for loss to follow‐up not provided. Intention to treat not reported |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information available to assess |
| Other bias | Unclear risk | Insufficient information available to assess |
| Implementation Integrity | Unclear risk | Insufficient information available to assess |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel could not be blinded, outcome likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information available to assess |