Protocol for the Healing After Loss (HeAL) Study: a randomised controlled trial of interpersonal psychotherapy (IPT) for major depression following perinatal loss

INTRODUCTION: This protocol describes a study testing the efficacy of interpersonal psychotherapy (IPT) for major depressive disorder following perinatal loss (early and late fetal death and early neonatal death). Perinatal loss is associated with elevated risk of major depressive disorder and post-traumatic stress disorder (PTSD). Perinatal loss conveys specific treatment needs. The trial will be the first fully powered randomised trial of treatment for any psychiatric disorder following perinatal loss. METHODS AND ANALYSIS: A sample of 274 women in Flint and Detroit areas in Michigan who experience a major depressive episode following a perinatal loss will be randomised to group IPT for perinatal loss or to group coping with depression. We anticipate that 50% of the sample will have co-occurring PTSD. Assessments occur at baseline, mid-treatment (8 weeks), post-treatment (16 weeks) and follow-up (28 weeks). Clinical outcomes include time to recovery from major depressive episode (primary), depressive symptoms, PTSD symptoms and time to recovery from PTSD. Additional outcomes include social support, social role functioning (including parental functioning for those with living children), well-being, grief (including complicated grief and fault beliefs) and fear of subsequent pregnancies. Social support and grief are hypothesised mediators of IPT effects on time to recovery from major depressive episode. ETHICS AND DISSEMINATION: The trial was approved by Michigan State University’s Biomedical Institutional Review Board. It has a data and safety monitoring board and has been submitted to the community-based organisation partners community ethics review board. Written operating procedures outline methods for protecting confidentiality, monitoring and recording adverse events, and safeguarding participants. We will share study results with research and clinical communities, community organisations through which we recruited, and will offer results to study participants. Deidentified datasets will be available through the National Institute of Mental Health Data Archive and to qualified investigators on request. TRIAL REGISTRATION NUMBER: NCT04629599.