Feasibility and potential effects of a dyadic coping intervention for patients with spinal cord injury and their spouses: a study protocol for a pilot randomised controlled trial.

INTRODUCTION

It remains difficult for patients with spinal cord injury (SCI) to fully recover their sensory and motor functions; thus, they must rely on the assistance of caregivers to complete activities of daily living. This leads to psychological distress and decreased quality of life in patients and caregivers. Interventions for dyadic coping are a promising option. However, no studies have examined the effects of dyadic coping interventions on patients with SCI and their spouses. Therefore, our team constructed a dyadic coping intervention programme for couples with SCI.

METHOD AND ANALYSIS

This two-arm, parallel-design, pilot randomised controlled trial will recruit 72 couples with SCI from two tertiary hospitals in Hefei, China. Couples will be randomly allocated to two arms. Couples randomly assigned to the intervention group will receive the usual care and the dyadic coping intervention. Couples randomly assigned to the control group will receive usual care only. The primary outcomes will be the feasibility and acceptability of the dyadic coping intervention for couples with SCI. Secondary outcomes will be quality of life, psychological distress, caregiver burden, marital satisfaction and dyadic coping. Outcomes will be collected at three time points: baseline (T0), post-intervention (T1) and after a follow-up period of 8 weeks (T2).

ETHICS AND DISSEMINATION

This study has been approved by the Research Ethics Committee of Anhui Medical University (84240008). The results will be published in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER

ChiCTR2300074556.