Clinical trial NCT04666662: A Prognostic Model to PREDICT Relapse of Depression in Primary Care
Official title: Development and Validation of a Prognostic Model to PREDICT Relapse of Depression in Adult Patients in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Prediction
Prognostic model
Relapse
Lead sponsor: University of York
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Keele University
First posted: 2020-12-14
Enrollment: 1244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will represent an undifferentiated primary care case-mix of patients with depression, meeting clinical criteria for remission at the point of prediction.

Brief summary: The investigators aim to develop a prognostic model to predict the risk of relapse within 6-8 months of patients entering remission. The long-term objective is to facilitate more efficient targeting of evidence-based relapse prevention strategies to these patients.

Detailed description: Most patients with depression are treated in primary care by general practitioners (GPs). Relapse of depression is common and leads to considerable morbidity and decreased quality of life for patients. Estimates suggest that at least 50% of patients treated for depression will relapse after a single episode. The majority of these will relapse within 6 months and the risk of relapse increases for each successive episode of depression. GPs see a largely undifferentiated case-mix of patients and, once patients with depression reach remission, there is limited guidance and no validated tools to help GPs stratify patients according to risk of relapse.This study will potentially derive a statistical model to predict relapse of depression in remitted depressed patients in primary care.

The investigators have created a longitudinal cohort of patients drawn from seven randomised controlled trials (RCTs) of non-pharmacological primary care-based interventions for depression and one longitudinal cohort study. The investigators will use logistic regression to predict the outcome of relapse of depression within 6-8 months. The investigators plan to include the following well-evidenced relapse predictors in the model: residual depressive symptoms; number of previous episodes of depression; co-morbid anxiety; and severity of the index episode. They will also control for RCT intervention received by participants.

If sample size and availability of predictor information allows, the investigators will include the following predictors in an exploratory analysis: age; relationship status; multi-morbidity; employment status; gender; and ethnicity. Generalisability will be assessed through internal-external cross-validation and net benefit will be explored.

Eligibility criteria: Inclusion Criteria:

* Remitted depressive disorder

Exclusion Criteria:

* Co-existing severe mental illness

Primary outcomes:
measure: Whether a participant relapses or not within 6-8 months (binary outcome)
timeFrame: 6-8 months
Secondary outcomes:
Other outcomes:
Locations:
city: York
country: United Kingdom
facility: University of York
Study officials:
affiliation: University of York
name: Andrew Moriarty, MRes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moriarty AS, Paton LW, Snell KIE, Riley RD, Buckman JEJ, Gilbody S, Chew-Graham CA, Ali S, Pilling S, Meader N, Phillips B, Coventry PA, Delgadillo J, Richards DA, Salisbury C, McMillan D. The development and validation of a prognostic model to PREDICT Relapse of depression in adult patients in primary care: protocol for the PREDICTR study. Diagn Progn Res. 2021 Jul 2;5(1):12. doi: 10.1186/s41512-021-00101-x.