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Evaluation of the effectiveness of a newly developed blended module for patients recovering from depression (STAIRS): a mixed methods RCT

Evaluation of the effectiveness of a newly developed blended module for patients recovering from depression (STAIRS): a mixed methods RCT - Effect study of STAIRS: a mixed methods RCT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54416
Enrollment
140
Registered
2021-12-21
Start date
2022-10-11
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression

Interventions

STAIRS is a 8-week program, in which 8 different themes are addressed. Coverage of each theme starts with a group meeting guided by a professional and expert by experience. In these meetings differe

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - age 18 to 65 years old; - in the last phase of treatment for a diagnosed Major Depressive Disorder; the acute phase of depression is over and a patient is in the process of regaining control over his life, or psychological treatment is ended in the last 6 months and an aftercare or maintenance antidepressant treatment is offered - Minimal reduction of depressive symptoms into moderate; an IDS-SR score of <38 - The willingness to participate in the study

Exclusion criteria

Exclusion criteria: - Bipolar depression or depression with psychotic features. - Comorbid schizophrenia spectrum or other psychotic disorder. - Comorbid moderate or severe dependence of alcohol or drugs. - Neurological disorder (e.g., dementia). - Insufficient command of the Dutch language. - Cognitive problems or indication of low IQ (i.e.< 80). - Not in possession of a pc or smartphone. - Having been referred to a different mental health service for other mental problems.

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is personal recovery, measured in each group as the change on the Individual Recovery Outcome Counter (I.ROC) and the Recovery Assessment Scale Domains and Stages (RAS-DS) between baseline and T1 and T2.

Secondary

MeasureTime frame
Secondary quantitative outcomes in each group are: depression relapse between T1 and T2, change in depressive symptom severity, level of empowerment, sense of control, level of functional disabilities due to depression, costs associated with psychosocial problems and recovery of Quality of Life from baseline to end of treatment and 6 month follow-up. Secondary qualitative outcomes in the experimental group are user experiences with the STAIRS-program.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)