Improving Personal Recovery After Depression With a Blended Module (STAIRS) (NCT05440812) | Clinical Trial Compass
CompletedNot Applicable
Improving Personal Recovery After Depression With a Blended Module (STAIRS)
Netherlands36 participantsStarted 2022-10-11
Plain-language summary
Almost all mental healthcare treatments of depression focus on symptomatic recovery. However, such recovery does not inherently mean that personal recovery is reached. In fact, many persons still experience functional impairments after symptomatic recovery. As this has a negative influence on daily life, a new blended module (STAIRS) was developed to promote personal recovery in persons that are in the final stage of symptomatic recovery from depression. The current study will investigate the efficacy of STAIRS, by adding STAIRS to care as usual and comparing it with care as usual. It is hypothesized that STAIRS will have a positive effect on personal recovery and that this effect is larger than in the control group.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 65 years old
* Being in the last phase (recovery phase) of treatment for a diagnosed Major Depressive Disorder; psychological treatment is expected to end within three months or treatment is finished within the past 3 months and patient receives an aftercare and/or maintenance antidepressant treatment.
* No more than moderate depression severity: Score of \<38 on the Inventory of Depressive Symptomatology - Self Rated (IDS-SR).
* The willingness to participate: an affirmative response to the question 'after being explained what participation means for you, are you willing to participate?'.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Inventory Recovery Outcome Counter (I.ROC) total score
Timeframe: Baseline, end of treatment (8 weeks) and 6 months follow up
2
Change from baseline in Recovery Assessment Scale, Domains and Stages (RAS-DS) total score
Timeframe: Baseline, end of treatment (8 week) and 6 months follow up