DepressionSTAIRSNCT05440812
Improving Personal Recovery After Depression With a Blended Module (STAIRS)
A study testing Storytelling and Training to Advance Individual Recovery Skills (STAIRS) in people with Depression, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Storytelling and Training to Advance Individual Recovery Skills (STAIRS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesNetherlands
- Study dates
- 11 Oct 2022to 17 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?'.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
GGZ Drenthe
Assen, Drenthe, 9401PJ
University Medical Center Groningen
Groningen, Provincie Groningen, 9713GZ
About this study
Official title: Evaluation of the Effectiveness of a Newly Developed Blended Module for Patients Recovering From Depression (STAIRS): a Mixed Methods Randomized Controlled Trial
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.
Read the detailed description
The study uses a mixed methods design to determine efficacy and underlying mechanisms contributing to the effect of the STAIRS-training. One hundred forty adults, who are in the last phase of their depression treatment, will be enrolled and randomized (1:1) to (1) a group receiving the STAIRS-training next to Care as Usual (CAU) or (2) a group receiving CAU added with three information letters. Level of personal recovery, symptom severity, empowerment and control will be determined at baseline, at the end of the program (8 weeks) and at 6 months follow up. Approximately fifteen participants from the STAIRS group will be asked about their experiences with the different elements of the program and the perceived effects, in a semi-structured interview at the end of the program.
- Conditions
- Depression
- Being tested
- Storytelling and Training to Advance Individual Recovery Skills (STAIRS)
- Keywords
- personal recovery
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storytelling and Training to Advance Individual Recovery Skills (STAIRS)Behavioural
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 different exercises are done (e.g., filling out an actual and desired week-schedule, role-playing a difficult situation), information is given and experiences are shared. Between meetings, participants can choose from a range of homework exercises to practice their desired skills in a tailored way. In addition, participants can share experiences with the other group members and exchange reactions using a private online community.
| Study group | Role | What they receive |
|---|---|---|
| Care As Usual plus STAIRS | Experimental | Care as usual added with a eight week STAIRS-training Receives: Behavioral: Storytelling and Training to Advance Individual Recovery Skills (STAIRS) |
| Care As Usual | No intervention | Care as usual added with three information letters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Inventory Recovery Outcome Counter (I.ROC) total score
The I.ROC is a self report rating scale containing 12 items measuring the level of personal recovery. Each item is rated on a 6-point ordinal scale, ranging from 0 (never) to 5 (always). Total scores range from 0 to 72. A higher score is better.
Measured: Baseline, end of treatment (8 weeks) and 6 months follow up
Change from baseline in Recovery Assessment Scale, Domains and Stages (RAS-DS) total score
The RAS-DS is a self report rating scale containing 38 items measuring the level of personal recovery. Each item is rated on a 4-point ordinal scale, ranging from 0 (untrue) to 4 (completely true). Total scores range from 0 to 152. A higher score is better.
Measured: Baseline, end of treatment (8 week) and 6 months follow up
Secondary outcomes (9)
Change from baseline in Inventory of Depressive Symptomatology - Self Report (IDS-SR) total score
The IDS-SR is a self report rating scale containing 30 items, of which 28 need to be answered, measuring the level of depressive symptom severity. Each item is rated on a 4-point ordinal scale, ranging from 0 to 3. Total scores range from 0 to 84. A higher score is worse.
Measured: Baseline, end of treatment (8 weeks) and 6 months follow up
Change from baseline in Sheehan Disability Scale (SDS) total score
The SDS is a self report rating scale containing 5 items, measuring the level of global functional impairments caused by symptoms. Three items are rated on a 11-point ordinal scale, ranging from 0 (not at all) to 10 (extremely). Total scores range from 0 to 30. A higher score is worse. Furthermore two items measure the number of days lost or unproductive caused by symptoms.
Measured: Baseline, end of treatment (8 week) and 6 months follow up
Depression relapse in the last six months, diagnosed with the Dutch version of the Mini International Neuropsychiatric Interview - Simplified (M.I.N.I - S), section MDEp
The Dutch version of the M.I.N.I. (MINI-S voor DSM-5 Nederlandse versie 2019, Overbeek \& Schruers / English - Version 2 © Hergueta \& Weiller, 2017) is a structured diagnostic interview for diagnosing psychiatric disorders. Section MDEp is used to diagnose the presence or absence of DSM-5 Major Depressive Disorder (MDD) in the past six months.
Measured: 6 months follow up
Change from baseline in Netherlands Empowerment List (NEL) total score
The NEL is a self report rating scale containing 40 items measuring the level of empowerment. Each item is rated on a 5-point ordinal scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 40 to 200. A higher score is better.
Measured: Baseline, end of treatment (8 weeks) and 6 months follow up
Change from baseline in Mastery Scale total score
The Mastery Scale is a self report rating scale containing 7 items measuring the level of control over events and ongoing situations. Each item is rated on a 5-point ordinal scale, ranging from 0 (strongly disagree) to 4 (strongly agree). Total scores range from 0 to 28. A higher score is better.
Measured: Baseline, end of treatment (8 weeks) and 6 months follow up
Change from baseline in Self-Management Ability Scale (SMAS-30) total score
The SMAS-30 is a self report rating scale containing 30 items measuring the level of self-management. Each item is rated on a 6-point ordinal scale, ranging from 1 to 6. Total scores range from 30 to 180. A higher score is better.
Measured: Baseline, end of treatment (week 8) and 6 months follow up
Economic evaluation, based on the Treatment Inventory of Costs in Psychiatric patients
The TIC-P is a self report questionnaire measuring the medical costs and productivity losses caused by health problems related to psychiatric disorders.
Measured: Baseline, end of treatment (8 weeks) and 6 months follow up
Perceived effects and program valuation by patients recovering from a depression
User experiences on program elements considered helpful, investigated with a semi structured interview with selected participants from the STAIRS-group containing questions about what helped them in which way in their personal recovery process
Measured: End of intervention (8 weeks)
Acceptability and usability of the STAIRS-training for patients recovering from a depression
User experiences on acceptability and usability, investigated with a semi structured interview containing questions about the content, didactics and organization of the meetings, homework assignments and used website.
Measured: End of intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start11 Oct 2022
- Primary completion17 May 2025
- Study completion17 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Efficacy of STAIRS will be assessed by conducting a randomized controlled trial (N=140). In this trial, participants will be randomly assigned either to the experimental group receiving care as usual complemented with the STAIRS-training or the control group receiving care as usual. Measurement points are at T0 (baseline), T1 (post-treatment) and T2 (6 months after end of treatment). Qualitative semi-structured interviews will be held in the experimental group at T1 about the value that participants assign to the elements of the training, as well as the experienced acceptability, and perceived usefulness of the training.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Hanze University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Robert Schoevers, prof, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440812
- Sponsor's protocol ID
- 202100347
- Acronym
- STAIRS
- Status last verified
- May 2026
- First submitted
- 21 Jun 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wedema D, Wardenaar KJ, Alma MA, van Asselt ADI, Korevaar EL, Schoevers RA. A blended module (STAIRS) to promote functional and personal recovery in patients with a major depressive disorder in remission: study protocol of a concurrent mixed methods randomized controlled trial. BMC Psychiatry. 2023 Oct 7;23(1):727. doi: 10.1186/s12888-023-05213-w.
PubMed 37805486
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Newly Developed Blended Module for Patients Recovering From Depression (STAIRS): a Mixed Methods Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05440812
- Acronym / sponsor ID
- STAIRS / 202100347
- Conditions
- Depression
- Keywords
- personal recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Hanze University of Applied Sciences
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 17 May 2025 (actual)
- Study completion
- 17 May 2025 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study uses a mixed methods design to determine efficacy and underlying mechanisms contributing to the effect of the STAIRS-training. One hundred forty adults, who are in the last phase of their depression treatment, will be enrolled and randomized (1:1) to (1) a group receiving the STAIRS-training next to Care as Usual (CAU) or (2) a group receiving CAU added with three information letters. Level of personal recovery, symptom severity, empowerment and control will be determined at baseline, at the end of the program (8 weeks) and at 6 months follow up. Approximately fifteen participants from the STAIRS group will be asked about their experiences with the different elements of the program and the perceived effects, in a semi-structured interview at the end of the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Efficacy of STAIRS will be assessed by conducting a randomized controlled trial (N=140). In this trial, participants will be randomly assigned either to the experimental group receiving care as usual complemented with the STAIRS-training or the control group receiving care as usual. Measurement points are at T0 (baseline), T1 (post-treatment) and T2 (6 months after end of treatment). Qualitative semi-structured interviews will be held in the experimental group at T1 about the value that participants assign to the elements of the training, as well as the experienced acceptability, and perceived usefulness of the training.
| Arm | Type | Receives |
|---|---|---|
| Care As Usual plus STAIRS | Experimental | Behavioral: Storytelling and Training to Advance Individual Recovery Skills (STAIRS)Care as usual added with a eight week STAIRS-training |
| Care As Usual | No intervention | –Care as usual added with three information letters |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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?'.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Storytelling and Training to Advance Individual Recovery Skills (STAIRS)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 different exercises are done (e.g., filling out an actual and desired week-schedule, role-playing a difficult situation), information is given and experiences are shared. Between meetings, participants can choose from a range of homework exercises to practice their desired skills in a tailored way. In addition, participants can share experiences with the other group members and exchange reactions using a private online community. | Behavioural | Care As Usual plus STAIRS |
Primary outcome
Change from baseline in Inventory Recovery Outcome Counter (I.ROC) total score
Time frame: Baseline, end of treatment (8 weeks) and 6 months follow up
The I.ROC is a self report rating scale containing 12 items measuring the level of personal recovery. Each item is rated on a 6-point ordinal scale, ranging from 0 (never) to 5 (always). Total scores range from 0 to 72. A higher score is better.
Change from baseline in Recovery Assessment Scale, Domains and Stages (RAS-DS) total score
Time frame: Baseline, end of treatment (8 week) and 6 months follow up
The RAS-DS is a self report rating scale containing 38 items measuring the level of personal recovery. Each item is rated on a 4-point ordinal scale, ranging from 0 (untrue) to 4 (completely true). Total scores range from 0 to 152. A higher score is better.
9 secondary outcomes
Change from baseline in Inventory of Depressive Symptomatology - Self Report (IDS-SR) total score
Time frame: Baseline, end of treatment (8 weeks) and 6 months follow up
Change from baseline in Sheehan Disability Scale (SDS) total score
Time frame: Baseline, end of treatment (8 week) and 6 months follow up
Depression relapse in the last six months, diagnosed with the Dutch version of the Mini International Neuropsychiatric Interview - Simplified (M.I.N.I - S), section MDEp
Time frame: 6 months follow up
Change from baseline in Netherlands Empowerment List (NEL) total score
Time frame: Baseline, end of treatment (8 weeks) and 6 months follow up
Change from baseline in Mastery Scale total score
Time frame: Baseline, end of treatment (8 weeks) and 6 months follow up
Change from baseline in Self-Management Ability Scale (SMAS-30) total score
Time frame: Baseline, end of treatment (week 8) and 6 months follow up
Economic evaluation, based on the Treatment Inventory of Costs in Psychiatric patients
Time frame: Baseline, end of treatment (8 weeks) and 6 months follow up
Perceived effects and program valuation by patients recovering from a depression
Time frame: End of intervention (8 weeks)
Acceptability and usability of the STAIRS-training for patients recovering from a depression
Time frame: End of intervention (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 37805486Wedema D, Wardenaar KJ, Alma MA, van Asselt ADI, Korevaar EL, Schoevers RA. A blended module (STAIRS) to promote functional and personal recovery in patients with a major depressive disorder in remission: study protocol of a concurrent mixed methods randomized controlled trial. BMC Psychiatry. 2023 Oct 7;23(1):727. doi: 10.1186/s12888-023-05213-w.
- official website of the interventionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Schoevers, prof principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storytelling and Training to Advance Individual Recovery Skills (STAIRS) in people with Depression, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Inventory Recovery Outcome Counter (I.ROC) total score (time frame: Baseline, end of treatment (8 weeks) and 6 months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05440812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.