An interventional study of Storytelling and Training to Advance Individual Recovery Skills (STAIRS) in Depression, sponsored by University Medical Center Groningen. Completed at 2 sites in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Supportive care
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 36 is below the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
Care as usual added with a eight week STAIRS-training
Behavioral: Storytelling and Training to Advance Individual Recovery Skills (STAIRS)
Care as usual added with three information letters
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.
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.
Time frame: 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.
Time frame: Baseline, end of treatment (8 week) and 6 months follow up
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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
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.
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
The TIC-P is a self report questionnaire measuring the medical costs and productivity losses caused by health problems related to psychiatric disorders.
Time frame: 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
Time frame: 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.
Time frame: End of intervention (8 weeks)
Plan to share: No
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