Improving Personal Recovery After Depression With a Blended Module (STAIRS)

NCT05440812 | Completed

• 1 other identifier: 202100347
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Depression

Keywords

personal recovery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Baseline, end of treatment (8 weeks) and 6 months follow up

• Change from baseline in Sheehan Disability Scale (SDS) total score

  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

  6 months follow up

• Change from baseline in Netherlands Empowerment List (NEL) total score

  Baseline, end of treatment (8 weeks) and 6 months follow up

• Change from baseline in Mastery Scale total score

  Baseline, end of treatment (8 weeks) and 6 months follow up

Study Arms (2)

Care As Usual plus STAIRS

EXPERIMENTAL

Care as usual added with a eight week STAIRS-training

Behavioral: Storytelling and Training to Advance Individual Recovery Skills (STAIRS)

Care As Usual

NO INTERVENTION

Care as usual added with three information letters

Interventions

Storytelling and Training to Advance Individual Recovery Skills (STAIRS) BEHAVIORAL

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.

Care As Usual plus STAIRS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?'.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Hanze University of Applied Sciences: collaborator

Study Sites (2)

GGZ Drenthe

Assen, Drenthe, 9401PJ, Netherlands

Location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37805486 DERIVED

Related Links

• official website of the intervention

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Robert Schoevers, prof

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 1, 2022
• Study Start: October 11, 2022
• Primary Completion: May 17, 2025
• Study Completion: May 17, 2025
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)