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

NCT ID: NCT05440812

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-11

Study Completion Date

2025-05-31

Brief Summary

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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

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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

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Depression

Keywords

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personal recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Care As Usual plus STAIRS

Care as usual added with a eight week STAIRS-training

Group Type EXPERIMENTAL

Storytelling and Training to Advance Individual Recovery Skills (STAIRS)

Intervention Type 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

Care as usual added with three information letters

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanze University of Applied Sciences

UNKNOWN

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Schoevers, prof

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

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GGZ Drenthe

Assen, Drenthe, Netherlands

Site Status

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 37805486 (View on PubMed)

Related Links

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http://stairstraining.nl

official website of the intervention

Other Identifiers

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202100347

Identifier Type: -

Identifier Source: org_study_id