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

U

University Medical Center Groningen (UMCG)

Status

Enrolling

Conditions

Depression

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05440812
202100347

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

Care As Usual plus STAIRS
Experimental group
Description:
Care as usual added with a eight week STAIRS-training
Treatment:
Behavioral: Storytelling and Training to Advance Individual Recovery Skills (STAIRS)
Care As Usual
No Intervention group
Description:
Care as usual added with three information letters

Trial contacts and locations

2

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Central trial contact

David Wedema; Robert Schoevers

Data sourced from clinicaltrials.gov

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