Clinical trial NCT05440812: Improving Personal Recovery After Depression with a Blended Module (STAIRS)
Official title: Evaluation of the Effectiveness of a Newly Developed Blended Module for Patients Recovering from Depression (STAIRS): a Mixed Methods Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Keywords: personal recovery
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Hanze University of Applied Sciences
First posted: 2022-07-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Inventory Recovery Outcome Counter (I.ROC) total score
timeFrame: Baseline, end of treatment (8 weeks) and 6 months follow up
measure: Change from baseline in Recovery Assessment Scale, Domains and Stages (RAS-DS) total score
timeFrame: Baseline, end of treatment (8 week) and 6 months follow up
Secondary outcomes:
measure: Change from baseline in Inventory of Depressive Symptomatology - Self Report (IDS-SR) total score
timeFrame: Baseline, end of treatment (8 weeks) and 6 months follow up
measure: Change from baseline in Sheehan Disability Scale (SDS) total score
timeFrame: Baseline, end of treatment (8 week) and 6 months follow up
measure: 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
timeFrame: 6 months follow up
measure: Change from baseline in Netherlands Empowerment List (NEL) total score
timeFrame: Baseline, end of treatment (8 weeks) and 6 months follow up
measure: Change from baseline in Mastery Scale total score
timeFrame: Baseline, end of treatment (8 weeks) and 6 months follow up
measure: Change from baseline in Self-Management Ability Scale (SMAS-30) total score
timeFrame: Baseline, end of treatment (week 8) and 6 months follow up
measure: Economic evaluation, based on the Treatment Inventory of Costs in Psychiatric patients
timeFrame: Baseline, end of treatment (8 weeks) and 6 months follow up
measure: Perceived effects and program valuation by patients recovering from a depression
timeFrame: End of intervention (8 weeks)
measure: Acceptability and usability of the STAIRS-training for patients recovering from a depression
timeFrame: End of intervention (8 weeks)
Other outcomes:
Locations:
city: Assen
country: Netherlands
facility: GGZ Drenthe
state: Drenthe
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: UMCG
name: Robert Schoevers, prof
role: PRINCIPAL_INVESTIGATOR
References: