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

Depression Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05440812
• Other study ID #: 202100347
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2023
• Source: University Medical Center Groningen
• Contact: David Wedema
• Phone: +31505953576
• Email: d.wedema[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Netherlands	GGZ Drenthe	Assen	Drenthe
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Hanze University of Applied Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline, end of treatment (8 weeks) and 6 months follow up
Secondary	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.	Baseline, end of treatment (8 week) and 6 months follow up
Secondary	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.	6 months follow up
Secondary	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.	Baseline, end of treatment (8 weeks) and 6 months follow up
Secondary	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.	Baseline, end of treatment (8 weeks) and 6 months follow up
Secondary	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.	Baseline, end of treatment (week 8) and 6 months follow up
Secondary	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.	Baseline, end of treatment (8 weeks) and 6 months follow up
Secondary	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	End of intervention (8 weeks)
Secondary	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.	End of intervention (8 weeks)

External Links

•   official website of the intervention