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

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Storytelling and Training to Advance Individual Recovery Skills (STAIRS)
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring personal recovery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • GGZ DrentheRecruiting
  • University Medical Center GroningenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Care As Usual plus STAIRS

Care As Usual

Arm Description

Care as usual added with a eight week STAIRS-training

Care as usual added with three information letters

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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
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.

Full Information

First Posted
June 21, 2022
Last Updated
May 11, 2023
Sponsor
University Medical Center Groningen
Collaborators
Hanze University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05440812
Brief Title
Improving Personal Recovery After Depression With a Blended Module (STAIRS)
Acronym
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen
Collaborators
Hanze University of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
personal recovery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care As Usual plus STAIRS
Arm Type
Experimental
Arm Description
Care as usual added with a eight week STAIRS-training
Arm Title
Care As Usual
Arm Type
No Intervention
Arm Description
Care as usual added with three information letters
Intervention Type
Behavioral
Intervention Name(s)
Storytelling and Training to Advance Individual Recovery Skills (STAIRS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Inventory Recovery Outcome Counter (I.ROC) total score
Description
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.
Time Frame
Baseline, end of treatment (8 weeks) and 6 months follow up
Title
Change from baseline in Recovery Assessment Scale, Domains and Stages (RAS-DS) total score
Description
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.
Time Frame
Baseline, end of treatment (8 week) and 6 months follow up
Secondary Outcome Measure Information:
Title
Change from baseline in Inventory of Depressive Symptomatology - Self Report (IDS-SR) total score
Description
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.
Time Frame
Baseline, end of treatment (8 weeks) and 6 months follow up
Title
Change from baseline in Sheehan Disability Scale (SDS) total score
Description
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.
Time Frame
Baseline, end of treatment (8 week) and 6 months follow up
Title
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
Description
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.
Time Frame
6 months follow up
Title
Change from baseline in Netherlands Empowerment List (NEL) total score
Description
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.
Time Frame
Baseline, end of treatment (8 weeks) and 6 months follow up
Title
Change from baseline in Mastery Scale total score
Description
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.
Time Frame
Baseline, end of treatment (8 weeks) and 6 months follow up
Title
Change from baseline in Self-Management Ability Scale (SMAS-30) total score
Description
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.
Time Frame
Baseline, end of treatment (week 8) and 6 months follow up
Title
Economic evaluation, based on the Treatment Inventory of Costs in Psychiatric patients
Description
The TIC-P is a self report questionnaire measuring the medical costs and productivity losses caused by health problems related to psychiatric disorders.
Time Frame
Baseline, end of treatment (8 weeks) and 6 months follow up
Title
Perceived effects and program valuation by patients recovering from a depression
Description
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
Time Frame
End of intervention (8 weeks)
Title
Acceptability and usability of the STAIRS-training for patients recovering from a depression
Description
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.
Time Frame
End of intervention (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Wedema
Phone
+31505953576
Email
d.wedema@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Schoevers
Phone
+31503618880
Email
r.a.schoevers@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Schoevers, prof
Organizational Affiliation
UMCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
GGZ Drenthe
City
Assen
State/Province
Drenthe
ZIP/Postal Code
9401PJ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shamira Kuiper, MSc
Phone
+31 (0)592 334200
Email
shamira.kuiper@ggzdrenthe.nl
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Wedema, MSc
Phone
+31 (0)50 595 3576
Email
d.wedema@umcg.nl
First Name & Middle Initial & Last Name & Degree
Robert Schoevers, Prof.
Phone
+31 (0)50 361 8880
Email
r.a.schoevers@umcg.nl

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://stairstraining.nl
Description
official website of the intervention

Learn more about this trial

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

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