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

Evaluation of the Effectiveness of a Newly Developed Blended Module for Patients Recovering From Depression (STAIRS): a Mixed Methods Randomized Controlled Trial

Sponsors

Lead Sponsor: University Medical Center Groningen

Collaborator: Hanze University of Applied Sciences

Source University Medical Center Groningen
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.

Overall Status Recruiting
Start Date 2022-07-15
Completion Date 2024-07-01
Primary Completion Date 2024-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline in Inventory Recovery Outcome Counter (I.ROC) total score Baseline, end of treatment (8 weeks) and 6 months follow up
Change from baseline in Recovery Assessment Scale, Domains and Stages (RAS-DS) total score Baseline, end of treatment (8 week) and 6 months follow up
Secondary Outcome
Measure Time Frame
Change from baseline in Inventory of Depressive Symptomatology - Self Report (IDS-SR) total score Baseline, end of treatment (8 weeks) and 6 months follow up
Change from baseline in Sheehan Disability Scale (SDS) total score Baseline, end of treatment (8 week) and 6 months follow up
Depression relapse in the last six months, diagnosed with the Mini International Neuropsychiatric Interview (M.I.N.I), section A 6 months follow up
Change from baseline in Netherlands Empowerment List (NEL) total score Baseline, end of treatment (8 weeks) and 6 months follow up
Change from baseline in Mastery Scale total score Baseline, end of treatment (8 weeks) and 6 months follow up
Change from baseline in Self-Management Ability Scale (SMAS-30) total score Baseline, end of treatment (week 8) and 6 months follow up
Economic evaluation, based on the Treatment Inventory of Costs in Psychiatric patients Baseline, end of treatment (8 weeks) and 6 months follow up
Perceived effects and program valuation by patients recovering from a depression End of intervention (8 weeks)
Acceptability and usability of the STAIRS-training for patients recovering from a depression End of intervention (8 weeks)
Enrollment 140
Condition
Intervention

Intervention Type: Behavioral

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

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.

Arm Group Label: Care As Usual plus STAIRS

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Robert Schoevers, prof Principal Investigator UMCG
Overall Contact

Last Name: David Wedema

Phone: +31505953576

Email: [email protected]

Location
Facility: Status: Contact:
GGZ Drenthe | Assen, Drenthe, 9401PJ, Netherlands Recruiting Shamira Kuiper, MSc +31 (0)592 334200 [email protected]
University Medical Center Groningen | Groningen, 9713GZ, Netherlands Recruiting David Wedema, MSc +31 (0)50 595 3576 [email protected]
Location Countries

Netherlands

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Care As Usual plus STAIRS

Type: Experimental

Description: Care as usual added with a eight week STAIRS-training

Label: Care As Usual

Type: No Intervention

Description: Care as usual added with three information letters

Acronym STAIRS
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Masking: None (Open Label)

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