The main objective of this study is to determine the efficacy of STAIRS. The secondary objectives are: (1) to investigate the association between improved personal recovery and depression relapse and (2) to gather qualitative insights into the…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is personal recovery, measured in each group
as the change on the Individual Recovery Outcome Counter (I.ROC) and the
Recovery Assessment Scale Domains and Stages (RAS-DS) between baseline and T1
and T2.
Secondary outcome
Secondary quantitative outcomes in each group are: depression relapse between
T1 and T2, change in depressive symptom severity, level of empowerment, sense
of control, level of functional disabilities due to depression, costs
associated with psychosocial problems and recovery of Quality of Life from
baseline to end of treatment and 6 month follow-up.
Secondary qualitative outcomes in the experimental group are user experiences
with the STAIRS-program.
Background 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.
Study objective
The main objective of this study is to determine the efficacy of STAIRS. The
secondary objectives are: (1) to investigate the association between improved
personal recovery and depression relapse and (2) to gather qualitative
insights into the elements contributing to (a) the effects and (b) the
usability and acceptability of STAIRS.
Study design
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.
Intervention
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, roleplaying 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.
Study burden and risks
Participants in the experimental group spend approximately 16 hours in group
meetings and 8 hours on homework assignments. For the experimental group,
additional time may be spent on traveling to and from the group meetings. The
study assessments include questionnaires (3 x 60 minutes) and interviews
(approximately 15 participants: 1,5 hour). This is time consuming and it might
be experienced as boring and/or annoying. Furthermore, some questions could
elicit some distress as these cover personal and emotional content. There is no
reason to expect any health risk of participation.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- age 18 to 65 years old; - in the last phase of treatment for a diagnosed
Major Depressive Disorder; the acute phase of depression is over and a patient
is in the process of regaining control over his life, or psychological
treatment is ended in the last 6 months and an aftercare or maintenance
antidepressant treatment is offered - Minimal reduction of depressive symptoms
into moderate; an IDS-SR score of <38 - The willingness to participate in
the study
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75317.042.21 |