Prior to conducting an RCT to study the efficacy of STAIRS, we conduct a pilot to (1) investigate the usability, feasibility and acceptability of the program and (2) to investigate the feasibility and acceptability of the intended measurement method…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
User experiences with the program and measurements.
Secondary outcome
At T0, T1 and T2 several questionnaires are administered that assess the level
of functional recovery (Outcome Questionnaire; OQ-45), severity of depressive
symptomatology (Inventory of Depressive Symptomatology- self report; IDS-SR)
and the level of the patient empowerment (Nederlandse Empowerment Lijst; NEL).
These scales will not be used as study outcomes in this pilot study. Rather, we
will evaluate the participants* experiences with these measurements.
Background summary
Almost all mental healthcare treatments of depression focus on symptomatic
recovery. However, such recovery does not necessarily mean that a person has
reached functional recovery. Consequently, many persons still experience
functional impairments after recovery. As this increases the risk of recurrence
of the depression, a new blended module (STAIRS) is developed to promote
functional recovery.
Study objective
Prior to conducting an RCT to study the efficacy of STAIRS, we conduct a pilot
to (1) investigate the usability, feasibility and acceptability of the program
and (2) to investigate the feasibility and acceptability of the intended
measurement method/scheme for the RCT.
Study design
A pilot trial (N=10) of the STAIRS program for 12 weeks. To evaluate the
patients* experiences, a questionnaire will be administered after 10 weeks and
at the end of the program. The answers are clustered into themes and discussed
in a focus group with the participants to evaluate the users* experiences with
the program*s contents, didactics and organisation; and to identify possible
points for improvement. In addition, all questionnaires we intend to use in the
full RCT (at intake [T0], 6 weeks [T1] and at the end [T3]) will be
administered and feasibility (i.e. incomplete data, drop-out) and acceptability
(participants* experiences) will be evaluated. To evaluate relevant
others* (e.g. family or friends) experiences with the program*s content and
organization, a questionnaire will be administered at the end of the program.
Also an assessment of the social functioning of the participant is askes in
this questionnaire. Trainers will be asked about their experiences with the
program*s usability, feasibility and acceptability in separate interviews.
Intervention
STAIRS is a 12-week program in which 9 different themes are addressed. 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 spend approximately 20 hours in group meetings and 40 hours on
homework. Additional time may be spent on travel to and from the group meetings
at the UCP. Assessment of the program takes approximately 3.5h (2h on
questionnaires and 1.5h on focus-group). The study assessments at T0-T2 take
approximately 3h in total. We expect no risk of participation. Participants can
benefit from STAIRS by attaining higher levels of functional recovery, reduced
levels of depression and higher levels of empowerment.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- Age 18 to 65 years old
- In treatment for a diagnosed Major Depressive Episode; psychological
treatment is expected to end within three months.
- Minimal reduction of depression symptoms; at least a reduction into absent,
or mild depression symptoms.
Exclusion criteria
- IDS >= 25 (still suffering from moderate/severe depression)
- Insufficient command of the Dutch language.
- Cognitive problems/indication of low IQ < 80
- Not in possession of pc and/or smartphone
- Being referred/to be 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 | NL72037.042.20 |