The objective of this study is to evaluate the potential effectiveness, effect size, and added value of the e-IMR.
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The participant outcome measures of the early trial are: illness management,
recovery, psychiatric symptoms severity, self-management, quality of life, and
general health.
Secondary outcome
The process of the IMR program and will be evaluated on fidelity and
feasibility using the IMR Fidelity Scales and semi-structured interviews with
participants and trainers.
Background summary
Consumers with SMI in the contemplation phase of recovery are referred to the
IMR-program. E-health interventions are expected to be more efficient, but
overall conclusion on e-mental health cannot be drawn. A blended e-health
application to the IMR-program is developed to contribute to the consumers*
recovery process and is supposed to be equally effective as face-to-face
delivery of the IMR-program.
Study objective
The objective of this study is to evaluate the potential effectiveness, effect
size, and added value of the e-IMR.
Study design
The e-IMR intervention will be tested in an early cluster randomized controlled
trial with an approximately twelve month follow-up from baseline. Early*
reflects the exploratory nature of the trial.
Intervention
Participants in the care as usual group receive guideline-based treatment
combined with the IMR-program. On top of this usual care participants in the
intervention group receive e-IMR, which adds an e-health application to the
IMR-program. On the e-health platform participants can execute home assignments
and view illustrative videos and texts showing peer-testimonials, and join
group discussions.
Study burden and risks
All participants in this early trial could benefit from the IMR program, which
have shown positive outcomes in earlier studies. This early trial could
determine whether e-health intervention for consumers with SMI contribute to
treatment. In the future consumers with SMI could get more possible treatment
options to choose from. The risks that participants in the intervention group
might face are estimated as small. Comparable studies have shown usability of
e-health and its potential to improve participants* well being. A possible
burden for participants might be to fill in the questionnaires and participate
in an interview.
Geert Grooteplein 21
Nijmegen 6525EZ
NL
Geert Grooteplein 21
Nijmegen 6525EZ
NL
Listed location countries
Age
Inclusion criteria
Participants meet the criteria for having an SMI: having a DSM-IV-TR diagnoses, with a duration of one year since onset, and a disability that is sufficiently severe to cause serious impairment of functioning
Participants are referred to the IMR by their clinician, which means the consumer acknowledges the illness and having a desire and motivation to change.
Exclusion criteria
Excluded are consumers with SMI who are overwhelmed by disability including dependence, denial, confusion, anger, or despair.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL49693.091.14 |
| OMON | NL-OMON24478 |