The aim of this study is to examine the effectiveness of the IMR program compared to care as usual (CAU) in patients with SMI.
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The illness management and recovery scale-patient self score version will be
the primary outcome measure. This scale has 15 items and is completed by
patients themselves. With this scale the effects of IMR in various domains can
be measured (Mueser et al 2004; Salyers 2007; Hasson-Ohayon et al. 2008; Dutch
translation De Vries 2011). The consumer and clinician versions of the Illness
Management and Recovery (IMR) scales have adequate psychometric properties.
Secondary outcome
a Illness management
- IMR-scale clinician-rated version This scale (15 items) will be used to
explore effects. This scale is scored by non-blinded clinicians, who are not
involved in the IMR-training.
- Coping is measured with the Coping self-efficacy (CSES) scale (Chesney et al.
2006): *13-items*. This scale has good psychometric properties and provides
according to the constructors a measure of a person*s perceived ability to cope
effectively with life challenges, as well as a way to assess changes in CSE
over time in intervention research.
- Social support is measured with the Multidimensional Scale of Perceived
Social Support MSPSS (Zimet, Dahlem, Zimet & Farley, 1988) (12 items) . This
scale has good psychometric properties.
- Medication compliance is measured with the Service Engagement Scale (SES)
(Tait et al. 2002) (14-items). This scale has good psychometric properties.
- Insight into own problems is measured with the Insight Scale (IS) (8
self-report items) (Birchwood et al, 1994). The psychometric properties of the
scale are called excellent (Tait et al.2003).
- Symptoms are measured with the Brief Symptom Inventory (BSI) (53 items) The
authors report good internal consistency reliability, test-retest reliability
and validity of the BSI. (Derogatis & Melisaratos 1983; Derogatis 1993; De
Beurs, 2008).
- Relapses: The number of relapses (operationalized in the number of hospital
admissions) during and after participating in the IMR-training will be compared
with the number of relapses in the year before participating in IMR.
- Alcohol & Drugs-use: One item (item 24) of the Addiction Severity Index
(ASI), asking how much respondents has been bothered the past 30 days by
problems with a. alcohol, b. drugs, (a & b separately scored on a 5-point
scale).
b. Recovery
The concept of recovery is complex. We choose to assess general recovery by
using a special scale as well as measuring different aspects of recovery
including aspects of what Mueser et al. (2006) call subjective recovery (self
esteem, self stigma, quality of life, satisfaction) and objective recovery
(functioning).
- General recovery, measured with the Mental Health Recovery Measure (MHRM)
(Young & Bullock, 2000); authorised translation in Dutch (Moradi, Brouwers, Van
den Bogaard & Van Nieuwenhuizen, 2007). The MHRM is a 30 item self-report
measure. This scale has good psychometric properties.
- Self stigma is measured with the Internal Stigma of Mental Illness (Ismi), 29
items (Ritsher 2003). This scale has good psychometric properties.
- Self esteem measured with the Self-Esteem Rating Scale-Short From (SERS-SF),
(20 items) (Lecomte et al., 2006). This scale has good psychometric properties.
- Quality of life measured with the EQ-5D (Prieto et al 2003), 5 items. This
scale has good psychometric properties.
- Satisfaction, Two questions: **Can you tell me how satisfied you are with
your life as a whiole? and *How satisfied are you with the health care services
you visited?* These questions are used in the Routine Outcome Monitoring of the
Long Stay sector of Parnassia Bavo Group and are supposed to correlate with all
other possible satisfaction-questions which were part of satisfaction
questionnaires. (see Delespaul et al. 2006)
- Social Functioning is measured with the Social Functioning Scale (19 items
and 4 checklists with in total 62 aspects). This Scale is called reliable,
valid, sensitive and responsive to change (Birchwood et al. 1990).
c. Cost-effectiveness
- Cost-effectiveness is measured by counting number and duration of contacts
(including the IMR-meetings), crisis contacts, (forced) admissions and duration
of admissions are calculated in costs in euro*s. These are related with changes
in quality of life measured by the EQ-5D (see above), By transforming scores on
the EQ-5D in so called *quallies* cost-effectiveness can be calculated. ). This
scale has good psychometric properties (Lamers et al., 2005), Staring (2010).
Background summary
In recent years some promising new services for people with serious and
persistent psychiatric illnesses (SMI) have emerged, mostly in the USA, but
their effectiveness in Dutch Mental Health Care has not yet been proven.
Several evidence based psychosocial interventions are at a basic level included
in the program of Illness Management and Recovery (IMR).
Illness Management and Recovery (IMR) is a program of care in the form of a
training course for patients with severe and persistent psychiatric problems,
based on a combination of different types of interventions focused on recovery.
The idea underlying the training course is that the patient learns to gain
control of his illness (illness management) and to make appropriate choices
based on accurate information and skills training.
The total duration of the training program is on average one year if there is a
meeting of 1,5 hour each week.
IMR is currently implemented in several countries. In the Netherlands there is
much interest in IMR, but implementation of IMR is in about 7 mental health
care institutions still at the beginning. In the Netherlands BavoEuropoort has
the most experience with IMR.The implementation of IMR at BavoEuropoort has
been evaluated with a pilot study.
IMR is named an EBP by the American researchers who have constructed IMR
because the ingredients of the program are evidence-based.
In the meantime however three RCT*s on the overall package of IMR have been
executed in different countries by Hasson-Ohayon et al (2007), Levitt et al
(2009) and Färdig et al. (2011), with positive results for IMR.
Despite these positive studies, IMR is not yet broadly accepted as an EBP in
Dutch mental health care. In particular, it is mentioned neither in the Dutch
multidisciplinary guidelines on schizophrenia of 2005, nor in the concept
guidelines of 2010. More research is needed, especially to investigate whether
IMR is effective in the Dutch context.
Study objective
The aim of this study is to examine the effectiveness of the IMR program
compared to care as usual (CAU) in patients with SMI.
Study design
The design is a randomized controlled trial in which patients are assigned to
the experimental condition (IMR) or the control group, after providing written
informed consent:
- Group 1. IMR program, offered in a group format + care-as-usual (CAU).
- Group 2. Care-as-usual (CAU)
We have planned three moments of measurement. These moments are
1. prior to the randomization, at baseline
2. after the training (the mean duration of the training in the pilot study was
12.6 months).
The second moment of measurement for the control group is 12 months after the
first moment of measurement.
3. The follow-up measurement is 6 months after the second measurement.
Intervention
The IMR-training consists of 11 modules that are given weekly, the first
module is given individually. During this individual module the patients decide
which goals they want to work on during the program.
Then the patients join an IMR group for the other modules. Each module takes
about 3 to 4 sessions of one and a half hour each. The IMR group is guided by
two trainers (psychiatric nurses). The trainers received a two-day course in
IMR and attend supervision once every two weeks.
The modules are described in the IMR-workbooks, translated into Dutch, which
the patients received. If necessary, the original American text is adapted to
the Dutch context. The modules are:
1. Recovery Strategies, 2. Practical Facts about Mental Illness, 3.
Stress-Vulnerability Model, 4. Building Social Support, 5. Using Medication
Effectively, 6. Alcohol and Drugs Use, 7. Reducing Relapses, 8. Coping with
Stress , 9. Coping with Problems and Persistent Symptoms, 10. Getting Your
Needs Met in the Mental Health System, 11. Health for you.
The trainers use techniques from motivational interviewing, psychoeducation and
cognitive-behavioral therapy (CBT). Peer group support is part of the
IMR-training. Home assignments are provided. Workbooks and homeassignments can
be accessed via the internet. There is feedback on homework from trainers on
the Internet.
Study burden and risks
Burden by completing questionnaires and by interviews.
The practical and theoretical relevance of the study justify conducting the
research in our opinion.
Monsterseweg 83
Den Haag 2553RJ
NL
Monsterseweg 83
Den Haag 2553RJ
NL
Listed location countries
Age
Inclusion criteria
- Patients with serious and persistent psychiatric illnesses. Most of them will be patients who have a psychotic disorder, schizoaffective disorders or bipolar disorders with or without comorbid disorders (such as substance abuse and personality disorders)
- The patient is treated on an outpatient basis
- Written informed consent
Exclusion criteria
- Having done an IMR-training
- Organic brain syndrome.
- Incompetence regarding the giving of informed consent.
- Patients with severe cognitive impairments who are unable to follow the training
- Insufficient knowledge of the Dutch language (they can not participate in the group)
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 | NL38605.078.12 |
| OMON | NL-OMON20008 |