Major Psychiatric Disorder Clinical Trial
Official title:
Balancing Everyday Life - A Lifestyle Intervention for People With Psychiatric Disorders
This is a RCT study, aiming at evaluating the effectiveness of the Everyday Life in Balance
(BEL) intervention.
The intervention: The BEL was developed on the basis of previous research on lifestyle
interventions made by the current research group and other researchers . It is a group-based
programme (5-8 participants) with 12 sessions, one session a week, and 2 booster sessions
with two-week intervals. The themes for the group sessions are, e.g., activity balance,
healthy living, work-related activities, and social activities. Each session contains a main
group activity and a home assignment to be completed between sessions. The main group
activity starts with analysing the present situation and proceeds with identifying desired
goals and finding strategies for how to reach them. The home assignment is aimed at testing
one of the proposed strategies. Self-analysis, setting goals, finding strategies and
evaluating the outcome of tested strategies form a process for each session, but also for the
BEL intervention as a whole. After completed BEL, the participants will have developed an
ability to reflect on their own situation and have strategies for changing their everyday
life in a desired direction, such that they feel their everyday life has a satisfactory
balance between rest and work, secluded and social activities, etc.
The BEL intervention is led by occupational therapists. They take part in a specifically
developed two-day education and follow the BEL manual [7]. They also participate in a
web-based discussion forum where they can seek support from the researchers and/ or other BEL
occupational therapists.
Selection of units and participants: On the basis of blocks of four units, two are randomized
to the BEL and two to the control condition, which is care as usual (CAU) and generally means
standard occupational therapy. Occupational therapists in the units select participants based
on the patients' needs for a lifestyle intervention and being likely to benefit from a group
intervention. The same criteria are applied in the BEL units and the CAU units.
Power analysis: The investigators desire 120 participants from each group. This will also
allow for analysis of subgroups.
Instruments: A number of self-report instruments tapping satisfaction with daily occupations,
well-being, perceived worker role, social interaction, recovery etc., will be used,
supplemented with qualitative interviews.
Procedure: As the intervention starts, the attendees answer questionnaires about their
personal situation regarding. Subsequently, the BEL is implemented in the units randomised to
that condition. After 16 weeks of intervention (including the booster sessions), the
measurements are repeated. A follow-up is then made after another six months. The same data
collection is made at corresponding time points in the comparison units.
Additional qualitative interviews are made in the intervention units, with strategically
selected participants (attendees and staff) to get a deeper picture of the intervention
process and its implications.
When the research project is finished, the comparison units will be given the opportunity to
go through the intervention.
Analyses: The primary analysis concerns differences in outcomes between the BEL group and the
CAU group. Analyses of the qualitative interviews, by means of grounded theory, will yield a
more detailed description of the BEL and its implications, as perceived by both attendees and
staff.
Current state of the study: The project is in the initial phase and the first units were
recruited in late 2012. At present, 24 units have been randomized to either condition. The
second measurements (after completed BEL) have just been completed and follow-ups will
continue until mid-2016, as will qualitative interviews. Analysing data and reporting results
will continue until late 2018.
By including 60 participants in each group the studies will be able to detect a medium effect
size (ES=0.4), which would be a difference of clinical and practical significance.
Age, gender and being of foreign origin will be considered as covariates, along with other
socioeconomic factors such as family situation, educational level and money at one's
disposal. Other factors that should be considered are the participant's functional status and
diagnoses. Research has not shown that diagnosis per se plays any substantial role in the
outcome of psychiatric rehabilitation, for the course of a psychiatric disability or for how
people perceive their everyday occupations, but this should be investigated further because
the evidence is inconclusive. Level of functioning, level of psychopathology, and negative
symptoms have indeed been shown to be of importance for outcomes of psychiatric
rehabilitation. Therefore, this project will also control for factors related to diagnosis
and functional status.
Balancing Everyday Life - evaluation of the effectiveness of an activity-based lifestyle
intervention for people with psychiatric disorders
This is a RCT study, evaluating the effectiveness of the Everyday Life in Balance (BEL)
intervention.
The intervention: The BEL was developed on the basis of previous research on lifestyle
interventions made by the current research group and other researchers. Other important
sources of inspiration were descriptive studies on everyday life among people with severe
mental illness. It is a group-based programme (5-8 participants) with 12 sessions, one
session a week, and 2 booster sessions with two-week intervals. The themes for the group
sessions are, e.g., activity balance, motivation, healthy living, work-related activities,
leisure and social activities. Each session contains a brief educational section, a main
group activity and a home assignment to be completed between sessions. The main group
activity starts with analysing the present situation and proceeds with identifying desired
goals and finding strategies for how to reach them. The home assignment is aimed at testing
one of the proposed strategies. The next-coming session starts with looking back at the home
assignment, and depending on the outcome, goals may need to be revised. Self-analysis,
setting goals, finding strategies and evaluating the outcome of tested strategies form a
process for each session, but also for the BEL intervention as a whole. After completed BEL,
the participants will have developed an ability to reflect on their own situation and have
strategies for changing their everyday life in a desired direction, such that they feel their
everyday life has a satisfactory balance between rest and work, secluded and social
activities, etc.
The BEL intervention is led by occupational therapists. They take part in a specifically
developed two-day education and follow the BEL manual. They also participate in a web-based
discussion forum where they can seek support from the researchers and/ or other BEL
occupational therapists.
Selection of units and participants: Units in both county council-based psychiatry
(outpatient units within general psychiatry and psychosis care) and community-based activity
centers (CBACs) in four counties in south Sweden have been invited. Cluster randomization is
used to assign the units to the BEL or the control condition. On the basis of blocks of four
units, two are randomized to the BEL and two to the control condition, which is care as usual
(CAU). CAU generally means standard occupational therapy. Four categories of participants
will be recruited: a) BEL participants from county-council-based psychiatry; b) BEL
participants from community-based psychiatry; c) CAU participants from county-council-based
psychiatry; and d) CAU participants from community-based psychiatry. Occupational therapists
in the units select participants based on the patients' needs for a lifestyle intervention
and being likely to benefit from a group intervention. The same criteria are applied in the
BEL units and the CAU units.
Power analysis: The investigators based the power calculation on the Satisfaction with Daily
Occupations (SDO) scale. A previous study found a mean difference of 0.5 points on the SDO
between groups of people with mental illness who had varying structure to their everyday
life. Based on the means and standard deviations from that study, the analysis pointed to 41
participants in each condition as the desired sample size to detect a difference on the SDO
of 0.5 with 80% power at p<0.05. The investigators still desire 60 participants from each
group (a - d above) since no solid base for a power calculation exists in the field. In all
240 participants are thus sought, 60+60 receiving the BEL and 60-60 receiving CAU.
The following instruments are used:
Rosenberg's self-esteem scale: Positive and negative attitudes towards the self; Global
Assessment of Functioning (GAF): Symptom severity and psychosocial functioning; Satisfaction
with Daily Occupations and Balance (SDO-B): Satisfaction with everyday occupation and
occupational balance; Occupational Value with pre-defined items (OVal-pd): Perceived value
with daily occupation; Pearlin's Mastery Scale: Self-mastery; Medical Outcomes Short Form
(SF-36) (1st item): Self-rated Health; Manchester Short Assessment of Quality of Life
(MANSA): Quality of life; Interview Schedule for Social Interaction (ISSI): The social
network; Worker Role Self-assessment (WRS): Attitudes and expectations concerning the worker
role; "Making decisions": Empowerment; Client Satisfaction Questionnaire (CSQ): Satisfaction
with the intervention; Estimating Perceived Meaning in Day Centers (EPM-DC): Characteristics
of day centers; Questionnaire of Personal Recovery (QPR): Recovery from mental illness;
Fidelity scale: Fidelity to the intervention.
In addition, consequences of the intervention will be reflected in qualitative interviews
with users and staff. Another important part of the data collection will be to make a
detailed description of the CAU provided in the comparison units.
Procedure: As the intervention starts, the attendees answer questionnaires about their
personal situation regarding satisfaction with daily occupations, well-being, perceived
worker role, social interaction, recovery etc. Subsequently, the BEL is implemented in the
units randomised to that condition. After 16 weeks of intervention (including the booster
sessions), the measurements are repeated. A follow-up is then made after another six months.
The same data collection is made at corresponding time points in the comparison units.
Additional qualitative interviews are made in the intervention units, with strategically
selected participants (attendees and staff) to get a deeper picture of the intervention
process and its implications.
When the research project is finished, the comparison units will be given the opportunity to
go through the intervention.
Analyses: The primary analysis concerns differences in outcomes between the intervention and
the control group (a+b versus c+d above), at the unit level (characteristics of the CBACs)
and the individual level (perceptions of worker role, satisfaction, well-being etc.), and the
stability of such outcomes. The sample size will also allow for comparison between
community-based and county-council-based BEL. Since measuring characteristics of CBACs is not
of relevance for county council-based psychiatry, the comparison at the unit level will only
concern community-based psychiatry.
Analyses of the qualitative interviews, by means of grounded theory [10], will yield a more
detailed description of the BEL and its implications, as perceived by both attendees and
staff.
Current state of the study: The project is in the initial phase and the first units were
recruited in late 2012. At present, 24 units have been randomized to either condition. The
second measurements (after completed BEL) have just been completed and follow-ups will
continue until mid-2016, as will qualitative interviews. Analysing data and reporting results
will continue until late 2018.
Methodological considerations By including 60 participants in each group the studies will be
able to detect a medium effect size (ES=0.4), which would be a difference of clinical and
practical significance.
Self-rating instruments are used and it is important to consider whether these produce
reliable data when used with people with SMI, particularly since many in the target group
have cognitive problems. However, research has shown that self-ratings of psychological
factors were valid and reliable among people with schizophrenia, also those with a poor
insight into their mental illness.
Age, gender and being of foreign origin will be considered as covariates, along with other
socioeconomic factors such as family situation, educational level and money at one's
disposal. Other factors that should be considered are the participant's functional status and
diagnoses. Research has not shown that diagnosis per se plays any substantial role in the
outcome of psychiatric rehabilitation, for the course of a psychiatric disability or for how
people perceive their everyday occupations, but this should be investigated further because
the evidence is inconclusive. Level of functioning, level of psychopathology, and negative
symptoms have indeed been shown to be of importance for outcomes of psychiatric
rehabilitation. Therefore, this project will also control for factors related to diagnosis
and functional status.
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