Major Psychiatric Disorder Clinical Trial
Official title:
Balancing Everyday Life - A Lifestyle Intervention for People With Psychiatric Disorders
| NCT number | NCT02619318 |
| Other study ID # | BEL (ViB) |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 2013 |
| Est. completion date | January 2019 |
| Verified date | January 2019 |
| Source | Lund University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 223 |
| Est. completion date | January 2019 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Having a major psychiatric disorder, - age of 18-65 years, - in need of a lifestyle intervention (as assessed by an occupational therapist) Exclusion Criteria: - Comorbidity of dementia or developmental disability, - substance use disorder as main diagnosis, acute psychosis, - not being able to communicate in Swedish |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Skåne Psychiatry | Lund | Skåne |
| Lead Sponsor | Collaborator |
|---|---|
| Lund University | The Swedish Research Council |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Satisfaction with the intervention received, as measured by the Client Satisfaction Questionnaire (CSQ) after the 16-week intervention | At completion of the 16-week intervention | ||
| Primary | Change in occupational satisfaction and balance as measured by the Satisfaction with Daily Occupations and Balance (SDO-B) scale | Perceived balance between one's everyday activities | Change from baseline to completed intervention, an average of 16 weeks | |
| Primary | Change in valued activities as measured by the Occupational Value with pre-defined items ( OVal-pd) | Change from baseline to completed intervention, an average of 16 weeks | ||
| Primary | Change in personal recovery as measured by the Questionnaire of Personal Recovery (QPR) | Personal perceptions of recovery, although clinical recovery has not been accomplished | Change from baseline to completed intervention, an average of 16 weeks | |
| Secondary | Change in quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA) | Change from baseline to completed intervention, an average of 16 weeks | ||
| Secondary | Change in self-mastery as measured by Pearlin's Mastery Scale | Sense of being able to influence one's life situation | Change from baseline to completed intervention, an average of 16 weeks | |
| Secondary | Change in self-esteem as measured by Rosenberg's Self-esteem Scale | Change from baseline to completed intervention, an average of 16 weeks |