Major Psychiatric Disorder clinical trials

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.