Balancing Everyday Life - A Lifestyle Intervention for People With Psychiatric Disorders
Condition: Major Psychiatric Disorder
MeSH terms: Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Balancing Everyday Life (BEL); Care as usual (generally standard occupational therapy)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Balancing Everyday Life (BEL); activity-based lifestyle intervention; standard occupational therapy