ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 73 for:    "The Swedish Research Council" [Exact]

Balancing Everyday Life - A Lifestyle Intervention for People With Psychiatric Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02619318
Recruitment Status : Active, not recruiting
First Posted : December 2, 2015
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Mona Eklund, Lund University

Brief 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.


Condition or disease Intervention/treatment Phase
Major Psychiatric Disorder Behavioral: Balancing Everyday Life (BEL) Behavioral: Care as usual (generally standard occupational therapy) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Balancing Everyday Life - A Lifestyle Intervention for People With Psychiatric Disorders
Study Start Date : November 2013
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Experimental: The Balancing Everyday Life (BEL) intervention
The BEL was developed on the basis of previous research on lifestyle interventions made by our own group and other researchers [1, 2]. 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.
Behavioral: Balancing Everyday Life (BEL)
Active Comparator: Care as usual (standard occupational therapy)
Standard occupational therapy involves support to open-market employment and support in managing everyday life in general.
Behavioral: Care as usual (generally standard occupational therapy)



Primary Outcome Measures :
  1. Change in occupational satisfaction and balance as measured by the Satisfaction with Daily Occupations and Balance (SDO-B) scale [ Time Frame: Change from baseline to completed intervention, an average of 16 weeks ]
    Perceived balance between one's everyday activities

  2. Change in valued activities as measured by the Occupational Value with pre-defined items ( OVal-pd) [ Time Frame: Change from baseline to completed intervention, an average of 16 weeks ]
  3. Change in personal recovery as measured by the Questionnaire of Personal Recovery (QPR) [ Time Frame: Change from baseline to completed intervention, an average of 16 weeks ]
    Personal perceptions of recovery, although clinical recovery has not been accomplished


Secondary Outcome Measures :
  1. Change in quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA) [ Time Frame: Change from baseline to completed intervention, an average of 16 weeks ]
  2. Change in self-mastery as measured by Pearlin's Mastery Scale [ Time Frame: Change from baseline to completed intervention, an average of 16 weeks ]
    Sense of being able to influence one's life situation

  3. Change in self-esteem as measured by Rosenberg's Self-esteem Scale [ Time Frame: Change from baseline to completed intervention, an average of 16 weeks ]

Other Outcome Measures:
  1. Satisfaction with the intervention received, as measured by the Client Satisfaction Questionnaire (CSQ) after the 16-week intervention [ Time Frame: At completion of the 16-week intervention ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619318


Locations
Sweden
Skåne Psychiatry
Lund, Skåne, Sweden, 22100
Sponsors and Collaborators
Lund University
The Swedish Research Council
Investigators
Principal Investigator: Mona Eklund, PhD, prof. Lund University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mona Eklund, Professor, Lund University
ClinicalTrials.gov Identifier: NCT02619318     History of Changes
Other Study ID Numbers: BEL (ViB)
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Mona Eklund, Lund University:
Balancing Everyday Life (BEL)
activity-based lifestyle intervention
standard occupational therapy

Additional relevant MeSH terms:
Disease
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms