- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07556575
Feasibility of "Mer Aktiv"
Mer Aktiv Rehabilitering - en Interventionsstudie Inom Vuxenpsykiatrin
The Mer aktiv rehabilitaion project aims to develop and evaluate a sustainable lifestyle intervention for individuals with mental ill health. By combining clinical experience, current evidence, and interprofessional collaboration between outpatient psychiatric services and community stakeholders, the project seeks to create conditions for a more active and balanced everyday life for individuals with mental ill health. The Mer Aktiv intervention focuses on breaking social isolation, promoting activity, and strengthening participants' empowerment through healthy lifestyle behaviours, group cohesion, and community-based activities. The aim of the intervention is to increase participation in everyday life and in society, as well as to support participants in remaining active after the intervention has ended. An increased level of activity, in which participants feel a sense of belonging within society, creates conditions for individuals to gradually move closer to the labour market over time. The project examines the feasibility and relevance of the intervention as a collaborative initiative between outpatient psychiatric care and community stakeholders, with the aim of refining the intervention and identifying potential barriers to implementation.
The aim is to develop and evaluate a multiprofessional lifestyle intervention for individuals receiving outpatient psychiatric care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Lönn, PhD
- Phone Number: +46707568928
- Email: maria.lonn@hh.se
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Enrolled in adult outpatient psychiatric care
- Not engaged in any form of organized occupation, such as employment, studies, or work-based rehabilitation
- Physical exercise/structured physical activity outside the home less than once per week
- Participation in organized leisure activities less than once per week
- Able to walk independently without assistance
- No need for an interpreter
Exclusion Criteria:
- Inability to attend sessions twice per week (e.g., due to distance or lack of transportation)
- Ongoing individual psychotherapy
- Current or planned participation in another group-based intervention
- Ongoing substance use disorder, acute suicidality, or active psychosis (assessed based on the individual's capacity to manage symptoms and ability to participate in a group setting)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multiprofessional lifestyle group-intervention
An 11 week group intervention (20 group sessions in total), including individual asessement before and individual follow-up after intervention.
Furthermore a booster goup session after 5-6 months.
|
Mer aktiv is a multiprofessional group-based intervention developed to meet a clinical need within outpatient psychiatric services and refined through collaboration among occupational therapists, physiotherapists, care workers, dietitians, and health coordinators across several clinics. The content of the group-based intervention Mer Aktiv includes:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of daily occupations
Time Frame: Pre-post, 6 months, 1 year
|
Level of daily occupations will be collected using the occupational therapy assessment instrument Satisfaction with Daily Occupations (SDO-13) (13 questions conserning daily occupations distributed across the domains work/studies, leisure, home and maintenance, and self-care: response options Yes or No, Range 0-13)(13 indicates the highest level of activity). Data-collection with SDO-13 at Pre, Post and 6 months. Data-collection with a 5-item questionnaire "Occupational level over time" at 1 years follow up (developed by the research group with inspiration from SDO-13 and specified inclusion criteria)(response options Yes or No)(Change in daily occupations from recruitment until 1 year)(Change from No to Yes indicates an improvement) in (Q1-2) employment/studies, (Q3) structured rehabilitation (Q4) physical exercise, (Q5) leisure activiries. |
Pre-post, 6 months, 1 year
|
|
Satisfaction with daily occupations
Time Frame: Pre-Post, 6 months.
|
Satisfaction with Daily Occupations (SDO-13) will be collected using the occupational therapy assessment instrument Satisfaction with Daily Occupations (SDO-13) (13 questions conserning daily occupations distributed across the domains work/studies, leisure, home and maintenance, and self-care: response options Yes or No; satisfaction with daily occupations based on the same 13 questions: 7-point scale, 1 = worst imaginable satisfaction, 7 = best imaginable satisfaction.
|
Pre-Post, 6 months.
|
|
Physical activity and sedentary behaviour
Time Frame: Pre-Post, 6 months, 1 year.
|
Physical activity and sedentary behaviour (3-item Swedish National Board of Health and Welfare). To measure physical activity, the indicator questions developed by the Swedish National Board of Health and Welfare will be used (3 questions; number of minutes spent in vigorous physical activity and everyday physical activities, respectively, as well as an estimate of the time spent sitting). Increase in minutes in physical activities is better, decrease in time spent sitting is better. The three items are analysed seperatly. |
Pre-Post, 6 months, 1 year.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occupational balance
Time Frame: Pre-Post, 6 months, 1 year.
|
Occupational Balance Questionnaire (OBQ11) Perceived occupational balance reflects an individual's perception of the amount and variation of occupations in everyday life.
Occupational balance will be assessed using the occupational therapy assessment instrument Occupational Balance Questionnaire (OBQ11) (11 items; 4-point Likert scale, 1 = strongly disagree, 4 = strongly agree)(A higher score indicates better occupational balance).
|
Pre-Post, 6 months, 1 year.
|
|
Anxiety
Time Frame: Pre-Post, 6 months, 1 year.
|
The Generalized Anxiety Disorder 7-item scale (GAD-7) (7 items; 4 response options, 0 = not at all, 3 = nearly every day) will be used for self-assessment of participants' anxiety symptoms during the past two weeks.
A higher score is worse.
|
Pre-Post, 6 months, 1 year.
|
|
Health / Depression
Time Frame: Pre-post, 6 months, 1 year.
|
The Patient Health Questionnaire (PHQ-9) To assess participants' health, the Patient Health Questionnaire (PHQ-9) will be used (9 items; 4 response options, 0 = not at all, 3 = nearly every day)(A higher score is worse).
The PHQ-9 can be used for clinical categorisation of depression.
|
Pre-post, 6 months, 1 year.
|
|
Sleep health
Time Frame: Pre-post, 6 months, 1 year.
|
RU-SATED will be used to collect data on participants' sleep health (6 items; 5 response options per item: never, rarely, sometimes, often, always; estimated time)(a higher score indicates better sleep health).
RU-SATED has been translated into Swedish by the research group (permission to translate and use RU-SATED has been obtained).
Test-retest reliability will be conducted prior to the start of the group intervention.
|
Pre-post, 6 months, 1 year.
|
|
Recovery
Time Frame: Pre-post, 6 months, 1 year.
|
The Questionnaire about the Process of Recovery (QPR-Swe-16) Participants' personal perceptions of recovery will be collected using The Questionnaire about the Process of Recovery (QPR-Swe-16) (16 items; 5-point Likert scale, 1 = strongly disagree, 5 = strongly agree)(A higher score is better).
The concept of recovery underpinning the QPR is derived from the CHIME framework (Connectedness, Hope and optimism, Identity, Meaning and Empowerment).
|
Pre-post, 6 months, 1 year.
|
|
Work ability
Time Frame: Pre-post, 6 months, 1 year.
|
The first item of the Work Ability Index (WAI) The first item of the Work Ability Index (WAI) is planned to be used as a measure of participants' perceived work ability (1 item; scale 0-10, 0 = unable to work at all, 10 = my work ability is at its best)(a higher score is better).
|
Pre-post, 6 months, 1 year.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maria Lönn, Region Halland Psychiatry
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-08744-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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