Feasibility of "Mer Aktiv"

April 24, 2026 updated by: Region Halland

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

Detailed Description

For guidance, the framework for the evaluation of complex interventions will be used, along with the use of progression criteria to determine whether it is appropriate to move on to the next phase. To study feasibility, the group-based intervention will be evaluated in the form of a feasibility study, assessing aspects such as recruitment, adherence to the intervention, and data-collection. During Phase 1, the experiences of both staff and participants will be explored to refine the intervention based on their feedback.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • Psychoeducation on lifestyle habits as part of active recovery (based on the six pillars of health), with a focus on physical activity, diet, sleep, stress management, and social connectedness.
  • Information about community-based actors and resources (integrated into Training in activity).
  • Training in activity (including physical and social activities) aimed at promoting a more active, meaningful, and balanced everyday life.
  • Planning and facilitation of next steps in an active rehabilitation process.
Other Names:
  • Mer aktiv

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

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)?

NO

IPD Plan Description

Participant privacy and confidentiality, sensitive data, data protection laws (e.g. GDPR) and regional policies limiting data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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