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NCT Number: NCT07556575

Feasibility of "Mer Aktiv"

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.

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric care

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Lönn, PhD

CONTACT

[email protected]

+46707568928

Sponsors and collaborators

Lead sponsor

Region Halland

Other

Collaborators

  • Adult Psychiatry Region Halland
  • Fontänhuset Varberg (Fountain house)
  • Göteborg University
  • Halmstad University
  • Kristianstad University
  • Lund University
  • Träffpunkten Halmstad (Halmstad municipality)

Registry information

Official study title

Mer Aktiv Rehabilitering - en Interventionsstudie Inom Vuxenpsykiatrin

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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