CClinicalTrials.gg
Not yet recruitingNCT07556575Updated Apr 29, 2026

Feasibility of "Mer Aktiv"

An interventional study of Mer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric care in Mental Ill-health, sponsored by Region Halland. Not yet recruiting. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Region Halland · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Mental Ill-health

Keywords

  • Feasability
  • Mental-ill health
  • Lifestyle
  • Group-intervention
  • Psychiatric services
03

In context

Lead sponsor

Region Halland is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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.

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

Interventions

  • BehavioralMer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric care

    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.

    Also known as: Mer aktiv

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What researchers measure

Primary outcomes

  1. Level of daily occupations

    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.

    Time frame: Pre-post, 6 months, 1 year

  2. Satisfaction with daily occupations

    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.

    Time frame: Pre-Post, 6 months.

  3. Physical activity and sedentary behaviour

    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.

    Time frame: Pre-Post, 6 months, 1 year.

Secondary outcomes

  1. Occupational balance

    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).

    Time frame: Pre-Post, 6 months, 1 year.

  2. Anxiety

    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.

    Time frame: Pre-Post, 6 months, 1 year.

  3. Health / Depression

    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.

    Time frame: Pre-post, 6 months, 1 year.

  4. Sleep health

    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.

    Time frame: Pre-post, 6 months, 1 year.

  5. Recovery

    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).

    Time frame: Pre-post, 6 months, 1 year.

  6. Work ability

    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).

    Time frame: Pre-post, 6 months, 1 year.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — Participant privacy and confidentiality, sensitive data, data protection laws (e.g. GDPR) and regional policies limiting data sharing.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07556575
Lead sponsor
Region Halland
Collaborators
Fontänhuset Varberg (Fountain house), Träffpunkten Halmstad (Halmstad municipality), Göteborg University, Adult Psychiatry Region Halland, Lund University, Halmstad University, Kristianstad University
Responsible party
Sponsor
First posted
Apr 29, 2026
Start date
Apr 20, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Apr 29, 2026

Study contacts

Maria Lönn, PhD
Contact
maria.lonn@hh.se
+46707568928
Maria Lönn
principal investigator · Region Halland Psychiatry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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