Mental Ill-healthNCT07556575
Feasibility of "Mer Aktiv"
A study testing Mer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric care in people with Mental Ill-health, run by Region Halland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Mental Ill-health
- What is being tested?
- Mer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Mental Ill-health
- Being tested
- Mer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric care
- Keywords
- Feasability, Mental-ill health, Lifestyle, Group-intervention, Psychiatric services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric careBehavioural
Also called Mer aktiv
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.
| Study group | Role | What they receive |
|---|---|---|
| Multiprofessional lifestyle group-intervention | Experimental | 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. Receives: Behavioral: Mer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-post, 6 months, 1 year
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.
Measured: Pre-Post, 6 months.
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.
Measured: Pre-Post, 6 months, 1 year.
Secondary outcomes (6)
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).
Measured: Pre-Post, 6 months, 1 year.
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.
Measured: Pre-Post, 6 months, 1 year.
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.
Measured: Pre-post, 6 months, 1 year.
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.
Measured: Pre-post, 6 months, 1 year.
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).
Measured: Pre-post, 6 months, 1 year.
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).
Measured: Pre-post, 6 months, 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Ill-healthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post single goup Feasability study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Halland
- Sponsor type
- University, hospital or other
- Collaborators
- Fontänhuset Varberg (Fountain house), Träffpunkten Halmstad (Halmstad municipality), Göteborg University, Adult Psychiatry Region Halland, Lund University, Halmstad University, Kristianstad University
- Responsible party
- Sponsor
- Investigators
- Maria Lönn, Principal investigator, Region Halland Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556575
- Sponsor's protocol ID
- 2025-08744-01
- Other IDs
- 2025
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant privacy and confidentiality, sensitive data, data protection laws (e.g. GDPR) and regional policies limiting data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mer Aktiv Rehabilitering - en Interventionsstudie Inom Vuxenpsykiatrin
- ClinicalTrials.gov ID
- NCT07556575
- Acronym / sponsor ID
- 2025-08744-01
- Conditions
- Mental Ill-health
- Keywords
- Feasability, Mental-ill health, Lifestyle, Group-intervention, Psychiatric services
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Region HallandUniversity, hospital or other
- Collaborators
- Fontänhuset Varberg (Fountain house), Träffpunkten Halmstad (Halmstad municipality), Göteborg University, Adult Psychiatry Region Halland, Lund University, Halmstad University, Kristianstad University
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post single goup Feasability study
| Arm | Type | Receives |
|---|---|---|
| Multiprofessional lifestyle group-intervention | Experimental | Behavioral: Mer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric careAn 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric careAlso: Mer aktivMer 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. | Behavioural | Multiprofessional lifestyle group-intervention |
Primary outcome
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.
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.
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.
6 secondary outcomes
Occupational balance
Time frame: Pre-Post, 6 months, 1 year.
Anxiety
Time frame: Pre-Post, 6 months, 1 year.
Health / Depression
Time frame: Pre-post, 6 months, 1 year.
Sleep health
Time frame: Pre-post, 6 months, 1 year.
Recovery
Time frame: Pre-post, 6 months, 1 year.
Work ability
Time frame: Pre-post, 6 months, 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. Participant privacy and confidentiality, sensitive data, data protection laws (e.g. GDPR) and regional policies limiting data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Lönn principal investigator
Region Halland Psychiatry
Questions about this trial
What is this clinical trial studying?
A study testing Mer aktiv rehabilitation - A group-based lifestyle intervention within psychiatric care in people with Mental Ill-health, run by Region Halland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Lönn, PhD (+46707568928, maria.lonn@hh.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of daily occupations (time frame: Pre-post, 6 months, 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.