NCT07556575

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Apr 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Dec 2028

First Submitted

Initial submission to the registry

April 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

April 17, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

FeasabilityMental-ill healthLifestyleGroup-interventionPsychiatric services

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Pre-Post, 6 months, 1 year.

Secondary Outcomes (6)

  • Occupational balance

    Pre-Post, 6 months, 1 year.

  • Anxiety

    Pre-Post, 6 months, 1 year.

  • Health / Depression

    Pre-post, 6 months, 1 year.

  • Sleep health

    Pre-post, 6 months, 1 year.

  • Recovery

    Pre-post, 6 months, 1 year.

  • +1 more secondary outcomes

Study Arms (1)

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.

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

Interventions

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
Multiprofessional lifestyle group-intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Maria Lönn

    Region Halland Psychiatry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Lönn, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Pre-post single goup Feasability study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 29, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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