NCT03963245

Brief Summary

Occupational therapy interventions are often part of the treatment and rehabilitation services offered to people with mental illnesses. Occupational therapy can be an important contribution when the purpose is to promote participation in everyday activities that are meaningful for the individual. (1-3) There is limited evidence to support whether occupational therapy interventions for people with mental illnesses have an effect. (2,3) Based on principles from Lifestyle Redesign®, which is an evidence-based occupational therapy intervention for older people, a comparative qualitative study with participant experiences from various psychosocial rehabilitation efforts, and a dialogue-based collaboration with experienced occupational therapists and peer staff from community mental health centers, we developed a new recovery oriented occupational therapy intervention to people with disabilities due to mental illness. The intervention "Meaningful activities and recovery" (MA\&R) - is an eight-month rehabilitation program. The aim of MA\&R is to enable participation in activities that are meaningful to the individual. Project Meaningful Activities and Recovery (MA\&R) is a clinical trial where the purpose is to compare the effects of: 1) "Meaningful activities and Recovery" (MA\&R) in addition to standard care and 2) standard care as it is now offered to people with psychiatric disabilities. The design is a randomized clinical trial with self-reported assessments. Based on sample size calculation, 128 participants will be included in the trials. The primary endpoint is activity engagement, and the secondary effect goals are personal recovery, functioning and quality of life. Participants are followed up at the end of the intervention, after eight months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

April 16, 2019

Last Update Submit

February 2, 2026

Conditions

Keywords

Psychiatric DisabilitiesRehabilitationRecoveryOccupational therapyPeer-support

Outcome Measures

Primary Outcomes (1)

  • Profiles of occupational engagement in people with severe mental illness (POES-S).

    Activity Engagement (engagement in meaningful daily activities, social roles, and connection to the community). rating is made on nine items expressing activity engagement, for example balance between rest and activity, being able to move between places, and taking initiatives. A four-point rating schedule is used. The range is 9-36, where higher values indicate better outcome

    Eight months

Secondary Outcomes (3)

  • WHODAS 2.0

    Eight months

  • Manchester Short Assessment of Quality of Life (MANSA).

    Eight months

  • Questionnaire about Process of Recovery (QPR)

    Eight months

Study Arms (2)

Intervention group

EXPERIMENTAL

MA\&R - an eight months rehabilitation intervention in addition to standard care and treatment in Community Mental Health Centres in Copenhagen, and psychiatric rehabilitation services in Copenhagen, Odense and Svendborg, Denmark

Behavioral: Meaningful Activities and RecoveryBehavioral: Standard Care and Treatment

Control group

ACTIVE COMPARATOR

Standard care and treatment in Community Mental Health Centres in Copenhagen, and psychiatric rehabilitation services in Copenhagen, Odense and Svendborg, Denmark

Behavioral: Standard Care and Treatment

Interventions

MA\&R is a new rehabilitation program for people with psychiatric disabilities. MA\&R aims to enable participation in everyday activities that are meaningful to the individual. MA\&R is based on occupational science, and the underlying premise that there is a connection between mental health, recovery and meaningful everyday activities. The goal of MA\&R is that participants through the course become better at connecting daily activities with values, interests, plans and goals. When this connection is strengthened, it supports the experience of meaningfulness in everyday life. MA\&R is led by two mentors where one mentor is an occupational therapist (or similar) and the other has lived experiences of mental vulnerability and recovery.

Intervention group

For community mental health centres: medicine, psychoeducation, relational support, peer-support, psychotherapy, social counselling, care manager For psychiatric rehabilitation services in Copenhagen, Odense and Svendborg: drop in centres, relational support, skills training, peer-support

Control groupIntervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years old
  • Has disability assessment assessed by researcher at Mini-ICF Rating for Limitations of Activities and Participation in Psychological Disorders (Mini-ICF-APP) (28)
  • Be diagnosed with a mental disorder and have been associated with the psychiatric treatment system, either by admission or outpatient contact.
  • Has given informed consent

You may not qualify if:

  • Diagnosed with dementia
  • Have abuse as a main diagnosis, or an abuse that stands in the way of participation in MA\&R
  • A forensic psychiatric status
  • Need for translator assistance
  • Do not want to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Copenhagen Socialpsychiatry

Copenhagen, 1550, Denmark

Location

Copenhagen Mental Health Center

Copenhagen, 2900, Denmark

Location

Odense kommunes rehabiliteringsteam (psychiatric rehabilitation team, Odense)

Odense, 5000, Denmark

Location

Impuls Mødested og Kursuscenter (Drop in centre)

Svendborg, 5700, Denmark

Location

Related Publications (3)

  • 1. Doroud N, Fossey E, Fortune T. Recovery as an occupational journey: A scoping review exploring the links between occupational engagement and recovery for people with enduring mental health issues. Aust Occup Ther J. 2015;62(6):378-392. 2. Gutman SA. Special issue: Effectiveness of occupational therapy services in mental health practice. Am J Occup Ther Off Publ Am Occup Ther Assoc. 2011;65(3):235. 3. Petersen KS, Bjørkedal STB, Torsting AMB, Eplov LF. Occupational Therapy Interventions in Mental Health - a scoping review of current evidence. (Submittet). 4. Eplov LF. Psykiatrisk & psykosocial rehabilitering: en recovery-orienteret tilgang. Munksgaard Danmark; 2010. 260 s. 28. Molodynski A, Linden M, Juckel G, Yeeles K, Anderson C, Vazquez-Montes M, m.fl. The reliability, validity, and applicability of an English language version of the Mini-ICF-APP. Soc Psychiatry Psychiatr Epidemiol. 2013;48(8):1347-1354. 33. Bejerholm U, Hansson L, Eklund M. Profiles of occupational engagement in people with schizophrenia (POES): the development of a new instrument based on time-use diaries. Br J Occup Ther. 2006;69(2):58-68. 34. Law H, Morrison A, Byrne R, Hodson E. Recovery from psychosis: a user informed review of self-report instruments for measuring recovery. J Ment Health. 2012;21(2):192-207. 35. Björkman T, Svensson B. Quality of life in people with severe mental illness. Reliability and validity of the Manchester Short Assessment of Quality of Life (MANSA). Nord J Psychiatry. 2005;59(4):302-306. 36. Üstün TB. Measuring health and disability: Manual for WHO disability assessment schedule WHODAS

    BACKGROUND
  • Bjorkedal SB, Bejerholm U, Hjorthoj C, Moller T, Eplov LF. Meaningful Activities and Recovery (MA&R): a co-led peer occupational therapy intervention for people with psychiatric disabilities. Results from a randomized controlled trial. BMC Psychiatry. 2023 Jun 6;23(1):406. doi: 10.1186/s12888-023-04875-w.

  • Bjorkedal STB, Bejerholm U, Eplov LF, Moller T. Meaningful Activities and Recovery (MA&R): the effect of a novel rehabilitation intervention among persons with psychiatric disabilities on activity engagement-study protocol for a randomized controlled trial. Trials. 2020 Sep 14;21(1):789. doi: 10.1186/s13063-020-04722-3.

MeSH Terms

Conditions

Mental Disorders

Interventions

Salvage TherapyStandard of CareTherapeutics

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Lene F Eplov

    Copenhagen Research Center of Mental Health (CORE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research, Associate professor

Study Record Dates

First Submitted

April 16, 2019

First Posted

May 24, 2019

Study Start

September 19, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Sharing individual participant data is restricted by GDP (EU legislation)

Locations