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Project Meaningful Activities and Recovery (MA&R)

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ClinicalTrials.gov Identifier: NCT03963245
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Mental Health Centre Copenhagen

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.


Condition or disease Intervention/treatment Phase
Mental Illness Behavioral: Meaningful Activities and Recovery Behavioral: Standard Care and Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Project Meaningful Activities and Recovery (MA&R)
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
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 Recovery

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.


Behavioral: Standard Care and Treatment

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


Active Comparator: Control group
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

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





Primary Outcome Measures :
  1. Profiles of occupational engagement in people with severe mental illness (POES-S). [ Time Frame: Eight months ]
    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


Secondary Outcome Measures :
  1. WHODAS 2.0 [ Time Frame: Eight months ]
    Functioning and disability. The WHODAS 2.0, 12-item version, self-administered instrument is used. WHODAS 2.0 has two scoring options: simple and complex. Simple scoring is a hand-scoring method that does not involve weighting individual items or converting to a standardized scale.The complex scoring method is based on item-response theory and requires use of a computer program, which is available from WHO. Normative values for the WHODAS 2.0 are based on this scoring method. In WHODAS 2.0, 12 items version, Disabilities within12 domains of functioning such as social relations, household chores, participating in the community etc. are measured on a 5 point scale. 1 is no difficulties and 5 is extreme difficulties/not capable of. The scores can be summarized, to a total score reflecting level of functioning and disability. The range is 12 - 60, where lower scores indicate better outcome

  2. Manchester Short Assessment of Quality of Life (MANSA). [ Time Frame: Eight months ]
    Quality of life (MANSA) contains 16 questions. Four of them investigating objective quality of life and 12 focus on subjective quality of life, in regard to satisfaction with life as a whole, job, financial situation, friendships, leisure activities, accommodation, personal safety, people that the person lives with, family and health. Satisfaction is rated on a 7 point scale ranging from 1 which is could not be worse to 7 which is could not be better, and an overall score of subjective quality of life may be calculated. The range is 12-84, higher values indicate better outcome.

  3. Questionnaire about Process of Recovery (QPR) [ Time Frame: Eight months ]
    QPR measures aspects of the personal recovery proces, such as sense of agency and hope. The QPR has 15 items. Each item is rated on a 4-point scale (0= disagree strongly, 1=disagree, 2=neither agree nor disagree, 3=agree, 4=agree strongly). The items are summarized to a total score. The range is 0 to 70. Higher values indicate better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

•>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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963245


Contacts
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Contact: Siv Therese B Bjørkedal 00 45 20 59 45 38 Siv-Therese.Bogevik.Bjoerkedal@regionh.dk
Contact: Bea Marie E Kolbe 00 45 2334 9551 bea.marie.kolbe.ebersbach@regionh.dk

Locations
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Denmark
Copenhagen Socialpsychiatry Completed
Copenhagen, Denmark, 1550
Copenhagen Mental Health Center Recruiting
Copenhagen, Denmark, 2900
Contact: Charlotte Pelch, Nurse    00 45 40213821    Charlotte.Pelch@regionh.dk   
Principal Investigator: Siv-Therese B Bjørkedal, MSc         
Odense kommunes rehabiliteringsteam (psychiatric rehabilitation team, Odense) Recruiting
Odense, Denmark, 5000
Contact: Erik Holm, Nurse    00 45 20 82 18 33    eho@odense.dk   
Principal Investigator: Siv-Therese B Bjørkedal, Msc         
Impuls Mødested og Kursuscenter (Drop in centre) Recruiting
Svendborg, Denmark, 5700
Contact: Tine R Lund    00 45 24886747    tine.rudbech.lund@svendborg.dk   
Principal Investigator: Siv-Therese B Bjørkedal, MSc         
Sponsors and Collaborators
Mental Health Centre Copenhagen
Investigators
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Principal Investigator: Lene F Eplov Copenhagen Research Center of Mental Health (CORE)
Publications:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT03963245    
Other Study ID Numbers: F-61171-15-05
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing individual participant data is restricted by GDP (EU legislation)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mental Health Centre Copenhagen:
Psychiatric Disabilities
Rehabilitation
Recovery
Occupational therapy
Peer-support
Additional relevant MeSH terms:
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Mental Disorders