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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00137189
Registration number
NCT00137189
Ethics application status
Date submitted
26/08/2005
Date registered
29/08/2005
Titles & IDs
Public title
Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation
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Scientific title
Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation: A Randomised Controlled Trial
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Secondary ID [1]
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RCT-MTPSY
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mental Disorders
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Mood Disorders
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Personality Disorders
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Schizophrenia and Disorders With Psychotic Features
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Condition category
Condition code
Mental Health
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0
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Schizophrenia
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Mental Health
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0
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Music therapy - See published study protocol
Other: Standard care - See published study protocol
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
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Assessment method [1]
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Timepoint [1]
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1
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Primary outcome [2]
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negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
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Assessment method [2]
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0
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Timepoint [2]
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3 months
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Primary outcome [3]
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0
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
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Assessment method [3]
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0
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Timepoint [3]
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0
9 months
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Secondary outcome [1]
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0
general symptoms
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Assessment method [1]
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0
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Timepoint [1]
0
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1
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Secondary outcome [2]
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0
general symptoms
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Assessment method [2]
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0
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Timepoint [2]
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0
3 months
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Secondary outcome [3]
0
0
general symptoms
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Assessment method [3]
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0
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Timepoint [3]
0
0
9 months
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Secondary outcome [4]
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0
general functioning
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Assessment method [4]
0
0
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Timepoint [4]
0
0
1 months
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Secondary outcome [5]
0
0
general functioning
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Assessment method [5]
0
0
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Timepoint [5]
0
0
3 months
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Secondary outcome [6]
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0
general functioning
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Assessment method [6]
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0
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Timepoint [6]
0
0
9 months
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Secondary outcome [7]
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clinical global impressions
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Assessment method [7]
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0
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Timepoint [7]
0
0
1 months
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Secondary outcome [8]
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0
clinical global impressions
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Assessment method [8]
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0
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Timepoint [8]
0
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3 months
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Secondary outcome [9]
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0
clinical global impressions
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Assessment method [9]
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0
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Timepoint [9]
0
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9 months
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Secondary outcome [10]
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interest in music
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Assessment method [10]
0
0
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Timepoint [10]
0
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1 months
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Secondary outcome [11]
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interest in music
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Assessment method [11]
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0
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Timepoint [11]
0
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3 months
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Secondary outcome [12]
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0
interest in music
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Assessment method [12]
0
0
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Timepoint [12]
0
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9 months
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Secondary outcome [13]
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motivation for change
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Assessment method [13]
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0
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Timepoint [13]
0
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1 months
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Secondary outcome [14]
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motivation for change
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Assessment method [14]
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0
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Timepoint [14]
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3 months
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Secondary outcome [15]
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motivation for change
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Assessment method [15]
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0
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Timepoint [15]
0
0
9 months
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Secondary outcome [16]
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self-efficacy
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Assessment method [16]
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0
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Timepoint [16]
0
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1 months
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Secondary outcome [17]
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0
self-efficacy
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Assessment method [17]
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0
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Timepoint [17]
0
0
3 months
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Secondary outcome [18]
0
0
self-efficacy
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Assessment method [18]
0
0
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Timepoint [18]
0
0
9 months
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Secondary outcome [19]
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self-esteem
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Assessment method [19]
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0
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Timepoint [19]
0
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1 months
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Secondary outcome [20]
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self-esteem
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Assessment method [20]
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0
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Timepoint [20]
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3 months
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Secondary outcome [21]
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self-esteem
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Assessment method [21]
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0
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Timepoint [21]
0
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9 months
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Secondary outcome [22]
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vitality
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Assessment method [22]
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0
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Timepoint [22]
0
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1 months
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Secondary outcome [23]
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vitality
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Assessment method [23]
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0
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Timepoint [23]
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3 months
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Secondary outcome [24]
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vitality
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Assessment method [24]
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0
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Timepoint [24]
0
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9 months
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Secondary outcome [25]
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affect regulation
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Assessment method [25]
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0
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Timepoint [25]
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1 months
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Secondary outcome [26]
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affect regulation
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Assessment method [26]
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0
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Timepoint [26]
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3 months
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Secondary outcome [27]
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affect regulation
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Assessment method [27]
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0
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Timepoint [27]
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9 months
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Secondary outcome [28]
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relational competence
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Assessment method [28]
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0
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Timepoint [28]
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1 months
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Secondary outcome [29]
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relational competence
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Assessment method [29]
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0
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Timepoint [29]
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3 months
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Secondary outcome [30]
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relational competence
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Assessment method [30]
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0
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Timepoint [30]
0
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9 months
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Secondary outcome [31]
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actual social relationships
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Assessment method [31]
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0
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Timepoint [31]
0
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1 months
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Secondary outcome [32]
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actual social relationships
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Assessment method [32]
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0
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Timepoint [32]
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3 months
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Secondary outcome [33]
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actual social relationships
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Assessment method [33]
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0
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Timepoint [33]
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9 months
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Eligibility
Key inclusion criteria
* Non-organic mental disorder
* Low therapy motivation
* Willingness to work with music
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Severe mental retardation
* Life-threatening somatic illness
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2010
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Sample size
Target
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Accrual to date
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Final
144
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sunshine Hospital/University of Melbourne, Faculty of Music - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Linz
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Country [2]
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Norway
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State/province [2]
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Rogaland
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Country [3]
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Norway
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State/province [3]
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Sogn og Fjordane
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Funding & Sponsors
Primary sponsor type
Other
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Name
NORCE Norwegian Research Centre AS
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Research Council of Norway
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Address [1]
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0
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Country [1]
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0
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Other collaborator category [2]
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Other
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Name [2]
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Helse Vest
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Helse Forde
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Address [3]
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0
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Country [3]
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0
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Other collaborator category [4]
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Other
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Name [4]
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Nordfjord Psychiatric Centre
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Address [4]
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Country [4]
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Other collaborator category [5]
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Government body
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Name [5]
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Helse Stavanger HF
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Jæren District Psychiatric Centre
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Address [6]
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Country [6]
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Other collaborator category [7]
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Individual
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Name [7]
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The Wagner-Jauregg Provincial Neuropsychiatric Clinic
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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University of Melbourne
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Address [8]
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Country [8]
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this study is to examine whether resource-oriented music therapy helps psychiatric patients with low therapy motivation to improve negative symptoms and other health-related outcomes.
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Trial website
https://clinicaltrials.gov/study/NCT00137189
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Trial related presentations / publications
Rolvsjord R, Gold C, Stige B. Research rigour and therapeutic flexibility: Rationale for a therapy manual developed for a randomised controlled trial. Nordic Journal of Music Therapy 14(1):15-32, 2005. Gold C, Rolvsjord R, Aaro LE, Aarre T, Tjemsland L, Stige B. Resource-oriented music therapy for psychiatric patients with low therapy motivation: protocol for a randomised controlled trial [NCT00137189]. BMC Psychiatry. 2005 Oct 31;5:39. doi: 10.1186/1471-244X-5-39. Gold C, Mossler K, Grocke D, Heldal TO, Tjemsland L, Aarre T, Aaro LE, Rittmannsberger H, Stige B, Assmus J, Rolvsjord R. Individual music therapy for mental health care clients with low therapy motivation: multicentre randomised controlled trial. Psychother Psychosom. 2013;82(5):319-31. doi: 10.1159/000348452. Epub 2013 Aug 9.
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Public notes
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Contacts
Principal investigator
Name
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Christian Gold, PhD
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Address
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Grieg Academy Music Therapy Research Centre GAMUT, Unifob Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Gold C, Mossler K, Grocke D, Heldal TO, Tjemsland ...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00137189