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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00137189
Other study ID # RCT-MTPSY
Secondary ID
Status Completed
Phase N/A
First received August 26, 2005
Last updated May 12, 2017
Start date April 2005
Est. completion date October 2010

Study information

Verified date May 2017
Source Uni Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Background: Previous research has shown positive effects of music therapy for people with schizophrenia and other mental disorders. In clinical practice, music therapy is often offered to psychiatric patients with low therapy motivation, but little research exists about this population. 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. An additional aim of the study is to examine the mechanisms of change through music therapy.

Method: 144 adults with a non-organic mental disorder (ICD-10: F1 to F6) who have low therapy motivation and a willingness to work with music will be randomly assigned to an experimental or a control condition. All participants will receive standard care, and the experimental group will in addition be offered biweekly sessions of music therapy over a period of three months. Outcomes will be measured by a blind assessor before and 1, 3, and 9 months after randomisation.

Discussion: The findings to be expected from this study will fill an important gap in the knowledge of treatment effects for a patient group that does not easily benefit from treatment. The study's close link to clinical practice, as well as its size and comprehensiveness, will make its results well generalisable to clinical practice.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Non-organic mental disorder

- Low therapy motivation

- Willingness to work with music

Exclusion Criteria:

- Severe mental retardation

- Life-threatening somatic illness

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Resource-oriented music therapy

Standard care


Locations

Country Name City State
Australia Sunshine Hospital/University of Melbourne, Faculty of Music Melbourne
Austria Wagner Jauregg Hospital Linz
Norway Jæren District Psychiatric Centre Bryne Rogaland
Norway Nordfjord Psychiatry Centre Nordfjordeid Sogn og Fjordane
Norway Stavanger University Hospital Stavanger Rogaland

Sponsors (9)

Lead Sponsor Collaborator
Uni Research Helse Førde, Helse Stavanger HF, Helse Vest, Jæren District Psychiatric Centre, Nordfjord Psychiatric Centre, The Research Council of Norway, The Wagner-Jauregg Provincial Neuropsychiatric Clinic, University of Melbourne

Countries where clinical trial is conducted

Australia,  Austria,  Norway, 

References & Publications (3)

Gold C, Mössler K, Grocke D, Heldal TO, Tjemsland L, Aarre T, Aarø 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. Psychot — View Citation

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary negative symptoms (Scale for the Assessment of Negative Symptoms [SANS]) 1
Primary negative symptoms (Scale for the Assessment of Negative Symptoms [SANS]) 3 months
Primary negative symptoms (Scale for the Assessment of Negative Symptoms [SANS]) 9 months
Secondary general symptoms 1
Secondary general symptoms 3 months
Secondary general symptoms 9 months
Secondary general functioning 1 months
Secondary general functioning 3 months
Secondary general functioning 9 months
Secondary clinical global impressions 1 months
Secondary clinical global impressions 3 months
Secondary clinical global impressions 9 months
Secondary interest in music 1 months
Secondary interest in music 3 months
Secondary interest in music 9 months
Secondary motivation for change 1 months
Secondary motivation for change 3 months
Secondary motivation for change 9 months
Secondary self-efficacy 1 months
Secondary self-efficacy 3 months
Secondary self-efficacy 9 months
Secondary self-esteem 1 months
Secondary self-esteem 3 months
Secondary self-esteem 9 months
Secondary vitality 1 months
Secondary vitality 3 months
Secondary vitality 9 months
Secondary affect regulation 1 months
Secondary affect regulation 3 months
Secondary affect regulation 9 months
Secondary relational competence 1 months
Secondary relational competence 3 months
Secondary relational competence 9 months
Secondary actual social relationships 1 months
Secondary actual social relationships 3 months
Secondary actual social relationships 9 months
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